LIBRARY

FOCUS ON:
TOP ENGINEERING
ESSENTIALS FOR MEDICAL
DEVICE TECHNOLOGY
A compendium of popular medical
device technology articles from the Brought to you by
editors of Machine Design

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Coil width
Inside
diameter
Spring Coil
height
Lead

Wire diameter

Groove
height

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 MACHINE DESIGN LIBRARY

FOCUS ON:
TOP ENGINEERING
ESSENTIALS FOR MEDICAL
DEVICE TECHNOLOGY
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INTRODUCTION
Biomedical engineers, more than any other type of engineers, needs to ensure the devices they
design will do little or no damage to the doctors that install them or the patients on or in which
they are used. In fact, medical devices must be proven to improve the lives of patients. For that
reason, biomedical engineers also need to reduce the risks and hazards in their designs and follow
strict FDA guidelines that help them do so. The first two articles address this issue and offer
some advice on how to best follow the FDA rules. The second group of articles looks at a variety
of technologies used in many biomedical devices. These include coatings and one- and two-part
epoxies that protect devices from fluids and chemicals in the body while also preventing the
circuits or stray voltages from affecting the patient. There are also a pair of articles addressing the
electrical connectors used in implants and medical equipment to carry power and data or control
signals. Seemingly simple cables must be designed to be safe, easy to use and clean, and reliable.
STEPHEN MRAZ Finally, the last three articles look at biomedical engineering approaches to three different medical
Senior Editor problems: Macular degeneration and loss of sight, loss or degradation of hearing, and prosthetic
Machine Design hands that have a sense of touch.

TABLE OF CONTENTS
CHAPTER 1: HOW TO DESIGN SAFE MEDICAL PRODUCTS..... 2
CHAPTER 2: CONTROLLING RISK IN MEDICAL DEVICES.......... 7
CHAPTER 3:
THE NEXT GENERATION OF MEDICAL
CONTACTS FOR MEDICAL IMPLANTS............... 10
CHAPTER 4:
DESIGNING CONNECTORS FOR PORTABLE
MEDICAL EQUIPMENT..................................... 14
CHAPTER 5: EPOXIES FOR MEDICAL DEVICE APPLICATIONS... 16
CHAPTER 6:
PROTECTING MEDICAL DEVICES
WITH PARYLENE............................................. 19
CHAPTER 7:
IMPLANTED TELESCOPE HELPS PATIENTS
OVERCOME MACULAR DEGENERATION.......... 22
CHAPTER 8:
TECHNOLOGY ADDS THE SENSE OF TOUCH
TO PROSTHETIC HANDS.................................. 25
CHAPTER 9: TECH ADVANCES UPGRADE HEARING AIDS..... 29
MORE RESOURCES FROM MACHINE DESIGN... 33

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 1:

HOW TO DESIGN

SAFE MEDICAL
PRODUCTS
It isn’t enough to design products that meet industry standards. Engineers must use a formal method
that identifies and mitigates risks.
PETER HAVEL, Senior Vice President Global Head of Medical & Health Services,
Director U. S. Medical Health Service Div., TUV SUD America Inc.

D
esigners new to the medical field sometimes hope to cover all risks. So designers must make up for the areas
are surprised to discover the lengths to which standards don’t cover by conducting a comprehensive risk analysis.
they must go before their medical devices can Risk management is actually a combination of several risk anal-
be considered safe for use. Young engineers, for ysis methods that should let designers identify all relevant risks.
example, frequently don’t expect that it takes five In the medical field, ISO 14971:2007 specifies a process by which
to ten times more effort to develop a device that
is safe and complies with regulations than to develop a laboratory
Management
prototype. A device can only be considered safe after undergoing
RISK
tests that prove its safety. So the safety discussion starts by devising MANAGEMENT
the right tests that provide that proof. Decision
IN A NUTSHELL database
Safety engineering principles emphasize that there are three as-
pects of making designs safe that are particularly important. They
apply to the hardware, the software, and the user interface. Medical Risk Acceptable
hardware uses a functional safety approach where two indepen- Risk
evaluation risk
dent failures are not allowed to harm the patient. There are rules
for designing software so the chances of harm arising from bugs are
Mitigating
acceptably low. Finally, user interface design should employ usabil- measures
ity rules that make the man-machine interface as safe as possible.
Engineers also are surprised to find that designing equipment Risk control
to medical industry standards isn’t enough to guarantee that it is
safe. It is understandable why this is so when you examine how A flowchart can express the principle of managing risks in
standards come about. Standards are set by committees of experts. medical products. Each risk gets evaluated both as a part
The standard-setting process is a political event; some committee of the development process and based on evidence from
members want strong requirements, some want weaker ones. It public data on device failures. Developers build in mitigating
generally takes a long time to agree on specifics, so many standards measures, then analyze the result to determine whether the
are outdated by the time they publish. All in all, standards can’t result is an acceptable risk.

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ISO 14971 RISK MANAGEMENT TYPICAL SAFETY SYSTEM

Patient
Severity of damage Equipment under control

Risk reduction
Probability of occurrence
1 2 3 4

10-1 – 10-2 6 Motor

10-2 – 10-3 5
Analyze Set safe state
10-4 – 10-5 4

10-6 – 10-7 3 Sensor Control Actor

10-7 – 10-8 2
Safety system
10-8 – 10-9 1

The ISO 14971 standard for product risk management spells Once developers have identified the risks in their product
out a method for categorizing risks according to their chance design, their next step is to define safety measures to mitigate
of occurrence and severity. The goal is to mitigate risks such them.
that they all lay in the bottom of the matrix below the main
diagonal. sure, an infusion of air, and a reverse in the direction of flow. De-
signers would consider all these factors during development so the
manufacturers can identify the hazards associated with medical device could cause no harm in the case of a breakdown.
devices, including in-vitro-diagnostic (IVD) medical devices, to Fortunately there are standards that provide guidance on safe-
estimate and evaluate the associated risks, to control these risks, ty. The IEC 60601-1-2-24 pertains specifically to infusion pumps.
and to monitor the effectiveness of the controls. The requirements Other standards pertain to other kinds of widely used medical
of ISO 14971:2007 are applicable to all stages of the life cycle of a equipment. An example is IEC 60601-2-16, which pertains to di-
medical device. alysis equipment. But, as stated before, standards aren’t enough to
However, medical devices have safety requirements that are less make devices safe. Designers must also conduct a formal risk anal-
stringent than those for certain other product categories. For ex- ysis to determine requirements for the design of the device.
ample, there are more requirements for making an airplane safe In that regard, ISO 14971 is a standard that details how manu-
than for a medical device. The reason is that a medical device usu- facturers should conduct risk management to determine the safety
ally can only kill one person at a time while a commercial aircraft of a medical device during the product life cycle. Such activity is
that isn’t safe might kill hundreds. Similarly, though medical de- required by higher level regulations and other quality standards
vices must have designs that prevent two independent hardware such as ISO 13485.
failures from harming a patient, elevator designs must be safe in The main standard for medical-device safety is IEC 60601-1 –
the event of three independent failures. All in all, the possibility of Medical electrical equipment – Part 1: General requirements for
multiple lost lives brings with it stiffer requirements for safety. basic safety and essential performance. Some countries also deviate
from the standard under certain circumstances and sometimes use
Risk and safety different versions of it. For example, the European and Canadian
The task of developing medical devices that are safe boils down versions of the standard are identical to the IEC standard, but the
to identifying risks and then establishing the measures that give the U.S. version of the standard (ANSI/AAMI HA60601-1-11) ex-
confidence to say the risks are acceptable. Developers must judge cludes nursing homes from coverage. It also emphasizes usability
the severity of potential harm and the probability that the harm oc- requirements. Devices typically mandated to use the new standard
curs. Once developers have identified the unacceptable risks, their include oxygen concentrators, body-worn nerve and muscle stim-
next step is to define safety measures to mitigate them. ulators, beds, sleep-apnea monitors, and associated battery char-
For example, consider the case of an infusion pump. Its main gers prescribed for use at home.
function is to pump fluid. Potential hazards related to the pumping One of the principles of IEC 60601-1 is that a medical device
function include a wrong flow rate, infusing the wrong volume, an must be safe in the case of a single fault. It defines a single fault as a
unintended start or stop of infusion, a buildup of excessive pres- failure of a safety system. Thus, one facet of designing a safe device

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MACHINE DESIGN LIBRARY CHAPTER 1: HOW TO DESIGN SAFE MEDICAL PRODUCTS

is to imagine how a first failure in a safety system could endanger IDENTIFYING THE SIL LEVEL
the patient, and then implement a safety system that still makes the W3 W2 W1
C — RISK CONSEQUENCE
device safe even in the event of a first failure. C1: Minor injury
One complicating factor is that the safety system has its own
C1 0 0 0 S C2: Serious permanent injury to one or
reliability level. Developers must establish what this level is. One P1
1 0 0
I more people or death of one person
C3: Death to several people
F1
approach to make safety systems reliable is to either use two redun-
P2 L C4: Many people killed
F — EXPOSURE TIME IN
dant safety systems or use one system that is tested periodically to 1 1 0
C2 HAZARDOUS ZONE
see if it is still functioning. P1
2 1 1
F1: Rare to more often
F2 F2: Frequent to permanent
The basic approach is to go through every component in the de-
P2
3 2 1 L P — POSSIBILITY OF AVOIDING
vice and figure out what happens if it fails. Each possible failure THE HAZARDOUS EVENT
is acceptable if it is obvious and an operator can stop operations F1 E P1: Possible under certain conditions
3 3 2 P2: Almost impossible
before the device can harm someone. For example, assume a safety C3 V W — PROBABILITY OF THE
F2 UNWANTED OCCURRENCE
system fails but the device continues to function properly. Design- 4 3 3
E W1: Very small
ers must anticipate what happens in the event of a second safe- C4
4 4 3 L W2: Small
W3: Relatively high
ty-system failure after a certain time. When the safety system fails
silently it no longer protects; still, the patient must be safe. The IEC 61508 standard lays out a method of categorizing
In the same vein, failures can be either systematic or random. each fault condition in terms of a specific safety integrity level
Systematic failures are basically built-in design flaws. Examples or SIL.
include errors in the PCB layout, components used outside their
specification, or unanticipated environmental conditions. redundant features or by adding self-testing or by adding a safety
All software bugs are systematic failures; there are no random system that reacts in the event of a random failure. (Readers should
software failures. The effect of software failures might be random. note that a failure of a software storage medium is, in fact, a hard-
For example, when a programmer doesn’t initialize a variable, its ware and not a software error.)
content on first use is random. This can cause a random effect at Designers typically use both redundancy and diversity as safe-
power on. The fact that the variable is not initialized is a systematic ty features. Redundancy is simply duplicating the same feature
failure. Other examples of systematic failures in software include while diversity is the use of two different methods to deliver the
errors in the software specification, and errors in the operating sys- same function. (The classic example is that of a seat belt and airbag
tem or compiler. Systematic errors in both hardware and software protecting a car occupant from hitting the dashboard.) Diversity
can be prevented through use of a robust development process. protects against random hardware errors as well as against some
Random errors, on the other hand, happen even though the de- systematic failures. Redundancy, on the other hand, protects only
sign is correct and production is flawless. Random hardware errors against random hardware failures.
can’t be predicted individually, they can only be described statis- One of the questions that designers must decide is how much
tically. The general approach to controlling random errors is with protection they must build in against random hardware failures.
The answer depends on such factors as whether a first failure is a
hazard and whether designers should assume there is a possibil-
PROTECTION ON THE SYSTEM LEVEL ity of a second, third, or even more numerous failures. The main
Self-test logic here is that hazards potentially able to kill multiple people
Position accuracy Patient

PROTECTION ON THE COMPONENT LEVEL

Sensor 1 Control 2

Self-test

Safety 1 Safety 2
Safety systems

It’s possible to build in a high degree of safety into the Patient

architecture of a product. Designers typically treat each When designers can’t determine the safety of a system or
function as a black box, then determine whether or not a subsystem, they must go deeper, perhaps down to the level
specific black box is safe or whether it can be made safe by of sensing and providing for problems with the operation of
the introduction of safety systems. individual components.

