Global Medical Devices

Market Summary
September 2024
Table of contents

1. Market overview 3

2. Industry challenges 9

3. Industry trends 16

4. Business model transformation 30

5. M&A trends 36

6. Software and AI as a Medical Device 40

7. Orphan medical devices 46

8. Software and data initiatives by big players 50

9. Recent regulatory insights 55

1.
Market
overview

Global Medical Devices Market Summary | September 2024

Summary: Global medical devices market
is expected to reach $712.9 bn by 2030
Global medical device market4 ($ bn) Regional market share1 (2024) Market drivers2,5
Africa; 2%
CAGR
5. 7%
712,9 North Technological
Europe;
America; advancements
28%
511,2 39%

Rise in geriatric
South population
America;
Asia Pacific*;
5%
25%
2024 2030E
Increased R&D investment
Key industry insights by MedTech companies

• Patients are increasingly demanding convenience, accuracy, and an overall smoother experience from
the healthcare system;2
Market restraints1
• Medical devices are becoming smarter, more AI-driven and more interconnected, enabling earlier
diagnosis and enhancing communication between doctor and patient;1
• Medical device companies are prioritizing protection against cyber-attacks, security backups and Regulatory approvals &
sustainability initiatives to improve general community safety;2 stringent barriers
• Popularity of digital therapeutics (software-based medical devices) skyrocketed during the pandemic
and shows no signs of slowing down.3
* Middle East countries are included in Asia Pacific

4
Summary: Class l medical devices accounts for majority
of the market share

% of device presence in the US2 In-vitro diagnostics (IVD) is the largest segment in 2024, with 19.3%
(as classified by the FDA) share of the global market5.

In-vitro diagnostics market is valued at $98.97 bn in 2024, and is

10% expected to grow at a CAGR of 2.72%5.

Class I In-vitro diagnostics market is set to grow rapidly with the rise of
remote patient monitoring systems enabling diagnosis outside
47% traditional healthcare4.
Class IIa & IIb

Class III
43% Neurology is expected to be the fastest-growing device specialty1.

Increasing prevalence of cardiovascular diseases has boosted the

use of medical devices in hospitals and clinics worldwide4.

5
1.1 Driver: Technological advancements are driving the
medical devices industry

Connected health Personalized Minimally invasive

AI & ML integration4
solutions2 healthcare2 innovations2
Technological advancements Devices can now gather Robotic-assisted surgeries, AI and ML are being applied
in medical devices are enabling patient-specific data to micro-scale implants, in medical devices to
real-time monitoring, data customize treatment and advanced imaging improve diagnostic accuracy,
collection, and analysis, approaches, leading to techniques are enhancing enhance patient outcomes,
allowing healthcare improved outcomes and precision and reducing patient and streamline clinical
professionals to make patient satisfaction. recovery times. workflows.
informed decisions promptly.

IoMT adoption: 43% of MedTech businesses use data to inform business choices1.
AI adoption: 69% of healthcare organizations are testing or adopting AI1.

Technological advancements are driving innovation and growth in the medical device industry, leading to improved patient outcomes, enhanced
healthcare delivery, and increased efficiency in medical device development and manufacturing2,3.

6
1.2 Driver: Rising geriatric population is a key driving factor
for the growth of the medical devices market
Persons aged 65 or over1 (mn) Key benefits2,3

There is a positive association between elderly individuals and an increase

1600
in the incidence of disorders such as cardiovascular, neurological, and
orthopedic conditions.

994
771 Aging population represents a crucial market for the medical devices
industry, driven by the increasing need for advanced home care solutions
tailored to the elderly.

Significant investments by market players in improving elderly care devices

are expected to bolster market growth. These investments are channeled
2022 2030E 2050E
into innovative startups dedicated to enhancing care for the elderly.

As per UN World Population Prospects Report 2022, the geriatric

Advancements in medical device technology have resulted in a significant
population is expected to reach 1.6 bn by 2050, which can be
increase in the number of conditions that can be managed in a home care
around 16% of the total world population1.
setting, providing opportunities for market expansion.

Aging population worldwide is leading to an increased demand for healthcare services and medical devices, particularly for
chronic disease management2.

7
1.3 Restraint: Regulatory barriers and stringent approval
processes pose significant challenges in the market

Medical devices are subject to various regulatory standards from multiple entities and agencies such as:
• FDA Regulations: FDA now requires a comprehensive software bill of materials (SBOM) and minimum cybersecurity standards for
connected medical devices1;
• EU Regulations: EU's new legislation for medical and in-vitro diagnostic devices includes stricter safety requirements and a longer
recertification process2.

Medical device companies must navigate multiple regulatory bodies and jurisdictions, which can be complex and time-consuming4.

Pre-Market Development Post-market

Manufacturing1 Clinical trial1
Approval1 (PMA) process2 surveillance2,4

Devices classified as Manufacturers must Devices requiring Manufacturers must Devices must be
Class III, which pose a demonstrate substantial clinical trials must follow formal monitored for post -
high risk to patients, equivalence to an obtain an development processes, market cybersecurity
require a more involved already cleared or investigational device documenting user threats and comply with
and costly approval approved device, which exemption (IDE) and needs, design inputs & regulatory requirements
process, involving can be a lengthy and conduct trials to validation to ensure for ongoing
rigorous testing and costly process. demonstrate safety and device safety & maintenance and
review. effectiveness. effectiveness. updates.

8
2.
Industry
challenges

Global Medical Devices Market Summary | September 2024

Summary: Challenges faced by the global medical devices
industry

1
Regulatory hurdles
Stringent regulations that differ from
country to country, also includes IPR

2
and counterfeiting issues.
Pricing and distribution
Complex factors lead to difficulties in
pricing and further add uncertainty for

3
Supply disruptions distributor agreements regarding margins.

Essential electronic components and

specific materials are highly vulnerable
to supply side shocks.

4
Changing customer needs
Consumers ask for more personalized
and customized medical devices on an

5
Competition in industry on-demand basis.

Big players in the industry often look to

expand their market share in diverse
geographies, making entry difficult.

10
2.1 Differing regulatory compliances across geographies
present a big hurdle to manufacturers and distributors
Existence of National Regulatory Regulatory frameworks across the world
Authorities (NRA)
% of countries with a legal framework for medical devices is highest in the European region
(91%) and lowest in the African region (32%).

EU and FDA have different risk classifications for devices, which increases approval times and
17%
compliance costs, especially for global players looking to diversify into new countries.

21% Countries having no legal framework for medical devices often pose risky markets for big players
62%
due to no assistance from local governments against any possible compliance issues.

