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TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
March 2025
VOLUME NO. 20 / ISSUE NO. 2
Features
COVER STORY
20 Manufacturing
by the micrometer
Micromachining
requires tiny tooling
to meet the medical
industry’s need for
precision.
12 Generative AI for
Manufacturing 4.0
Generative artificial
intelligence technology
drives long-term
improvements – from
boosting efficiency to
meeting sustainability
goals.
24 Precious metals
Understanding and
achieving the key
characteristics of
precious metals
designed for
deployment in
innovative medical
devices and implants.
Contents
4
Editor’s Letter
6
News
8
Infographic
9
MedTech MindSet
TODAY’S MEDICAL DEVELOPMENTS (ISSN# 19418817) is published semi-monthly in January/February, March, April, May, June, July, August, September, October and November/December. Copyright 2025 GIE Media
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20
DESIGN & A U T O M ATION UPDATE
Departments
10
Regulatory
15
Featured Product
23
Cover Shots
27
3D + Additive
28
Medical Innovations
29
Products + Tech
29
Classieds/Ad Index
30
1 Last Look
16
HFE for
medical device
development
18
News
12
24
4
Editors
I’M NOT AN ECONOMIST, but aer siing
through numerous presentations by
economists, they’ve all echoed the same
insight: tariffs don’t work; tariffs tend to
have a negative economic impact.
e Feb. 11, 2025 MarketWatch opinion
column by Prof. Peter Morici echoes
similar insight, as he wrote, “Trump’s new
steel, aluminum, and reciprocal tariffs
will boost inflation. Big tariffs on Canada,
Mexico, Europe, Japan, and others will
weaken those economies, encourage retali-
ation against the U.S., and drive these reli-
able U.S. allies into accommodations with
Russia and China. Ultimately, America will
become isolated, with smaller markets for
its technology products and fewer resourc-
es for both research and development and
advancement in artificial intelligence.
is will result in diminished growth and
leave the U.S. a poorer nation. at’s why
Trump’s tariffs and tax-cut aspirations
must reflect voter sentiments. Otherwise,
Trump won’t reduce the U.S. trade deficit
or boost U.S. manufacturing.”
e moment tariffs were placed,
altered, put on hold – tariff whiplash –
then more added (steel and aluminum as
of the writing of this column), industry
associations have asked for exemptions for
their industries. AdvaMed President and
CEO Sco Whitaker advocated for relief on
most medical devices. Jay Timmons, pres-
ident and CEO at the National Association
of Manufacturers wrote “a % tariff on
Canada and Mexico threatens to upend
the very supply chains that have made
U.S. manufacturing more competitive
globally.”
Right aer the November elections Am-
ber omas, VP, advocacy at AMT – e
Association For Manufacturing Technol-
ogy, wrote, “AMT believes targeted tariffs
should be used cautiously and sparingly…
Rather than relying on unilateral tariff
measures, the em-
phasis should be on
pursuing multilater-
al trade agreements
that open markets
and reduce barriers,
fostering a global
trading environment
that benefits all
parties involved.”
And, in the Fortune/Deloie CEO
Survey: Fall , respondents’ opti-
mism about the global economy surged
from % in Fall to %; but % see
international trade and tariffs as potential
risk for their businesses. e concern is
real. In a report by the Board of Governors
of the Federal Reserve System, Division
of Research and Statistics, the authors
summarize that, “Aer two years of robust
gains, manufacturing industrial produc-
tion (IP) declined by more than .% from
December to July . Notably, this
decline followed shortly aer the U.S. im-
posed substantial tariffs on some imports
and U.S. trade partners retaliated with
tariffs on some U.S. exports… We find that
rising input costs and retaliatory tariffs
can account for around half of the recent
decline in manufacturing IP growth.”
It’s clear tariffs pose significant chal-
lenges to manufacturing – boosting in-
flation, increasing the cost of production,
disrupting supply chains, diminishing U.S.
competitiveness, creating compliance and
regulatory challenges, impacting innova-
tion, and reducing project margins. Tariffs
can be a tool for smart industrial and trade
policy but shouldn’t be the centerpiece of a
national economic strategy.
So, who are the tariffs fine for if many
are claiming tariffs are fine for others but
not for their industries?
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
// BY ELIZABETH ENGLER MODIC
PUBLISHER/SALES
Mike DiFranco Group Publisher
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JKauman@gie.net / 216.393.0217
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Contributing Columnists
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Patrick Roberts Classied Ads Manager
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PBarrett@gie.net / 44.7778.357722
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MaggieLiu@ringiertrade.com / 86.2885.5121
CORPORATE
Richard Foster Chairman
Chris Foster President and CEO
Dan Mooreland Publisher Emeritus
James R. Keefe Executive Vice President
Kelly Antal Controller
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ph: 800.456.0707 / fax: 216.525.0515
Tariffs: Fine for
thee, not for me
6
News
TODAYSMEDICALDEVELOPMENTS.COM
TODAYSMEDICALDEVELOPMENTS.COM
PHOTOS COURTESY OF RESPECTIVE COMPANIES
Advancing workforce training
A collaborative partnership has been
set up between HEIDENHAIN Corp. and
the Machinists Institute, a non-prot
training organization in association with
the International Association of Machin-
ists and Aerospace Workers (IAM) trade
union. The Machinists Institute, with facil-
ities in Seattle, Spokane, and Vancouver
Washington, as well as Oakland and Long
Appointments,
promotions, new hires
Greg Haley has been
named president of
the Americas Region
operations at Fas-
tems LLC. Bringing
more than a decade
of automation and
long-term strategy
experience to this
role, Haley plans to focus on growing the
sales and service teams throughout the
United States to provide more local-
ized support of Fastems partners and
customers. This also includes increasing
Fastems’ footprint and services in Cana-
da and Mexico.
Haley holds a Bachelor of Science in
mechanical engineering from the Uni-
versity of Florida and has completed the
postgrad program in articial intelligence
& machine learning with an emphasis on
business applications from The University
of Texas at Austin.
https://www.fastems.com
INDEX has restructured its sales team
along with a reorganization of territo-
ries. Bryan Young joined the company
as national sales manager, while John
Kemezis and Jason Shorette have joined
as regional sales representatives.
Young was selected to lead the
INDEX sales team for the United States
and Canada. Through roles that have
encompassed machine programming
and operation, applications, service, and
Beach, California, provides apprentice-
ship and training in support of workforce
development in the manufacturing, ma-
chining, and industrial sectors.
The Machinists Institute provides a
standard training curriculum in manual
and CNC machine operation and pro-
gramming, robotics, additive manufactur-
ing, and shop economics.
The HEIDENHAIN Connect Manufac-
turing Innovation Hub, launched in April
2024 in Fremont, California, will serve as a
hands-on training facility enabling an ex-
tension of outreach to the Bay Area com-
panies, universities, and trade schools.
https://www.heidenhain.us/
Greg Haley
7
News
TODAYSMEDICALDEVELOPMENTS.COM
TODAYSMEDICALDEVELOPMENTS.COM
Star SU, the market-
ing, sales, and service
aliate of Star Cutter
Co., has appoint-
ed Richard (Rick)
Rickert as its round
tool product manager.
Rickert is responsible
for identifying customer needs and mar-
ket trends for product development, cul-
tivating relationships with key accounts,
and supporting regional sales distributors
to achieve sales goals. Based in the
Farmington Hills oce, he will report to
Andreas Blind, Star SU president.
https://www.star-su.com
sales, he has a strong track record of
applying a broad and deep understanding
of complex manufacturing systems to de-
velop prot-maximizing solutions tailored
to customers’ specic needs.
In his new role, Kemezis will leverage
his deep understanding of the market
and customer needs to help companies
optimize their manufacturing processes
and attain greater eciency.
Shorette’s practical knowledge of
machine tools and customer focused
mindset will enable him to provide in-
sightful recommendations to overcome
companies’ most challenging manufac-
turing issues.
https://www.index-group.com/en_us/
Continuing in his
role as general
manager for Latin
America, REGO-
FIX USA General
Manager William
(Bill) Obras will
spearhead strate-
gic relationships
as director of partnerships for the Center
for Machining Excellence (CME), which he
was a driving force in developing. Obras
has been with the company for nearly 30
years.
Je Schemel
is being promoted
from North Ameri-
can sales manager
to general manager
USA. Schemel has
more than two de-
cades’ experience
with REGO-FIX
customers and will oversee all business
activities in the U.S. and Canada.
https://regousa.com
(Left to right) John Kemezis, Bryan Young,
and Jason Shorette
William (Bill) Obras
Je Schemel
Richard (Rick) Rickert
8TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
ICONS: ADOBE STOCK
SOURCE: https://www.cinde.org
COSTA RICA
A STRATEGIC HUB FOR MEDICAL DEVICE
MANUFACTURING AND EXPORTATION.