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MACHINE DESIGN LIBRARY CHAPTER 1: HOW TO DESIGN SAFE MEDICAL PRODUCTS

at one strike demand more attention. The potential for harm will of a specific safety integrity level or SIL. Designers usually start by
give guidance on how many independent failures designers must dividing risk consequences into four categories ranging from mi-
consider in the lifetime of the device. The potential for harm also nor injury, serious injury, several deaths, and many deaths. They
determines the amount of redundant/diverse safety systems neces- further subdivide risks according to the amount of exposure time
sary. Normally medical devices kill one person, so designers must to the hazard and the possibility of avoiding the hazardous event.
consider a maximum of two independent failures. Finally, they categorize the probability of the unwanted occurrence
In general, designers must consider the possibility of ever-more as very small, small, or relatively high.
unlikely events, the higher the risk of harm. For electrical medical Designers often start the safety analysis with a functional dia-
devices, the IEC 60601-1 standard specifies that a combination of gram of the product. This is an appropriate starting point because
two independent failures should not be life threatening. This man- it’s possible to build in a high degree of safety on the level of sys-
date expresses the concept of the single fault condition for medical tem architecture. Designers typically treat each function as a black
devices. The principle is that a first failure should not cause a haz- box. They then try to determine whether or not a specific black
ard. If the first failure is obvious to the operator, the operator stops box is safe, or if it can be made safe by the introduction of safety
using it and has it repaired. If the first failure can’t be detected, the systems. When they can’t determine the safety of a black box, they
designers must assume that a second failure will arise sometime then open the box and go deeper, perhaps down to the level of in-
later. They must also arrange the design so a combination of the dividual components.
first and second failures won’t cause a hazard. Fortunately designers in the U.S. need not rely on their own anal-
Unfortunately the term “single-fault condition” can be mislead- ysis of product functions to note safety red flags. The U.S. FDA
ing in the context of medical safety standards. It can suggest that maintains a market surveillance system that can give designers a
designers need only assume that the device experiences only one heads-up on potential problem areas in medical devices. Any time
failure. This is not correct. a medical device has a failure, the manufacturer must report the
Usually there is a time period after the first failure where the details to the FDA. Alarms are raised if a specific device has a fail-
combination of a first and second failure is not allowed to be a haz- ure rate exceeding a certain threshold. Thus, medical-device engi-
ard. For example, suppose the safety system has a first failure and neers can consult this database to see what kinds of failures similar
undergoes a self-check within 24 hr that reveals the safety system devices are experiencing.
is dead. That level of safety is acceptable in many medical systems. Other countries have similar databases of medical device fail-
The assumption is that two independent safety-system failures ures. However, their data tends to be less useful than that in the
would not arise within 24 hr of each other. Conversely, there is an U.S. simply because individual countries each collect their own
unacceptable level of hazard if there is no self-check in the 24 hr af- information. There is no central repository as yet for tabulating
ter the first failure. In this case, the device either needs a self-check
routine or a second safety system. RISK-BASED V-MODEL
There is a progressive procedure for analyzing each hardware
De

failure that could be dangerous. It is a risk graph spelled out in the

com

System
po

IEC 61508 standard. It categorizes each fault condition in terms

siti
on

DECOMPOSITION EXPLAINED Software

requirement Subsystem design

SPECIFICATION VERIFICATION
A Software
De
com

Create a box Is it a box (yes/no)

po
siti

Create a cardboard box Is it made out of B

on

Create a cardboard box with cardboard? (yes/no)

dimensions x, y, z and thickness d Check the dimensions x, y, z, d
The opening should be … Check opening dimensions
C

The principle used for determining whether software functions Software-safety analysis frequently employs a so-called
properly and safely is that of decomposition: Each software V-model that is analogous to that widely used for visualizing
function is defined precisely enough to make possible some the progression of system-development tasks. The model
kind of check of its properties that will reveal whether or not is named for its graphic depiction of how designers should
the software has done what has been designed to do. The decompose software requirements into ever-more-detailed
decomposition process is often illustrated with the example of specifications, then test and validate from the detailed levels
verifying the construction of a cardboard box. up through to the system level.

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MACHINE DESIGN LIBRARY CHAPTER 1: HOW TO DESIGN SAFE MEDICAL PRODUCTS

worldwide results. tentially tragic consequences. Complicated instrumentation puts a

demand on the operator’s intellectual ability. But users aren’t get-
The safety of software ting cleverer.
Software for medical devices has its own standard, IEC 62304. Unfortunately, standards for human-factor usability aren’t well
It specifies life-cycle requirements for the development of medical developed. For example, one such document is IEC 62366 Annex
software and software within medical devices. The standard spells D 1.4. It is weak in that it only supplies general guidelines about the
out a risk-based decision model and defines testing requirements. steps necessary to identify risks of usage problems. It basically re-
The primary principle for verifying software is to describe the quires designers to analyze how users will interact with the device
function it is supposed to perform, then devise a test that verifies and implement risk-mitigating measures to avoid erroneous usage.
the software works as planned. The key lies in devising a test that is It can be quite expensive for manufacturers to analyze the ergo-
specific enough to identify all functions. nomics and usage of their equipment. One widely used technique
Unfortunately, the U.S. medical-device industry is not as ad- is to round up 10 users, then ask them to say out loud what they are
vanced as it should be when it comes to implementing such proce- thinking as they operate the device. The whole set of interactions
dures. In many cases, software descriptions tend to be ambiguous, get recorded on video.
and this condition causes several harmful side effects. For example, A typical finding in sessions like this is that only about 10% of
software engineers may develop something that has unintended instrument functions get used daily. The other 90% get used rarely
functions. Equally bad, poor descriptions often prevent designers or not at all. But it is not unusual to find often-used features buried
from devising all the tests that will expose harmful software bugs. in complicated menu structures with a huge potential for acciden-
Additionally, many software engineers seem to have a too-high tally making an error.
opinion of their own work. They seem to forget that numerous However, there is no standard that requires an ergonomic analysis
studies have shown software developers typically create between or user studies. These practices are simply recommended practices
five and 10 bugs daily, a statistic that illustrates why an accurate among firms that have experience developing medical equipment. n
description of software functions is essential.
Software safety analysis frequently employs a V-model named ☞ BACK TO TABLE OF CONTENTS
for its graphic depiction of how designers should decompose soft-
ware requirements into ever-more-detailed specifications, then test
and validate from the detailed levels up through to the system level.
The software risk model defines A, B, and C levels of safety. Level A
software is harmless if it fails. Level C software that fails can injure
or kill someone. If software is neither A nor C, then it is level B by
default.
Most V-models divide decomposition steps into three levels.
Top level is termed the system level. The lowest level represents
the smallest software unit that can be 100% tested. The V-model
represents the principle that designers must clearly describe soft-
ware tasks in several levels of detail. There must be tests at every
level that check that the software delivers its intended functions
and identifies any bugs.
The software risk model defines three different levels of safety.
Level A software is nonharmful if it fails. Level C software that fails
can injure or kill someone. If software is neither A nor C, then it is
level B by default. Categorizing software into one of the three levels
helps determine how much testing is appropriate. Level A software
just needs a system test. Level B tests must be detailed enough to
check individual software modules. And as you might expect, most
safety-system software in medical devices is at level C, which tests
subsets of software code at the unit level.

The human element

It is no secret that appliances and instrumentation of all kinds
are getting more complicated to operate. And medical instrumen-
tation that is complicated is also prone to operator errors with po-

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 2:

CONTROLLING RISK IN

MEDICAL
DEVICES
Applying everyday principles to product development can reduce hazards and increase patient safety.
P.J. TANZILLO, Embedded Software Product Manager & Biomedical Segment Lead
National Instruments, Austin, Tex

E
ngineers developing medical equipment may not have Although interviews are an important first step, they can be use-
much control over the hazards inherent in devices less if pertinent questions aren’t put to the right people. Another
they are designing. X-ray imagers and anesthesiology problem with interviews is that those being interviewed may not
equipment will always pose some risks to patient know what they want until after seeing and understanding a set of
safety. But if a design fails, consequences can be options. This is where prototypes can play a helpful role.
catastrophic. So one of every medical designers’ tasks Focus groups are useful because they let people discuss opinions
is to reduce the risks and probabilities of failure. And almost every with their peers, and the group is usually reacting to a relatively
design decision can affect these two factors. fleshed-out concept or set of options. However, as with interviews,
Here are some strategies that may help reduce risk and failures in focus groups may not capture all the requirements needed for a
medical equipment. (And the same concepts can be applied to all successful device. For example, focus-group members typically
forms of engineering.) won’t give negative feedback if they believe the moderator is in-
volved with the design. They don’t want to hurt anyone’s feelings.
Gathering requirements Software modeling lets design teams simulate devices so end us-
According to some estimates, nearly half of all project costs stem ers can evaluate the controls and outputs. This lets users more fully
from rework to correct inadequate features or add ones that were understand what the designers have in mind so they can give more
left out of the design process. Missing and inadequate requirements informed feedback as to what is wrong, what works well, and what
also account for an estimated 75% or more of the software bugs in might need to be changed before taking on the expense of build-
medical equipment. So it is important the design team start with a ing a physical prototype. Teams often then take the next step and
list of valid, must-have requirements. develop a physical “mock-up” of the controls and display panels so
Interviews are the most common way design teams gather re- users have a more realistic experience with the latest design.
quirements. Interviews let all stakeholders quickly provide the var- Functional prototyping, the next logical step after software mod-
ious bits of information designers use to construct a list of require- eling, involves a working model built using off-the-shelf develop-
ments. For example, doctors can explain traditional methods and ment tools. It lets users operate the device in its normal environ-
the range of measurements or outputs expected from the equip- ment. Prototypes should use as few custom parts as possible to
ment. Patients can provide feedback on the comfort and conve- reduce development costs and time. After all, because the design
nience of using the device. And health-care managers should be team is still looking for user feedback and gathering requirements,
able to address costs and market scope. the design will likely change. There’s no need to spend much time

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MACHINE DESIGN LIBRARY CHAPTER 2: CONTROLLING RISK IN MEDICAL DEVICES

refining features that may need significant rework. one instruction at a time, so resources such as memory, peripher-
als, and registers must be shared by several processes to handle any
Design process type of multitasking between parallel processes.
Design inputs and outputs should not only be clearly defined On FPGAs, however, independent subsystems are truly inde-
in requirements documents. These documents should also be pendent because true parallelism is possible on FPGAs. Each tick
mapped to source code. This ensures that all requirements are cov- of the clock can result in latching many parallel registers and exe-
ered by code, and that all code is mapped to requirements. Often, cuting many paths of combinatorial logic. Therefore, tested FPGA
requirements that have not been implemented are simple to detect. code is traditionally deemed more reliable than tested processor
It can be more difficult to find implementations not covered by re- code. OptiMedica Corp., Santa Clara, Calif., discovered this when
quirements documentation. Such gaps in requirements may lead it developed an FPGA-based photocoagulator. Management found
to incorrect assumptions and miscommunications between engi- that FPGA chips provide the reliability of hardware and does not
neering groups. Well-mapped requirements also ensure traceabili- require the same level of code reviews as processor-based devices
ty so that when a requirement changes, there is a clear mapping to when obtaining FDA approval.
affected source code. Design reviews are extremely important at all phases of devel-
opment. Requirements, architecture, and specifications should go
Why FPGAs are easier to validate than microprocessors through a formal review process, but source-code reviews by peers
When developing an embedded medical device, validating and are also essential to produce high-quality code. Best practices in-
verifying it can take longer than the time it took to develop the clude having developers walk through the code for an audience of
firmware. And even after testing each component, a completed mi- their peers. For lower-risk items, tools for static-code analysis can
croprocessor-based device needs to be put through extensive test- also be used for automated code review.
ing to demonstrate the safety of the device as a whole. This is nec- The importance of a smooth design transfer is sometimes over-
essary because seemingly independent subsystems in software can looked, and miscommunications in this process can be one of the
conflict and cause catastrophic failures through common bugs like sources of software bugs. Most design teams consist of domain ex-
resource contention. That’s because a processor can execute only perts responsible for algorithm and concept development as well