Counterfeiting remains a big problem in lower-income countries where local-made (often

inferior) devices are sold off under a brand name for a premium price.
Countries with NRAs
Countries without NRAs e.g. In India, counterfeit oximeters were being sold in Kolkata by a local manufacturer due
to poor implementation of Medical Devices Rules 2019 and IPR regime.
Data not available

• Low-income countries are not attractive markets due to a lack of regulatory frameworks, substantially lower purchasing power, and counterfeiting
of devices;
• High-income countries continue to be high-revenue geographies with the EU and North America dominating the global revenue share for devices;
• IPRs and enforcement for medical devices are stringent in the developed world which makes them safer markets for patented devices.

11
2.2 Downward pricing pressure on players coupled with
rising costs presents a difficult scenario

Demand for cost High manufacturer Reimbursement Negotiating power of

effective solutions costs prices2 providers

Hospitals and healthcare Steadily climbing costs to Downward pricing Group Purchasing
facilities want lower-priced producers due to R&D, pressures due to the Organizations (GPOs) and
solutions due to patients’ commitment to advanced reduction in purchase price consultation
concerns about rising out-of- technology, quality assurance, reimbursement prices, services have led to reduced
pocket expenditures. and regulatory compliance which decrease willingness prices in market.
costs. to pay.

Price in the market faces downward pressures while costs to

manufacturers have increased in the past decade

Margin squeeze trap1

(Difficulties setting appropriate margins with distributors)

12
2.3 Supply chains tend to be vulnerable to many shocks
with large impacts due to larger interdependencies
Critical raw materials (e.g. titanium) have become scarce due to energy crises, geopolitical High degree of global
Material interdependencies
volatility, and overdependence on specific locations for supply. Semiconductor chip shortages
supply
still pose a big threat.

A large challenge of high demand and low supply of skilled technicians. The industry also
Labor
struggles to keep hybrid working opportunities available which are demanded by the
trends
workforce.

Systems like JIT, Lean, and Six Sigma have been overleveraged by the industry to such an extent
Inventory Complexities within the
that there are increased risks of stockouts and disruptions due to the inability to absorb a risk supply chain
systems
event.

Government-imposed trade restrictions and logistical challenges, compounded by natural

Trade and
disasters or geopolitical events hinder the timely movement within the upstream and
transport
downstream supply chains.

The inorganic growth of companies has led to a narrower supplier base due to companies
Supplier Greater risks and larger
trying to leverage their spending, while new suppliers take a long time to enter the equation due
issues impact of supply shocks
to high qualifying regulations.

13
2.4 Rapidly changing consumer needs necessitates
innovation in products and processes by the players
Changing consumer trends
• User-friendly devices: More and more consumers especially patients with chronic diseases are demanding ease-of-use monitoring devices to
avoid visiting the physician as much as possible.
• Proactive users: Patients are actively involved with healthcare providers in decision-making and tend to ask for the latest device/technology for
treatment.
• Digital integration: A common digital platform for integrating many devices is a recurring demand, especially after the trend of wearable
monitoring devices (smartwatches).

Evolving physician needs

Interoperability Digitalization Reliability Data security

Physicians want most of their Use of Digital platforms and More accurate and consistent Increased risks of cyber attacks and
devices to seamlessly integrate records to support day to day diagnosis using emerging liabilities arising due to
together to avoid data transfer works of clinicians. applications of AI and cloud technology-related medical errors.
issues. diagnosis.

More specialized and personalized medical devices lead to greater demand for low-volume production, which has inspired a shift toward on-demand
production. This can lead to greater inefficiencies for manufacturers.

14
2.5 Presence of established players in the global markets
presents to be a significant barrier to entry

Major players in the

industry

High barriers to entry for new firms due to regulatory compliance

requirements and medical efficacy standards.
Large players operate in high-revenue
established markets in the EU and North
Longer life devices are already established in renowned facilities, thus
curbing demand for new devices.
America and control a high market share. They
also look for opportunities in emerging
markets due to higher growth trends.
Major hospitals may have long term contracts with the big players, thus
decreasing incentive to switch providers.

15
3.
Industry
trends

Global Medical Devices Market Summary | September 2024

Summary: Innovation trends transforming the global
medical devices industry

Wearables and surgical robotics are driving the

innovation trends followed by other trends.

Immersive technology 3D Printing Technological innovations, such as robotic-assisted

15% 11%
surgery and minimally invasive techniques,
Wearables
enhance surgical precision, shorten recovery times,
21% and improve patient outcomes.

Minimally
invasive
Cybersecurity devices
IOMT
5% 4%
10%
Wearable medical devices, such as smart watches
and wearable sensors, are empowering individuals
Medical
to proactively manage their health by continuously
waste monitoring vital signs and health parameters
manageme outside clinical settings.
Surgical robots Artificial Intelligence nt 5G
18% 8% 4% 4%

17
3.1 Wearable technologies are growing due to chronic diseases,
aging population, home healthcare, and remote monitoring
Factors affecting wearables market

$40.7 Market size

in 2023 Ease of use and convenience: These are user-friendly, enabling patients to monitor their health at home, reducing
hospital visits, and improving patient outcomes.
Real-time data & increased awareness: They offer real-time data, helping healthcare professionals track patient health
and make decisions. They promote continuous vital sign monitoring, increasing the adoption.
Growing demand for RPM & focus on preventive care: Adoption of wearable devices for remote patient monitoring
11.2% Poised to
be CAGR
has increased, offering a convenient, effective way to track health and play a key role in preventive care and chronic
disease management.

Partnered to monitor US hospitals for 30-day post-acute hospital-to-home distribution rights of the BioButton
+ multi-parameter wearable for continuous monitoring.

Announced the development of a new consumer bio wearable, Lingo, designed to detect critical body signals like
ketones, glucose, and lactate, helping people better understand their general health and take necessary action.

Fitbit partnered with Medtronic to develop a wearable device that tracks vital signs and can detect irregular
+ heart rhythms.

Apple and Google collaborated to innovate healthcare by integrating medical devices with tech products,
+ digitizing the system, and incorporating wearable health monitors.

There has been substantial growth in the home healthcare market, driven primarily by the expanding geriatric population, a growing incidence of chronic
diseases, and the accessibility of advanced medical devices, including wearable medical devices.
18
3.2 Surgical robotics transforming minimally invasive
surgeries and enhancing precision in medical devices
$18 bn 78% 4.8 mn 56%
market size and estimated of the surgeons in the U.S. are estimated laparoscopic of all laparoscopic procedures
to grow $83 bn by 2032 interested in surgical robotics procedures will be performed in the U.S. will be robot-assisted
globally using robots by 2032 by 2032

Key advantages Recent approvals

• Enhanced surgical precision; Mar, 2024 Intuitive gains FDA clearance for 5th generation of da Vinci Robotic
• 3-D images aid visualization; System, da Vinci 5 introduces numerous enhancements aimed at improving
surgical precision, workflow efficiency, and overall user experience.
• Minimally invasive surgeries improve
outcomes;
Feb, 2024 Virtual Incision gains the de novo clearance from the FDA for its MIRA
• Long-term benefits like tissue preservation; surgical robot, in the development of miniaturized robotic-assisted surgery
• Robotic systems enable novel techniques. (miniRAS) devices.

