Board’s Back Page
Two more members of the MDT
Editorial Advisory Board respond
to questions regarding the medical
Q: In the medical device industry, where are you
seeing the most exciting innovations?
Dubreuil: We are beginning to see more integration of capabilities in order to provide imaging,
diagnostics, and tissue manipulation within a single
device and procedure. This allows the clinician,
after confirming suspicious tissue, to biopsy, ablate,
or remove tissue without having to reschedule
the patient and subject them to another visit and
procedure. The implications are significant – reducing costs and number of visits, while reducing the
number of patients who never bother to follow
up to address a diagnosis. In addition, some of
these newer devices are designed to be minimally
invasive, allowing procedures to be completed in a
doctor’s office with higher patient comfort.
Pereira: Innovations are occurring from multiple
paths, all fueled from a consumerization of the
medical industry. Our expectations as patients, or
as clinicians, or even as payers are changing what is
acceptable coming from the medical device industry.
This is raising the bar on products and furthering a
complex relationship with medical device companies, hospital systems, payers, and patients.
New products coming from established
medical device companies not only need to meet
the safe and efficacious requirements, they also
need to fit within current care paths or provide
enough financial return to entice hospital systems
to adopt new technologies and new paths. This
means truly understanding how care paths
function, understanding how each stakeholder
functions within the flow of work, and adopting
user-centric design to encourage acceptance and
proper usage by individuals.
Startups are fueling another innovation path.
They are made up of individuals that see need
or have been personally impacted by an event in
their lives. They have a sense of urgency to push
new solutions to these challenges. Inspired by the
innovators of the consumer electronic industry,
they are not encumbered by the old ways of
doing things. But the successful ones leverage
experienced persons from medical device backgrounds to navigate the complex field including
the regulatory landscape.
This all leads to having technologies such
as better, faster, and lower costing imaging and
diagnostics, with sensors that monitor us more
regularly and create baselines for not only com-
paring us individually but using big data to com-
pare population groups. Treatments will evolve
using this data. Drug delivery will improve using
devices’ feedback sensor loops to allow drugs to
benefit patients directly while reducing dosing
and compliance issues.
Q: What significant factors are influencing the
development of medical devices?
Dubreuil: The most significant factor is still the
regulatory burden that’s imposed upon device
development. The process, the cost, the time, and
the additional scrutiny of the FDA all create an
environment of uncertainty for both investors and
for OEMs involved in early stage medical device
development. It has affected the number of innovative new devices that are being developed today. At
the same time, the Affordable Care Act is putting
additional cost pressures on the R&D budgets of
device OEMs. All of this pressure means that more
attention will be placed on assuring that only the
most clinically effective, most user friendly and
distribution friendly (i.e., packaging, sterilization,
recycling) products are developed in the future for
U.S. and emerging markets.
Pereira: This is a matter of perspective. From a
startup’s point of view, finding the “right” advisors
that can guide you through an appropriate path,
finding technically sound people that have a
sense of urgency balanced with the understanding of medical device development nuances,
and deciding “are you developing product or are
you building a quality management system and
company?” are all tough issues and can distract
or hinder a startup’s ability to get their idea to
becoming products that help people.
From a large established device company’s
point of view, the challenge becomes how they
stay nimble to the needs of clinicians, patients,
and ultimately, to the market. A conservativeness
sets in at larger companies that acts like a large
speed bump to getting technologies out.
The good news is that both startups and big
med companies recognize the challenges facing
them and are using other parties to help them
succeed. Startups are using established contract
development, contract manufacturing, and distri-
bution companies to essentially buy ready-made
systems and experienced people they need. Some
big med companies are creating and investing in
startup companies outside their own systems to
get the most innovative opportunities going. All
of which mirror what occurred over decades in
the electronics industry.
Q: Where is the medical device industry headed?
Dubreuil: Preventing and reducing hospital admissions are key to healthcare cost reductions. Devices
that can predict adverse events in high risk patients
will be developed and implemented to reduce and
eliminate hospital admissions and to improve patient
lifestyles. Heart disease, diabetes, and pulmonary
disease are the primary targets of this effort.
Devices that can monitor a patient’s compliance with prescribed medications will be just a
piece of the huge wave of technologies needed to
monitor patients’ physiological responses to those
drugs as well as their responses to food, exercise,
and their environment. We will collect data of all
types to help diagnose and treat patients.
Tissue and regenerative medicine will become
a reality, requiring devices that deliver the biologics, scaffolds that help build tissue and organs, and
devices that deliver target therapeutics to specific
parts of the anatomy in predictable doses, replacing many oral and systemic drugs. The coming
decades will offer truly exciting developments in
Pereira: Larger medical device companies will
need to work more closely with hospital systems
and payers in order to push for their effective
technologies, which will inevitably mean that
consolidation and mergers will continue to occur
to help leverage their positions. We will also see
hospitals and payers create and fund their own
“startups,” not waiting for the middle man of
med device to provide solutions. The number of
startups will also continue to grow, all hoping to
be the one with the “killer app” that gets bought.
Outcomes-based medicine is replacing fee-for-service and will be the metric that everyone will
adjust to. As I mentioned before, better, faster,
and lower costing imaging, sensors, and other
diagnostics (with some providing feedback loops
that take the human error or compliance element
out) will be cornerstones of future medical device
treatment and drug delivery systems.
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