San Jose
Medical Infographic
With the medical device sector’s steady growth and sophistication,Costa Ricahas ex-
panded to handle increasingly more complex processes within the life sciences global
value chain. Today, the country manufactures and assembles Class I and II medical de-
vices and has advanced in the design, development, and validation of Class III products.
14 of medtech’s 30 major
multinationals have set up
operations in Costa Rica
2017-2023
• Medtech companies have grown from 67 to 86
•Jobs increased from 22,399 to more than 55,000
• Number of original equipment manufacturers (OEMs) up by 39%
•Exports have doubled
• Number of jobs increased by 127%
$7.5 MILLION
2023 export value
18%
Average annual increase in
exports since 2017
2ND
Largest exporter of medical
devices in Latin America
5TH
Largest supplier of medical
devices to the U.S.
Medical devices – the
#1 EXPORT
product of Costa Rica
2023:
42% of OEM exports
were precision, medical
equipment products
92 companies in the
life sciences sector
in Costa Rica
9
Medtech Mindset
MedWorld Advisors
https://medworldadvisors.com TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
BY DAVE SHEPPARD
IF THERE’S ONE THING WE CAN COUNT ON IN MEDTECH
MANUFACTURING, it’s change – and not always the kind we’d
-
-
-
-
NAVIGATING THROUGH
THE TARIFFS IN MEDICAL
DEVICE MANUFACTURING
-
-
-
-
While mergers and acquisitions (M&A) have always
been a tool for growth, the current environment may
accelerate deals focused on supply chain realignment
rather than purely technological synergies.
-
-
ABOUT THE AUTHOR: This column was written by guest author Daniel Sheppard,
CM&AA. He has spent nearly two decades advising founder-owned medtech and
nance companies in mergers and acquisitions, corporate nance, and strategic
growth initiatives. He is currently a managing director at MedWorld Advisors
and can be reached at Daniel@MedWorldAdvisors.com. Value = Strategic Fit +
Timing® is a registered trademark of MedWorld Advisors.
PHOTO © TGIF | ADOBE STOCK
10
Regulatory
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
PHOTOS COURTESY OF RESPECTIVE COMPANIES
Medtech approvals
Zimmer Biomet
Holdings Inc.’s
Persona Solu-
Tion Porous
Plasma Spray (PPS) Femur, a total knee implant compo-
nent oering an alternative for patients with sensitivities
to bone cement and/or metal, received U.S. Food and
Drug Administration (FDA) 510(k) clearance. The Persona
SoluTion PPS Femur features a porous coating for
cementless xation and leverages a proprietary surface
treatment designed to enhance wear performance.
Persona SoluTion PPS Femur oers cementless
xation with its clinically proven PPS coating providing
initial scratch t stability and supports biologic xation
through bony ongrowth. When combined with Persona
OsseoTi tibia and Vivacit-E Highly Crosslinked Polyeth-
ylene (HXLPE), the total knee implant minimizes the most
common metal sensitizers (nickel, cobalt, and chromi-
um) likely to elicit an immune response and is made of
a proprietary Tivanium (Ti-6Al-4V) alloy with more than
17 years of clinical use. The Tivanium alloy is treated
with the Ti-Nidium Surface Hardening Process and is
compatible with Vivacit-E HXLPE articular surfaces. The
Persona SoluTion PPS femur coupled with a Vivacit-E
bearing demonstrates similar wear performance com-
pared to a Persona cobalt chromium alloy femur coupled
with a Vivacit-E bearing.
Additionally, the OsseoFit Stemless Shoulder Sys-
tem for total shoulder replacement received FDA 510(k)
clearance. The implant is designed to match the natural
humeral (upper shoulder bone) anatomy to optimize
anatomical t while maximizing preservation of healthy
bone. The OsseoFit Stemless Shoulder System expands
the company’s total shoulder portfolio and integrates
with Identity Humeral Heads with Versa-Dial Technol-
ogy for innite oset placement as well as the Alliance
Glenoid for a broad range of glenoid options to adapt to
a patient’s unique anatomy.
The anatomically designed left- or-right-sided anchor
implants feature ns creating a press-t during insertion
and contain fully porous windows. The n geometry
and anchor spacing of the implant determine proper
orientation and t into the natural bone and help avoid
cortical impingement, while reaching dense bone
11
Regulatory
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
superior ergonomics through the new ErgoFeel control body and
EasyOn connector. These design updates have the potential to im-
prove the quality of procedures and optimize the clinical workow.
In addition to the two new endoscope models, PENTAX Medical
also received clearance for their add-on Right/Left Wheel Extend-
er, model OE-B17. This reusable piece is attached to the outer
right/left wheel of the endoscope to improve accessibility of the
outer wheel for endoscopists with smaller hands.
https://www.pentaxmedical.com/us
areas. In addition, the design includes strategically located
anterior reattachment suture holes on the anchor to facilitate
subscapularis repair. The system is available in a singular
instrument tray to maximize workow and sterile process
eciency, to t nicely in a variety of settings including ambu-
latory surgical centers.
https://www.zimmerbiomet.com
The PENTAX Medical i20c Video Endoscope Series, now including
slim models EC34-i20cL and EG27-i20c.
PENTAX Medical obtained U.S. FDA 510(k) clearance for
new models of the PENTAX Medical i20c Video Endoscope
Series – PENTAX Medical Video Colonoscope EC34-i20cL,
PENTAX Medical Video Upper GI Scope EG27-i20c, and
Right/Left Wheel
Extender OE-B17.
The new slim
models include the
signature features
of the i20c endo-
scope generation:
advanced imaging,
enhanced maneuver-
ability with adjust-
able stiness, and
Right/Left Pentax Wheel Extender for i20c
Video Endoscope Series, model OE-B17.
12 TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
12
ARTIFICIAL INTELLIGENCE
GENERATIVE AI FOR
Generative artificial intelligence
technology drives long-term
improvements – from boosting
efficiency to meeting
sustainability goals.
By Charles Orlando
Manufacturing’s evolution
through Industry 4.0 is
driven by the adoption of
digital tools and artificial
intelligence (AI), reshaping how industries
optimize production, design, and opera-
tions. Generative AI, a powerful offshoot
of AI, is incredibly transformative as it
empowers manufacturers to integrate
advanced cost engineering, adaptive
decision-making, and efficient project
management into their processes. While
AI-driven cost estimation is still an emerg-
ing field, its ability to augment traditional
PHOTOS COURTESY OF GALORATH
Generative AI revolutionizes cost engi-
neering and operational workows in
medical device manufacturing by oering
real-time insights and adaptability.
methods with real-time, data-driven
insights accelerates adoption. According
to McKinsey, generative AI alone could
add between $2.6 trillion and $4.4 trillion
to the global economy annually, with
manufacturing and supply chain sectors
expected to capture a significant share of
this potential value1.
The current state
of AI in cost engineering
e adoption of AI in manufacturing has
advanced rapidly, with applications like
predictive maintenance, digital twins, and
intelligent quality control now embedded
in production processes. ese technol-
ogies have collectively enhanced manu-
facturing productivity, enabling manu-
facturers to predict equipment failures,
streamline operations, and reduce costs.
e global AI manufacturing market
was valued at $4.1 billion in 2023 and is
anticipated to grow at a compound annual
growth rate of more than 44% through
2030, driven by rising demand for
automation, optimization, and machine
learning applications in manufacturing2.
Despite this growth, AI in cost engi-
Manufacturing 4.0
13
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
to shis in market conditions, material
costs, or supply chain disruptions.
Additionally, generative AI’s ability to
address common data-related challenges
in manufacturing, such as fragmented or
siloed data sources, enables comprehen-
sive visibility and contextual understand-
ing, which are critical for accurate cost
forecasting4. is positions generative
AI as a transformative tool, helping
manufacturers streamline operations and
reduce uncertainty in cost projections,
ultimately enhancing speed to market
and profitability.
Use cases for generative AI in
manufacturing cost engineering
Generative AI is already demonstrating its
versatility across various manufacturing
applications, showing promise in areas
that extend beyond cost estimation. Here
are several specific use cases that illustrate
its impact:
• Design optimization: Generative AI
accelerates design cycles by analyzing
large datasets, enabling engineers to
explore manufacturing options that
optimize cost and quality. is has
proven valuable in the automotive and
aerospace sectors, where generative AI
aids in simulation and testing, helping
engineers make rapid design iterations.
Generative AI enables manufacturers to
keep sensitive data secure using private
data sets, improving product quality
without compromising data security.
• Inventory and supply chain man-
agement: Generative AI can improve
inventory tracking and demand
forecasting by analyzing historical and
GENERATIVE AI:
TRANSFORMING
MEDICAL
MANUFACTURING
EFFICIENCY
Generative AI revolutionizes cost engi-
neering and operational workows in
medical device manufacturing by oer-
ing real-time insights and adaptability.