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MACHINE DESIGN LIBRARY CHAPTER 2: CONTROLLING RISK IN MEDICAL DEVICES

as implementation engineers responsible for converting the design timers and other failure mitigation techniques to detect system fail-
into a form that can be commercialized. The transition from one ures and then recover gracefully.
team to another is typically done with specification documents, but The most-complex systems, those that need computationally in-
source code may also be transferred if a prototype has been devel- tense algorithms or extremely rich user interfaces, require desk-
oped, By using high-level design tools like state charts and other top-computing capabilities. Although desktop-computing failures
graphical representations of code, design teams can deliver execut- like e-mail or browser crashes can be common and inconvenient,
able specifications used to derive final implementations. users need only reboot the computer and continue to work in most
Design changes should be tracked, justified, and validated against cases. But this is not nearly the level of reliability designers need
the entire system. To ensure small code changes do not have large for critical medical devices. Therefore, if a desktop PC is needed,
and unintended effects, design teams should have an automated designers should add hardware that will monitor and correct for
test suite in place that runs as an acceptance test against any code failures to minimize patient risk.
changes. In addition, regardless of the size of your design team, For example, a touch-panel display running a desktop-operating
you should set up source-code control systems to track history and system can connect via Ethernet to a 32-bit processor running an
changes. RTOS. The RTOS checks for failure and adds reliability. Including
an FPGA in this signal path would further improve reliability. The
System architecture FPGA could monitor signals to ensure nothing went outside of the
Another way to reduce risk in medical devices is by choosing safe and acceptable operating range. With this third layer of protec-
system architectures with various layers of redundant protection tion, simply powering the device ensures outputs remained within
for the most-hazardous elements. For example, designers can ranges specified in hardware.
choose whether control elements will be carried out by software or
hardware. Dedicated hardware is considered more reliable but also Verification and validation
more difficult to design for complex tasks. Software can be easier Although designers need to test all aspects of their code, they
to put in place and update. And software is well suited for features should focus their most rigorous software testing on high-risk ar-
such as networking and data storage. But software bugs can be dif- eas. High-risk code can be identified several ways. Code complex-
ficult to identify and correct. ity analysis, for example, can help determine which code is statis-
When designing complex digital or mixed-signal hardware, ap- tically most likely to fail. When coupled with code coverage tools,
plication-specific integrated circuits (ASIC) are commonly chosen it ensures testing all paths of the most complex code. In addition,
for mass-produced devices. They provide the reliability of hard- coding situations identified as high risk for failure should undergo
ware circuits without the complexities of manufacturing and as- the most-rigorous testing. Some high-risk areas, for example, con-
sembly. However, fabricating ASICs can be prohibitively expensive, cern user interfaces (keys pressed too quickly), kernel-driver data
so unless mass production is a certainty, use field-programmable transfers (buffer over and under flows), data conversions (pointer
gate arrays (FPGA) instead. casts and loss of precision), and multithreaded portions of code.
FPGAs have the reliability of ASICs and are almost as easily Good designers reuse parts of the design process in validating
changed as software. And although unit costs are higher compared and verifying code. The simplest way to do this is to construct the
to ASICs, overall production costs are lower for most designs. In test based on the requirements documents rather than the code.
addition, FPGAs can be repeatedly reprogrammed, making them a In fact, it is best if someone outside the design team puts together
good choice for designs with requirements likely to change. the tests. Models or prototypes developed during the design pro-
When it comes to executing software, complex code is more like- cess can be used as comparison for acceptance tests. Furthermore,
ly to contain bugs than simple code. This often makes 8-bit micro- any models used to design algorithms can be used in a hardware-
controllers the more reliable choice. These controllers are usually in-the-loop (HIL) setup to serve as a verification tool for device
programmed in “C” or “assembly” and almost never run operating acceptance.n
systems. Instead, they carry out simple tasks such as updating a
display or monitoring buttons. Though they’re useful and relatively ☞ BACK TO TABLE OF CONTENTS
easy to program, the scope of what 8-bit chips can do is limited by
their relatively small memory.
More-complex systems often call for cooperative multitasking,
communications drivers, and other high-end features. This means
they need more-powerful processors with more memory. Most of-
ten, these systems use 32-bit processors with real-time operating
systems (RTOS) containing drivers and middleware like TCP/IP
stacks and file systems. But with these features comes more com-
plexity and additional risk of failure. Most designers add watchdog

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 3:

THE NEXT GENERATION OF

ELECTRICAL CONTACTS FOR

MEDICAL
IMPLANTS
MARK RUSSELL, Global Market Manager for Medical Electronics,
Bal Seal Engineering Inc.

“
Medical devices that alter brain, spine, or nerve activity
for therapeutic benefit are a fast-growing segment of the
healthcare industry,” notes a recent report from Life Science
Alley, a Minnesota-based medical device trade association.
The 2015 report, Sector Landscapes: Neuromodulation,
projects that the strong global market for neuromodulation
devices will double by 2018, reaching $6 billion to $7 billion. This
article examines the electrical contact technologies that are driving
this market toward the next generation of device development.
The global neurostimulation/neuromodulation market is surg-
ing as an aging population faces diseases such as Alzheimer’s, ep-
ilepsy, spinal-cord injury, and Parkinson’s disease. The therapies
for these diseases are dominated by implantable neurostimulation
devices, which make up the largest part of this market with a 96% Here is a cutaway view of a canted coil-spring assembly that
share of the total. According the Life Science Alley report, neu- serves as an electrical contact. The male connector (shown)
romodulation devices are registered in more than 1,000 ongoing goes through the middle and makes contact with many of the
FDA-regulated clinical trials worldwide in which more than 1,300 spring’s coils.
indications, including metabolic disorders, inflammation, mi-
graine, and psychiatric disorders are being investigated. and much of this is dependent upon the performance of electrical
The report also notes that one of the key developments within contacts and contact systems used to connect leads to batteries and
this growing market is the emergence of closed-loop systems that electronics in these devices.
are “capable of sensing ongoing brain or nerve activity and incor- Highly conductive and space-efficient components, such as
porating it into stimulation parameters for optimized therapeutic the Bal Conn electrical contact and the Sygnus implantable con-
efficacy in real-time.” This closed-loop functionality in active im- tact system, are designed to support the signal-isolation require-
plantables requires optimal power efficiency and signal isolation, ments of closed-loop, high-connector-count arrays. With the use

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MACHINE DESIGN LIBRARY CHAPTER 3: NEXT GENERATION OF ELECTRICAL CONTACTS FOR MEDICAL IMPLANTS

of closed-loop devices becoming more widespread, the Sizing a Canted Coil Spring
ability to support smaller footprint connections for ac-
Coil width
tive implantables in a proven and reliable design will be Inside
diameter
increasingly critical. Spring Coil
height
Lead
Unpacking the Technology
For over two decades, the Bal Conn electrical contact Wire diameter
has been helping manufacturers improve implantable
medical-device performance and push the technology Groove
envelope. OEMs developing each generation of active height
implantables have relied on electrical connections that
use canted coil springs as contacts. It’s estimated that
canted coil spring–based contacts have been used in
more than a million pacemakers, defibrillators, neurostimulators, The Bal Conn’s individual spring coils provide multipoint con-
and other active implantables that deliver life-improving ther- ductivity, adjusting individually to maintain maximum contact
apies to patients worldwide. These electrical contacts have also with electrodes on the lead that is inserted into the device head-
dramatically simplified the process surgeons use to connect leads er. The contact’s compact size allows for greater connector density
to implantables across the therapy spectrum, including cardiac where space is limited, and its unique design eliminates the need
healthcare, pain management, and sensing therapies, ultimately for tools during the connection process.
shortening procedure times. Due to its redundant contact points, the Bal Conn offers low
Developed in cooperation with a medical electronics manufac- contact resistance, and its canted coils provide excellent resistance
turer seeking to reduce package size while increasing reliability, the to fatigue. With its ability to offer low insertion force and excep-
Bal Conn electrical contact is an electrically conductive component tional electrical conductivity, it is ideal for use in devices with high
consisting of a precision-engineered canted coil spring retained in connection counts such as neurostimulators.
a metal housing. The contact, which is molded into a device header, In a typical neuromodulation device, the lead diameter ranges
facilitates a uniform, consistent electrical connection between the from 0.9 to 1.4 mm. The Bal Conn is sized so that its spring coils
lead and the battery in active implantable devices. exert a measured, consistent force, also called the breakout force,
on the lead when it is first inserted. The force needed to slide the
lead further in, the running force, is as predictable and reliable as
the breakout force, and engineers can adjust these forces through
design. These forces are low enough to make it easy for surgeons to
insert and remove the lead. Applications requiring light forces have
a theoretical breakout force as low as 0.5 N and a running force as
low as 0.2 N, depending on design parameters. For those applica-
tions requiring heavy forces for latching, the theoretical breakout
forces are as high as 15 N and the running forces are as high as 4 N
with a single spring.
The spring material for neuromodulation applications is typ-
ically platinum iridium. Platinum iridium is selected for its bio-
compatibility, durability, electrical conductivity, and radiopacity.
The housing for neuro applications can be made from a variety of
materials, including MP35N, 316L stainless steel, medical-grade
titanium, or platinum iridium.
Within the contact, both the coils of the spring and the spring it-
self have precise diameters, but there is no “standard” size for neu-
romodulation devices. Each Bal Conn is custom designed to fit the
particular unit’s lead interface, and the lead is held in place via fric-
tional fit. A set screw or locking detent, located at either end of the
channel into which the lead slides, anchors the lead in place. Once
the electrodes are aligned with each Bal Conn, the device becomes
Coils can be made in a variety of sizes, such as these from Bal operational. The spring electrically connects the implantable pulse
Seal Engineering Inc. generator to the lead through all of its individual coils.

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 Due to its redundant contact points, the Bal Conn offers cations is typically platinum/iridium. Platinum/iridium is
low contact resistance, and its canted coils provide excellent selected for its biocompatibility, durability, electrical con-
resistance to fatigue. With its ability to offer low insertion ductivity, and radiopacity. The housing for neuro applica-
MACHINE DESIGN LIBRARY CHAPTER 3: NEXT GENERATION OF ELECTRICAL CONTACTS FOR MEDICAL IMPLANTS
force and exceptional electrical conductivity, it is ideal for tions can be created using a variety of materials, including

Tech SpecS for coiled Spring connecTorS types are available

Lead Max. Running Static dry for other active im-
Force Spring
Applications diameter
category
breakout force range Housing material
material
contact plantables; however,
(mm) force (N) (N) resistance (mΩ)
once integrated into
MP35N Platinum/iridium 70±20
Medium 1.2 0.009 to 0.4 the IPG header, the
316L Platinum/iridium 600±200
Neuro
distinction is no lon-
1.35 Medical-grade titanium Platinum/iridium 350±150
(bi-directional) ger significant and
Light 0.70 0.07-0.3 MP35N Platinum/iridium 80±30 has no impact on the
Platinum/iridium Platinum/iridium 40±15 surgeon or device
IS-1 functionality.
2.67 Medium 3.1 0.25 to 0.75 316L MP35N 100±60
(bi-directional)
IS-4/DF-4
(uni-directional)
3.2 Heavy 2.7 0.5 to 1.0 MP35N MP35N 80±50
Simplifying
IS-4/DF-4
3.2 Medium 2.7 0.25 to 0.75
MP35N platinum/
Platinum/iridium 40±20
Design for OEMs
(bi-directional) iridium
The Sygnus im-
VAD 3.2 Medium 2.7 0.25 to 0.75 Platinum/iridium Platinum/iridium 30±20 plantable contact
Neuro applications are usually neurostimulators; the IS-1 and IS-4 connectors are for cardiac pacemakers. system, which com-
Neuro applications are usually neurostimulators; the IS-1 and IS-4 connectors are for cardiac pacemakers. IS-4 I is replacing IS-1 as the stan-
IS-4
dard. VAD I is replacing
stands for ventricularIS-1 as device,
assist the standard. VAD stands
a pump inserted for ventricular
into the heart assist
to keep cardiac device,
patents a pump
alive until a donorinserted into avail-
heart becomes the bines electrical con-
able, though it is often left in patients long-term.
heart to keep cardiac patents alive until a donor heart becomes available, though it is often left in patients tacts and isolation
long-term. seals in a standard-
ized, platform-ready
Using the spring
AD24-28_NeuroContacts-SM-DONE.indd 25
as an electrical contact provides redundant stack configuration, is designed to improve speed to market and
2/29/2016 11:32:59 AM
paths for power and information signals, and the redundant con- eliminate the need for procurement and testing of individual com-
tact points provide for low contact resistance. Their canted coil de- ponents. It lets OEMs concentrate on the design and function of
sign helps ensure that they resist compression set and fatigue, pro- the implantable rather than worrying about the intricacies and
viding consistent performance over a long operational life, one that technology behind the connectors. It also creates greater connector
typically exceeds that of the implantable device itself. The springs density with pitches, or distances between contacts.
compensate for imperfections on the surface of leads, accommo- Implantable-grade silicone isolation seals keep the contacts elec-
dating a certain amount of misalignment. trically separated, as well as separating the different segments of
Engineers at Bal Seal Engineering work with medical OEMs to the lead. The seals help prevent signal leakage that can disrupt the
ensure that they have the right design for the application. With its active implantable’s function. The result is a densely packed con-
long history of designing for active implantables, the company has nector stack that accommodates leads with diameters down to 0.7
developed both uni-directional and bi-directional contacts, which mm. A 0.64 mm version is currently under development. Sygnus
enables OEM integrators to choose which design works best for can be modified to suit device-manufacturer requirements for size
their particular requirements. With uni-directional versions, the and number of connections, as long as they are within design limits.
lead must be inserted from one specific side of the contacts. With The seal design and dielectric materials were tested in accor-
bi-directional contacts, the lead can be inserted from either side. dance to industry standards
For neuro devices, the contacts are always bi-directional. Both by submerging them in sa-
line, a good substitute for the
conditions inside the human
body. The goal of the testing
is to measure impedance be-
tween connectors in a simu-

The table lists the functional

and physical attributes of
a Sygnus multi-contact
connector used for
neurostimulation. The
This cutaway view of a Sygnus connector shows a lead connector lets OEMs save
segmented into three sections inserted to mate with three space while increasing the
canted coil spring contacts. functionality.

