and environments. Io T medical devices
may have completely new workflows,
users, and user experiences. Too many
firms wait until their design is finalized
before studying usability and realizing
that unseen risks are looming.
For many medical devices, user-related
hazards often dwarf device-failure
hazards. Putting additional data into
the hands of patients and clinicians
can be incredibly powerful, but creates
new challenges and risks for accurate
collection, interpretation, storage, and
dissemination that must be clearly
understood. A human factors-centered
design process including formative
studies helps drive lower-risk implementations and establishes a culture
and documentation focused on risk
mitigation, user benefits, and compelling experiences.
3. Don’t Fake the Risk Analysis
A careful hazard analysis should be
the center of your development focus.
Rigorously use tools, such as failure
mode and effects (FMEA) and hazard
analysis to provide a mechanism for the
entire design team to identify, discuss,
prioritize, and document use and device
risks along with their severity and likelihood. Use the hazard analysis as a
defining tool to galvanize the development and validation of your strategy.
4. Recognize New Risks & Adopt a
While connected med devices can
provide benefits, they also pose new
and sometimes unexpected risks.
Make sure you and your team have
carefully thought through the risks
• New clinical risks and possibilities
for compromised care.
• Data privacy, management, and
• Device integration, interoperability,
and continuity of service.
• Technology churn and obsolescence.
• Hacking and device security.
5. Be Informed & Realistic about New
The Food and Drug Administration
(FDA) is grappling with balancing the
risks and rewards as it works to pro-
tect patients. Expect a rapidly shift-
ing regulatory environment and be
prepared to build a compelling case
for your product’s safety, security,
and efficacy. A pre-market human fac-
tors review with the FDA can identify
approval risks and help determine
testing, validation, and submission
6. Remember, It’s Still a Medical
The speed, fluidity, and flexibility
of consumer product development
practices is an alluring benchmark.
This will lead to frustration at the
perceived slow pace associated
with medical device development.
“Go fast, fail early” strategies are
extremely valuable for need-finding
and conceptual design phases but
strategies, such as the minimally
viable product and ability to refine
based on early adopter feedback
can be problematic with medical
devices. Discipline is required for the
validation stages of a project. It’s the
responsibility of the design engineer
to ensure that development proceeds
rapidly, but in a safe, careful and
organized fashion. PDD
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