By integrating seamlessly into backend
systems, AI provides tailored solutions
that enhance precision and innovation
across complex projects.
Key advantages include:
● Streamlined design cycles: Gener-
ative AI accelerates prototyping by
analyzing material performance and
enabling rapid iterations, crucial for
medical devices requiring rigorous
testing.
● Proactive cost management: AI syn-
thesizes production and procurement
data to predict overruns and optimize
resource allocation, ensuring prot-
ability without compromising quality.
● Workforce optimization: By re-
ducing routine burdens, AI shortens
ramp-up times for new professionals
and empowers experienced sta to
focus on innovation and compliance.
Generative AI transforms manufacturing
from reactive to proactive, addressing
challenges in quality, compliance, and
cost. Its ability to adapt dynamically
positions it as a cornerstone of medical
manufacturing’s future.
Generative AI solutions
such as SEERai, developed
by Galorath, are reshaping
cost engineering within
Manufacturing 4.0, oering
opportunities for precision,
adaptability, and eciency
across design, inventory
management, and sustain-
ability.
Generative AI allows
manufacturers to go be-
yond static estimation by
synthesizing information
from diverse data sources
to generate dynamic,
adaptable models.
Unlike traditional tools, generative AI
adapts dynamically, supporting cross-de-
partmental collaboration and addressing
medical manufacturing’s unique demands.
neering – an essential function to manage
project profitability and feasibility – lags
behind. Traditional cost estimation meth-
ods have relied heavily on static models
and historical data, limiting their capacity
to adapt to real-time conditions. Genera-
tive AI, however, allows manufacturers to
go beyond static estimation by synthesiz-
ing information from diverse data sources
to generate dynamic, adaptable models.
For instance, AI-driven production plan-
ning systems now optimize inventory and
resource allocation based on historical
trends and predictive analytics, making
them invaluable for resource management
and demand forecasting3. Manufacturers
can harness these advanced insights by
integrating generative AI into cost engi-
neering to improve project accuracy, boost
competitiveness, and drive profitability.
Generative AI’s potential
in cost engineering
Generative AI stands out from traditional
AI by enabling dynamic, data-driven in-
sights that adapt to complex and changing
variables across manufacturing. Unlike
conventional AI models, which rely on
historical data and fixed models, gener-
ative AI synthesizes inputs from diverse,
real-time sources, allowing for more
flexible and accurate estimations. Early
adopters of generative AI in manufactur-
ing can benefit from greater efficiency and
competitive advantage, particularly in op-
erations where cost pressures and supply
chain volatility demand agile responses.
is adaptability is especially valuable in
cost engineering, as it allows manufactur-
ers to generate tailored models that adjust
14
PHOTOS COURTESY OF GALORATH
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
real-time data. IBM’s research shows
that generative AI-driven tools can
consolidate insights across fragmented
data systems, enhancing visibility and
enabling predictive maintenance. is
approach is instrumental in preventing
disruptions and reducing excess inven-
tory, crucial for managing costs and
meeting demand.
• Enhancing worker safety and skills
training: Generative AI offers inter-
active, real-time training combining
operator actions with machine perfor-
mance data, allowing for tailored skills
development. is type of AI-driven
training provides customized support
that can accelerate operator proficiency
and improve overall shop floor safety,
addressing a significant need in modern
manufacturing5.
• Sustainability and resource efficien-
cy: Generative AI supports manufactur-
ers in meeting sustainability goals by
optimizing material use and reducing
waste. For example, AI algorithms can
model the environmental impact of
different resource choices, enabling
companies to choose options that
align with their sustainability targets.
IBM highlights that generative AI can
streamline resource allocation and con-
tribute to carbon footprint reductions,
making it an essential tool for manufac-
turers aiming to balance profitability
with environmental responsibility.
Overcoming challenges
and ethical considerations
As generative AI becomes more integral
to manufacturing, addressing ethical
considerations and operational challenges
is essential to maintaining trust, transpar-
ency, and accountability. Implementing
AI at scale introduces several ethical risks,
including data security, bias in algorithmic
decision-making, and the need for human
oversight in automated processes.
Data security and privacy
With AI systems aggregating data from
numerous sources, data privacy and
security are paramount. Manufacturing
environments oen handle sensitive data
across supply chains, proprietary designs,
and operational strategies, making them
susceptible to breaches. Best practices in
AI security include rigorous data en-
cryption, anonymization protocols, and
adherence to regulatory standards like
the General Data Protection Regulation
(GDPR) in Europe and emerging AI-specif-
ic standards in the U.S. AI deployments in
manufacturing should prioritize isolated
data environments and controlled access,
especially for cloud-based applications, to
safeguard critical information.
Bias and fairness
AI’s reliance on large datasets introduc-
es risks related to bias, especially when
historical data reflects existing inequali-
ties or biases in decision making. In cost
engineering, biased data could influence
AI predictions, leading to potentially
unfair resource allocation or pricing
strategies. To counteract this, it is critical
to establish clear, bias-reducing standards
at the outset, with oversight by multidis-
ciplinary teams to examine and mitigate
any unintended biases. Regular audits and
transparent reporting ensure that AI-driv-
en decisions align with ethical guidelines.
Transparency and accountability
As generative AI plays a more significant
role in decision making, ensuring trans-
parency becomes crucial. Algorithmic
decisions can appear opaque, especially to
end users or stakeholders needing more
technical expertise. Maintaining a human-
in-the-loop approach is one effective way
to ensure AI systems remain interpretable
and accountable. Human oversight allows
organizations to review AI-generated rec-
ommendations, providing an added layer
of responsibility and enabling adjustments
based on evolving project needs. is
approach aligns with industry calls for
responsible AI practices, emphasizing the
balance between automation and human
judgment.
Human oversight and
the role of ethical AI
Maintaining ethical standards in AI is
essential for responsible adoption. For
example, AI systems must be designed
with ethical fail-safes to prevent misuse or
over-reliance. Implementing policies for
continuous monitoring involving ethics
commiees or AI review boards can help
proactively identify and address potential
risks. Adopting a rigorous ethical frame-
work ensures AI systems are beneficial and
trustworthy, seing a foundation for sus-
tainable AI integration in manufacturing.
Conclusion
Generative AI is reshaping cost engineer-
ing within Manufacturing 4.0, offering
unprecedented opportunities for preci-
sion, adaptability, and efficiency across
design, inventory management, and
sustainability. By leveraging data from
multiple sources, generative AI enables
manufacturers to make proactive decisions
that optimize costs, minimize waste, and
enhance safety, ultimately contributing
to greater competitiveness and resilience.
While the benefits of generative AI are
clear, the technology’s effective deploy-
ment requires careful consideration of
ethical and operational challenges, from
ensuring data security and reducing algo-
rithmic bias to maintaining transparency
through human oversight.
As manufacturers move toward a future
that integrates AI across their operations,
embracing these best practices will be
crucial. Companies can harness generative
AI’s full potential by embedding respon-
sible AI principles and building adaptable
ecosystems, supporting long-term innova-
tion and sustainable growth. Generative AI
is not merely a tool for improving today’s
manufacturing processes – it’s a transfor-
mative approach that will shape the future
of cost engineering, guiding the industry
toward a more responsive, intelligent, and
ethically grounded tomorrow.
Galorath Inc.
https://galorath.com
About the author: Charles Orlando is chief
marketing officer at Galorath Inc.
Manufacturers can harness advanced
insights by integrating generative AI
into cost engineering to improve proj-
ect accuracy, boost competitiveness,
and drive protability.
Endnotes
1. The Potential Value of Generative AI,
McKinsey & Company
2. Artificial Intelligence in Manufactur-
ing Market Report, 2030, Grand View
Research
3. The Role of AI in Production Planning and
Inventory Management, Deloitte Insights
4. 4 ways generative AI addresses manufac-
turing challenges,” IBM
5. How Generative AI Could Revolutionize
Manufacturing, Manufacturing.net
ARTIFICIAL INTELLIGENCE
15
Featured Product
PHOTO COURTESY OF HORN
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
HORN
Supermini tool system:
Inserts available
in three sizes
HORN USA Inc.
https://www.horn-group.com/us/
THE SUPERMINI TOOL SYSTEM CAN BE
ADAPTED for numerous machining oper-
ations – from boring, prole turning, and
internal grooving to threading, chamfering,
face grooving, drilling, and slot broaching.
The solid carbide inserts are used for bor-
ing from a diameter of 0.2mm to around
10mm. The carbide blanks, developed
for the tool as a teardrop shape, enable
large, precise contact surfaces in the tool
holder, resulting in greater overall system rigidity. Additionally,
the teardrop shape prevents the insert from twisting, leading to
consistently precise positioning of the center height of the tool.