Top players Feb, 2024 Zimmer Biomet gets FDA clearance for ROSA Shoulder system, marking
it as the world's first robotic-assisted surgery system for shoulder replacement.

Aug, 2023 Levita Magnetics gained FDA clearance for its MARS platform aimed
at abdominal surgery, a first-of-its-kind minimally invasive surgical platform
that combines magnets and machines.

Driven by the advantages of robotic minimally invasive surgery, including greater accuracy, repeatability, and efficiency, the surgical device market
looks promising in the future outlook of the medical device industry.
19
3.3 Immersive technologies are revolutionizing the
medical devices industry
Applications

Medical education AR surgical Overcoming mental

Pain management 3D body mapping
and training navigation health disorders

MGH's Department of Johnson & Johnson has St. Jude Research Hospital XRHealth developed a Iowa Spencer Hospital
Orthopedic Surgery uses a developed an AR-based implemented EaseVRx, a virtual clinic for mental implemented an AR
system called PrecisionOS surgical navigation system VR platform, to help health treatment. Patients solution using SLAM
to train medical students that uses an optical see- patients manage chronic receive treatment at home technology. By directing a
and allows them to through head-mounted pain without opioids. through VR headsets. smartphone at the
develop the essential display (HMD) to provide solution offers immersive Solution helps with stress patient’s body, doctors
motor skills they'll need in real-time guidance and games, relaxing reduction, psychosis, could virtually map organs
the operating room visualization to surgeons environments, and depression, helps in and tumors. This approach
through safe, simulated during procedures. educational tools. After six effective drug-free therapy. increased biopsy success
practice. months, pain scores were rates by 50%.
reduced by 50%.

AR and VR have the potential to revolutionize the healthcare industry by providing immersive and realistic experiences to deliver new types of
treatments and diagnostics.
20
3.4 Intelligent health ecosystem

Cloud Computing Sensors (IOT) Quantum Computing Spatial Web

Next &
Now
beyond

5G Technology VR / AR / XR Web 3.0 Metaverse

Philips’ Capsule Medical Device Information Honeywell’s Genesis Touch connects Offers a platform for manufacturers and
Platform connects medical devices and patients with remote care providers via a healthcare providers to monitor patients’
EMRs in hospitals through a vendor-neutral dashboard that receives biometric data. It compliance with medical advice. Sensor-
system. It enables easy device integration, supports video visits, allows multiple based monitoring allows patients to stay at
vital signs monitoring, and clinical providers to access vital statistics, and home, reducing travel time and hospital
surveillance, allowing caregivers to access integrates with an oximeter, blood pressure costs. For healthcare providers, it enables
patient data and respond to high-risk events monitor, and precision health scale. frequent assessments, timely treatments,
more quickly. and transparent compliance, aiding
insurance reimbursements.

Smart health system uses different digital health tools that can work together. It also uses big data and artificial intelligence to collect and analyze
information. This helps in providing better support and care for people's health.

21
3.4 Advancements are creating a new Internet of Medical Things
(IoMT) “inside” and “on” humans, resulting in IOMT “everywhere”

24/7 Virtual care

monitoring Benefits
Smart Specialist Care Facility

• Enabling real-time data acquisition;

Sleep &
Always-on nutrition Smart Home
Connected
access to trackers • Wireless data transmission to
appliances
multidisciplinary healthcare professionals;
care team AI enabled
Motion robots, drones,
Sensors virtual
Virtual • Personalized tracking and feedback;
assistants
assistants
• Remote monitoring reduces hospital
In and On the body visits, lowers costs, and provides
Smart clothing
Smart patches
timely interventions;
Ambient Sensor- Autonomous
enabled pills
• Intelligent algorithms and data
vital sign vehicles with
sampling
Bioelectronic
sensor arrays
analytics enhance diagnostic
implants accuracy;
Smart dust
Integral
IoT tracker Nanobots Bioinformatic comprehensive • Improved communication between
assisting
workflow
tattoos diagnostic patients and service providers.
environment

Smart HVAC, Connected to

furniture & smart city
22 flooring infrastructure
3.5 Rise of AI/ML enabled solutions
No. of FDA approved AI/ML enabled medical
devices

FDA approved AI/ML medical devices

2024 191 882 (as of May, 2024)
2023 108

2022 139

2021 123

Increase of FDA approved AI medical

2020 107
280% devices since 2018
2019 77

2018 63

2017 26

FDA-approved AI/ML-enabled medical devices

76%
2016 18
belong to the radiology subspeciality
2015 5

2014 6

23
3.5 AI/ML enabled new innovations and M&A activity in the
market
Although the broader MedTech sector M&A activity has declined since 2021, strategics continue to adopt & invest in AI-related
healthcare technology.

L&T Technology Services revealed a new Smith+Nephew announced a forthcoming new Precision DL, an innovative deep learning-
partnership with chip maker NVIDIA to create feature for its CORI◊ Surgical System, this based image processing software that is
software-defined architectures. Leveraging exclusive image-agnostic robotic-assisted engineered to provide increased small, low-
NVIDIA's Holoscan and IGX Orin platforms, the surgical solution is designed to help contrast lesion detectability compared to the
solution offers low-latency data transfer, personalize surgery, advance efficiencies & conventional Time-of-Flight PET/CT scanner.
superior image processing & scalability. optimize performance.

Target Acquirer Deal Value Date Deal Type

ScienceIO Veradigm $140 Mn Feb, 2024 Acquisition

Volpara Health Technologies Lunit $194 Mn Dec, 2023 Acquisition
Spectral AI; Spectral MD - $170 Mn Apr, 2023 Merger
Envoy Medical - $150 Mn Apr, 2023 Merger
Globus Medical; NuVasive - $3752 Mn Feb, 2023 Merger
24
3.6 3D & 4D printing in medical devices industry
• 3D printing builds physical medical devices from digital designs; IoMT AND 3D printing interaction
• 4D printing goes a step further. It creates objects that can change shape or
properties over time.

Implants & Tissue Tissue Tissue

Prosthetics Engineering Engineering Engineering IoMT
Smart IoMT
Surgical, Dx Tissue Tissue Design
Drug Delivery Sensor
Tools Engineering Engineering

X Stimuli
X Y Prototype 3D Printer
3D 4D Responsive
Printing Printing
Y Z
Z Key benefits
• Improved patient outcomes through customized devices tailored
• High personalization;
• Cost-effective; to individual anatomy;
• Self-morphing capacities;
• Design flexibility; • Reduced costs and increased efficiency in the manufacturing
• Incorporates stimuli- process;
• Reduced waste; responsive materials, such as
• Ability to create smart medical devices that can adapt to patient
• Rapid prototyping; shape-memory polymers,
movements and provide better functionality;
• Better functionality. hydrogels, and bio-inks;
• Potential for targeted drug delivery and improved bioavailability;
• Less error-prone.
• Potential for tissue engineering and regenerative medicine
applications.
25
3.7 Software-laden medical devices raise the cybersecurity
and data breach vulnerability

Healthcare reported the Healthcare data breach cost Over the past three years, the Report from HIPAA Journal that 24 data
highest costs for the 13th amounted to $10.93 mn average cost of a data breach breaches of 10,000 or more healthcare
year in a row. in 2023. in healthcare has grown by 53.3%. records were reported in January 2024.