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MACHINE DESIGN LIBRARY CHAPTER 3: NEXT GENERATION OF ELECTRICAL CONTACTS FOR MEDICAL IMPLANTS

lated body condition. The seals are cleaned to 10K cleanroom stan- array was conceived to help OEMs pack more functionality into
dards and packaged in antistatic bags to prevent contamination. active implantables and shrink the size of the electrical connec-
Evergreen Medical Technologies has used Sygnus technology tors in medical devices. The array combines one or more canted
in its device development, including in its Encompass Lead-Inter- coil-spring contacts, a non-conductive polymer interface, and im-
connect System. In the Encompass, the Sygnus system is combined plant-grade silicone. Some of the uses envisioned for the vertical
with a pre-molded 16-channel header. By combining the header, array are in implantables where small size is critical, such as co-
connector, sealing components, and lead into a single, reliable sys- chlear implants and deep-brain simulators.
tem, the system lets companies developing neurostimulators short- Life Science Alley’s report points out that the complex nature
en the time needed to design, develop, source, and test the final of neurodegenerative disorders has set the stage for “numerous
device. Although it was originally designed for implanted neuro- potential physiological targets, low competition in treatment-re-
stimulator devices, the system could find use in other implantables sistant diseases, and significant drive for innovative treatments
as well. and novel technology.” As active implantables in neurotechnology
continue to advance and prove to be the gold standard for thera-
Preparing for the Next Generation py, there will be increased adoption of these life-changing devices.
Future developments are being driven by the need for higher And, as advances such as closed-loop configurations lead to the
connection counts, more compact footprints, closed-loop config- need for higher connection counts and more compact footprints,
urations, and high levels of manufacturability. One reason for such design engineers will be faced with the challenge of making the
improvements, especially the move toward smaller lead interfaces, required number of connections in less space with proven under-
is to give OEMs the platform on which to build cutting-edge treat- lying technologies. n
ments for hearing and vision loss. One of the engineering chal-
lenges they must overcome is that as the connectors get smaller, ☞ BACK TO TABLE OF CONTENTS
tolerances become more crucial and manufacturability becomes
more complex.
With the use of closed-loop devices becoming more widespread,
the ability to support smaller-footprint connections for active im-
plantables in a proven and reliable design will become increasingly
critical. To address this, Bal Seal Engineering has developed a new
sub-assembly concept to help engineers dramatically improve de-
vice functionality while reducing overall package size. The concept,
which can incorporate a “cap” or cover design, uses vertically po-
sitioned pins or rods of varying diameters to double or triple the
amount of connections available to the device lead. It can be engi-
neered to minimize insertion force issues that present challenges in
serial arrays with small leads, and it offers designers new opportu-
nities for improved contact density.
Essentially a “build up, not out” approach that challenges the
established linear contact/header layout, the high-density vertical

The Encompass implantable multi-contact connector accepts

two leads, each with eight separate contacts or signal paths.
The bottom one is rendered so that you can see the inner
workings.
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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 4:

DESIGNING CONNECTORS FOR

PORTABLE MEDICAL
EQUIPMENT
As medical equipment becomes more portable and is used in small clinics and homes, connectors
must be safe, simple, and reliable.
CARL BUNKE, Project Engineer, Advanced Technology
ITT Interconnect Solutions, White Plains, N.Y.

E
ngineers designing connectors for portable unmated in less than 2 sec and cost 25% less per mated line than
medical equipment must take several factors into high-density rack-and-panel versions.
consideration, including size and insertion force, Designers have also come up with a quick-disconnect breakaway
shielding from interference, and preventing electrical connector that includes a simple push/pull mating mechanism rat-
shocks. Here’s a closer look at mechanical, electrical, ed at more than 5,000 cycles. And the coupling mechanism’s canted
and safety requirements, as well as customer spring cuts the time it takes to hook up medical gear.
concerns. Breakaway features that remove the danger of tearing connectors
off equipment or out of walls are another recent innovation. Break-
Mechanical considerations away connectors are often used in portable medical imaging and
Connectors must often be small but have high pin counts. Cus- diagnostic equipment because they are rugged and reliable enough
tomers are also demanding more mating cycles (connect-discon- to withstand field use. Some breakaway connectors feature a spring
nect) along with consistent and reliable connections. In many probe pin and pad contacts for durability and to withstand harsh
cased, customers also want zero-insertion-force (ZIF) designs. environments. The probe pin in the plug connector works across
To meet demands for smaller connectors with more pins, de- multiple sizes. An internal clip ensures individual pins and sockets
signers are working to cut pin spacing to less than 1 mm. This can remain electrically connected and accommodate misalignments.
shrink the size of the connector by more than 60% compared to The spring probe lets the connector receptacle house individual
older connectors with the same number of pins. As a result, some touch-pad areas, providing reliable electrical contacts. Further, the
connectors boast 260 contacts, each with a 0.8-mm contact pitch, spring probe and touch pads make connectors easy to clean in the
in PC-board mountings that measure just 74 × 19.4 × 18.5 mm. field. The individual touch pads, for instance, contain no crevices
Having more pins lets engineers choose from a variety of ground- that let contaminants accumulate.
ing schemes to maintain signal integrity, and this makes these ZIF connectors, besides being easy to engage and disengage,
connectors well suited for portable ultrasound machines, patient also rate high in terms of mating cycles, durability, and minimiz-
monitors, and test equipment. ing cross-talk. This lets them serve well in patient monitors and
Engineers have devised several approaches to extending con- portable imaging equipment like ultrasound devices. ZIF connec-
nector life, including new materials and entirely new designs. For tors often use landed contacts, which eliminate engagement forces
example, modern connectors with rugged nickel-plated aluminum and reduce wear on the contacts to the short time they are pressed
housings can have minimum rated lives of 20,000 mating cycles together and lightly wiped past each other during cam-and-lock
with no performance loss. Such connectors can also be mated and operations. As a result, contacts in the plug and receptacle do not

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MACHINE DESIGN LIBRARY CHAPTER 4: DESIGNING CONNECTORS FOR PORTABLE ELECTRICAL EQUIPMENT

touch each other while connector halves are being engaged. Not Some connectors use springs and shield-locking mechanisms to
only do these connectors have minimum rated lives of 10,000 mat- ensure pressure around the perimeter of the mated connector is
ing cycles, they can be mated in less than 2 sec. uniform and creates an EMI/RFI shield. By eliminating EMI/RFI
disruptions, signal noise can’t affect pacemakers, nor can it corrupt
Electrical considerations data or images traveling from or stored in patient monitors and di-
Once engineers determine a connector’s mechanical character- agnostic equipment. And shield cans placed on PC boards protect
istics, electrical issues come into play, including contact resistance circuits from signal interference.
and shielding requirements. Filter connectors also play a critical role in managing and con-
Contact resistance impedes current flowing through the connec- trolling EMI and RFI. Some connectors have standard filtering fea-
tor. One way to decrease this resistance is by choosing the right ma- tures, including individual isolated-pin filtering for high-frequency
terial. For example, gold plating over contacts made of high-con- noise, built-in ground plane barriers in connector inserts, and shield
ductivity copper alloys lowers resistance. If strength is a concern, cans on PC boards to protect circuits from signal interference.
consider using beryllium copper as the base material. Beryllium But the filter-design approach is more effective. It lets engineers
copper also has low stress relaxation which boosts the number of define and change individual circuit capacitance, ground, and elec-
mating cycles the connectors will withstand. tromagnetic-pulse (EMP) performance during development.
Spring-probe-and pin-pad designs mentioned earlier also re- To ensure medical devices work, especially in critical applica-
duce electrical resistance, thanks to the internal clip that always tions, engineers must design interconnects that are reliable and
provides a highly conductive path. maintain signal fidelity. This can be done by using breakaway con-
nectors, EMI-shielding, and grounding-electronics cables. Such
Tools for getting the perfect connector designs allow for shell-to-shell grounding at less than 10 mΩ, as
Design-failure-mode-effects analysis (DFMEA) and process-fail- well as EMI performance of greater than 85dB at frequencies from
ure-mode-effects analysis (PFMEA) play significant roles in meet- 40 MHz to 10 GHz. Performance is further enhanced by termina-
ing the mechanical and electrical design challenges of building the tion processes which allow for 360° shield/connector coverage.
right connector for a specific application. DFMEA explores ways Complex EMI/RFI electronic issues have driven connector man-
products might fail during real-world use, while PFMEA investi- ufacturers to develop higher-performance and more-cost-effec-
gates whether manufacturing process will be able to handle a given tive EMI-suppression methods, including spring-probe contacts a
design. chip-on-flex (CoF) filter. CoF filters, using a flex circuit with chip
Another tool, 3D modeling, often via stereo-lithography (SLA) capacitors, are surface-mounted to a pad on the feed-thru contact.
or selective-layered sintering (SLS), is also crucial to successful This replaces traditional planar-array block capacitors and while
medical-connector designs. It has become the preferred way to provides reliable filtering. In addition, the filters perform well de-
make connector prototypes. Manufacturers can also drop a 3D spite thermal shocks and vibrations.
model of a connector into a model of the customer’s equipment to
verify that it will meet design specifications. Safety considerations
Shielding against EMI and RFI signals, another consideration, is From a safety aspect, portable medical devices need finger pro-
critical for devices such as pacemakers and patient monitors. Sig- tection and touchproof connectors. IP2X, a finger-protection stan-
nal noise can affect a pacemaker’s operation and corrupt data in dard, requires that a connector’s live or electrified parts cannot be
monitors. In these applications, it is also vital that connectors use touched by a human finger. Because portable medical equipment
nonmagnetic materials because magnetic emissions degrade image may need to be repaired in the field, touchproof connectors pre-
clarity and increase signal noise. As a result, connector manufac- vent health-care professionals and patients from getting shocked
turers rely on stainless steel, alloys, and brasses, as they offer non or when they touch a connector. Touchproof construction often in-
low-magnetic fields, thus keeping EMI/RFI from interfering with volves placing a plastic plunger over male pins, letting only the fe-
equipment. Shielding effectiveness lets some connector manufac- male contacts touch the male pin. Making pins on the active side
turers offer EMI performance greater than 85 dB at frequencies of the connector touchproof using any means eliminates the risk
from 40 MHz to 10 GHz. of shocks. n
Another method of minimizing effects of EMI/RFI is to over-
mold the connector cable. This is often accomplished by attaching ☞ BACK TO TABLE OF CONTENTS
a stainless-steel shield over the shell (the shielding lies between the
wires and connector jacket), and then premolding or overmolding
the end of the cable to the connector. So when there is EMI/RFI,
it is absorbed by the overmolded cable, thus minimizing insertion
loss and any electrical variations. The overmold also adds tensile
strength to the cable.

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 5:

EPOXIES FOR

MEDICAL DEVICE
APPLICATIONS
Biocompatible epoxies let designers affix subcomponents to medical devices that meet USP Class VI
guidelines.