With long tool overhangs, it reduces deection and minimizes
vibration during turning. Depending on the application and the
diameter to be machined, Horn oers the inserts in three dier-
ent sizes (types 105, 109, and 110) and dierent blank types. All
types allow internal coolant supply directly to the cutting zone.
Chipping problems solved
One of the biggest challenges in internal machining is the gen-
eration of long chips. Depending on the material, boring often
leads to stringers wrapping around the tool, clogged holes or,
in the worst case, tool breakage. This is where chip breaking
geometry helps guide and shape the chip, causing it to break.
Previously, specially lasered or ground chip-breaking geome-
tries were used for this purpose, but this increased insert cost.
With Supermini type 105, Horn has developed a universal boring
tool with sintered chip-breaking geometry and high process
reliability. The cutting edge geometry extends far into the corner
radius of the insert ensuring chip control even with small infeed
settings.
In addition to the geometry, Horn optimizes the carbide blanks
of the inserts to have greater rigidity and an even more stable
cutting edge area. Horn oers the inserts as standard in three
lengths (15.0mm, 20.0mm and 25.0mm) and in carbide grades
TH35 and IG35. The corner radius is 0.2mm. The tool is suitable
for use from a bore diameter of 6mm.
16 TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
16
DESIGN & AUTOMATION UPDATE
P. 18 | NEWS
HFE for
medical device
development
Why every medical device needs human factors
engineering (HFE) for long-term success.
By Shilpa Gampa
PHOTO © TOOWONGSA | ADOBE STOCK
Medical
device
develop-
ment is a
high-
stakes game. Patient
safety, compliance
with complex regu-
lations, and your company’s reputation
are all on the line, but one factor oen
makes or breaks success: human factors
engineering (HFE) also referred to as
human factors, which is used to design
human interfaces. HFE bridges the gap
between technology and user interaction.
It’s essential to ensure the device operates
as intended by all users, avoiding potential
risks and failures. It’s not like puing in a
Shilpa Gampa
17
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
tickler file to fulfil a regulatory submission
requirement. It’s a necessary component
of your design approach, and here’s why.
HFE leverages interdisciplinary fields
such as psychology, ergonomics, and sys-
tems engineering to enhance human-de-
vice interaction. By aligning device func-
tionality with real-world usage scenarios,
HFE ensures medical devices meet safety
standards, improve user performance, and
minimize the risk of errors.
What’s HFE and
why does it matter?
HFE is defined as the application of scien-
tific information to design equipment by
considering the people, technology, and
their environment. It’s about the ways
users engage with your device and make
it safe, effective, and easy to use. e aim
is to reduce the margin of human and
technical mistakes and to increase the ef-
ficiency and functionality of the patient’s
safety and benefit of the devices in view. A
well-executed HFE approach leads to intu-
itive and user-friendly devices, increasing
patient confidence and device adoption.
Additionally, HFE focuses on mitigating
cognitive load and error-prone scenarios
during critical device usage, especially in
high-stress medical environments.
e MDR of the European Union,
the FDA, and other governing bodies
are focusing on the usability of medical
devices. Why? Since user-related errors
are one of the primary causes of recalled
products, several improved methods of
risk management communication will be
introduced in this paper. A medical device
may be very good mechanically, but if it’s
confusing, you’re seing yourself up for
failure.
HFE proves the device to be developed
not only follows all the regulatory require-
ments but also the best design possible to
avoid the risk of misuse and misunder-
standing. By designing with HFE princi-
ples, you enhance usability and safeguard
your device from unnecessary errors and
costly recalls.
Early integration of HFE
Time and cost efficiencies in medical
device manufacturing must be achieved
to keep global investors happy. You may
think you can add in HFE later, but this is
a much more expensive and longer way of
doing things. Some issues discovered in
any of these phases of design are signifi-
cantly more costly to address than others,
especially when identified during the later
stages of a project. Studies indicate that
correcting usability issues costs as much as
x its initial cost when done later in the
cycle.
Integration of HFE from the onset elim-
inates the occurrence of design modifica-
tions and additional time it will require.
e need to get feedback and testing on
usability early on reduces costs incurred
when problems appear at a later stage
and makes aaining market approval a
smoother process. is proactive approach
minimizes future design revisions and
helps stay within budget and timelines,
avoiding delays in approvals and market
entry.
The role of HFE in reducing risk
A poorly designed device not only neg-
atively impacts a business, it may also
become dangerous to patients. Mistakes
from improper device design aren’t just
costly, they could be fatal. When you pay
early aention to HFE you’re likely to
avoid these errors. Other research has
ascertained that more than half of all
adverse effects associated with medical
devices stem from design. ese issues can
be minimized significantly through the
right HFE strategies, such as:
• Usability testing at each design
and development phase; including
heuristic evaluations, cognitive
walkthroughs, and iterative testing
with representative users to ensure a
seamless design evolution.
• More specifically, one is always keen
to ensure there’s clarity in design to
avoid entailing a problem of confu-
sion or misuse.
• Actual feedback from the users of the
technology is an important source
used to enhance usability and func-
tionality.
• Assess the risks associated with the
usability of the medical device.
e regulatory authorities are geing
more demanding, but compliance is only
the first step. What HFE can do for you
goes far beyond the adequacy rule to a
level above compliance. While usability
testing and user-centered design make
it more likely you meet your compliance
goals, they also make it more likely your
product works smoothly when in the
hands of doctors and patients.
But compliance isn’t just doing the bare
minimum to meet the rules set down, it’s
about convincing customers that your
device is useful and safe to use. rough
proper HFE, you demonstrate you’ve
considered users’ needs for a user-friendly
and safer product.
Why starting with
HFE is a no-brainer
Integrating HFE early fosters cross-func-
tional collaboration, enhancing design
efficiency and compliance readiness.
Here’s why HFE should be part of your
strategy from day one:
• Cost efficiency: e later HFE is
adopted, the more costs for redesigns,
recertifications, and recall possibil-
ities.
• User safety: Errors must be mini-
mized by having a design that’s easily
navigated, eliminating chances of a
wrong selection to protect the patient
and your brand.
• Faster adoption: Ease of use is
important in driving adoption of
devices. When a product performs as
advertised, consumers – including
healthcare providers and patients –
will adopt it.
• Regulatory success: HFE directs
you to several regulatory standards
and oen helps go beyond them to
achieve necessary market authoriza-
tion.
• Improved product differentiation:
A device designed with HFE princi-
ples stands out in the market for its
superior usability and safety, giving it
a competitive edge compared to less
user-friendly alternatives.
How to apply HFE
to improve your design
• Understand your users: You can’t
create a product without understand-
ing the intended consumer of that
product. Learn more about tasks
18
PHOTO COURTESY OF CRITICAL MANUFACTURING
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
healthcare workers, patients, or any
other user may encounter. It’s crucial
to perform user research at the begin-
ning of this step so one can compete
with pain points and create solutions
meeting these requirements.
• Usability testing is key: is is the
only effective way to learn how the
users are using the device you’re
developing or have developed. It’s not
necessary to make these decisions
when you’re already halfway down
the development cycle. Early testing
and iterating ensure you meet the
needs of the users and prevent costly
changes later. It’s recommended that
usability testing should begin as early
as the conceptual stage and be modi-
fied whenever necessary.
• Work collaboratively: A cross-func-
tional team including designers,
engineers, regulation specialists, and
marketers must work collaborative-
ly to develop one simplified device
meeting the needs of the user and
conforming to the set standards.
• Improve and iterate: HFE isn’t a one-
time question-and-answer session.
It’s a continuous process because aer
each round of testing the feedback
must be incorporated when designing
subsequent rounds. Implementing
the proposed iteration process afford-
ably results in a steady improvement
of the device to make it safe to use,
efficient, and reliable.
Implementing HFE
At Freyr Solutions, we revisit realizations
made with HFE. Our experts collaborate
with you from the outset to apply HFE
principles to your design, so your device
achieves the client’s safety objectives and
the intended use.
Here’s how we help:
• Global expertise: With FDA, MDR,
and many other standards successful-
ly implemented, we know everything
about your device’s usability require-
ments.
• Tailored solutions: Each device and
user base are distinct. Depending
on your situation, we adapt our HFE
strategies to augment usability of
your product.
• End-to-end support: Our services
also include every process of your
product life cycle starting from iden-
tifying the basic concept to post-re-
constructive market surveillance. Our
ongoing feedback loop guarantees
that throughout the product life
cycle your device is easy to use and
compliant.
HFE isn’t something you do once a product
is ready – it’s an integral part of your
development process. It’s most effective to
incorporate it in your project from the first
day of development because incorporation
from the initial stage cuts down on time
and cost and provides a guarantee of the
safety and usability of the device. When
you design with HFE in mind you’re doing
more than meeting regulations; you’re
designing for consumers and establishing
credibility and market viability.
