Addressing The Challenges Of Home Medical Devices
2017-09-01
: Plexus Addressing-The-Challenges-Of-Home-Medical-Devices addressing-the-challenges-of-home-medical-devices white papers resources english-media media plexus
Open the PDF directly: View PDF 
.
Page Count: 12
A white paper by Plexus Corp.
Medical devices come home:
How to address the challenges
The long and short of it: Taking the long view of lowest total cost of ownership to avoid costs and shorten time-to-marketii
Executive Summary
Section 1: Demand Driven by Demographics
1.1 Global Drivers Increasing Need for Medical Care
1.2 Preparation and Early Engagement Ensures Success
Section 2: Enabling Technologies: Opportunities and Challenges
2.1 Wireless Communication
2.2 Smart Phone Technology and mHealth Applications
2.3 The Rise of mHealth and its Current Limitations
2.4 Security Challenges: Intermittent Wi-Fi Networks and Medical Bands
2.5 Privacy Challenges and Related Regulation
Section 3: Bringing Medical Devices to Market, Into Homes
3.1 Designing for the Home vs. Professional Environment
3.2 Usability and FDA Regulations
Conclusion
1
2-3
4-6
7-8
9
Table of contents
The use of electronic medical devices is increasingly migrating from health care centers to homes. A new set
of challenges faces device designers and manufacturers. In the past, it was nearly impossible to conceive of
a patient undergoing dialysis in his or her own home, linking remotely to his or her physician for daily blood
pressure or glucose checks, or downloading pacemaker activity via a telephone line. Today, all possibilities are in
development, and the advancement of innumerable more in-home medical devices is on the health care horizon.
The accessibility of wireless technology, mobile applications and other connectivity platforms facilitates device
manufacturers’ ability to make complex medical devices available for home use. This trend offers beneficial new
opportunities to multiple , including added convenience for health care providers; improved care for patients; and
cost savings for insurers and government payers.
Taking these devices out of the security of a hospital setting also introduces significant HIPAA, FCC and FDA
regulations. Thus, regulatory and technical requirements for bringing these devices to market are still catching up
with the eager anticipation of health care suppliers and providers.
This paper explores the impact of recent market trends surrounding the large-scale introduction of medical
devices in the home. It outlines challenges of pursuing this opportunity in product development and offers insight
from key industry insiders and corporate stakeholders on the oft-conflicting expectations of patients, health care
providers, device designers and regulatory bodies.
1
Executive Summary
The shift in the demand for medical devices for the home
is a global trend. The global market for consumer medical
devices is expected to grow at a steady rate with revenue
forecasted to reach $8.9 billion by the end of 2014 (see
figure 1).
According to IHS, a global scientific, technical and medical
information company, revenue expansion for the next
several years will range from five to nine percent, with
industry revenue amounting to $10.6 billion by 2017, as
shown in figure 1. (Source IHS, Inc., September 2013)
So what is driving this multibillion dollar growth?
Three global drivers for the increased demand of consumer
medical devices stand out:
1. An increasingly aging global population and the
associated rise in chronic illness, leading to more
long term care.
2. Patient expectations of ubiquitous and constantly
accessible healthcare.
3. Cost pressure on healthcare system
First, let’s discuss aging demographics and rise of chronic
care…
Roeen Roashan, Analyst for Consumer Medical Devices
and Digital Health at IHS Research recently explained,
“One important reason for the consistent rise in revenue
over the years (in the consumer medical device sector)
is that the worldwide population of those age 65 and
above will continue to grow. As a result, there will be an
increased need for health monitoring.”
In his book, The Creative Destruction of Medicine,
cardiologist, author and healthcare technologist Eric Topol,
M.D. writes of the phenomenon of Aging in Place: “The
concept of wireless monitoring to create a ‘smart’ medical
home may be particularly well suited for select seniors,
preserving their ability to stay at home by providing a
greater safety margin. Nearly all seniors, more than 95
percent in surveys, want to stay in their own homes
rather than move to an assisted living facility or nursing
home.”
Closely associated, the global healthcare system will see
a rise is expenses associated with aging people living
with chronic diseases that require consistent monitoring.
Chronic conditions such as cardiovascular disease,
diabetes and obesity continue to increase and are no
longer diseases primarily prevalent in Western societies.