LINDSEY FRICK, Contributing Editor

O
ne-component epoxies find use in
a wide variety of medical products.
Part of the reason is that the materials
can be specially formulated to resist
chemicals — including multiple cycles
of autoclaving — while meeting rigorous
biocompatibility standards. One-part epoxies also adhere
well to metals, plastics, glass, and other substrates used in
medical devices.
Medical-grade one-part epoxies commonly serve in dis-
posable and reusable devices such as catheters and surgical
instruments. They can also be found in orthopedic devices
and in diagnostic equipment such as MRI machines and ul-
trasound devices.
Both one- and two-part epoxy-based systems can be used
in bonding, sealing, coating, and encapsulating applications.
But one-part systems have a few added benefits for medical Pictured here is a central vein puncture and catheterization in an
applications. Before one can understand the nature of one- operating room. The catheter and guidewire assembly uses one-
part systems, it is important to first understand two-part component adhesives that meet USP Class VI and ISO 10993
systems. biocompatibility standards. Most of these one-part adhesives,
Two-part systems, the most basic of epoxies, are formed developed by Tangent Industries, Winsted, Conn., cure in fractions
through the polymerization of two starting compounds: of a second under LED or UV light. Applications for these adhesives
a resin and a curing agent. The curing process takes place include manifold bonding and thermistor potting.
when the reactive constituents of the resin and curing agent
combine. As this reaction proceeds, an exotherm develops, en- The majority of industrial-grade epoxies are two-part systems,
hancing the cross-linking of the two components. The speed of the which offer a comprehensive range of properties. Two-part systems
reaction, plus the ultimate cured properties, both depend on the require mixing and have a corresponding open time. Open time
nature of the resin and the curing agent. can be defined as the maximum time between mixing and the time

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MACHINE DESIGN LIBRARY CHAPTER 5: EPOXIES FOR MEDICAL DEVICE APPLICATIONS

when the product can no longer be applied. The time it takes to ful- fixture parts together quickly. If heat is withdrawn the system will
ly cure a two-part system can range from as little as a few hours, to continue to cure at ambient conditions. This will not happen with
as much as two weeks. Often, heat can be added, thereby accelerat- a one-part system.
ing curing, enhancing cross-linking, and optimizing performance So why choose one-part epoxies for medical applications? Fully
properties . cured one-part epoxies offer important properties including high
With two-part systems, designers must consider a number of bond strength to a wide variety of substrates, high-performing me-
processing issues. First and foremost, all two-part systems have chanical and physical strength properties, robust temperature re-
a mix ratio. Some ratios are simple one-to-one weight or volume sistance, and the ability to withstand chemicals. One-part epoxies
ratios. Others are more specific and unforgiving — 100-to-7 by can be formulated in almost any viscosity imaginable. However,
weight, for example. The process of mixing also requires a certain a paste consistency is often preferred for bonding applications to
level of skill, especially when trying to ensure the two components avoid material flow when heat is applied for curing. Chemical resis-
are fully mixed. Complete mixing is as critical as avoiding air en- tance, the ability to withstand high temperatures, electrical proper-
trapment. Often, technicians mix more epoxy than is needed for ties, optical clarity, thermal conductivity, and cure speed can also
the job — thereby wasting epoxy. be modified to meet specific medical applications. For example,
One-part epoxies are more efficient from a processing point of formulations are available to withstand cryogenic conditions, or to
view. In a one-part epoxy, the resin and curing agent are premixed pass USP Class VI biocompatibility standards.
with inhibitors that prevent a reaction. The reaction only takes One significant application issue regarding one-part epoxies is
place when heat is added because heat eliminates these inhibitors. that they are more exothermic than two-part systems, and in most
But it is important to heat the epoxy for the recommended cure situations, are limited by curing depths 0.25 in. or less.
time. Otherwise, it will only cure partially. Most one-part systems
require a cure temperature of 257 to 302°F, although, there are now
specialty grades for a 176°F cure. This lower curing temperature is
useful for bonding heat-sensitive substrates.
Another benefit of one-part epoxies is quick curing — usually
in just a couple of minutes or several hours at most. Yet, there’s
often a trade-off between curing time and performance. Long-cure
epoxies often offer more-advanced properties than quick-cure ver-
sions — including better electrical insulation and higher physical
strength.
A point to note is storage temperature. A range of 40 to 75°F
is safe for most one-part epoxies, but refrigeration is desirable in
most cases. Higher storage temperatures (above 75°F) can degrade
the system.

Custom-formulated one-part epoxies

Most epoxies can be modified through appropriate selection of
resins and hardeners and through the addition of fillers, diluents,
and other components to realize a variety of processing conditions
and performance properties. While two-part epoxy systems offer
the broadest array of properties and applicability among all adhe-
sive families, one-part epoxies are also highly multifunctional.
A number of resins can be used in one-part epoxies including
conventional, high temperature, and flexible, as well as low-ionic
versions. The selection of a suitable curing agent is more restricted.
Unlike two-part systems, which have a huge array of curing agent Shown here is a breathing circuit that was assembled using
options, the number of compounds available to function as a cur- LED-curable adhesives. The adhesives are made by Tangent
ing agent in a one-part epoxy is limited. Industries and are capable of bonding multiple substrates
All curing agents for one-part epoxies require heat activation including acrylic, PVC, polyethylene, polycarbonate, and
and continuation of heating. If the heat is withdrawn prior to full styrene. This wide range of substrates lets engineers connect
cure, the curing process stops and the epoxy remains partially various components to build products like anesthesia masks,
cured. In contrast, for a two-part room-temperature curing system, breathing bags, tubing and connectors, and laryngeal mask
one can initiate curing by adding heat. This is primarily done to airways.

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MACHINE DESIGN LIBRARY CHAPTER 5: EPOXIES FOR MEDICAL DEVICE APPLICATIONS

North America is the United States Pharmacopeia (USP) Class VI.

Delicate devices Any polymeric material that meets Class VI requirements is suit-
One-part systems are used in delicate applications like medical able for direct and indirect patient contact. Before granting Class
devices with electronics and optoelectronics. A typical use is as an VI certification, scientists test the materials by injecting and im-
underfill system, where the epoxy is designed to protect and sup- planting material samples into subjects and then monitoring the
port delicate flip chips. Important considerations would be good subjects for signs of reactivity and toxicity.
flow and superior dimensional stability upon curing. Epoxies with Class VI certification are suitable for both dispos-
Ultralow-viscosity one-part epoxies can also be used in vacu- able and reusable medical devices, including endoscopes and infu-
um-impregnation applications, ranging from transformer coils to sion pumps. These medical-grade epoxies are also useful in pros-
carbon-fiber composites. On the other side of the spectrum, thixo- thetics and diagnostic equipment.
tropic one-part epoxies can be used as glob tops. Glob tops can However, just because a material complies with USP Class VI
be applied to circuitry, wire bonds, and even to delicate electronic doesn’t mean it can go in a medical device. That’s because a pleth-
components in medical equipment. ora of other FDA regulations also apply to medical devices. For
One unusual iteration of these one-part systems is epoxy films. example, designers that submit a device for FDA approval must
Films are becoming increasingly used in medical applications, es- also ensure that its materials undergo International Organization
pecially where uniform bond-line thicknesses are needed. There for Standardization (ISO) 10993 certification, which includes tests
are a host of other applications where they are being used — lid to verify compatibility with blood and bodily fluids.
sealing, the bonding of electronic components to heat sinks, and Tip for engineers: If a device assembly requires the use of an
attaching substrates in microelectronic packages. epoxy to hold subcomponents together, identify the right Class
In addition to determining the level of biocompatibility needed, VI-approved epoxy before submitting the medical device to the
it’s important to look at several factors before choosing a one-part FDA. The industry categorizes adhesives by the number of com-
epoxy. Factors that may influence the selection process include ponents they mix together and how they cure. However, each type
cured properties, especially bonding and physical strength, chem- of epoxy changes with the appropriate selection of resins and hard-
ical resistance, thermal and electrical properties, temperature re- eners and the addition of fillers, diluents, and other components. n
sistance, thermal-cycling capabilities, and color. The handling and
processing characteristics such as viscosity, exotherm, curing con- ☞ BACK TO TABLE OF CONTENTS
ditions, and temperature also play a role.

USP Class VI-approved epoxies

Medical devices must be biocompatible, which means they must
be made of nontoxic materials that don’t irritate or damage living
human tissue and don’t cause physiological or immune-system re-
actions. One stringent certification of material biocompatibility in

Tangent Industries has developed a series of one-part LED

light-curable adhesives that bond stainless-steel cannula
into hubs of various substrates and configurations. The
biocompatible adhesives are ideal for high-volume production
of disposable hypodermic needles, syringes, safety syringes,
pen needles, winged infusion sets, and biopsy needles.

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 6:

PROTECTING MEDICAL
ELECTRONICS WITH

PARYLENE
This biocompatible conformal-coating material protects medical devices against
fluids, chemicals, and stray electrical charges
LONNY WOLGEMUTH, Senior Medical Market Specialist

M
Specialty Coating Systems Inc.

any medical devices and their electronics urethane, or epoxy. But one of the best materials for this purpose
need protection from moisture, chemical is parylene.
contamination, electrical charges, and body
fluids. Otherwise, patients and healthcare Parylene basics
providers may be put at risk. One way Parylene is the generic name for a series of organic polymers
biomedical engineers provide this protection — poly(para-xylylene) polymers — used as coatings. They are
is by encapsulating devices in a conformal coating, one made of a polycrystalline and linear in nature, optically clear, and colorless.
dielectric, or poor conductor of electricity, such as silicone, acrylic, Parylene coatings have useful dielectric and barrier properties
and are chemically inert.
Three different types give
engineers a range of di-
electric and other proper-
ties from which to choose.
The coatings contain no
fillers, stabilizers, solvents,
catalysts, or plasticizers,
so they are not subject to
any leaching, outgassing,
or extraction issues.
Parylene coatings are
also compatible and stable
in the presence of bodily
fluids and tissues, critical
factors in the medical-de-
vice industry.
Parylene provides dry-
film lubricity with coeffi-
cients of friction similar
to that of PTFE (Teflon),
and dielectric strengths

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MACHINE DESIGN LIBRARY CHAPTER 6: PROTECTING MEDICAL ELECTRONICS WITH PARYLENE

up to 7,000 V at a mil (25 microns) of coating thickness. No other are critical to the device’s performance.
material can be applied as thinly as parylene and provide the same An added benefit of parylene is its ability to strengthen delicate
levels of protection. wire bonds by an estimated factor of 10.
Parylene withstands all common sterilization methods — steam, The preparation and coating processes vary from device to de-
ethylene oxide, electron beam, hydrogen peroxide plasma, and vice. Typical turn times are five to 10 business days, but that can be
gamma radiation. It can be applied to most vacuum-stable mate- negotiated. Times may be extended if parts require extra inspec-
rials, including plastics, metals, ceramics, fabrics, paper, and even tion, pretreatment, or masking and demasking.
granular materials. For example, parylene coatings could be ap- Many medical-device manufacturers send parts to coating-ser-
plied to microspheres or moisture-absorbent powders. vice providers due to the art and complexity of parylene coating
Parylene can be selectively removed with plasma, lasers, or process. Also, medical-device manufacturers typically do not want
strong abrasion, for instance, to repair devices. Parylene is not sol- to become experts in a coating process they may use on only one
uble in harsh detergents and chemicals; in fact, it protects com- or two product lines. Some device manufacturers do, however, pur-
ponents from such chemicals. Parylene is not a “hard” coating, chase VDP equipment and bring the process in-house.
so excessive abrasion will remove it. However, most components
coated with parylene do not abrade or rub against other parts. If an Parylene variants
application does include abrasive contact, it is not a good candidate The parylene family includes several members. Parylene N, for
for parylene. example, is nonchlorinated poly(paraxylylene) that has a low dissi-
pation factor, high dielectric strength, and a dielectric constant that
Parylene deposition doesn’t vary with the frequency of the electrical current. Parylene
Parylene coatings are applied using vapor- deposition polymer- N also performs well when it comes to penetrating and coating into
ization (VDP) in a vacuum chamber at room temperature. Film a device’s small crevices and spaces.
deposition actually takes place on the molecular level, with the Parylene C is produced from the same dimer used to make Pa-
coating literally growing one molecule at a time. This lets parylene rylene N, but it is modified by a chlorine atom attached to the mol-
penetrate and coat small cracks, crevices, and openings, and pro- ecule’s benzene ring. It has a useful combination of electrical and
tect even hidden surfaces in areas where other coating methods physical properties, plus a low permeability to moisture, fluids, and
such as sprays and brushes cannot reach. Coating thickness is corrosive gases. Its ability to provide pinholefree conformal barri-
uniform, even on irregular surfaces. And VDP is a clean, self-con- ers makes it the coating of choice for many critical medical elec-
tained process that uses no additional chemicals. tronic assemblies.
Parylene is deposited as a vapor, so it surrounds the target and Parylene HT is the newest commercially available parylene. It
perfectly follows its contours, literally encapsulating it. Parylene carries fluorine atoms on the benzene ring instead of hydrogen at-
coatings are ultrathin and pinhole-free. oms. It has the lowest dielectric constant and dissipation factor of
The only raw material used in the coating process is known as all the parylenes, as well as the highest continuous service tem-
dimer. Technicians place the powdered double-molecule dimer perature (350°C). It also maintains its properties despite exposure
into the vaporizing chamber at one end of the coating machine. to UV light. The other two parylenes are susceptible to damage by
The dimer is heated, sublimating it directly to a vapor, and then UV light.
heated again until the dimer cracks into a monomeric vapor. This All three parylene formulations are biocompatible and biostable,
vapor flows into an ambient-temperature deposition chamber kept as confirmed by ISO-10993 and USP Class VI biological evalua-
at a medium vacuum (0.1 torr) where it spontaneously polymerizes tions.
onto all surfaces, forming an ultrathin, uniform film. No curing or
additional steps are required. Parylene applications
The size of the coating chamber may be an issue if products are As noted, parylene coatings protect devices from moisture, bio-
too large to fit inside. For example, medical wire on a reel that fluids, and biogases that can cause assemblies to fail prematurely.
needs to be coated as one continuous piece may not be suitable for This protection extends product life, prevents costly repairs and,
parylene. However, if wires are precut to various lengths, hundreds most importantly, reduces the risk of failure.
of pieces might fit into one chamber. Parylene has also been helpful in tackling challenges raised by
Because there is never a liquid phase in VDP, there is no me- new regulations. Metallic whiskers, for example, are one of the
niscus or pooling. There is also no bridging or blocking of small unintended by-products of removing lead from solder as part of
openings, which can happen when applying a liquid coating. RoHS regulations. These whiskers can lead to reliability problems
The thickness of a parylene coating can range from 500 Å to 75 for electronic assemblies. Parylene coatings suppress the formation
microns, so it does not significantly change the coated device’s di- of metallic whiskers.
mensions or mass. In many medical devices, such as intraocular Another benefit is parylene’s dry-film lubricity, which makes it
and cochlear implants, maintaining minimal dimension and mass an ideal release agent for molds. Being solid and inert, parylene

