platform vendor use a quality management system for clearly defined development, verification and validation processes as well
as any required standards for compliance with FDA and patient
information privacy regulations.
Another issue is design and adherence to user interface and
human-factor engineering found in IEC62366 (which specifies a
process for a manufacturer to analyze, specify, design, verify and
validate usability, as it relates to safety of a medical device).
Numerous reports of confusing or unclear on-screen user
instructions, which may lead to improper treatment, should be
examined for patients using tablets and smartphones for critical
Finally, there is still a big chasm between the consumer and
medical world in regard to product lifetime. Time from concept
to end of production for a consumer device may be less than 24
months. For medical devices, with the exception of disposable
devices, normal time span has ranged from five to 10 years—with
a fraction of the volume compared to mobile phones. As medical devices head into the consumer realm, volumes will increase
and lifecycles will decrease but the disconnect will remain. Supply chain partners can help mitigate this issue by developing risk
management guidelines and procedures adherent to ISO 14971
(which outlines a process to ensure that all aspects of risk management are considered throughout the product life cycle for
medical devices), including management of critical outsourced
and single-sourced components, selection of long-term support
parts from automotive or industrial sectors, order management
and negotiation of dedicated parts under special contracts and
management of required lifetime buys.
The right design and manufacturing partner can offer device companies a deeper understanding of wireless, compute,
storage and consumer architectures and technologies for planning next-generation devices. Miniaturization of sensors for a
desired form factor, integration of wireless connectivity and antennas through a module or on-board circuitry, use of innovative process technologies for reduced manufacturing complexity, identification of bio-compatible materials, handheld design
for communicators and programmers and after-market services
all are managed under a quality management system and ISO
13485-certified environments (13485 deals with medial device
quality management systems.
Competitive differentiation is becoming harder to define and
sustain in the medical device market. As tablets and smartphones
become the user interface to medical devices, and as computing and analytics move from the device to the cloud, medical
device manufacturers should be concentrating more on the value
and profit in solving the problems on the edges, simplifying the
Continuing to drive development of intellectual property
through higher accuracy, increased performance and less costly
front-end sensing technology is highly differentiating. Many
companies in the healthcare industry are focusing on development of algorithms for data interpretation and treatment guid-
Medical Device Connectivity
ance combined with high-level data analytics in the cloud. User
interface must be redefined from a static display and keypad to
the incorporation of forms that promote patient engagement
throughout various interactions with devices, social media and
physical and web communities. Support services must morph
from a call to the doctor’s office or a random internet search to
easy retrieval of education and support sprinkled through patient
touch points, such as phone, texts and face-to-face visits.
Cost savings to the overall system must remain a priority
by continually removing redundancies in the system and in
the devices. Reductions in product cost might be offset with
new services along the value chain. The right partner can help
medical device firms manage product portfolios through these
Whether it is the current smartphone or a new future form
factor, consumer devices with mobile apps should remain the
preferred method of self-management of health and wellness.
Medical devices will continue to be impacted as new trends and
technology advancements shape generations of our medical device sensing and remote monitoring ecosystems.
No matter what you call it, change is coming. The entire industry must focus on containing unsustainable increases in healthcare costs and extending access to care. Collaboration with your
partners in the value chain can help ensure that you continue to
provide highly desired, highly differentiated and highly valued
products and services that drive more effective patient outcomes
and contribute to lower healthcare costs. v
Ralph Hugeneck is the director for medical technology for Jabil HealthCare & Life Sciences. He joined Jabil in 2005 as a business unit manager and was named to the current position in 2009 and is responsible
for developing and implementing strategies and technologies to accelerate the growth of Jabil’s medical portable on-/in-body devices. Prior to
joining Jabil, Hugeneck spent 14 years with Royal Philips Electronics.
His most recent position was director of process development & manufacturing engineering at Philips Creative Display Solutions. Prior to
that role, Hugeneck had several management positions in the product development and process development area of Philips Consumer
Electronics division. Hugeneck holds a bachelor’s and master’s degree
in mechanical engineering from Vienna University of Technology in
Switzerland, including a degree in biomedical engineering.
Donna Fedor is the lead strategist for The Arden Group, which she
founded in 2009. During that time, she also was director of strategy for
the healthcare industry sector at Jabil Circuit Inc., an $18 billion global
electronics design and manufacturing services company. Throughout
her career of more than 20 years, Fedor has held numerous strategy,
technology, business development and management, channel management, and marketing positions with Flextronics and National Semiconductor. She also founded a Web-based startup company focused on
employee services during the early Internet boom. Fedor holds a bachelor’s degree in electrical engineering from Boston University.