About the author: Shilpa Gampa is a regulatory aairs
strategist with expertise in FDA submissions and C-lev-
el executive consultation for developing go-to-market
strategies. She is acting as the regional delivery head
for America’s clients at Freyr in her primary role for
global market submissions.
Freyr Solutions
https://www.freyrsolutions.com
Critical Manufacturing’s MES and In-
dustry . International Summit (MESI
. Summit), returns this year, offering a
platform at which global manufacturing
leaders will come together, innovate, and
share ideas about their digital transforma-
tions. e two-day conference will take
place June , , at the Alfândega
Congress Centre in Porto, Portugal.
Under the theme of Connecting Global
Manufacturing Champions, MESI .
Summit will bring together IT
and operations experts in electronics,
semiconductors, medical devices, and
industrial equipment to discuss the latest
smart manufacturing and Industry .
technologies, and their application. e
summit will provide practical insights and
effective strategies to help stay ahead in
an ever-competitive market, including
exploring the role of MES in automating
operations across multiple sites.
e conference will also offer a
host of new features focused on helping
users understand emerging innovations,
including a Technology Track dedicated
to the future of artificial intelligence (AI),
low code, devOps, and other next-gen
solutions.
“e response to our first edition was
overwhelming, and we are very excited to
come back in with an even more am-
bitious program. MESI . Summit isn't
only about technology; it’s about creating
connections that will lead to real change.
e event will equip aendees with practi-
cal ideas necessary to implement scalable
smart manufacturing solutions that will
enable them to keep pace in today’s com-
petitive landscape,” says Francisco Almada
Lobo, CEO, Critical Manufacturing.
Beyond the Technology Track, the MESI
. Summit will have other parallel tracks
that target the specific needs of customers
and partners. Roundtables and workshops
will also dive into digital transformation is-
sues across the MES functionality spectrum.
Since most of the speakers are hands-on
practitioners of manufacturing technology
implementation efforts, aendees will get
the benefits of first-person accounts of
successful digital transformation at some
of the world’s leading companies. Building
on the diverse participation last year –
two-thirds from operations, IT and C-level
executives – the event next year aims to
aract an even broader set of industry
professionals eager to advance their digital
capabilities.
https://mesi40-summit.com/
CRITICIAL MANUFACTURING
EVENT COVERING, ACCELERATING
DIGITAL TRANSFORMATION
20
PHOTOS COURTESY OF
KENNAMETAL
COVER STORY
Micromachining
requires tiny tooling
to meet the medical
industry’s need for
precision. By Clare Scott
In medical manufacturing, smaller is
oen beer. Surgery, for example, relies
on precision, with intricate tools used to
perform delicate procedures. Implants need
to fit patients comfortably without excess
bulk. As medical developments advance,
manufacturing must keep pace with the
industry, fabricating the increasingly tiny,
precise components medical professionals
need. It’s a job for specialized manufactur-
ing – micromachining.
Micromachining is an evolving tech-
nology whose purpose is in its name – to
machine components at the micrometer
level. It originated in the mid-20th century
and is still increasing its capabilities to
manufacture smaller and smaller parts.
Processes such as turning, milling, drilling,
and grinding are being miniaturized, and
they require specialized tooling capable of
removing tiny amounts of material with the
utmost accuracy and delicacy.
Expanding creative freedom
while reducing tool size
Kennametal, a developer of metal cuing
tools, materials, and other manufacturing
products, has been providing microma-
chining tooling systems for years. Founded
more than 85 years ago, Kennametal has
a long history with industries such as
aerospace and transportation, and recently
entered the medical manufacturing space.
e increasing demand for micromachin-
ing applications in medical manufacturing
has created a need for small, high-precision
tools – a need Kennametal’s expertise in
precision tooling has seamlessly addressed,
making its entry into the medical industry a
natural progression.
“If you think about a bone screw, it could
start out as a cylindrical part,” explains
Sco Etling, vice president, global product
management at Kennametal. “e process
is first shaping it with a turning or grooving
tool, next threading it, and finally cuing
it off to bring it to size. To do this precise-
ly requires the right tools, machine, and
knowledge in the micromachining area
which can be vastly different from, say,
machining an engine block which uses a
completely different machining environ-
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
20
MICROMETER
Manufacturing by the
XXXXXXX
21
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
ment. Kennametal is focused on being a
leader in micromachining.”
Many engineers who design precision
medical components don’t think about the
logistics of machining them, which is where
Kennametal comes in. e company works
directly with its customers to develop de-
signs for medical components as well as the
tools required to manufacture them.
“When cuing tool companies collab-
orate with manufacturers that require
micromachining, it enables creativity and
precision required for the next generation
of medtech components,” Etling says.
is creative freedom enables the design
of parts such as patient-specific implants or
devices, an area of healthcare that’s growing
rapidly as patients and professionals move
toward increased personalization for beer
comfort and effectiveness. A tooling manu-
facturer that can support micromachining
technology allows for a more effective
iterative process – if an engineer creates a
part, tests it, and decides it needs changes,
a company such as Kennametal can tweak
the tools accordingly. is adds up to finely
tuned medical devices for optimal, individ-
ualized patient care.
The recipe for the right tool
Micromachining requires extremely
tight tolerances, and Kennametal works
to come up with technologies to design
inserts, drills, end mills, and other tooling
systems that can hold those tolerances.
e precision of micromachining requires
high spindle speeds, and many medical
components are made from exotic, diffi-
cult-to-machine materials such as titanium,
cobalt chrome, and stainless steel. For those
materials to withstand the necessarily high
heat generated by the machining process,
they need to be coated, and Kennametal’s
products include coatings as well as the
carbide substrates themselves. Typically, for
this type of application, Kennametal would
use a physical vapor deposition (PVD)
coating, which is thin but hard and results
in high corrosion- and wear-resistance.
e company recently released several new
grades including carbides KCU10B and
KCU25B as well as titanium grade KCS10B,
all featuring new PVD coatings for beer
abrasion resistance and longer tool life.
Micromachining involves a delicate bal-
ance – an operator needs to apply enough
pressure and heat for chip formation, but
not so much pressure that the miniature
tool or workpiece breaks. When machin-
ing to tight tolerances, the goal is to avoid
failures such as notching and breakage,
and designing a tool to machine miniscule
depth of cut (DOC) while avoiding excessive
wear and maintaining a long, productive
life depends on several factors including
material, workpiece, and a customer’s spe-
cific needs. Developing the optimal grade
for a specific application is like following a
complex recipe – a challenge Kennametal
embraces as it works with its customers.
Thinking small for the future
Recently, Kennametal launched KenDrill
Micro, a solid carbide drill series specifi-
cally for machining small parts. Currently
the drill is offered in diameters as small as
1mm, but the company will be releasing a
0.5mm diameter as well – about the size of
mechanical pencil lead and suited for mi-
cromachining components such as coolant
OPPOSITE PAGE:
KSC10B insert machining
acetabular cup for hip joint
replacement.
RIGHT, CLOCKWISE FROM TOP:
TopSwiss MBS micro boring
solid platform of tools for
precision, Swiss, and small
parts machining.
TopSwiss inserts for small
parts machining allow stable
cuts and smooth chip ow in
low feed, high depth-of-cut
applications.
Kennametal end mills for
medical-grade applications,
including machining titanium
femoral stems.
COVER STORY
22 TODAYSMEDICALDEVELOPMENTS.COMTODAYSMEDICALDEVELOPMENTS.COM
PHOTOS COURTESY OF KENNAMETAL
valves. Around the same time, Kennametal
introduced TopSwiss (MBS), which stands
for micro boring solid and includes nearly
200 toolholders and inserts with options
for standard, premium, or high-perfor-
mance precision.
“ese are highly precise, micro boring
bars, with features that are specifically
needed in micro component manufac-
turing,” Etling says. “In micromachining,
you have to reach into parts and create a
bore or a hole inside the parts. It could be
to reduce weight or create the thread that
you might see on a spinal implant pedical
screw for example. We already have, on
the medical side, a prey solid portfolio.
In the past, our portfolio had a few gaps on
the micromachining side where customers
required smaller inserts and drills. We’ve
launched innovative new lines of drills and
inserts to fully support micromachining
applications.”
Kennametal plans to continue devel-
oping and releasing new tooling systems
for micromachining, a technology Etling
believes will continue to grow in every
market segment. In the medical industry,
this translates to less cost and more overall
ease for patients, as micromachining not
only creates greater precision in medical
devices but also beer comfort. No one
wants to physically feel a medical or dental
implant in their body, so the smaller and
more precise the implant can be, the beer
for the patient – a challenge for machine
tool manufacturers to see just how “micro”
they can go.