According to the World Health Organization, cardiovascular
disease or hypertension is responsible for more than
30 percent of annual deaths worldwide. (Source: World
Health Organization Report on Global Health Estimates,
2000-2011)
Growth rates for consumer medical devices also look
promising due to government initiatives in preventive care.
Efforts from public and private health organizations result
in increased awareness among consumers of the benefits
of consistent health monitoring, especially for chronic
Figure 1: Forecast for Consumer Medical Devices
(billions of US Dollars)
1.1 Global Drivers Increasing Need for Medical Care
The long and short of it: Taking the long view of lowest total cost of ownership to avoid costs and shorten time-to-market2
Section 1: Demand Driven by Demographics
conditions. Due to the rising number of consumers
investing in their physical well-being, personal care devices
such as activity monitors, body composition analyzers
and heart-rate monitors are among the fastest-growing
consumer medical devices.
“I want my medical treatment to fit my lifestyle and not
the other way around.”
Secondly, patient expectations about the convenience of
their medical treatment are driving the growth in demand
for in-home medical devices. Patients expect more from
their medical treatment options deriving in large part from
their comfort and experience with computers, tablets and
smartphones.
Keely Wagner, Senior Hardware Design Engineer at Plexus
comments on changing patient expectations:
“Because technology is now an integral part of our daily
routine, people have come to expect it in every part of
their lives. Wireless technology specifically has been at
the forefront of that expectation. We don’t want to
have to wheel around medical devices with wires strung
from them and having to connect them to local ethernet
connections. We as consumers expect them to be mobile
and connected.”
Finally, recent seismic changes in U.S. healthcare legislation, most
notably the Affordable Care Act, puts pressure on hospitals and
healthcare facilities to reduce costs which, by extension also
puts pressure on device OEMs.
Reducing service time, or time spent with patients by
health care providers, can reduce overall cost for healthcare
facilities; therefore, some experts expect in-home medical
devices will fulfill that desire. Jack Levin is a Partner at
Venetia Systems, a consulting firm specializing in helping
product manufacturers be more solutions focused with
M2M and the Internet of Things. Levin explains, “In the
medical sector, the traditional doctor-patient monitoring
element is one of the highest cost factors in the healthcare
system. For instance, after surgery, mobile health devices
such as home monitors allows patients to be placed in a
much lower-cost treatment environment while ensuring
the patient is in compliance with his or her prescribed
treatment. This ends up relieving a lot of financial stress
on the healthcare system.”
Motivated by all the technology available, engineers
and product managers are eagerly exploring how to
bring these consumer-driven devices to market. Given
the complexities of patient and provider expectations
and regulatory compliance, product developers must
thoughtfully build time and testing into their earliest
attempts at product realization.
Jeffrey Newhouse, Senior Quality Engineer at Plexus Corp.,
explains: “Performance standards are now recognizing the
importance that risk management and essential performance
has on the device under evaluation. As such, Safety Agencies
are now required to review your risk management file and
evaluate essential performance during test. In order to
successfully design a device to meet these requirements
it is essential to have a well-organized risk management
strategy and conduct early engagement activities with your
Safety Agency in order to assure a successful certification
during your official submission.”
“Because technology is now an integral
part of our daily routine, people have come
to expect it in every part of their lives.
Wireless technology specifically has been at
the forefront of that expectation....”
3
1.2 Preparation and Early Engagement
Ensures Success
The two most common benefits of wireless communication
are mobility and access to real-time data. Patient mobility
allows them to move freely within a hospital setting,
but more importantly, leave the hospital while still being
monitored. An example of such a product is an implantable
device that monitors glucose levels while a patient is in
the comfort of his or her own home. This same device
transmits real-time data to a networked computer in the
patient’s home, allowing healthcare professionals access
to the data remotely. (Source: The Wireless Revolution in
Medical Devices, http://www.medicaldevice-network.
com/projects/wireless_revolution)
Wireless communication solutions are largely accessible.
Keely Wagner of Plexus said, “There are a range of wireless
modules readily available for manufacturers to integrate
into their products requiring minimal engineering efforts.”
However, the complexities of wireless medical devices still
pose challenges that engineers and project managers need
to overcome.
For instance, commercial product time cycles differ greatly
from those of medical devices. Wi-Fi technology changes
quickly and a durable medical device has an average life
cycle of seven years. Designers and engineers need to
be sure to incorporate technology that can accommodate
and adapt to the changes that surround it. Currently,
astute Wi-Fi module makers are aware of the discrepancy
in end-device requirements and provide solutions that are
designed for these longer product life cycles.