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MACHINE DESIGN LIBRARY CHAPTER 6: PROTECTING MEDICAL ELECTRONICS WITH PARYLENE

leaves no residue to contaminate molded products. And parylene’s A short history of parylene
lubricity extends the life of forming tools such as wire mandrels by In 1947, Michael Szwarc was pursuing his academic career in
eliminating flaking and delamination. physical chemistry at the Univ. of Manchester, England. His in-
terest in the strength of individual chemical bonds led him to in-
Coating costs vestigate a class of aliphatic carbon-hydrogen bonds in which the
The cost of coating a product with parylene depends on several carbon was directly attached to a benzene ring. While doing so,
factors, including: he heated gases of the simplest compounds having both benzene
• Complexity of the item being coated. Do one or more areas need and carbon — toluene and the xylenes — to high temperatures. He
to be masked so that parylene does not coat them? monitored both the decomposition products and rates of decom-
• How thick a coating is needed? This depends on the coating’s in- position as a function of temperature.
tended function. Will it be used to protect electronics, add lubric- With p-xylene only, a tan-colored deposit formed in the cooler
ity, be a tie-layer for other coatings, or be an elution-control layer reaches of his glassware. The material has been described as a thin,
for drugs? € imsy, tube-shaped mass, “the skin of a small snake.”
• What type of parylene is required? N, C, or parylene HT? Szwarc correctly deduced that this … lm had been formed by po-
• How many parts are to be coated at one time? It is obviously less lymerizing reaction products of the p-xylene, called p-xylylene. He
expensive to coat hundreds of parts in a large chamber than 10 or also noticed the new polymer’s physical properties and chemical
20 parts in a smaller chamber. inertness. This serendipitous polymerization was the world’s … rst
While some elastomeric O-rings can be coated for less than a vapor deposited poly(paraxylyene). Today its purer colorless form
penny each, a single, large, complex, military circuit board can cost is called parylene N.
hundreds of dollars to coat. In general, parylene is competitive A few years later, William Franklin Gorham at Union Carbide
with other coatings given the right production volumes, complex- Corp. continued the research on parylene. By 1967, this work led
ity, and other variables. And although it may be more costly than to the availability of a new polymeric coating. “Parylenes” was the
some other coatings, rylene may be the only option for the protec- term used to describe both a new family of polymers and the vac-
tion needed by a given device. uum-deposition process for applying them. In fact, Union Carbide
For the sophisticated microdevices being developed for medi- developed over 20 types of parylene, but only three were deemed
cal implants, parylene provides longterm biocompatibility and commercially viable. n
device protection. The available parylene formulations, coupled
with newly developed adhesion-enhancement technologies, let ☞ BACK TO TABLE OF CONTENTS
parylene coating perform on medical-device components, circuits,
and equipment, regardless of their size, configuration, or material.

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 7:

IMPLANTED TELESCOPE
HELPS PATIENTS OVERCOME

MACULAR
DEGENERATION
Implanting some magnifying optics into patients’ eyes lets them salvage what’s left of their vision.
STEPHEN MRAZ, Technology Editor

A
ge-related macular degeneration (AMD) is the
leading cause of vision loss and affects 10 million
Americans, more than those suffering from
cataracts and glaucoma combined. That number
could grow to over 20 million by 2020 as the U.S.
aged population grows. Worldwide, the number
afflicted in 2020 could be as high as 196 million.
There currently is no cure and doctors could do little more than
prepare patients for the inevitable loss of vision in one or both eyes.
Now, however, patients have an option, thanks to researchers at Vi-
sionCare who have developed an implantable telescope that can
preserve a patient’s vision.

The Telescope
The implantable telescope consists of two lenses within a glass
tube. It is about the size of a pencil eraser (3.6-mm in diameter and
4.4 mm) and uses bi-convex and bi-concave convergent and diver- The implantable telescope from VisionCare improves the
gent micro-lenses coupled with air lenses, according to VisionCare. central vision of patients suffering from advanced macular
Details on the micro-optics are proprietary, but the outcome is that degeneration. It gets implanted in one eye so that it can detect
the implant acts like a fixed telephoto lens that works with the cor- central vision (where the person is looking); the other eye then
nea to project images onto the retina that are enlarged by a factor picks up the task of peripheral vision.
of 2.7. The iris is also left in place, but the implant is longer than it
is deep, so the end of the telescope protrudes through the inactive to the patient.
iris. Although the macula of the retina is partially destroyed and The implant also has a polymethylmethacrylate (PMMA) carrier
useless, the magnified image overlaps the diseased section to stim- and a blue PMMA restrictor. The sealed optical components snap-
ulate undamaged rods and cones to partially return central vision fits into the carrier, which includes shaped projections that hold the

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MACHINE DESIGN LIBRARY CHAPTER 7: TELESCOPE HELPS OVERCOME MACULAR DEGENERATION

The implanted telescope sends visual information to areas

outside the damaged macula (the dark red spot).

When implanted, the telescope is behind the undamaged implant in place. These are similar to those found on intraocular
cornea. The restrictor, the blue components, prevents too lenses implanted in patients who have had cataract-removal sur-
much light from entering around the edges of the telescope gery in which part of their natural lens is removed. The projections,
and washing out the image. called “haptics” by VisionCare, are snugged into the capsular bag,
a smooth transparent membrane that surrounds the natural lens.

THE THREAT: AGE-RELATED MACULAR DEGENERATION

AGE-RELATED MACULAR DEGENERATION (AMD) is an in- ly, unlike the slower pace of dry AMD. But not everyone who gets
curable eye disease that damages the macula, the small area dry AMD develops wet AMD.
near the center of the retina that contains a People with early AMD in only one eye
high concentration of light receptors (rods and have a 5% chance of developing late-stage
cones). The macula is responsible for sharp, AMD within 10 years. These with early AMD
central vision and lets people see objects they in both eyes run a 14% chance of developing
are looking directly at. late-stage AMD in at least one year after 10
AMD is a slow-working disease and those years.
with it might not notice any symptoms for There is another form of macular degen-
years. Over time, however, the person’s cen- eration called Stargardt disease. It is found in
ter of vison in the affected eye(s) becomes in- younger patients and is caused by a recessive
creasingly blurry. The blurred spots grow and gene. There is no cure for AMD, although high-
blind spots can develop in the eye’s field of vi- dose vitamins and minerals and a healthy diet
sion over time. Eventually, central vision is lost have been known to slow its progression. It’s
altogether, rendering the person legally blind. also recommend that those with AMD stop
They still might be able to see objects in their smoking. (Smoking doubles the chances a
peripheral vision, but they can no longer read, person will contract AMD.)
see faces, drive safely, or do close work. Other risk factors for contracting AMD
There are two types pf AMD, dry and wet. This image simulates what a include genetics; AMD does run in families,
The dry version, which accounts for 90% of all person with AMD sees: The but researchers have identified 20 genes that
AMD cases, results from the slow breakdown central portion of the image affect the risk of developing AMD, and many
of light-sensitive cells in the retina and the sup- is totally unusable, but the more are suspected. That’s why there are cur-
porting tissue beneath the macula. The other peripheral vision is still available rently no genetic tests that reliably predict if
type, wet AMD, accounts for 10% of AMD pa- (though blurry). someone will come down with it. AMD is also
tients, and is also known as late-stage AMD. In more common in Caucasians than among Af-
this stage, abnormal blood vessels grow underneath the macula. rican-Americans, Asians, or Hispanics. But the largest risk factor
The vessels often leak fluids and blood, leading to swelling and is age: the older you get, the more likely you are to be afflicted by
damage to the macula. The damage is severe and happens quick- AMD.

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MACHINE DESIGN LIBRARY CHAPTER 7: TELESCOPE HELPS OVERCOME MACULAR DEGENERATION

Over time, the membrane grows up and around the haptics, secur- reprogram the optical cortex of the brain and how it processes in-
ing the implant in place. But patients are still warned to avoid sit- puts from the eyes. This is needed because the patients are now
uations in which their head or eyes are exposed to trauma so they using their eyes in a completely new way. In fact, vision gradually
don’t damage or dislodge the implant. They are also told to refrain improves and it can take a few months before all the benefits are
from rubbing their eyes too forcefully. realized.
The blue-tinted restrictor, a washer-shaped component, sur- In post-op patients, the eye with the implant provided their
rounds the implant and reduces the amount of light that can enter brain with visual details of what they are looking directly at while
the eye from the periphery so it does not wash out images coming the other eye provides peripheral vision. AMD does not affect pe-
in through the implant. ripheral vision, a low-resolution form of vision humans rely on for
The optics are designed and built to have an optimal focusing detecting objects near or nearing them and those moving in their
distance of about 11.5 ft., assuming an average-sized eyeball. Pa- field of vision. So instead of using two parts of the same eye, the
tients are prescribed glasses if distance or near-viewing corrections patients (and their brains) need to switch between eyes to get the
are needed. There are no moving parts or electronics in the im- same information.
plant. The implant has been shown to improve a person’s ability to iden-
The device is implanted behind the iris in one eye during an tify what they are looking at, to “look” someone in the eye during
outpatient surgical operation that also involves removing the eye’s conversation, and to see facial expressions. The implant can’t com-
natural lens. The implant is sterilized by the manufacturer using pletely restore a person’s natural vision. However, in clinical tests,
ethylene oxide (EtO). This gas infiltrates packaging and kills germs. 50% of the people with the implant could read two to three lines
EtO is often used on medical devices and components that need to lower on the standard eye chart, and 90% reported improved vi-
be sterilized but cannot withstand conventional high-temperature sion. Patients might also still require a magnifying glass to see fine
steam sterilization. After sterilization, the implant is packaged and details or small print.
then not opened until inside the clean operating room. The implant is practically unnoticeable to others because it is to-
tally inside the eye and behind the iris, the colored portion of the
Post-Op Results eye.
After the operation, which usually lasts one to one-and-a-half The implant, which costs about $15,000, is approved by the FDA
hours, patients are given eye exercises and go through some train- for patients 65 and older, and is covered by Medicare. It is designed
ing to get the most out of the implant. For example, they practice to last the life of the patient. n
tracking objects with the new implant, as well as watching TV and
reading. The exercises, which can last six to 12 weeks, also help ☞ BACK TO TABLE OF CONTENTS

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 8:

TECHNOLOGY ADDS
THE SENSE OF TOUCH TO

PROSTHETIC
HANDS
Biomedical researchers at the Veterans Administration are exploring options and developing techniques
for directly stimulating nerves to let prosthetic users feel sensations in their artificial hands.
STEPHEN MRAZ, Technology Editor

L
osing an arm is a traumatic, life-changing event. Too served the missing hand.
many military personnel suffer that loss. Even in The goal of the project, according to team member Assistant
peacetime, as many as 20 armed services members Professor Dustin Tyler, Director of Engineering, Quality, and
endure upper or lower limb amputations annually due Regulatory Affairs at APTC and a faculty member in nearby Case
to noncombat accidents. To help wounded warriors Western Reserve University’s Biomedical Engineering Dept., is de-
return to active and healthy lifestyles, the Department termining what kind of sensations the sensors on prosthetics can
of Veterans Affairs not only provide users, how many sites
provides medical assistance, can be given this artificial sense
prosthetics, training, and other of touch, and what technologies
assistance, it also funds R&D can best do the job.
into better prosthetics.
At the Advanced Platform Sensors
Technology Center (APTC) at “The sensors we currently use
the VA Medical Center in Cleve- are thin-film, force sensor resis-
land, one team of biomedical tors (FSRs) from Tekscan Inc.,”
researchers is working to devel- says Tyler.
op technology that would give An FSR consists of two elec-
veterans (and civilians) with up- trodes separated by a thin sheet
per-limb losses a sense of feeling of material. Applying pressure
in their prosthetics. They are in- moves the electrodes closer
stalling sensors on the artificial together and changes the sen-
hand portion of the prosthetic, sor’s resistance as a function of
then processing and routing Users with prosthetics that give them a sense of touch and pressure. FSRs are simply taped
those sensor signals to the user’s feel are more proficient at locating and picking up objects like to the artifical hand, a classic
brain via the nerves that once these cubes. three-jaw hand prosthesis from