Endpoint security and education: A centralized management portal for a comprehensive endpoint security solution is essential for reinforcing
enterprise security.

Multi-factor authentication: Adopting multi-factor authentication enhances data sharing and protects patient data from unauthorized
access and tampering.
Real-time analytics: Real-time analytics in medical devices is limited but can effectively prevent outsider attacks and detect internal threats.
Strategic partnerships: Medical device companies are partnering with tech firms to enhance offerings and protect against cyberattacks.

Cybersecurity regulations: Hacking risks for connected medical devices like infusion pumps & pacemakers have increased pressure for
cybersecurity regulations.

March 13, 2024: FDA issued the draft guidance Select Updates November 15, 2023: FDA contracted with MITRE to develop the
for the Premarket Cybersecurity Guidance: Section 524B of the report, Next Steps Toward Managing Legacy Medical Device
FD&C Act, which proposes updated recommendations to the industry Cybersecurity Risks, the publication outlines practical approaches
on cybersecurity considerations for cyber devices and provides and recommendations that build on previous work and can further
recommendations for documentation in device premarket submissions. drive sector-wide legacy device cyber risk management efforts.

26
3.7 Partnerships in cybersecurity in medical devices industry
To ensure patient safety, the FDA demands robust cybersecurity in medical devices. Manufacturers must prioritize cybersecurity throughout development
and lifecycle management to gain approval.

Check Point collaborated with Tuttnauer’s CloudWave, announced the renewal of MedCrypt, Inc. announced its
T-Connect software, utilized in medical its MOU with the United States Food and partnership with Stratigos Security to
and laboratory sterilization devices, Drug Administration (FDA), to share offer a suite of third-party assessment
integrates Check Point Quantum IoT critical threat intelligence in the case of and advisory services, with specialized
Nano Agent for embedded protection, nationwide suspected threats to medical penetration tests for medical device
safeguarding against evolving cyber device security and the integrity and makers to assure the safety and
threats and end-to-end security for security of the surrounding healthcare IT effectiveness of their devices.
patient data and device integrity. infrastructure.

New tech brings benefits, but also risks. Considering safety, security, and ethics when using AI, robotics, and wearables in medical devices has
become significant.

27
3.8 5G is changing the medical devices landscape

Wearable devices Transportation

Patient health monitoring

using 5G

Smart medical Management of preventing

Smart hospital care
device infectious diseases using 5G

Cloud
computing

Robotic surgery using 5G

5G
XR technology Remote diagnostics

5G in wearable technology

28
3.8 5G is at the forefront of this transformation, and its use
cases in healthcare are already promising

Connected ambulances Remote collaborations 5G-Connected drones 5G Private networks

Mobile tech (broadband & 5G) 5G-enabled AR/VR headsets They can be steered by a remote Private 5G networks offer
lets ambulances transmit real- would let specialists directly pilot, offering a swift and safe healthcare providers a secure
time patient data. 5G slicing guide remote procedures, alternative. 5G-connected drones and dedicated solution, meeting
creates dedicated networks for ensuring patient data privacy have the potential to transform cybersecurity needs and
ambulances on existing with high-speed, private the medical device industry by ensuring reliable connectivity
infrastructure. connections. improving efficiency, safety, and through network slicing.
access to care.

In Milan, Italy, Vodafone has set up Rodes & Cones solution, the Wingcopter partnered with Celona's private 5G network
5G-connected ambulances to mirrOR KIT, allows medical device Vodafone, NUIG, Skytango, Survey provides reliable connectivity for
facilitate real-time communication reps to attend surgeries remotely Drones Ireland and Novo Nordisk clinical communications and
between paramedics, ambulance and provide technical support to to evaluate the first diabetes monitoring applications.
operators, trauma center surgeons. medication delivery via drone.
coordinators, and hospital staff.

29
4.
Business model
transformation

Global Medical Devices Market Summary | September 2024

Summary: Four potential business model transformations
that can be implemented

1
Pricing and • Pricing models that can share risks and benefits with buyers
payment • Strategic innovative pricing
innovations • Alternative forms of financing

2
Localization • Frugal innovation
of model in • Deskilling
LIMICS • Simplified services

3
Expansion • Multipurpose devices
into new • Widespread indication coverage
indications • Lower cost ancillary equipment for additional use cases

4
• Knowledge based partnerships with academic institutions
Diversify
• NGOs can act as accelerators, incubators or funders
partnerships
• Private companies for various business contracts and agreements

31
4.1 Pricing and payment innovations

Innovative pricing Leasing of devices Risk sharing model

Shared savings contracts: Supply devices at Direct leasing: Customized contracts with Outcome guarantee: Manufacturers give
a low price in exchange for a % of revenue flexible terms based on length, installments, large discounts/rebates if certain outcomes
from the device. depreciation, etc. are not met.
Risk-sharing services contracts: Hospitals Leasing through distributors: Distributors Gain sharing: Provide products at low prices
pay an annual fee to the service provider for purchase devices upfront and lease them to with an agreement to share revenues/cost
all device needs. hospitals. savings.

ü Aligned incentives on both the buyer and ü Long-term revenue streams for ü Protection from price erosion and stickier
seller side; manufacturer; relationship with customers;
ü Lower barrier to new technology ü Revenue from buyers who can’t afford ü Increased use of non-reimbursable
adoption. lump-sum payment. products.

x Revenue is dependent on performance. x Long time to recover investment costs x Resistance from insurers or government
and the burden of contract. payers.

GE is responsible to optimize TUHS’s In China, Siemens cooperated with Medtronic reimburses hospitals if its Tyrx
radiology services and receives part of the distributors that specialize in diagnostic antibacterial sleeve can’t prevent infections in
shared savings based on goals. imaging centers. cardiac implant patients.

32
4.2 Localization of model in low- and middle-income countries
(LMICs)
Solutions LMICs
GE made Vscan,
Current status in LMICs
Focus on cost reduction and addressing local needs while which was 85%
Frugal

50
maintaining performance. Maximize value-to-resource ratio cheaper than
innovation ultrasound units
for solutions tailored to resource-constrained environments.
% used in China.

of medical equipment is
broken, unused or unfit in
Cervical Cancer
LMICs
Simplification of manufacturing processes for lesser-skilled Prevention Project
Deskilling or resource-limited personnel. This may help expand medical simplified Pap
services by empowering individuals with limited training. smear technique
in Vietnam.
x No access to spare parts;
x No properly trained
maintenance personnel; GE developed a
Simplifying an existing premium product for a mid- or low- low-cost battery
x No access to proprietary Simplified tier market and still generate profit, by lowering operating powered portable
device maintenance services costs. Centralizing operations with smaller supply chains to ECG machine for
documents. decrease operational costs and increase output. rural India.