Smart phone technology is quickly evolving into medical
device technology. Jack Levin said that smartphones, or
mobile devices, are already playing an important role in
health care in what has become known as mHealth. “We
see more and more healthcare applications working in
combination with mobile devices, with companies leveraging
their medical devices or services around the smartphone.”
Remote patient monitoring will provide the most cost
savings to the healthcare industry when it results in less
time in hospitals and fewer outpatient visits. These benefits
are further enhanced by the combination of smartphone
apps and mHealth attachments in collecting data, delivering
information directly to patients and providers, and real-
time monitoring.
One example of this is the development of cardiac
monitoring systems. Sensors are attached to the body,
yet the technology utilizes the patient’s phone for all its
communication. Instead of building the communication
capabilities into the medical device, the system is taking
advantage of the fact that the majority of the technical
features required to enable its communication features are
already integrated parts of the smartphone.
The integration of mobile devices into a patient’s life is
more accessible today thanks to the wide availability of
mHealth applications. This can range from applications
that support a healthy diet, to applications that provide
education about surgical procedures. However, many
pressing questions remain:
• To what extent can apps support a patient’s
medical condition or his or her treatment?
• Can advice and treatment be given via a
smartphone and expect to be implemented
properly?
• Is the data that is being transferred secure and
properly documented in the patient’s records
How do physicians, nurses and other healthcare
professionals see the advent of mHealth devices and
apps that transfer care from the clinic to the home?
The long and short of it: Taking the long view of lowest total cost of ownership to avoid costs and shorten time-to-market4
2.1 Wireless Communication
Section 2: Enabling Technologies:
Opportunities and Challenges
2.2 Smart Phone Technology and mHealth Applications
2.3 The Rise of mHealth and its Current Limitations
Dr. Orrin Franko is an orthopedic surgery resident at
University of California, San Diego. Dr. Franko is also the
Founder and CEO of TopOrthoApps.com, a website that
educates physicians on benefits and limitations of apps
along with providing reviews.
Franko stated, “Today, patients expect more when it comes
to accessibility of their medical care. Many patients feel
physicians should be available at their disposal prepared with
clear information to make complex disease and treatment
easily understandable to them.” According to Franko,
apps have been able to assist in meeting some of these
demands by providing illustrations of a surgical procedure
or by providing patients with a post-surgical treatment plan
to follow. “These are beneficial tools for patients and may
help to minimize health care costs, but still don’t relieve the
workload for physicians themselves.” In Franko’s opinion, the
best mobile apps are ones designed or developed jointly with
physicians and are geared towards supporting treatment,
improving patient insight and ultimately contributing to the
success of the care objectives.
However, Franko cautions of several challenges that mHealth
devices and apps present to the healthcare system. He
opines, “Simply collecting more data won’t automatically lead
to better patient care.” For example, Franko is concerned
that even though devices are capable of collecting patient
monitoring data like vital signs or glucose level on a 24/7
basis, databases and case histories don’t exist yet that help
physicians understand this data deluge. Furthermore, Franko
feels, “There is always risk when diagnosing or proposing a
treatment plan without physically seeing the patient.”
Chad Walters, Senior Industrial Designer at Plexus,
comments: “When we are designing products or
applications we empathize with the target audience of
that device. We will spend an entire day with physicians
to understand how they interact with current devices
and what needs are unmet or what challenges they see
with the new product we are developing.”
A good example of an application Franko would recommend
is one that is a complete resource for patients considering
knee replacement surgery. The in-app features include a
calendar with reminders of surgery-specific details and
checklists, e-mail alerts to remind patients what to do
and when, and location-based resources for local hospitals
and surgeons with quality outcome data and more.
“The rise of mHealth applications has certainly helped
enable independent patient care and given patients more
freedom and control. I see the healthcare system overall
accepting this trend as they hope to see cost reductions.
But on the flip side, I see hesitation with physicians
giving up face-to-face interaction with their patients. It’s
risky,” Franko concludes.
5
“When we are designing products or
applications we empathize with the target
audience of that device. We will spend an
entire day with physicians to understand
how they interact with current devices....”
The rise of wireless communications in the medical space
immediately raises security-specific challenges. Cellular
networks like 3G or 4G are still relatively vulnerable
ways of transporting data, which piques the interest of
regulatory bodies.
