Medical Design Briefs - October 2021 - 33

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Making Devices for Inpatient vs. Outpatient Care:
Responding to New Manufacturing Demands
Tessy Plastics
Skaneateles, NY
Advances in technology and the momentum
to reduce healthcare costs have provided
the incentive for hospitals and physicians
to seek ways to replace in-patient surgeries
with minimally invasive procedures. In -
dustry experts predict that new technology
incorporating AI and robotics will streamline
hospital administration and provide
higher levels of patient safety and satisfaction.
Healthcare delivery in rural areas and
the growth of ambulatory surgical centers
require further development in making
medical devices more portable.1,2
The aging population, stronger Medicare
rate increases, and improvements in patient
care should continue to support growth in
North American hospitals. Interoperability,
the ability of different information systems,
devices, or applications to connect, in a coordinated
manner, within and across organizational
boundaries to access, exchange, and
cooperatively use data amongst stakeholders,
with the goal of optimizing the health of
individuals and populations is viewed as the
ideal solution toward meeting these needs.
Deloitte cites interoperability as the force to
enable hospitals of the future to help hospitals
move from episodic to collaborative and
longitudinal care.3
As in-house surgeries shift to outpatient
facilities, communication among the various
devices both within the surgical theater
as well as with hospital data management
systems compel the medical device industry
to design for both portability and adaptability.
Original equipment manufacturers
(OEMs) must design devices that meet the
demand for features that support interoperability
to improve patient outcomes and
provide accurate tracking of each procedure,
resulting in detailed patient records
to be used for outpatient services and
future procedures.
■ Speed-to-Market Challenges
According to strategic technology provider
Intersystems Healthshare, " In the new medical
device market, the value of the device
and data alone will not drive sales. Instead, it
will be solutions that bundle device, data, and
real-time analytics that clinicians, health systems,
and payers will want to buy. " 4
The mandate for new, value-added products
coupled with the challenge of navigating
the FDA's approval process with the
added expense of additional approval fees,
will continue to challenge OEMs to drive
sales and deliver quality products while
holding profit margins.
Ongoing product development to add
value by improving quality and utility while
remaining cost-efficient is the strength of
Medical Design Briefs, October 2021
Intro
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Contract manufacturers enable OEMs to save
time and capital expenses. (Credit: Tessy
Plastics)
www.medicaldesignbriefs.com
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OEMs. As existing devices change shape and
utility, the devices must be tested and retested
to ensure product viability in terms of safety
and reliability, and then, in many cases, reenter
the premarket regulatory process.
As products change, the question be -
comes how to manufacture to scale according
to quality standards within a compressed
timeline.
■ Agile Manufacturing
Contract manufacturers with a focus
on medical device product development
can be key partners, enabling OEMs to
save time and the capital expense of re -
tooling their plants in order to come up
to scale with a new or revised device.
OEMs considering partnerships should
vet contract manufacturers to verify their
capability to perform rapid prototyping
and work collaboratively with medical
professionals to ensure that the finished
device meets all testing requirements.
Agile partners can then work to evaluate
the product design for manufacturability
to ensure that production is brought up
to scale using lean techniques in the most
cost-efficient manner.
Prospective contract manufacturers should
be able to answer " yes " to these questions:
* Can you manufacture in compliance with
ISO13485 and ISO 14001?
* Are you FDA/GMP registered?
* Do you have ISO Class7/8 clean room
manufacturing?
* Does your quality management system
comply with FDA and EU requirements?
* Do you practice sustainable procurement?
Be certain to ask:
* What is your experience with manufacturing
products for companies with FDA obligations?
*
How do you support your clients in this
effort?
* Are you prepared for FDA inspections?
■ Contract Manufacturing vs.
In-House Production
" The key to integrating a new product
quickly and efficiently is rapid prototyping
with the end goal of design for manufacturability
(DFM). Our rapid prototyping metho -
dology, for example, is based around the
idea of 'failing fast,' says Stafford Frearson,
vice president of engineering for Tessy
Plastics, a global contract manufacturer specializing
in injection molding and custom
automated assembly solutions.
" In other words, through our capabilities
with 3D printing parts and developing rapid
prototype molds, we are able to produce several
iterations of initial concepts for a project/program.
This allows us to quickly identify
which design concepts will be the most
suitable for production of the product. "
This methodology has proven successful
in cases where customers want initial samples
without spending a significant amount
of capital up front in order to prototype multiple
designs. This prototyping process allows
the customer to test various designs for their
product in a short period of time and for less
investment when compared to traditional
tooling. Ultimately, this allows the customer
to quickly determine which design is best
suited for release and thus reduce time to
market.
References
1. O. Lam, et al. (12 December 2018) Pew Research
" How far Americans live from the closest hospital
differs by community type, " https://pewrsr.ch/
2L2nthb
2. P. Kazanzides et al., " Modular Interoperability in
Surgical Robotics Software, " Department of
Computer Science Johns Hopkins University
Mechanical Engineering. Sep 2015, 137(09): S19S22,
Paper No: ME-15-SEP-10, https://
doi.org/10.1115/1.2015-Sep-10
3. Deloitte Center for Health Solutions (2017) " The
hospital of the future: How digital technologies
can change hospitals globally, " https://
www2.deloitte.com/content/dam/Deloitte/glob
al/Documents/Life-Sciences-Health-Care/uslshc-hospital-of-the-future.pdf
4.
" The Key Challenges Facing Medical Device
Manufacturers, " InterSystems HealthShare,
InterSystems white paper, https://www.
intersystems.com/devices/
This article was written by Beth Ryan, a freelance
writer based in Cambridge Springs, PA. For
more information, visit https://tessy.com.
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https://www.pewrsr.ch/2L2nthb https://www.doi.org/10.1115/1.2015-Sep-10 https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/us-lshc-hospital-of-the-future.pdf https://www.intersystems.com/devices/ https://www.tessy.com http://www.medicaldesignbriefs.com http://info.hotims.com/79418-966
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