A goal for medical professionals is to be
as minimally invasive as possible when it
comes to both procedures and implants,
for reduced risk and quicker healing.
New developments in minimally invasive
technology will continue to emerge as
other technologies, such as robotics and
advanced imaging, progress. To support
these developments, the medtech industry
will need increased collaboration between
manufacturers and medical professionals,
as well as collaboration between medical
device manufacturers and tooling compa-
nies, and micromachining should be on
everyone’s mind.
Kennametal
https://www.kennametal.com
About the author: Clare Scott is associate editor
for GIE Media’s Manufacturing Group. She can be
reached at CScott@giemedia.net or 216.393.0314.
KSC10B grade
inserts featuring
High polyimidaz-
olium salts (PIMs)
coating technology
machining medi-
cal-grade parts.
23
Cover Shots
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
Walter; Cetec ERP;
Mitutoyo America Corp.
WALTER
Exchangeable heads, boring bars for Swiss machining
WE exchangeable heads are for internal
machining from 0.276" (7mm) in diameter
and axial grooving from 0.472" (12mm) in
diameter. The WE positive engagement
with three contact surfaces provides a
high level of process reliability, stability,
and accuracy. The tool maximizes exi-
bility due to the ability to replace the WE
head in the same toolholder.
W3270/W3271 boring bars are
available in 12mm to 16mm and 0.500"
to 0.625" with clamping surface in steel
and carbide. For universal applicability,
the coolant outlet is on both sides for
the W3270 radial boring bars. Rake face
cooling and an additional ushing hole
enable high-volume ow. The W3271 axial
boring bars are handed (right hand/left
hand) and have the coolant outlet either
on the right- or left-hand side of the bar
optimized for the most ecient cooling.
Inserts are made of grade WSM23X or
WSM13X. The WSM23X is primarily for
cutting steel, stainless steel, and mate-
rials with dicult machining properties.
The secondary application is cutting
non-ferrous metals. The PVD grade with
a multiple-layer titanium aluminum nitride
(TiAlN) coating and titanium nitride (TiN)
top layer is for parting o/grooving and
turning with a moderate to low cutting
speed (vc) and axial depth of cut (ap).
The WSM13X has a higher wear resis-
tance than WSM23X for stable machining
conditions. The primary applications for the
WSM13X are cutting steel, stainless steel,
material with dicult machining properties,
and non-ferrous metals. The PVD grade
features a multiple-layer TiAlN coating.
The exchangeable head types include
copy turning, thread turning, axial groov-
ing, reverse turning, forward turning, for-
ward turning with a ground chip breaker,
and internal grooving.
https://www.walter-tools.com/us
CETEC ERP
Work location, time tracking feature
Cloud-based enterprise resource plan-
ning (ERP) solution provider Cetec ERP
launched a new Work Location and Time
Tracking feature aimed at helping medical
device manufacturers ensure compliance
and improve workforce eciency.
This feature prevents employees from
logging time to a work order if they aren’t
authorized to work at the designated
location. Locations may be modeled as
machines, pieces of equipment, specic
processes, or steps in production. On
a per user basis, companies can select
multiple work locations where a user is
allowed to log labor.
Benets include:
Ensure compliance: Prevent employ-
ees from working on equipment or tasks
they aren’t certied or trained for by
restricting time logging to approved work
locations.
Accurate labor tracking: Track time
spent on tasks and locations, allowing for
better management of labor costs and
compliance with industry standards.
Improved eciency: Gain real-time
visibility into workforce activity to help
allocate employees more eectively and
minimize downtime.
Easy to implement: It integrates
directly into the Cetec ERP system and is
simple to activate and manage.
https://www.cetecerp.com
MITUTOYO
Fast, accurate micrometer
High speed, accuracy: QuantumMike
achieves spindle movement 4x faster
than standard metric micrometers, en-
abling more ecient measurement with
a maximum permissible error ±1μm. It’s
produced with a highly accurate, wider
thread pitch for the slim spindle. Unlike a
typical metric micrometer with a 0.5mm
screw lead, the thimble moves the spindle
2.0mm in a single rotation, allowing for
rapid measurement. Because the spindle
can be released by a large amount with
just a small amount of rotation, it’s suit-
able for when various dimensions must be
measured.
Reliability: The micrometer determines
whether the measurement value is within
the upper and lower limits of tolerance
and displays a tolerance judgment mark.
The user can judge pass/failure immedi-
ately and, using the calculation function,
it’s possible to calculate correction values
for machine tools from the measurement
results. This eliminates the potential in-
convenience of calculations and prevents
human errors such as confusing plus and
minus values when entering correction
values into a machine tool.
Ease of use: Equipped with various
features to meet the needs of operators,
such as a large display and bidirectional
communication, it’s designed for ease of
use, and the main unit enables comfort-
able measurement during manufacturing
processes. Frequently used functions
can be easily recalled for improved work
eciency.
https://www.mitutoyo.com/
PHOTOS COURTESY OF RESPECTIVE COMPANIES
24 TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
24
MATERIALS
Understanding and achieving
the key characteristics of
precious metals designed
for deployment in innovative
medical devices and implants.
By Kunihiro Shima and Yusuke Minagawa
Precious metals
Materials and components made from high-quality precious metals
are playing a growing role in medical devices for a wide variety of
procedures including cardiovascular, peripheral vascular, neuro-
vascular, and mammography. e following is a summary of precious metals
and their characteristics and expectations in the medical industry.
Whereas polymers tend to break down with hydrolyzation and dis-
solve in human bodies throughout the years, precious metals and their
alloys have proven more durable. Acids, alkalis, and oxidation tend to
have limited negative effects on precious metals, making them especial-
ly valuable when used in medical devices intended to remain in the body
for a long time, such as for remote monitoring.
But there are additional crucial questions the medical device indus-
try must satisfy in choosing which precious metals to use in which
instruments. What qualities make which metals suitable for existing
and emerging medical processes, especially the minimally invasive and
Various cardiovascular
procedures increasingly
rely on materials and
components made from
high-quality precious
metals. This is an im-
plantable cardioverter
debrillator. PHOTO
CREDIT: ADOBE-
STOCK_302072970
25
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
non-invasive procedures increas-
ingly favored over traditional
surgeries? For example, which
metals are safest and most com-
patible with the human body? Which
metals enhance the visibility of devices
during X-rays? And what’s necessary to
produce metals and alloys so they meet the
medical device industry’s requirements in
other areas, such as purity percentage?
Biocompatibility
Medical devices coming into contact with
human tissue and fluids must be safe, non-
toxic, non-irritating, and not encourage
blood cloing, inflammation, or other
postoperative complications. Consequent-
ly, the proven biocompatibility of precious
metals such as platinum, iridium, and
gold have made them preferred choices for
more cardiovascular, dental, and ortho-
pedic implants as well as other medical
devices.
Platinum iridium rings, for example,
are being used in electrophysiology (EP),
ablation, irrigation, and intravascular
ultrasound (IVUS) catheters, and platinum
alloy wires are being used as coil tips for
guidewires, embolic coils, and flow divert-
er stents. Many of today’s mammography
filter applications leverage rhodium sheets
of certain key qualities. Gold and platinum
alloys in patient implants promise key
However, the magnetic susceptibility
and hardness of certain gold and plati-
num alloys have shown promise in terms
of being used in artifact-free devices for
biomedical applications. Consequently,
research and development are vigorous
across metals, devices, and procedures to
boost the applicability of MRIs.
Radiopacity
Radiopaque properties vary widely among
the different precious metals, and this is
a huge factor in their viability as compo-
nents of electrodes, sensors, and other
devices that must be visible under X-ray
imaging.
For example, radiopacity is one of the
key factors making platinum alloy rings an
increasingly common choice for marker
bands in most catheters and stents. For
the same reason, platinum wires have
grown essential for the medical industry’s
guidewires, embolic coils, and flow divert-
er stents. In more and more applications
where the precise placement of devices in
the body is of utmost importance, devices
based on precious metals have grown
more prominent because of their superior
radiopaque properties.
However, it’s crucial the metals and
alloys for these components and materials
are produced at a four nines purity level
(99.99%). Impurities in the metals and al-
loys can yield a variety of poor results, in-
cluding issues with visibility under X-ray,
device malfunctions, patient discomfort,
and decreases in longevity and reliability.
breakthrough benefits and improvements
for procedures such as magnetic resonance
imaging (MRI).
Metals and MRI historically haven’t
mixed well. e induced currents and
heating from radio frequency (RF) mag-
netic fields related to some metals can
harm patients. In addition, the images
captured in MRIs can suffer from severe
distortion and degradation when per-
formed on patients with some metallic
implants. Given the healthcare industry’s
increased reliance on various forms of
such implants, this is no small problem for
a growing portion of the world’s popula-
tion and their care providers.