The network’s wireless signal is a big concern relating
to the performance of the medical device. To overcome
intermittent signal strength, current available techniques
include buffering and queuing. The configuring of a mobile
device to work on Wi-Fi is a real challenge, especially if
it is moved in and out of various Wi-Fi networks and
initiates new manual logins each time. Overall, Wi-Fi and
cellular networks present relatively unstable connections
for medical devices, which can bear significant security
risks as reliability is crucial to their operation.
One alternative in the medical sector is the use of
previously unlicensed frequency bands. Medical telemetry
bands are available from the Federal Communications
Commission (FCC) and are specifically designed to provide
secure options for monitoring patient developments,
making the use of the device much more safe and
reliable. (Source: Federal communication commission,
wireless medical telemetry service, http://www.fcc.gov/
encyclopedia/wireless-medical-telemetry-service-wmts )
Working with a product realization company that is aware of
these challenges in wireless applications is imperative. The
Food and Drug Administration (FDA) ensures that before all
wireless medical devices are introduced into the market, that
they be properly tested and that the manufacturers have
considered, outlined and tested the potential limitations
associated with wireless connectivity (Source: Cutting the
Wires: FDA Provides Industry Guidance, http://blogs.fda.gov/
fdavoice/index.php/2013/08/cutting-the-wires-fda-provides-
industry-guidance)
Not only do OEMs and device manufacturers have to
keep tabs on FDA regulations, but when collecting patient
data, they also have to make sure they are HIPAA and
HITECH compliant. Both of these acts ensure that
protected health information (PHI) is confidential and
secure when it is transferred, received, or shared.
The security of data being transferred over Wi-Fi is
being studied and as a result additional regulations
are being developed to address these issues. Doug
Biette, Vice President of Medical Device Development
and Manufacturing at United Therapeutics commented,
“Regulations are not keeping up with technology. Data
protection is a big topic in the medical industry, but all of
the hoops manufacturers have to jump through to get
products approved are limiting innovation.”
Bluetooth technology wireless protocol in the medical
space and provides a bit more data protection than
traditional Wi-Fi methods. An article on the wireless
revolution in medical devices shares that Bluetooth was
designed to allow small groups of up to eight devices
to communicate with each other over a Personal Area
Network (PAN). These ad hoc networks have the potential
to make seamless the integration between medical
equipment in hospitals and at home. Patient privacy can
easily be designed into products, since Bluetooth supports
many security features, including password protection
and encryption. (Source: The Wireless Revolution in
Medical Devices, http://www.medicaldevice-network.
com/projects/wireless_revolution)
The long and short of it: Taking the long view of lowest total cost of ownership to avoid costs and shorten time-to-market6
2.4 Security Challenges: Intermittent Wi-Fi Networks
and Medical Bands 2.5 Privacy Challenges and Related Regulation
The home environment is less uniform and much more
unpredictable than a hospital or medical facility. Medical
device designers have to incorporate feature sets that
overcome those obstacles while ensuring proper device
function.
“Incorporating the proper feature set into a medical
device that will be used in a patient’s home is the most
challenging hurdle an industrial designer has to face when
designing a new product,” says Chad Walters, Senior
Industrial Designer at Plexus . “The challenge is what
does the device actually need and why?”
Industrial designers have to be cognizant that they are
designing devices which will be used by a wide range
of patients with varying levels of proficiency. Simple and
straightforward is best, Walters believes. “Just because
we have the technology to incorporate a feature set,
doesn’t always mean we should,” he explained. “We
should only be adding features to the device if they are
required to make the device functional or add value to the
patient’s care.”
There has been a strong demand for devices featuring
touchscreen capabilities. Yet despite their modern look
and feel, this feature can unnecessarily prolong the
development of the product and add unwarranted costs.
It is ultimately the decision of the manufacturer, but
often the technology the patient demands isn’t feasibly
integrated into his or her medical device.
It is the responsibility of an industrial designer to
incorporate the proper feature sets while meeting the
requirements of the product and keeping it easy to
use. “This is how the method works at Plexus.” Walters
described, “We are involved early and work closely with
the project team throughout the whole process to ensure
our customer’s needs are being met and that we are
delivering a product that will improve the lives of patients.”
• An industrial designer ensures the right questions
are being asked about the required performance
of the product and the environment in which the
product will be used.
• The designers then work closely with software,
electrical, and other engineers to discuss the types
of technology that can be incorporated.
