White Paper

Scaling New Performance Heights

with High-Grade Medical Textiles

By Felice Szeto-Wong, Han Dols, Erik Becker of DSM

and John Gray of Biomedical Structures LLC

February 2011
 Scaling New Performance Heights with
High-Grade Medical Textiles
By Felice Szeto-Wong, Han Dols, Erik Becker of DSM and John Gray of Biomedical Structures LLC

Medical device companies (MDCs) operating in today’s marketplace can be forgiven for feeling stuck between
the proverbial rock and a hard place. While new – and some would say harsh – economic, demographic and
cultural realities have definitively reshaped healthcare delivery models and mandates,
they haven’t fundamentally altered the missions of most MDCs to develop products
with the potential to enhance patients’ lives and improve medical outcomes. But they
have made the mechanics of delivering on that promise significantly more rigorous.
...deliver better
In today’s environment, it’s not enough to develop a product that addresses unmet
market or clinical needs – it must also deliver better performance and higher value performance and
than ever before. higher value than
ever before.
Harnessing a Legacy of Innovation to Address a Litany of Challenges
It’s hardly surprising that performance and value have become the holy grail of device design in a medical land-
scape wracked by a complex convergence of new and long-standing challenges. Changing patient demographics
and expectations, for example, are adding new pressures to an already strained healthcare system. Highly active
patients are demanding more of their medical products and services. Highly informed patients are expecting
more, and aging populations are simply utilizing more.

Changing economics are taking their toll as well. Two decades of steady healthcare cost increases, followed
by a global economic recession, have had a marked impact on every patient, provider, payer, institution and
organization participating in the delivery or consumption of healthcare products and services. And while the fate
of healthcare reform – in its current iteration – remains uncertain, there’s no question that tighter management
of healthcare costs will be paramount in the future environment. In fact, device industry pundits have been
especially concerned – and vocal – about the chilling effects reform could have on industry innovation, but
we’ve yet to see a diminished thirst for new ideas among any of our customers,
particularly when those ideas promise to yield the higher-performing cost-effective
devices required by an increasingly price- and outcomes-conscious marketplace.
Biomaterial innovations
are capturing designers’ But it’s not just these macroeconomic and demographic forces that are honing the industry’s
focus on device performance and value. Sophisticated new treatment options are fueling
attention for the many the need for medical tools and technologies with higher performance characteristics.
ways they can help Surgeons are embracing minimally invasive approaches to cardiovascular and orthopedic
MDCs deliver on their procedures, for example, and demanding the materials (smaller, stronger, and more
flexible) that promote those treatments. These same surgeons are also looking beyond
mission... approaches that simply support, replace or repair damaged tissue, cartilage and bone and
toward those that actively re-grow tissue, cartilage and bone or restore natural or
near-natural function.

The device industry has a long history of capitalizing on advancements in science, medicine, engineering and
technology to meet practitioners’ needs, and now, with the convergence of the multiple trends outlined above,
biomaterial innovations are capturing designers’ attention for the many ways they can help MDCs deliver on
their mission while simultaneously managing the many market challenges. While device makers have been
utilizing fabrics, textiles and plastics made from biomaterials for orthopedic implants and other medical
applications for more than half a century, it’s only recently that they have been going into the body. Even prior
to the 1960s, MDCs have merely scratched the surface of biomaterials’ potential in the continued evolution of
medical devices. But interest in exploring that potential further has sparked dramatically in the last few years,
Scaling New Performance Heights with High-Grade Medical Textiles

...allow designers to
break free from some
as evidenced by the number of commercial medical products utilizing advanced of the constraints (and
biomaterials, as well as by the more recent trend among MDCs of hiring in some cases risks)
biomaterials experts into their design and development groups: a sure sign of associated with
the increasing importance material selection has in ensuring the performance
of medical devices, especially those designed for orthopedic and cardiovascular traditional metal and
applications. plastic materials.
Another event that has triggered more intense interest in biomaterials’ potential
is the emergence of high-performance fibers such as Dyneema Purity®, a medical-grade ultra-high molecular
weight polyethylene (UHMWPE) whose fibers are 15 times stronger than typical cable steel, and novel processing
techniques such as fiber knitting, braiding and weaving that can help device makers realize the most value from
those fibers.

Dyneema Purity® Fiber: A Unique Medical-Grade Fiber Uniquely Suited for

Next-Generation Devices
Why do we feel comfortable crediting one type of medical-grade fiber for helping to push MDCs to the next
frontier in device design? In part, because the unique properties of Dyneema Purity® fiber allow designers to
break free from some of the constraints (and in some cases risks) associated with traditional metal and plastic
materials. That’s intriguing to designers aiming for improved device performance, higher economic value and
better overall medical outcomes.