There is no “one size fits all” framework to successfully invent and implement devices due the complexities of regulatory and business operating
environment, expensive market readiness costs, and extensive safety testing of the device.

33
4.3 Expansion into new indications
Process flow for expansion into new indications

Expensive and large medical devices with expensive applications are the most suited for expansion, especially
Existing device in clinics
within the same medical subcategory (e.g. oncology).

New use/indication Physicians and clinicians are legally allowed to use devices in additional ways that they deem safe and effective
discovered for patients’ specific needs.

Ancillary equipment Additional applications and multiple purposes for the devices need significant acceptance in the field before they
(if required) can be legally considered as a “labeled” indication. These may require additional equipment from the manufacturer.

Device used in new Once established as a new indication and widely accepted, the manufacturer can reap the revenue benefits
indications through ancillary equipment sales and consumers gain additional benefits without substantial capital expenditure.

• Cancer radiotherapy devices have expanded to be able to treat various types of cancer-like lung, pancreas, liver, etc.;
Examples • Redesigning a surgical robot to have additional robotic arms with different precision levels suited for different parts of the body;
• J&J ThermoCool SmartTouch catheter for cardiac ablation was granted FDA label extension to treat atrial fibrillation.

Manufacturers can help make a device more attractive to buyers under budget pressure looking to recoup up-front procurement costs as quickly as
possible. Manufacturers will need to plan life cycle strategies starting early in development to access the full potential of their products.

34
4.4 Diversify partnerships

Academic institutions NGOs Local stakeholders

Universities, research organizations, Accelerators, incubators, funders (social Medical providers, biomedical engineers,
medical colleges sector improvement NGOs) patients, government

Strengthening local human capacity, Identify promising innovators and provide Contextual expertise is essential, as they are
training for staff in the medical field a network of resources such as financial best suited to analyze the needs of their
researching efficacies of medical devices, investment, expertise, and access to patients and the country’s health systems
and innovating newer devices. development opportunities. capabilities.

ü Partnerships with academic institutions ü Promote innovation at all stages and ü In-country manufacturers and distributors
can lead to powerful new health enhance access to other stakeholders; have existing supply chains;
technologies; ü Incorporate government support into ü Physicians can serve as product
ü Increases acceptance of new devices at product development. champions.
the institutional level.

LSO partners with many universities in the Gates Foundation invests in promising GE and Sinopharm are in a joint venture to
USA to support research projects dealing innovators and provides extensive support expand access to CT and ultrasound imaging
with medical devices. throughout the device life. in China.
35
5.
M&A
trends

Global Medical Devices Market Summary | September 2024

M&A – MedTech, devices,
digital health and wearables
Insights

120,0 140
• In 2023, there were 47 M&A deals in MedTech,
compared to 51 in 2022, indicating a slight reduction in
99,2 120 the number of mergers and acquisitions.
100,0

100 • Total upfront cash and equity for M&A deals in 2023
80,0 amounted to $12.72 Bn, with a total deal value of
$14.21 Bn, which is significantly lower than 2022, which
65,3 80 had $24.60 Bn in upfront cash and equity and a total
60,0 deal value of $28.26 Bn.

60
43,3 • Most MedTech deals in 2023 were tuck-in acquisitions
51
40,0 34,1 of products or services that fit within the existing
27,728,2 47 40 pipelines of the acquiring companies, rather than novel
26 23,5
21,5 22,4 acquisitions that could have brought them into new
20,0 17,5 areas.
14,2 20
6,5 9,0 7,2 8,2
• The pandemic has forced medical device companies to
0,0 0 adapt to new challenges and opportunities, leading to
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
a shift in M&A strategies toward strategic acquisitions,
regulatory expertise, and digital capabilities.
Total Amount Raised ($Bn) No. of Deals

37
Top M&A by value in MedTech industry

Type Target Acquirer Size Date Description

$2.3 Mar Ingersoll Rand bought ILC Dover to grow in life sciences, ILC Dover brings established market
Acquisition
bn 2024 positions and brands in the biopharmaceutical, pharmaceutical, and medical device markets.

To expand J&J's cardiovascular portfolio into two high-growth segments: coronary artery
$13.1 Apr
Acquisition disease (CAD) and peripheral artery disease (PAD) with Shockwave's intravascular lithotripsy
bn 2024
(IVL) enhancing J&J's offerings in cardiovascular care.

$3.7 Jan Deal focuses on Boston Scientific’s expanding its urology portfolio with differentiated
Acquisition
bn 2024 technologies and enhancing its presence in the sacral neuromodulation market.

To expand Thermo Fisher's capabilities in the proteomics market, as Olink's technology

$3.1 Oct
Acquisition provides high-throughput analysis for quantitative PCR and next-generation sequencing
bn 2023
systems used by biopharma companies and academic researchers.
Spectrum's expertise in advanced manufacturing and customer relationships with major
$1.7 May
Acquisition medical device OEMs complements DuPont's existing healthcare offerings, including Liveo
bn 2023
silicone solutions and Tyvek medical packaging.

$3.7 Feb To create the world's leading musculoskeletal technology company by combining their
Merger -
bn 2023 portfolios and operational strengths.

Warburg Pincus and Advent International to acquire Baxter to form Simtra. Simtra will be a
$4.2 May
Acquisition fully independent, end-to-end contract development and manufacturing organization
bn 2023
(CDMO) offering services from clinical development to commercial fill/finish.

38
Key trends driving the medical devices M&A, investment
markets
Outsourced providers with regulatory expertise are in high demand due to increasingly complex approval processes
Outsourced and higher R&D spending.
1 regulatory
support Continued development of complex medical products and devices is driving increased demand for full-service CMOs
that can provide solutions from front-end design and development work through high-volume productions.

Shift to Investors now prefer funding devices that utilize a quicker 510(k) pathway, making a shift from recent years when
2 510(k)
pathway
they preferred devices requiring Premarket Approval (PMA).

Increased
3 digital
transformation
Industry is undergoing significant digital transformation, with companies investing heavily in digital technologies
such as artificial intelligence, blockchain, and the Internet of Things (IoT).

The orthopedic market is expected to grow significantly due to backlogged procedures, particularly joint

4 Orthopedic &
cardiac markets
replacements, driven by factors such as the COVID-19 pandemic and demographic shifts.
Emerging cardiac markets, with companies actively engaging in deals to capitalize on growth opportunities presented
by advancements in cardiac technologies and treatments.

5 Strategic shifts
Companies are shifting their focus from large acquisitions to organic growth and smaller, strategic tuck-in deals to
manage risks better and integrate new capabilities more efficiently.