• This is followed up by end-user research which
may involve the use of 3-D models and watching
actual patients interact with a to-scale model of
the product.
It is critical for the success of the product to get the
end-user of the device involved early. This is true both
for medical devices designed for a hospital setting and
individual homes. Gathering end-user feedback isn’t
just for successful device function—it is also required
documentation for the FDA.
Companies need to demonstrate that the feedback they
receive from test groups of end- users is being taken
into account at each step in the design process and that
these changes are ultimately improving the functionality
or usability of the device. Failing to actively seek end-
user feedback throughout the development process
is frowned upon by official regulatory bodies. A well-
informed product realization partner will know this.
7
“Incorporating the proper feature set into
a medical device that will be used in a
patient’s home is the most challenging
hurdle an industrial designer has to face
when designing a new product.” Chad
Walters, Senior Industrial Designer at Plexus
Section 3: Bringing Medical Devices
to Market, Into Homes
3.1 Designing for the Home vs. Professional Environment
3.2 Usability and FDA Regulations
Medical OEMs have to get creative with their business
model strategies because of recent significant changes
in the medical industry. Stricter regulations and cost
constraints are making it more difficult to design
products that previously would have been an easy sell.
The growth potential with in-home medical devices and
mHealth shows signs of hope for device OEMs whose
current or previous business model is struggling.
As Doug Biette of United Therapeutics stated, “We have
invested a significant amount of money in human factors
engineering to align with products that now need to be
more personalized for at-home patient use. We also added
to our market research budget to ensure we are aligning
with end-user needs.”
Full product realization companies are of added value
to OEM’s changing their business model because they
provide access to a broad spectrum of key resources
that all work in tandem to meet the customer’s requests
such as:
• Quality engineers who keep tabs on regulatory
standards
• Hardware and software engineers who are on top
of newest technology advancements
• Industrial designers who specialize in human factor
engineering
The value of working with one company is the cohesion of
all resources aligning to produce the best possible product.
The long and short of it: Taking the long view of lowest total cost of ownership to avoid costs and shorten time-to-market8
3.3 Changing Landscapes in Medical Device
OEM Business Models
Today’s medical electronics market has seen an explosion of technologies that will have a lasting impact on the way
patients and providers experience health care. The combination of rapid technology developments together with the
expectations of increasingly tech savvy patients is driving lasting changes in the medical device space.
The impact of bringing more medical devices into the private realm of the patient’s home environment will be felt across
the entire healthcare sector, driving changes in hospitals, homes, the economy and society as a whole. Working with a
partner that supports product developers at each point in the process is key to success.
About Plexus Corp. – The Product Realization Company
Plexus (www.plexus.com) delivers optimized Product Realization solutions through a unique Product Realization Value
Stream service model. This customer-focused services model seamlessly integrates innovative product conceptualization,
design, commercialization, manufacturing, fulfillment and sustaining services to deliver comprehensive end-to-end
solutions for customers in the America, European and Asia-Pacific regions.
Plexus is the industry leader in servicing mid-to-low volume, higher complexity customer programs characterized by
unique flexibility, technology, quality and regulatory requirements. Award-winning customer service is provided to over
140 branded product companies in the Networking/Communications, Healthcare/Life Sciences, Industrial/Commercial
and Defense/Security/Aerospace market sectors.
Seek out tightly integrated industrial design and engineering relationships with specialist teams working across all
disciplines to create beneficial intersections where ideas and innovation happen. The medical device market will become
increasingly complex, more specialized and more heavily regulated. With the right support, insights and infrastructure,
companies can use new technologies to stay on top and lead the market in new medical device development.
9
Conclusion
“As a partner to many of the leading global medical device companies, it is
exciting to be a part of and to see the positive outcomes made possible
by remote patient care. Industry cost pressures are inevitable but cost
savings can never come at the expense of patients. Remote patient
care empowers patients, ultimately resulting in both reduced cost to the
healthcare system and improved patient care.” Michael Tendick,
Market Sector Vice President at Plexus
Publication date: JUN 2014
©2017 PLEXUS CORP. | Plexus and the Plexus logo are registered trademarks of Plexus Corp., Neenah, WI, USA. | JUN 2014
PLEXUS.COMAMERICAS
+1 877 733 7260
EUROPE
+44 (0)1506 637 997
ASIA PACIFIC
+604 632 5252