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MACHINE DESIGN LIBRARY CHAPTER 8: TECHNOLOGY ADDS THE SENSE OF TOUCH TO PROSTHETIC HANDS

Ottobock with one degree of freedom — the new combinations of stimulation pulses.
index and middle finger move together to- That’s one reason the stimulator and PC
ward and away from the thumb. The center’s will likely remain separate even in later
current prosthetic has four FSRs that mea- versions, says Tyler.
sure the finger opening or span between the “In the future, users might be able to
thumb and fingers, as well as pressure at the control some gain parameters so that the
tip of the thumb, index finger, and middle hand is more sensitive for doing delicate
finger. work and less sensitive for heavier-duty
“These let users grasp and release objects work,” explains Tyler. “But it would likely
and give an indication of how much force be nothing more sophisticated than a vol-
they are exerting in their grasp. But in the fu- ume knob.”
ture, sensors need to be more rugged to with- The relatively simple stimulator, the
stand daily use without breaking down. And product of biomedical engineers at the
they will be mounted so they are protected. VA’s Functional Electrical Stimulation
But there are some drawbacks to ‘hardening’ Center (FESC) in Cleveland, creates three
sensors,” notes Tyler. current-controlled pulse trains. The three
“One medical-device manufacturer puts stimulation signals get sent to the three
sensors on the internal structural metal parts major nerves that usually carry sensory
of its prosthetics. This provides a level of pro- signals from the hand to the brain: the
tection, but limits the range of forces they median, ulnar, and radial nerves. This
can detect,” Tyler says. stimulation is ac in nature and biphasic
“Down the line, as we try to detect forces with balanced current flow in successive
distributed over artificial hands, we will need negative and positive impulses. Biomed-
to find mounting locations that let sensors ical engineers long ago discovered that
detect surface sensations and pressure with While this setup works to give people long-term monophasic stimulation with
better resolution, and not just a gross output who have the instrumented prosthetic all positive or all negative pulses creates
of total forces but better spatial resolution,” hand a sense of touch, it would have to chemical and charge imbalances that
says Tyler. “We will always want to detect be miniaturized and made more rugged break down nearby blood vessels and
feelings from fingers, so sensors will likely before it could be economically produced muscle tissues.
mount on the prosthetic’s fingertips, which in volume and widely used. The APTC project’s goal is to eventu-
means they will have to be protected against ally replace the PC with an embedded
wear and liquids.”
In APTC’s current setup, an exterior battery powers the sensors.
Actual prosthetics, however, would not tether users to external bat-
teries or power supplies.
“Batteries are getting more capable, and motors and sensors
are becoming more efficient, so the ideal would be to have a sin-
gle-charged battery pack last all day,” says Tyler. “But until then,
biomedical engineers will likely design artificial hands and arms
with quick-change-out battery packs holding a minimum of 4
hours of use.”

The PC and nerve stimulator

Raw sensor data gets amplified, filtered, digitized, and then sent
to the PC at no more than 100 Hz, which is enough bandwidth
for an artificial hand’s sense of touch. The PC, a standard desktop
model running Windows, records all the sensor data and performs
some numerical processing on it using Matlab (from Mathworks).
In general, the PC maps the sensor information to stimulation
patterns for nerves that will generate the desired sensations in us- The sense of touch lets prosthetics users adjust their grips
ers. Currently, only researchers can adjust or change settings on strength on the fly so they can pick up or manipulate delicate
the PC and stimulator, letting them update programming and try objects like these grapes.

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MACHINE DESIGN LIBRARY CHAPTER 8: TECHNOLOGY ADDS THE SENSE OF TOUCH TO PROSTHETIC HANDS

processor that would be small enough to mount inside the pros-

thetic. It would pull in sensor data, do some processing, and match
incoming sensor data with the proper nerve stimulation signal
(pulse, timing, and amplitude).
“One long-term approach is to use prosthetic-mounted sen-
sors that detect the raw haptic data, which will be processed in a
module attached to the artificial hand, perhaps no larger than a
wristwatch,” says Tyler. “This would communicate with a stimula-
tor implanted in users like a pacemaker but send sensory signals
to the proper nerves. The prosthetic would also record the muscle
activity (electromyogram, or EMG) of the user trying to control
his missing hand. These EMG signals would get processed and be
used to control the prosthetic’s drive motors that move the digits The APTC haptic system currently uses a pair of implanted
and hand.” eight-site electrodes like this one. Each runs along a nerve,
The sense of touch lets prosthetics users adjust their grips delivering different stimuli to eight different portions of the
strength on the fly so they can pick up or manipulate delicate ob- nerve. The strings attached to it are sutures used to secure the
jects like these grapes. electrode in place inside the user’s forearm. The system also
uses a four-site spiral electrode that wraps around one of the
The right stimulation user’s nerves.
One of the most difficult but intriguing parts of the APTC proj-
ect is determining what stimulation to apply given a specific sensor “We would also like to find the right stimulation that would rec-
input. reate shear, which would let users ‘feel’ when something is sliding
“Biomedical engineers started by copying the paradigm used to through their grasp,” says Tyler.
control the muscles of people with spinal-cord injuries. It relies on “Another sensation amputees really miss is warmth, especially
consistent trains of pulses sent to muscles via efferent nerves (those the warmth of a child’s or spouse’s touch,” says Tyler. “Unfortu-
that go from the spinal cord to muscles). The higher the pulses’ am- nately, that would add another type of sensor to a space-limited
plitude, the more muscle fibers get excited, so the muscle generates prosthetic. And nerves that relay heat and cold to the brain are
more force,” Tyler says. smaller than those that carry pressure information. Smaller nerves
“But this doesn’t work on afferent nerves (which carry informa- are more difficult to locate, isolate, and stimulate, and special elec-
tion from sense organs to the brain). Users felt sensations, but they trodes would have to be developed. So giving prosthetics a sense of
weren’t natural. Instead, they got that ‘pins and needles’ feeling, like hot and cold is not our focus.”
their fingers or hand had fallen asleep. This wasn’t too useful, but
to people who had never felt anything from their prosthetics, it was Connectors and electrodes
better than nothing,” he explains. In the APTC setup, different stimulation signals are sent to
These results were not surprising. Sensation is much more com- 20 nerve sites accessed by three implanted electrode cuffs, each
plex than muscle movement. For example, muscles do little if any on a different nerve. There is a pair of eight-contact cuffs, and a
processing on incoming nerve signals, while the brain does a host four-contact spiral cuff wraps around one of the nerves, making
of processing on incoming sensory nerve signals. That’s because 20 sites. On the eight-contact electrode, for example, each of the
sensory signals include more information, which could be encod- eight wires or leads is connected to a small piece of platinum foil
ed in the signal’s frequency, the pulse duration and amplitude, the in contact with the nerve. Platinum is biocompatible and provides
space between pulses, or the interference or combinational effects good electrical contact with the nerve tissue.
of signals travelling along the same and nearby nerves. “Or the in- Each of the 20 leads terminate in pins, which attach to 20 corre-
formation might be a contained in a permutation of all these pa- sponding transcutaneous leads via a matched-pin connector. This
rameters,” notes Tyler. connector uses a spring to connect two lead pins.
Over time, Tyler and his team have gone far beyond letting us- Mating pins are inserted in either end of the spring, which is
ers just feel how tightly they are grasping an object. “In fact, we’ve wound around each pin in the opposite direction of its spiral, a
elicited feelings and sensations in as many as 19 different places in time consuming process. Pulling the connected leads apart tight-
the users’ missing hands,” says Tyler. “This includes a couple places ens the spring around the pins, much like a Chinese finger trap.
in the palm, the fingertips, a few places on the back of the hand The spring and pins are then covered with a silicone sleeve to iso-
and wrist, and several down the outside edge of the pinky. So our late and insulate the electrical connection from body fluids. The
technology for sensors on the prosthetic hand is behind in terms of benefit of this somewhat arcane connector, which will be replaced
the number of places we can elicit sensations in users.” in future, refined versions of the system, is that it creates solid elec-

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MACHINE DESIGN LIBRARY CHAPTER 8: TECHNOLOGY ADDS THE SENSE OF TOUCH TO PROSTHETIC HANDS

wider variety of different stimulus combination to give users more

sensations.”

Do Prosthetic Feet Need Feelings?

Prosthetic lower limbs, especially those for people with amputa-
tions below the knee, have been very successful at replicating the
needed biomechanics to get users up and walking, even running
in many cases. Yet none of them give users any sense or feeling in
their artificial limbs. So do prosthetic feet need haptic technology?
“Yes, the mechanics of lower-limb prosthetics are spectacular,
but they are usually being used on flat, level surfaces,” notes Assis-
tant Professor Dustin Tyler, Director of Engineering, Quality, and
Regulatory Affairs at the Advanced Platform Technology Center
(APTC) at the Veterans Center in Cleveland and faculty member
in nearby Case Western Reserve University’s Engineering Depart-
ment.
“It becomes more challenging on uneven surfaces when the ar-
tificial foot moves unpredictably because the user cannot feel the
The APTC system will be upgraded to use a flat interface ground. So users probably could benefit from receiving foot po-
nerve electrode (FINE). It opens so surgeons can place the sition data, which the sense of touch should be able to provide,”
nerve inside of it. When the housing closes, the nerve is held Tyler says.
flat, making it easy to access more nerve fibers. The nerve is Climbing steps and hills also present problems to people with
held loosely in place so blood flow is not interrupted and the prosthetic feet. For example, they have to watch carefully to know
nerve is not damaged. whether their entire artificial foot is on a step or just a portion, and
they don’t know which portion, the toe or the heel. “Giving them
trical connections and is replaceable. the sense of pressure on the bottom of their ‘feet’ would give them
These second leads run under the skin up the arm to the user’s better capability and confidence in climbing steps,” says Tyler.
shoulder, where they exit the user’s body, leaving 2 or 3 in. of wires “Plus, receiving sensation from an electromechanical device, foot
terminating in a multilead jack protruding from the skin. or hand, lets people consider the device as part of themselves rather
Tyler uses flat interface nerve electrodes (FINEs) in the haptic than just a tool hanging on the end of their limb,” says Tyler. n
system. Such electrodes have a two-part housing that opens like
a clamshell to let surgeons place a nerve longitudinally down its ☞ BACK TO TABLE OF CONTENTS
center. Closing the housing holds the nerve in place with mini-
mal force, ensuring it is not damaged and blood flow to it is not
interrupted. In future versions, the bulk of the electrode will be
reduced by using high-performance polymers, such as PEEK, to
give the electrode good mechanical properties, as well as more pre-
cise alignment of the more closely positioned electrical contacts.
Eventually, the electrodes will include thin-film componenets con-
taining small and precisely postioned contacts, thanks to photo-
lithographic manufacturing, the same processes used to make ICs.
Larger nerves are much like ropes in that they are made up of
smaller fibers or fassicles. Fassicles are about 0.5 mm in diameter,
so the typical 10-mm-wide nerve likely has at least 16 of them go-
ing from side to side. With these more refined and precise FINEs,
Tyler plans to increase the number of contacts from eight to 32, or
16 on each side of the nerve. Eventually, FINEs could each have 64
contacts.
“This would let us stimulate more areas in the brain that cor-
relate to more places on the prosthetic hand,” says Tyler. “Or if we
combined thin-film technology with FINE, we could add rows of
electrodes along the nerve, stimulating more nerve sections using a

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MACHINE DESIGN LIBRARY TOP ENGINEERING ESSENTIALS
FOR MEDICAL DEVICE
TECHNOLOGY

CHAPTER 9:

TECH ADVANCES UPGRADE

HEARING AIDS
Advances in MEMs and signal processing let hearing aids provide understandable speech and more
natural, comfortable sounds to the hearing impaired.