39
6.
Software and AI
as a Medical Device

Global Medical Devices Market Summary | September 2024

Software and AI as a Medical Device making significant
advances in medical industry
Software as a Medical Device (SaMD)
Medical Devices
• SaMD is defined as software intended to be used for one or more medical
Software as a Medical Device (SaMD) purposes that perform these purposes without being part of a hardware
medical device;
AI as a Medical Device (AIaMD) • Software used to drive or control the infusion pump or an implantable
pacemaker;
Machine Learning • These types of software are referred to as embedded software, firmware,
Enabled Medical Devices or micro-code.
(MLMD)
AI as a Medical Device (AIaMD)
• AI approaches are being incorporated into SaMD, and these may be
described as AIaMD;
SaMD market value • Just like traditional medical devices, AIaMDs are designed to assist
(in $ Bn) healthcare professionals and improve patient outcomes;
6,1 • AIaMD leverages extensive datasets and intricate statistical methodologies
to unveil novel connections among inputs, actions, and outcomes.

Key market insights (SaMD)

1,8 • The g lobal SaMD market is calculated to reach $6.1 Bn by the end of 2034;
• The m arket is projected to grow at a CAGR of 13% during the forecast
period of 2024-2034;
2024 2034E • Cutting-edge innovations drive growth in the market size.

41
Trends impacting the SaMD and AIaMD industry

Personalized healthcare and Government initiatives and

Data analytics and integration
remote monitoring competitive landscape
AI-powered SaMD solutions and remote AI adoption in healthcare fuels SaMD Several regional governments are actively
monitoring tools are personalizing growth, but robust data security and user promoting digital healthcare and
healthcare by analyzing data, predicting trust are paramount to overcome privacy investing in SaMD, creating a supportive
risks, and enabling early intervention. concerns and achieve widespread use. environment for market expansion.

Regulatory framework and Cybersecurity risks Mobile health boom and

documentation and integration technological advancements

Evolving SaMD/AIaMD regulations High cybersecurity concerns, requiring High mobile penetration in Asia-Pacific
emphasize post-market monitoring, AI- robust safeguards for safe devices, and fuels SaMD/AIaMD adoption, while AI,
specific challenges, and efficient delivery, integration with existing healthcare machine learning, and cloud
while robust documentation with SBOMs systems demand careful documentation & advancements drive innovation for more
is key for compliance and safety. compliance for smooth operation. effective healthcare solutions.

42
SaMD and AIaMD are changing the industry by improving
outcomes, reducing costs and enhancing the quality of care
SaMD AIaMD

Remote patient Surgical planning AI-powered Predictive Personalized

monitoring diagnostic tools analytics medicine
& medical imaging

Computer-aided detection Robotics & Medical device

Telemedicine
(CAD) software automation maintenance & repair

Major players in the industry

43
Regulatory scenario of AIaMD in UK

Medicines and Healthcare products Regulatory Agency (MHRA) is the independent regulator of medicines,
Regulatory body
medical devices, and blood components for transfusion in the UK.

Regulation of medical devices in the UK is in a transition phase. Currently medical devices on the UK market (including SaMD and AIaMD) are regulated
under the UK’s Medical Devices Regulations 2002 (as amended).

In September 2021,MHRA announced the Software and AI as a Medical

UK regulatory framework for AIaMD is evolving, with a focus
Device Change Programme, a programme of work to ensure regulatory
on balancing innovation and safety
requirements for software and AI are clear and patients are protected.

MHRA’s Software Group has responsibility for all SaMD and AIaMD • UK Medical Devices Regulations 2002 are being reformed,
placed in the UK market. goal is to ensure safety and performance while with new regulations expected to be introduced in 2025;
enabling rapid innovation.
• MHRA has launched a pilot regulatory sandbox, AI Airlock,
in spring 2024, to identify and address the unique challenges
posed by AIaMD from a regulatory perspective;
Pre-market requirements Post-market requirements
• MHRA is exploring the use of AI to enhance its regulatory
decisions, including leveraging AI to improve the timeliness
A regulatory 'airlock' will be MHRA currently uses the Yellow Card of access to medical products;
introduced to help devices Scheme for the reporting of medical
• MHRA is developing a data strategy that prioritizes applying
intended to meet an device adverse events and this system
advanced analytics and AI within the regulator safely and
unaddressed clinical need to will be integrated into the Change
responsibly, aiming to improve the quality of applications for
generate the necessary pre- Programme, clarifying reporting medicines licenses and enhance regulatory services.
market phase evidence. obligations and next steps.

44
Regulatory scenario of AIaMD in US

FDA reviews medical devices through an appropriate premarket pathway, such as Approach to total product lifecycle for
premarket clearance (510(k)), De Novo classification, or premarket approval. AI/ML medical devices:

FDA published, "Proposed Regulatory Framework for Modifications to (AI/ML)- • Quality Management Systems (QMSs):
Apr, FDA expects QMSs to be adapted to the specifics
Based (SaMD)”, which describes a potential approach to premarket review for
2019 of developing AI/ML Medical Devices.
artificial intelligence and machine learning-driven software modifications.

Jan, • Initial premarket assurance:

In January 2021, the FDA published the "AI/ML SaMD Action Plan”. FDA requires data on the Valid Clinical
2021
Association, Analytical Validation, and Clinical
Validation of AI/ML Medical Devices to ensure
Oct, Proposed “Good Machine Learning Practice for Medical Device Development: ethical AI and accurately address bias.
2021 Guiding Principles”.
• “Predetermined Change Control Plans” system:
Mechanism of the FDA pre-approving changes to
Apr, Draft Guidance: Marketing Submission Recommendations for a Predetermined
medical devices that include AI components
2023 Change Control Plan for (AI/ML)-Enabled Device Software Functions. where careful justification and evidence exist to
support allowing these changes.
Oct, Predetermined Change Control Plans for Machine Learning-Enabled Medical
2023 Devices: Guiding Principles. • Transparency and post-market surveillance:
FDA wants to ensure AI/ML medical devices are
FDA published the "Artificial Intelligence and Medical Products: How CBER, performing well over time and that developers
Mar, are being transparent when changes in
CDER, CDRH, and OCP are Working Together," which represents the FDA's
2024 performance occur.
coordinated approach to AI.