More specifically, Dyneema Purity® fiber offers designers:

A fiber specifically designed for use in the human body. The product is fully compliant with ISO 10993 and
produced through a proprietary process that is compliant with ISO 13485. There is also an FDA Master File
available for the material, which is increasingly important to device manufacturers in the current environment.

The high specific strength per volume of Dyneema Purity® fibers allows profile reduction, contributing to
the development of ever-smaller devices that do not compromise strength in the process and therefore can
perform in an increasing number of minimally invasive surgical procedures.

Dyneema Purity® fiber offers high stiffness with great softness and pliability – a unique combination that
supports enhanced fixation, particularly in orthopedic applications such as knee and shoulder arthroscopy.

Also important is Dyneema Purity® fiber’s high fatigue and abrasion resistance, which support a long life-
time in dynamic situations. These mechanical properties can be especially advantageous in cardiovascular
applications that require very fine fabric structures. In such cases, structures made from a material with less
fatigue and abrasion resistance are at greater risk of breaking down due to internal or external stressors.

And last but not least, a fourth highly advantageous property is that it is a biocompatible material suitable
for implantation in the human body. Given the ongoing concerns regarding potential risks associated with
the metal ions potentially released into the body by some metal-on-metal implants and the continued
commitment to improving patient outcomes, this particular property is attracting much positive attention
from medical device manufacturers, as well as surgeons and, most especially, their patients.
 Scaling New Performance Heights with High-Grade Medical Textiles

10.00
The resulting device
is going to be more
Dyneema Purity®

comfortable and
Specific Strength (N/Tex)

1.00
PP PET better-performing
nylon for the patient...
cPTFE

0.10
biodegradable Specific strength versus tensile
polymers steel
strength of Dyneema Purity®
yarns in comparison with other
0.01 medical-grade materials.
10 100 1000 10000

Tensile Strength (MPa)

High-performance fibers, of course, aren’t the answer for every application, but they are exciting because the
advancements in this sphere of biomaterials reflect some of the long-term goals that innovation within
biomaterials is striving to achieve: more compatible, lifelike, comfortable and durable devices. How? Well, if
design developers incorporate a material that is more lifelike, such as a fiber processed in a way that mimics
the body’s natural anatomy, the resulting device is going to be more comfortable and better-performing for the
patient, more compatible in the body than many traditional materials and, potentially, longer-lasting.

While there are several examples of improved performance that can

be referenced, spinal fixation devices in particular are trending toward
Companies such as Biomedical fiber usage and the lessening of surgeons’ reliance on using rigid rods
Structures LLC, enable contract and/or metallic plating exclusively, and are resulting in better patient
manufacturers to create true outcomes, higher patient compliance, and reduced dependence on and
abuses of pain-killing medications commonly prescribed post-surgery
biomedical structures out of (including morphine, codeine, oxycodone, hydrocodone and other
high-performance fibers such analgesics). In addition, the extreme strength characteristics of high-
as Dyneema Purity® fiber. performance fiber offer designers the potential to reduce the size and/
or profile of both temporary and permanent implants, which supports
the goals of surgeons embracing minimally invasive techniques. These
advantages and others have positive implications for both costs and
patient outcomes if they lessen the risk of a repeat procedure or promote faster healing, etc. So while we can’t
say that high-performance fibers processed via sophisticated techniques have the potential to replace traditional
systems, they do have the potential to improve their performance and value in the overall healthcare system.

Biomedical Structures LLC: Extracting the Most Value from a High-Performance Fiber
Why is specialized textile engineering such a critical component of biomaterial utilization? Sophisticated
processing techniques developed by companies such as Biomedical Structures LLC, enable contract manufacturers
to create true biomedical structures out of high-performance fibers such as Dyneema Purity® fiber and further
leverage the unique properties of the material through processes that magnify strength, texture or any other
characteristic ultimately desired for the application.

Processes can include knitting, braiding, weaving and non-wovens, and each approach has specific benefits and
performance attributes. Customers that seek out specialized textile engineering often are looking for guidance
Scaling New Performance Heights with High-Grade Medical Textiles

on which approach will best achieve the performance level desired by

the material within the application. Most textile engineering houses
specialize in one or two specific processes, but Biomedical Structures
is unique in that it offers all the textile processing techniques under one
roof. Partners benefit from this approach not only because Biomedical
Structures can offer expertise in and equipment for all four approaches,
but also because the company doesn’t steer customers toward a particular
technique simply because that’s what’s on offer rather than because it’s
what has the potential to optimize the desired characteristics of the material.