RIGHT, FROM TOP:
Guidewires such as this one
must use materials of proven
biocompatibility. Platinum is
a precious metal that is relied
upon in such medical devices
because it has proven to be
safe, non-toxic, non-irritating
and not encouraging of blood
clotting, inammation, or other
postoperative complications.
PHOTO CREDIT: ADOBE-
STOCK_66768465
High radiopacity is one of the
key factors that have rendered
precious metals increasingly
depended upon in devices
such as endovascular meshes.
PHOTO CREDIT: ADOBE-
STOCK_520195696
Various cardiovascular proce-
dures – such as angioplasty
employing heart stents and
catheters like these – today
often rely on materials and
components made from
high-quality precious metals.
PHOTO CREDIT: ADOBE-
STOCK_964574566
26 TODAYSMEDICALDEVELOPMENTS.COM
MATERIALS
TODAYSMEDICALDEVELOPMENTS.COM
PHOTO CREDIT: TANAKA PRECIOUS METAL TECHNOLOGIES
ing to meet the medical device industry’s
needs. ISO 13485, Medical devices – Qual-
ity management systems – Requirements
for regulatory purposes, for example, is a
crucial standard in the space, defining a
widely cited framework designed to con-
tribute to the consistent design, develop-
ment, production, and delivery of medical
devices that are safe for their specified
purposes.
New customer requests take shape
for particular mechanical properties
(bendability, elongation, etc.) in metal
wires, rods, rings, tubes, sheets, foil, and
more, and drive innovation in alloys and
processes. ough the time to achieve
clinical trials and regulatory approval is
lengthy, this innovation in the precious
metals industry is already redefining
imaginations across the medical device
industry in terms of how the advances
ultimately could contribute to proce-
dures which extend patient quality and
longevity of life. How might forthcom-
ing improvements enable reductions in
recovery time and burden on patients and
increased success rates of treatments?
Could they open new possibilities for
treatment of patients conventionally
believed to be too weak or old for certain
surgical procedures? As the healthcare
industry continues its shi toward more
minimally and non-invasive procedures
and remote, long-term patient monitor-
ing, key unique properties of precious
metals and ongoing innovation in their
development stand to expand their role
across the gamut of medical devices.
TANAKA Precious Metal Technologies
https://tanaka-preciousmetals.com
Additional considerations
Controlling all operations across the
rollout of precious metals – from bullion
procurement to material processing,
manufacturing, sales, and recycling – is
key to delivering on device manufacturers’
critical requirements around a metal’s
biocompatibility, radiopacity, purity, and
About the authors: Kunihiro Shima is head
manager of R&D at the Isehara plant in Japan
and has worked in the field of technology since
joining TANAKA Precious
Metal Technologies in 1995.
He has been in the medical
device field since 2010 and
has developed several new
precious metal alloys. Yusuke
Minagawa is section manag-
er of the sales department
with TANAKA Precious Metal
Technologies in charge of the
hard disk field and the single
crystal field. He has been the
head of sales in the medical
device sector since 2022.
Both can be reached at
tki-usa@ml.tanaka.jp.
Kunihiro Shima
Yusuke Minagawa
alloy composition. It’s not uncommon
for one or more of those processes to be
outsourced in the development of some al-
loys, so device manufacturers increasingly
demand meticulous recordkeeping around
the origin and refinement of precious met-
als for their components and materials.
e precious metals industry is adapt-
27
3D + Additive
PHOTOS COURTESY OF RESPECTIVE COMPANIES
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
ADDUP
Company earns ASTM Additive Manufacturing Safety Certification
AddUp has received the ASTM Additive
Manufacturing Safety (AMS) Certica-
tion, becoming the rst original equip-
ment manufacturer (OEM) in the additive
manufacturing (AM) industry to achieve
this milestone.
As an industry leader, AddUp played
a pivotal role in the creation of the AMS
certication program. During the past
few years, AddUp has partnered closely
with ASTM, helping dene the safety
protocols and guidelines ensuring safe
operation in AM facilities. These eorts
were crucial to establishing a roadmap
for other manufacturers entering the
additive space, ensuring safety is at the
forefront of the industry’s growth.
The comprehensive audit process
for this certication included a detailed
evaluation of AddUp’s AM facility, with
specic attention to personal protective
equipment (PPE), machine installa-
tion and grounding, powder handling,
hazardous waste disposal, and facility
cleanliness. AddUp’s team guided ASTM
through the various safety measures
needed in an AM facility, drawing on
their own experiences from their North
American headquarters in Cincinnati.
This audit, conducted by the Safety
Equipment Institute (SEI), was a rst-of-
its-kind for AM. AddUp volunteered to
be the inaugural company audited for
AMS certication and worked close-
ly with SEI auditors to ensure each
requirement was not only met but thor-
oughly understood. The audit served as
an opportunity to educate and provide
feedback to SEI, reinforcing why each
safety protocol is essential for AM
operations.
https://addupsolutions.com/
MATERIALISE
Mimics platform to accelerate adoption of personalized medical care
The fully integrated Materialise Mimics platform is for
enhanced eciencies in advanced 3D planning and person-
alized device creation, providing accessible patient care for
medical device companies and hospitals globally. The plat-
form leverages Materalise’s medical engineering software,
Mimics, used to create virtual and 3D-printed patient-specic
anatomical models for pre-procedural planning, as well as the
design of patient-specic implants and surgical guides.
The end-to-end solution provides hospitals with a single
integrated platform to enable personalized
patient care and medical device companies to
gain access to a workow enabling all phases
of the medical device design process – from
research and development through clinical
trials to full scale-up and commercialization.
The release incorporates Mimics soft-
ware projects into a unied Mimics platform
– including desktop and cloud applications,
enabling better collaboration, automation, and
easier access to new technology, including
unied case management, articial intelligence
(AI)-enabled segmentation, and visualization
of surgical plans and models via augmented
reality and extended reality.
Clinicians and engineers can work together
to quickly, eectively, and securely plan their
cases within the platform. The cloud and desk-
top applications sync with ease while oering
advanced traceability through ongoing activity
and version logs, improving quality control and reducing lead
times by allowing a patient’s medical team and their medical
technology suppliers to work in les simultaneously. Sharing
of case information can be completed in compliance with
data privacy standards such as HIPAA, ISO 27001 (data secu-
rity), and ISO 27701 (data privacy).
https://www.materialise.com/en/healthcare/mimics/
whats-new/2024
2828
Medical Innovations
PHOTO CREDIT: CHALMERS UNIVERSITY OF TECHNOLOGY | BOID | DAVID LJUNGBERG
RESEARCHERS, WHO ARE ALL PART OF THE U.S.-BASED CORTICAL BIONICS
RESEARCH GROUP, have discovered a method for encoding natural touch sensations
of the hand via specic microstimulation patterns in implantable electrodes in the brain.
This allows individuals with spinal cord injuries to control a bionic arm with their brain
and to feel tactile edges, shapes, curvatures, and movements.
“In this work, for the rst time the research went beyond anything done before in
the eld of brain-computer interfaces (BCI) – we conveyed tactile sensations related
to orientation, curvature, motion, and 3D shapes for a participant using a brain-con-
trolled bionic limb. We’re at another level of articial touch now. We think this richness is
crucial for achieving the level of dexterity, manipulation, and a highly dimensional tactile
experience typical of the human hand,” says Giacomo Valle, lead author of the study
and assistant professor at Chalmers University of Technology.
Importance of the sense of touch
For individuals with a spinal cord injury, electrical signals coming from the hand to the
brain – that should allow an individual to feel tactile sensations – are blocked by the
injury and that sense of touch is lost. A bionic limb controlled by the user’s brain signals
can bring back some functionality and independence to someone with a paralyzed
hand, but without the sense of touch, it’s very dicult to lift, hold, and manipulate
objects. Previously, a bionic hand wouldn’t be perceived by the user as part of the body,
since it wouldn’t provide any sensory feedback. This study aimed to improve the usabil-
ity of an extracorporeal bionic limb, which would be mounted on a wheelchair or similar
equipment close to the user.
Implantable technology
For the study, two BCI participants were tted with chronic brain implants in the sen-
sory and motor regions of the brain representing the arm and hand. Over the course of
ARTIFICIAL TOUCH
FOR BRAIN-CONTROLLED
BIONIC HAND
EDITED BY ELIZABETH ENGLER MODIC
several years, the researchers were able
to record and decode all the dierent pat-
terns of electrical activity that occurred in
the brain related to motor intention of the
arm and hand. This was possible, since
electrical activity was still present in the
brain, but paralysis was blocking this from
reaching the hand. Decoding and deci-
phering brain signals with this technology
is unique and allows the participants to
directly control a bionic arm and hand
with the brain for interacting with the
environment.