45
7.
Orphan medical
devices

Global Medical Devices Market Summary | September 2024

Orphan medical devices are used to treat rare diseases which
present various challenges
Rare diseases by numbers

Diagnostic odyssey
• Time for correct diagnosis: 5 to 7 years
• Physicians consulted: up to 8

~300Mn 50% 6000+ 72% • Misdiagnoses: 2 to 3

people worldwide live affected by rare different identified rare rare diseases are Genomics can improve these indicators, but it is
with a rare disease diseases are children diseases genetic expensive

Challenges identified

Limited
No universal Delayed Financial
Misdiagnosis treatment Social burden
definition diagnosis burden
options

Orphan Medical Devices need to cater to a broad diversity of symptoms and disorders that vary for patients suffering the same disease.
Rare diseases have a big impact on patients’ quality of life, thus making it imperative for orphan devices to be effective and affordable for chronic
management of disease.
47
Significant shortage of orphan medical devices globally due to
complex landscape of application
Over 90% of medical specialists in a US Survey indicated the need for more and specific
orphan medical devices Development flow

o 64% clinicians are dissatisfied with existing orphan medical devices;

Existing device

o FDA has an approval rate of around 1 out of 20 designations for rare disease applications;
Causes for Off-label use
unmet needs
o 37% clinicians repurpose an existing medical device for rare disease applications;
New Orphan Device
o Only 2 countries – USA(FDA) and Japan(PMDA) have orphan device authorizations.

Special focus area - children

Lack of orphan devices affects children more, because of smaller body parts and even rarer diseases than adults;

o Prosthetics: Used after rare cancer surgery in children which will grow as the child grows;

Devices required
o Implantable pacemakers: For children with rare heart conditions, which can be replaced over time;
especially by
children
o Smartphone apps: Support parents with their child’s nutrition and drug regimen;

o Alarming device: for small and big seizures in rare epilepsy conditions.

48
Some examples of orphan medical devices and
their manufacturers
Congenital talipes equinovarus (CTEV) is a birth defect where one or both feet are
Brace for clubfoot in rotated inward and downward.
newborns Treatment involves initial casting for 6 weeks, followed by surgery and continued
casting for several weeks, then brace support will lead to a total cure.

Cystic fibrosis is a genetic condition that affects cells that produce mucus, sweat and
digestive juices.
Nebulizers for cystic
fibrosis Treatment involves controlling symptoms through nebulizer therapy with drugs like
albuterol, pulmozyme, and inhaled antibiotics (Tobi and Tobramycin), varying from
patient to patient.

Thoracic insufficiency syndrome is a chest wall deformity that interferes with lung
Vertical expandable function and development.
prosthetic titanium rib Treatment involves implanting the rib into infants and expanding the device through
(VEPTR) outpatient surgery every 6 months. The device stays in place and adjustments can
be made till skeletal maturity.

49
8.
Software and data
initiatives by big
players

Global Medical Devices Market Summary | September 2024

Patient support programs (PSPs) and education initiatives are
driven by data management and software applications (1/2)
Companies Therapy Areas Descriptions

Cardiology, neurology, • a:care app and website: Personalized treatment schedules and behavioral analysis of patients
women’s health, digestive through gamification. Patients can stay informed through the news on disease management,
health, respiratory health nutrition, and lifestyle support.

Cardiology, diabetes, • Medtronic patient services: General educational information about all medical devices offered,
neurology, invasive along with contact lines for support for doctors and patients. Separate procedures and channels
therapies for communication regarding returns and replacements.

Orthopedics, surgery, • JnJInstitute: Offers healthcare professionals access to a robust collection of educational content,
interventional solutions, available online through a website;
vision • Support resources and information: Specific details for each product and support contact lines.

Cardiology, hepatology, • eHealth solutions: Care collaboration, patient engagement, and information exchange
radiology, neurology, platforms to assist doctors to collaborate and deliver the best care possible;
oncology, women’s health • Education and Coaching are provided for staff upskilling in hospitals through an online portal.

• Support possibilities platform: Educational content on complete treatment pathways and

Hepatology, patient care,
relevant information about all aspects of kidney disease. Portal for connections with other
mental health
patients for insights and personal experiences.

• New care settings and patient self-care management are priority areas under innovation
Critical care, surgery,
through technology;
diagnostics, urology
• The webinar series for Critical Care on the website is conducted every month.
51
Patient support programs (PSPs) and education initiatives are
driven by data management and software applications (2/2)
Companies Therapy areas Descriptions

• Large patient care solution portfolio: Data driven solutions to physician needs like access to
Surgery, observation,
data, knowledge base and especially tracking of monitoring data for better care and quicker result
critical care
for patients. Indirect benefits to patients through improving capabilities of clinicians.

• Patient education: Informative sites on various therapy areas for patient aid relating to lifestyle
Orthopedics, ENT, chronic
improvements and overall wellbeing to foster their return to an active life. Orthopedic surgeons
back pain
can be located and found for patients based on their requirements.

Respiratory, imaging, • RespirTech: Payment obligations for patients needing financial help for inCourage Airway
monitoring, oncology, Clearance Therapy are covered by the online application;
diagnostics • Education resources for Imaging, Monitoring, Oncology, and Diagnostics for support staff.

• Patient access and support insights: Patient care products designed for home care, which can
Patient care, oncology,
ease patient access, eliminate cost concerns;
ophthalmology, neurology
• Educational resources on the website for healthcare professionals and other stakeholders.

3/10 4/10
Companies offer dedicated Companies offer patient
PSP platforms/portals education initiatives

Medical Device companies still seem to be lagging in terms of PSPs and education initiatives (especially for patients), as only a few of them have a dedicated
platform or portal for the same.
52
Data related partnerships of industry players revolve around
cloud computing and IoT

Improve business agility, Accelerating device research and Enhancing overall customer
consolidate operations, support development, securely sharing experience, improving patient and
connected health products data externally with regulators economic outcomes

Data storage, sharing and Develop early cancer Connect and manage IoT
analysis for connected detection software solutions enabled devices and platform
devices to collect and process data
from records
Personalized healthcare
On-premise cloud platform through Apollo platform
Hybrid cloud strategy in 2014
to switch computing
Data security platform Created a data mesh for
workloads to the cloud for
decentralized ownership of
J&J (parent)
data

Medical Device companies have already adopted the cloud computing trend and now largely look forward to expansion into AI&ML and
IoT driven partnerships.
53
The Big Four tech companies show increasing interest in the
healthcare industry

Precision medicine Clinical research Pharmacy & virtual care Cloud market
AI can create a new paradigm CEO’s goal is to build Apple Seeks to leverage existing Transform care by combining
for the detection, diagnosis, Health as a big contributor to presence as an eCommerce research, health product
and treatment of disease mankind giant to expand into healthcare development and partnerships

• Algorithm that can diagnose • Certified by FDA for a faster • PillPack: online pharmacy that • Upsell current healthcare
diabetic retinopathy in high- approval track for innovations; works with insurance plans; clients and forge new
quality images; • Partnered with Stanford • Software that mines patient collaborations;
• Project baseline: study that Medicine for the Apple Heart medical records to be used to • Significant number of patents
aims to establish a baseline of Study based on watches; improve treatments; filed for AI and Telehealth;
good health and understand • HealthKit: health information • Echo and Alexa: medication • Healthcare NExT: AI-driven
risk factors for disease; database on iPhones; management for the elderly, initiative for the future of
• If AI can better detect and • ResearchKit: enables users to blood pressure management, health;
manage disease, turn to the enroll in medical tests for their programs and tips for a • Over 14,000 partnerships
insurance business that can condition. healthier lifestyle. with hospitals and healthcare
help patients manage risk. institutions worldwide.