STEVE MRAZ, Technology Editor

T
echnological developments in hearing aids (HAs) Here’s a look at some of the other ways biomedical engineers
have always been driven by efforts to miniaturize are using new technologies to improve the lives of the hearing im-
hardware and give those with hearing problems—an paired.
estimated 35 million in the U.S.—the ability to better
hear and understand the people and environment Microphones
around them. Miniaturization lets engineers pack Two types of microphones are commonly used to pick up the
more amplification and signal processing power in small, wearable sounds that will be amplified by HAs: electret and MEMS. Both
housings. It also lets hearing-impaired people use HAs small have sensitivities of between -32 to -35 dB, according to Eric Bran-
enough to go largely unnoticed. da, product manager for Sivantos Inc., the hearing-aid division of
Advancements in HAs have always been spurred by develop- Siemens.
ments in electronics and MEMS and their manufacturing process- Electrets, long used in HAs, are electrostatic ca-
es, and HAs are often the first commercial devices to make use pacitor-based microphones. They measure about
of those developments. For example, the first consumer use 3.6 × 2.5 × 1.27 mm and use a Teflon or polymer
of transistors was in a 1952 HA from Sonotone, accord- diaphragm. These diaphragms are sensitive to tem-
ing to John Dzarnoski, director of technology devel- perature, humidity, and aging, which can be a prob-
opment at Starkey Hearing Technologies. It used a lem.
transistor and two vacuum tubes for amplification MEMS microphones are made of silicon using the
in a device that measured 3 × 2.75 × 0.5 in., small processes similar to those that make ICs. Thus, they
enough to fit in a shirt pocket. do not have the electrets’ material-related problems.
“That is the story of hearing aid development,” They are also smaller than electrets, measuring 3.2 ×
says Dzarnoski. “It uses new technologies ahead 2.5 × 1 mm, so engineers can fit several on a single
of other industries to build smaller, more capa- HA.
ble devices. And that story continues.” Their downside is that HA need a bandwidth of
about 8,000 Hz to detect
The Pure hearing aid from Sivantos, a all the sounds needed
division of Siemens, is a behind-the-ear for speech and normal
model that features dual microphones for environmental noises.
better directionality and a telecoil, which MEMS microphones
lets telephones and facilities equipped with currently have a difficult
an induction loop such as churches and task doing this, though
theaters beam sounds directly to the user’s they are fine for cell phones
hearing aid. where their limited bandwidth is

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MACHINE DESIGN LIBRARY CHAPTER 9: TECH ADVANCES UPGRADE HEARING AIDS

The Insio in-the-ear hearing aid from The approach taken by Starkey to reduce feedback is
Sivantos is said to be the first such to decorrelate or change the output from the input by
device to employ wireless technology frequency shifting the output b t5 to 20 Hz. “A 20-
for exchanging data with another Insio Hz shift represents an aggressive feedback prevention
in the user’s other ear to synchronize scheme while a 5-Hz shift is used when listening to
settings and exchange audio signals. music,” says Dzarnoski.
It can also be adjusted by the user Digital processors also carry out sound compres-
through an iPhone or Android device. sion, reducing the dynamic range of sounds so that
it better matches the users hearing capability.
At Sivantos, some HAs use digital signal process-
not a problem, says Dzarnoski. ing for SpeechFocus. It’s a feature that selects the best directional
Companies often place two microphones on HAs, especially be- pattern or amplification scheme for incoming microphone signals
hind-the-ear and in-the-ear types, to let the wearer tell what direc- based on where a speaker is located. First it uses spectral analysis to
tion the sound is coming from (directionality). “Inputs from these recognize speech by its frequency spectrum. Then it boosts ampli-
microphones, both of which are omnidirectional, can be electron- fication to the microphone best positioned to pick up that sound.
ically manipulated or processed (after being converted to digital Sivantos and other HA manufacturers also use digital algorithms
signals) to give users a sense of directionality,” says Branda. “The to reduce transient and impulsive noises such as rustling paper or
inputs also help in identifying and tracking unwanted noise, letting clanging dishes without affecting speech signals. Sivantos’ version,
the HA reduce amplification of those sounds.” Directionality and called Sound Smoothing, relies on spectral and temporal analysis
selective amplification also helps users understand speech when it to attenuate only the transient frequencies, usually high or low fre-
comes from behind them. quencies, within one millisecond of their onset.
One of the major goals HA designers have been working on for
Processing years is to use signal processing to let HA wearers hear and under-
Today’s HAs have about the same processing power as a 386 chip stand speech from one individual in a room full of people talking,
and can handle about 5 million instructions per second, which is such as in a crowded restaurant or bar. “The ability of hearing aids
a lot of computational power to be running on a small battery, Dz- to recognized unwanted sounds is still primitive, and the top com-
arnoski points out. plaint for years has been their inability to recognize speech in the
Some of that processing power goes to reduce or eliminate feed- presence of noise, even other speech,” notes Dzarnoski.
back. Feedback happens when sound from the speaker “leaks” back
to the microphone and gets repeatedly amplified into a loud squeal. Receivers
The receivers in HAs, or what those outside the industry might
call speakers, are electro-acoustic balanced-armature magnetic

The Lyric in-the-ear hearing aid from Phonak is so small, it

can be placed deeply in the ear canal, only 4 mm from the ear
drum. It is said to be the first extended-use device that can
be continuously worn for months at a time. To bring Lyric to
maker, Phonak engineers had to come up with a low-power
circuit, a long-life battery, and materials and a design that
could safely reside in the ear canal for long periods of time. The Lyric in-the-ear hearing aid.

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MACHINE DESIGN LIBRARY CHAPTER 9: TECH ADVANCES UPGRADE HEARING AIDS

transducers. They consist of a magnetic armature precisely centered and oxygen pulled from the air. These disc-shaped batteries have
between a pair of electromagnets. Electric current sent through storage capacities that depend on how much zinc they contain.
the magnets’ coils induces force which moves the armature back They range in size from 6 Ñ… 2mm up to 11 Ñ… 5 mm and last
and forth. This mechanical force is transferred to a membrane that from four to 10 days, depending on how much they are used and
converts the motion to air-pressure differences or sound, explains how much amplification the HA provides. They cost about $0.60 to
Branda. $1.60 and are not rechargeable.
Receivers vary in size from 1 × 2.5 × 5 mm for small devices and The Lyric, an in-the-canal HA from Phonak, uses extremely little
moderate amplification to 5 × 6 × 8 mm for larger, more powerful power, thanks to ultra-low power electronics and the fact it is so
receivers. How much power the receivers require is a function of deep within the ear canal, the receiver is only 3 to 4 mm from the
the amplification needed. eardrum. It operates for months on a single battery. In fact, users
HA designers are coming with smaller receivers, letting them fit can keep Lyric in their ear for up to six months before a technician
in smaller housing that sit nearer to the ear drum. Some designers removes and replaces it.
are also adding two or more receivers, each optimized for a specific Sivantos, however, does make HAs that use rechargeable bat-
range of frequencies. This is much like hi-fi speakers that contain teries, the only major HA maker to do so. “Rechargeable batteries
tweeters for high frequencies and woofers for the low tones. Cross- hold less capacity than regular batteries,’ says Branda. “Only HAs
over circuitry routes the sounds to the proper receiver. that are sufficiently energy efficient, such as some Sivantos makes,
can use rechargeables and still last a full 16-hr before needing re-
Batteries charged.”
Zinc-air batteries are the power source of choice for HAs based
on their safety and energy densities. “Zinc-air batteries are very Protection
safe,” says Dzarnoski, “And they will not get hot enough to burn a Biomedical engineers consider the ear canal a hostile environ-
person even if the positive and negative side of the battery is short- ment when it comes to materials and electronics. “The ear canal is
ed out. loaded with wax-generating glands that remove foreign material
They generate 1.35 to 1.45 V of electricity using metallic zinc from the canal naturally,” explains Dzarnoski. When hair follicles
in the canal sense something in the canal, it stimulates pores to
secrete a chemical that results in ear-
wax. So putting a hearing aid in the The Ponto BAHA.
canal can lead to excess wax creation,
which plugs up ports and holes, and is
somewhat corrosive.
In most cases, the tight plastic
housing that goes in the canal keeps
out most debris and wax. Some
manufacturers, such as Starkey, add a
screen over the microphone. When it
gets clogged, it is replaced. Starkey also
uses molecular vapor deposition to put
a proprietary nanocoating called Hy-
draShield on its housing and exposed
components. The 100-nm thick layer

The Ponto bone anchored hearing aid (BAHA) from Oticon takes
sound form the outside words, processes it, and then sends it
through a titanium screw implanted just behind the user’s ear. The
screw penetrates the skins and is embedded in the user’s skull.
Users hear the sound through bone conduction, the same way you
can hear yourself chewing or biting. Because using BAHAs involve surgery,
the price for one can range from $15,000 to $25,000. Nevertheless, they are a last
option for patients who have occluded ear canals or lack them entirely, or have
some other physical restriction that prevents them from using more traditional
hearing aids.

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MACHINE DESIGN LIBRARY CHAPTER 9: TECH ADVANCES UPGRADE HEARING AIDS

makes oil and water to bead up and run off the coated parts. aural HAs in which users put a HA in each ear. Just as natural hear-
Sivantos makes a completely water and dust proof HA, Aquaris. ing combines inputs from both ears and process it in the brain,
It has been tested to IP68 standards and can be fully immersed in outputs from one HAs gets sent to the other to maximize direction-
water. The technologies which make that possible include a bot- ality and increase the ability to pull sound out of noise.
tle–housing concept, extra microphone and receiver protection, a The main wireless platform used by HA seems to be the Apple
waterproof battery door with a membrane seal, and acoustic vents. iPhone and its proprietary 2.4-GHz protocols, according to Dz-
arnoski. “Companies are building Android-based devices, but An-
The Wireless Advantage droid is not a single standard. There are many different types and
Designers are now taking advantage of wireless innovations to versions,” he says. “That means companies have to develop HA apps
improve the usability and function of HAs. A common application and systems for each one, making development more complex. Ap-
lets HA wearers adjust the controls on their devices - while they ple also forbids anyone from using its protocols with Android. But
are wearing them - from a smart phone or PDA. They can also key Apple does work with hearing-aid developers and iPhones seem to
in various profiles, a group of settings for low-noise environments, have the best functionality.”
speech in a noisy room, or for listening to music, among others. All this technology does not come cheap. HAs cost from $2,500
Starkey has a similar feature they call Geo Tagging. Wearers use to $7,000, depending on the level of technology, but this cost in-
their iPhone and an app to adjust their HA’s controls for a partic- cludes an audiologist who helps patients choose the proper device
ular setting, which could be a theater, classroom, or subway plat- and helps fit and adjust it. Lyric, from Phonak, is sold as a subscrip-
form. The app stores the settings, as well as the GPS-derived lati- tion that costs about $2,400 per year, which includes up to seven
tude and longitude for the place. The next time the person goes to replacements and visits with an audiologist. n
that place, the iPhone recognizes it from the GPS coordinates and
automatically switches the settings to those saved for that location. ☞ BACK TO TABLE OF CONTENTS
Wireless technology has also made it easier to use and wear bin-

TYPES OF HEARING AIDS good for mild to moderate hearing loss. Users do, however, get
THERE ARE FIVE BASIC TYPES of hearing aids, and which ones better sound localization because the microphone takes advan-
patients choose depends on their level of hearing impairment, tage of the outer ear’s sound-reflecting properties. ITC devices can
their physiology and health, and their lifestyle. amplify sound by 35 to 50 dB.
Behind-the-ear (BTE): These are the more traditional devices Completely-in-the-canal (CIC): The smallest of all hearing aids,
that consist of a durable plastic housing that rests behind the out- CIC versions are almost invisible to others. There are also more
er ear connected via a thin plastic tube that snakes into the ear compatible with talking on the phone and they, like ITC models,
canal. The tube carries sound from a receiver in the housing to the use the outer ear to reduce wind noise and help in sound localiza-
tympanic membrane in the ear, so there is no sound directionality. tion. Its size limits battery capacity and how much amplification it
Its relatively large size lets it provide more amplification and larger can provide, but CIC devices do not need much amplification be-
batteries, so it is well-suited for those with severe hearing loss. cause they place the receiver so close to the tympanic membrane.
They can also contain more processing power, so audiologists, They are uncomfortable for some patients due to their small ear
the medical professionals who fit patients with hearing aids, have canals and how deeply the HA must be inserted. It can also take
more options in tailoring the sound. BTE units can have amplifica- several visits to the audiologist to get the device to remain com-
tion or gains of 35 to 82 dB. fortably in the ear.
In-the ear (ITE): These devices contain the microphone and Bone anchored hearing aids (BAHA): Some patients suffering
speaker, as well as the battery and processor, and fit into the ear. hearing loss have an occluded or non-existing ear canal, or their
Its size accommodates two microphones for directionality, as well ear canal secretes too much wax. For these people, traditional
as larger batteries, and makes it is easier to insert and remove for hearing aids aren’t an option. To get around their limitations, en-
older persons whose hands aren’t as nimble as they once were. gineers have developed a hearing aid that picks up and amplifies
ITE hearing aids provide 40 to 70 dB of gain. sound, then sends it to the patient’s hearing centers in the brain
In-the-canal (ITC): Smaller than ITE hearing aids, this fits directly using bone conduction though a titanium anchor inserted in the
into the canal. Being smaller makes is less noticeable, but it is only skull just behind the ear.

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