Complex touch typed into the brain
The participants were able to accomplish
a series of complex experiments requiring
rich tactile sensations. To do this, the
researchers typed specic stimulations
directly into the users’ brains via the
implants.
“We found a way to type these tactile
messages via microstimulation using the
tiny electrodes in the brain and we found
a unique way to encode complex sensa-
tions. This allowed for more vivid sensory
feedback and experience while using a
bionic hand,” Valle says.
The participants could feel the edge
of an object, as well as the direction of
motion along the ngertips.
By using the BCI, the researchers could
decode the intention of motion from the
participant’s brain in order to control
a bionic arm. Since the bionic arm has
sensors on it, when an object encounters
these sensors, the stimulation is sent to
the brain and the participant feels the
sensation as if it were in their hand. This
means participants could potentially
complete complex tasks with a bionic
arm with more accuracy than previously
possible.
The future of complex
touch for neural prosthetics
This research is just the rst step toward
patients with spinal cord injuries being
able to feel this level of complex touch. To
capture all the features of complex touch
researchers can encode and convey to
the user, more complex sensors and ro-
botic technology are needed (for example
prosthetic skin). The implantable technol-
ogy used to stimulate would also require
development, to increase the repertoire
of sensation.
This brain-computer interface (BCI)
allows the individual to control a
bionic limb that’s not attached to the
body, directly with thoughts. Because
of embedded sensors, the bionic
hand senses the grasped object as if
it were being grasped with the human
hand, communicating the touch
sensations to the user’s brain via
advanced neurostimulation.
Chalmers University of Technology, https://www.chalmers.se;
Cortical Bionics Research Group, https://www.corticalbionics.com
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
29
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
Ad Index / Classifieds
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Company.....................................Pg# Company.....................................Pg#
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Platinum Tooling Technologies Inc ..... 11
PMTS ................................................................. 19
Renishaw Inc ..................................................10
Rollomatic Inc................................................32
Rotor Clip Co ....................................................6
Royal Products .............................................29
Schutte Corp ....................................................7
Star CNC Machine .........................................2
Star Cutter Co ............................................... 26
Sumitomo Electric Carbide .......................5
Webinar Series .............................................31
Products + Tech
KURT WORKHOLDING
5-AXIS VISES
Featuring three vise-body sizes and three jaw options, the
Kurt PFW 5-axis 96mm vises allow mounting using a 96mm
pull-stud pattern on Kurt zero-point quick-release pallets.
Choose any of three jaw options including serrated, machin-
able, or dovetailed styles in 4" widths. Kurt 5-axis vises allow
maximum part access for done-in-one machining opera-
tions on 3-, 4-, or 5-axis machines.
User-friendly features include quick-change jaws,
spring-loaded gibs, quick-lash adjustment, hexes on both
ends of the vise, and side-body pull stud locations for robotic
machine tending and pick and place. Kurt PFW vises range
from 2.625" to 6.625" openings, making them the perfect vise
for milling small- to medium-sized parts. The AngLock design
naturally pushes the vise jaws down and forward allowing
much greater surface contact onparts – maximizing holding
strength and minimizing part deformation.
https://www.kurtworkholding.com
WTO
Ultra-high-speed spindle technology
CoolSpeed MAX is a powerful ultra-high-
speed spindle solution with speeds ranging
from 20,000rpm to 60,000rpm. It’s a main-
tenance friendly and easy-to-use coolant
driven ultra high-speed spindle designed
for turning and milling centers. The Smart
spindle monitoring system measures
spindle speed, vibration, and temperature
in real time to easily and eciently monitor
processes. Rotation of the spindle powers
the Smart system, reducing any extra maintenance or required connections.
Simply install CoolSpeed MAX in any standard 20mm bore toolholder, con-
nect to the mobile app, turn on the coolant, and it’s ready to go!
The spindle is driven by two turbines of dierent sizes and an adjustable
number of jets, designed for speed or torque, to maximize spindle perfor-
mance depending on the application. Cutting tool shanks up to 1/4" or 7mm
can be clamped with the high-speed ER11 collet system. CoolSpeed MAX
works well with most machine tools and coolant systems operating on a range
of pressures and ow rates (150psi to 1,100psi @ 2gpm to 10gpm).
http://www.coolspeed.com
PHOTO COURTESY OF RESPECTIVE COMPANIES
30
1 Last Look
TODAYSMEDICALDEVELOPMENTS.COM MARCH 2025
PHOTO CREDIT: EMPA
EMPA’S LABORATORY FOR HIGHPERFORMANCE CERAMICS’ Research
Group Leader Frank Clemens, along with his research team, are developing soft
sensor materials based on ceramics that can feel temperature, strain, pressure,
or humidity.
While ceramics are an inorganic, non-metallic material produced from a
collection of loose particles via sintering, composition of ceramics can vary,
and their properties change as a result. Empa’s researchers work with materials
such as potassium sodium niobate and zinc oxide, but also with carbon parti-
cles. None of these materials are soft, so to fashion them into exible sensors
the researchers embed ceramic particles in stretchable plastics.
“We work with so-called highly lled systems,” Clemens says. “We take a
matrix made of a thermoplastic and ll it with as many ceramic particles as
possible without compromising the elasticity of the matrix.”
If this highly lled matrix is then stretched, compressed, or exposed to
temperature uctuations, the distance between the ceramic particles changes,
and with it the electrical conductivity of the sensor. It’s not necessary to ll the
entire matrix with ceramic, Clemens notes, because using 3D printing allows
researchers to embed the ceramic sensors as nerves in exible components.
Selective and intelligent
The production of soft ceramic sensors isn’t trivial. Usually, soft sensors are sen-
sitive to dierent environmental inuences at the same time, such as tempera-
ture, strain, and humidity. “If you want to use them in practice, you need to know
what you’re measuring,” Clemens says.
His research group has succeeded in producing soft sensors that react very
selectively only to pressure or only to temperature. The researchers integrated
these sensors into a prosthetic hand. The prosthesis senses the exion of its
ngers and notices when it touches a hot surface. Such sensitivity would be an
SENSITIVE CERAMICS
An unexpected material may allow robots
to sense touch and perceive temperature
differences. EDITED BY ELIZABETH ENGLER MODIC
Empa Laboratory for High-Performance Ceramics
https://www.empa.ch/web/s201
advantage for robotic grip-
ping tools and for human
prostheses.
The Empa team even
went one step further,
developing a soft robot
skin. Similar to human skin,
the multi-layered plastic
skin reacts to touch and
temperature dierences.
To evaluate the complex
data, Empa researchers
developed an articial
intelligence (AI) model with
researchers from the University of Cambridge
and trained it using data around 4,500 measure-
ments – reminiscent of human perception, as the
nerve impulses from our skin are evaluated and
extrapolated in the brain.
In their most recent project, the researchers
combined ceramic sensors with articial mus-
cles. Together with researchers from ETH Zurich
and the University of Tokyo, they have developed
a bio-hybrid robot that recognizes its contrac-
tion state with the help of a soft, biocompatible,
tissue-integrated piezoresistive sensor.
Safe collaboration
The aim, Clemens says, is for humans and ma-
chines to work together safely and harmoniously.
“Today’s robotic systems are big, clunky, and
very strong. They can be dangerous for humans.
If you accidentally touch another person, you
automatically pull away. We want to give robots
the same reex.”
Researchers are now looking for industrial
partners in the eld of robotic gripping systems.
But soft sensors are also in demand in medicine
– the team recently completed an Innosuisse
project with the company IDUN Technologies,
where they produced exible electrodes for brain
wave measurements.
The researchers want to make their soft
ceramic sensors even more sensitive and intel-
ligent, which involves combining new ceramic
materials and soft polymers and optimizing their
sensor properties. The secret to success lies in
the interaction of these two components.
LEFT:
Empa researcher Frank Clemens and his
team develop soft and intelligent sensor
materials based on ceramic particles.
BELOW, INSET:
Empa researcher Christopher Bascucci
demonstrates a soft material which can
be enhanced with ceramic sensors.
2025
MANUFACTURING GROUP VIRTUAL EVENTS
AerospaceManufacturingAndDesign.com TodaysMedicalDevelopments.com EVDesignAndManufacturing.com
NOVEMBER
November 12 Workforce Roundtable
November 19 Lisa Anderson
— Supply Chain
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DECEMBER
December 11 Lunch + Learn
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MAY
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AUGUST
August 13 Laurie Harbour
August 21 Lunch + Learn
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March 20 Lunch + Learn
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APRIL
April 9 Spring Aerospace Outlook
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SEPTEMBER
September 10 AI/ML Roundtable
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JUNE
June 12 Lunch + Learn
June 25 Shopfloor Connectivity
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September 25 Archetype Consulting
— Medtech
JUNE
June 3 Ai-Enabled Multi-Domain
Operations