Consumer demands for fast healthcare services have led to the healthcare industry moving towards digital tech, and big tech companies are lending their
expertise to become partners for the job.
54
9.
Recent regulatory
insights

Global Medical Devices Market Summary | September 2024

European Union reformed its existing medical device
regulations
Council of EU adopted new medical device regulations (MDR) to reform existing medical device & in-vitro diagnostics regulations. Under the new
guidelines, all medical devices will need to undergo safety & performance assessment before they can be marketed in Europe.

Dec 2020 26 May 2021 Sept 2021 26 May 2022 26 May 2024 26 May 2025

EUDAMED Unique
New EU IVDR Devices certified
EUDAMED Actor Implementation device identifier
(classifies IVDs) EU MDD under the EU
registration date for the (UDI) /Devices
applies across the certificates expire MDD can no
(module 1) EU_MDR registration and
EU from May 26, longer be sold or
released notified bodies /
2022 distributed
Certificates

o EU MDR, which came into effect in 2017, has a transition period ending on 31 December 2027 or 31 December 2028, as applicable;
o Commission implementing regulation as of 5 December 2023 designates European Union reference laboratories (EURLs) in the field of in vitro
diagnostic medical devices;
o On 15 March 2023, Regulation (EU) 2023/607 was formalized, providing medical device manufacturers more time to certify medical devices
to mitigate potential shortages.

56
Impact of EU MDR on Medical Device Manufacturers (1/2)

Reclassification or up-classification Elevated clinical testing Focus on post-market

of devices requirements surveillance

• Under the MDR and IVDR, changes will • For medical devices, the new regulations • Under the new IVDR and MDR, there will
made to the way medical devices are require reassessment of clinical data for be an increased emphasis on post-market
classified; devices already on the market; surveillance;
• Requirements will be scrutinized based on • If the data do not meet the new • This includes proactively monitoring device
risk to the patients; requirements, devices will be required to performance for recertification, rapid
• E.g., certain devices that meet the spinal undergo additional testing to be reporting of safety incidents, and annual
cord will move up from class II to class III recertified, increasing the expense of safety updates for higher-risk class devices.
maintaining legacy devices;
• Reclassification will require a costly
certification process for new & existing • Due to the reclassification of IVDs, device
products. makers that have not previously been
required to perform clinical testing will
have to develop the ability to do so.

57
Impact of EU MDR on Medical Device Manufacturers (2/2)

Separate regulatory framework Risk based classification Robust verification regime

• With the MDR 2020 coming into effect in • For medical devices, the new regulations • Under the new IVDR and MDR, there will be
April 2020 providing an all-inclusive and require reassessment of clinical data for an increased emphasis on post-market
comprehensive definition of medical devices already on the market; surveillance;
devices, until then unregulated sector has • If the data do not meet the new • This includes proactively monitoring device
been given a due and separate regulatory requirements, devices will be required to performance for recertification, rapid
framework from that of drugs and undergo additional testing to be reporting of safety incidents, and annual
medicines; recertified, increasing the expense of safety updates for higher-risk class devices.
• From April 2020, all medical device maintaining legacy devices;
manufacturers have been mandated to • Due to the reclassification of IVDs, device
register themselves with a government- makers that have not previously been
designated portal to carry out any required to perform clinical testing will
manufacturing, distribution, sale, and have to develop the ability to do so.
importing of a medical device.

58
Recent key regulatory highlights in the US medical devices
market
Modernizing the 510(k) programme
Sept 2023 FDA released guidance to improve the 510(k) program’s predictability and transparency, especially for implants. This aims to
enhance review processes and device safety.

Revamped guidance document: cybersecurity in Medical Devices

Sept 2023 Due to increased cyberattacks, the FDA released updated cybersecurity guidance for medical devices. It includes
recommendations for risk assessments and premarket documentation.

List of Medical Device shortages gets shorter

June 2023 FDA updated its list of medical device shortages, removing several categories. CDRH will invest $11.6 Mn in the Resilient Supply
Chain Program by September 2024.

Transitioning COVID-19 EUA Medical Devices

May 2023
FDA’s CDRH issued guidance to transition COVID-19 devices from EUAs to traditional marketing. This aims to normalize
operations after over 4,000 devices received EUAs.

New rules on AI and ML-based Medical Devices

April 2023 FDA issued guidance for AI/ML-enabled devices, supporting their improvement while ensuring safety. It outlines requirements
for a Predetermined Change Control Plan in marketing submissions.

59
Recent regulatory scenario in other parts of the world

In India, Medical device trade margins is China’s Center for Medical Device Recently, South Korea’s Ministry
set to be capped at 30% Cardiac stents, Evaluation recently released new of Food and Drug Safety (MFDS)
drug-eluting stents, and intra-uterine procedures for device registration in 2020. released a draft revision to the Regulation
devices are included in the National List This includes increased standardization of on Medical Device Codes & Classification.
of Essential Medicines and are, therefore, the filling review process and new Amendments include a new category
subject to notified price caps. Stents and withdrawal and re-submission procedures in the product classification system for
knee implants were the latest to be for up-classified devices. SaMD, a new category for medical
brought under the price control. respirators, and minor adjustments
to existing medical device product
classification codes.

A global harmonization effort among the US, Canada,

Brazil, Japan, and Australia, which became operational on
January 1, 2017. Additional markets and organizations,
including the World Health Organization (WHO), Medicines
and Healthcare products Regulatory Agency (MHRA),
Singapore’s Health Science Authority (HAS) , and European
Union (EU), are official observers of the Medical Device
Single Audit Program (MDSAP).
Confidential. Internal Use Only. 60
60
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About Nagarro Nagarro Life Sciences & Healthcare

Nagarro, a global digital engineering leader, helps future-proof At Nagarro we leverage the newest technologies to build tailored and compliant
your business through a forward-thinking, fluidic, and CARING solutions in MedTech, BioPharma & Digital Health, BioStatistics, Hospitals &
mindset. We excel at digital engineering and help our clients LIMS, and Manufacturing Execution Systems. Be it streamlining your medical
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their ability to be responsive, efficient, intimate, creative, and medical technologies, we make it all possible.
sustainable. Today, we are over 18,300 experts across 37
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countries, ready to help our customers succeed.
industry experience make us the preferred partner for leading global pharma
For more information, visit www.nagarro.com. companies, biotech companies, hospitals, and all in need of life sciences and
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For more information, visit go.nagarro.com/life-sciences.

Authors
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Dr. Purav Gandhi
linkedin.com/company/nagarro
[email protected] linkedin.com/showcase/life-sciences-at-nagarro/

Gabriel Turcu
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