Another advantage Biomedical Structures offers partners is the fact that its facility is purpose-built for medical
textile structure development and was founded day one to serve this market. This history not only sets it apart
from many of its competitors, but also supports the company’s commitment to quality standards and processes
– an increasingly critical consideration in an environment characterized by heightened regulatory scrutiny and
more complex pathways to sanctioned commercial approvals.

To ensure customers and partners encounter as few challenges as possible in navigating those pathways, the
facility is ISO 13485 registered and functions as a dedicated contract manufacturer exclusively for medical
implantation. Independent of that, Biomedical Structures offers dedicated clean rooms for fiber preparation right
through to the final output – whether for a device or a technician doing downstream processing on a material.
Additionally, Biomedical Structures rigorously maintains device history records and offers proven repeatability
and validation processes, all with the aim of providing customers the type of support that gives them confidence
in the product Biomedical Structures provides.

The Partnership – Supporting the Development of Next-Generation Devices

Since the launch of Dyneema Purity® fiber in 2004, the high-strength sutures
made with the fiber have since become the Gold Standard in a broad range of
They offer the potential
orthopedic applications including devices for shoulder, knee, hip, small joint
and cranial procedures. In the ensuing seven years, DSM has launched stronger to develop critical
grades of fiber. And when those stronger grades are braided, they allow better new cardiovascular
conformance to the anatomic needs of load-bearing bones and structures, making applications that can’t be
them interesting candidates to use in the design of spinal applications.
achieved via traditional
In addition to introducing an array of grades, Dyneema Purity® fiber is also fibers or materials.
offered in a range of deniers. At present, the smallest commercial grade denier
is 25 dtex, which can be appropriate for various cardiovascular applications.
What’s exciting about smaller deniers is that although they are really thin, they are still very strong, and as a
result, they offer the potential to develop critical new cardiovascular applications that can’t be achieved via
traditional fibers or materials.

In addition, DSM is the only company to have created an UHMWPE fiber with color, which provides critical
contrast and makes it easier for surgeons to perform standard tissue and joint repairs.

In terms of other applications built on the fruits of DSM’s and Biomedical Structures’ partnership, the optimized
strength properties are of great use in a wide variety of general surgery, orthopedic and cardiovascular devices.
Some of the biomedical textiles that Biomedical Structures has created using Dyneema Purity® fibers are
particularly appropriate for minimally invasive approaches to rotator cuff repair and other orthopedic procedures
where reducing size without compromising strength is critical.
Scaling New Performance Heights with High-Grade Medical Textiles

Our more recent work together has focused on optimizing certain

characteristics of Dyneema Purity® fiber in order to replicate some solid
materials to support the trend in orthopedics toward better mobility, lighter
weight and better biocompatibility.

In addition, current work with Dyneema Purity® fiber enhanced with

specialized textile engineering techniques is aimed at bringing structure
to the ultimate strength requirement for regenerating tissue by creating
a scaffolding or architecture that allows for tissue ingrowth, thereby
supporting another growing trend among surgeons.

For future work together, we envision tremendous potential for new

applications to support novel approaches to spinal fixation, including spinal repair and stabilization that utilizes
materials other than bone screws and plates. Other areas for future work would be rotator cuff repair, where
surgeons are aiming to move beyond sutures to textile structures for rotator cuff repair and tendon replication.

While the medical device community is already actively embracing the

potential of novel biomaterial structures, it’s important to note that the world
of materials is changing daily, and fulfilling the promise these materials offer ...and improve device
requires ongoing study, commitment and investment. With market challenges performance and
increasing and patient demands growing, it’s critical we all work together to
continue to explore – and commercialize – the many benefits biomaterials
outcomes so that costs
have to offer. stay manageable.
We view this partnership between DSM, Biomedical Structures and our MDC
partners as an ideal template in service of that goal – companies with unique,
specific expertise working together to understand unmet medical needs, support surgeons and their patients, and
improve device performance and outcomes so that costs stay manageable. If our experience working together
offers any lessons, it’s that if the value chain is understood and we all work together, we can achieve these
objectives and realize the goals of all participants in the broad healthcare community. We are well aware of the
many pressures weighing on MDCs in the current environment, and we believe that with the support of
companies such as DSM and Biomedical Structures, we can all work in tandem to help them successfully
hurdle the challenges and continue to deliver on their missions.