Human factors is vital for discovering, designing, developing, & deploying medical devices that are safe, effective, usable, and innovative. But, it can’t do it alone. Instead, it must successfully collaborate with numerous roles on the medical device development team.

1. ABSTRACT
Medical device companies arguably face greater challenges today than at
any point in recent history. They originate from a variety of sources. First,
they are seeing declining profits, lower shareholder returns, increased
competition from traditional and new market entrants, and greater
regulatory oversight, just to name a few. Second, the United States health
care ecosystem is transitioning toward rewarding improved quality and
accessibility of care while reducing costs, thus necessitating development of
business models that embrace this new reality. Finally, users are expecting
similar experiences with their medical devices as they have with their
personal devices. When taken together, it’s a tough environment for most
companies to survive in, let alone, prosper and grow.
While these – and other challenges – must be acknowledged; this simple
fact should not be lost: we are in a golden age for human factors in health
care. The discipline has never had greater acceptance by such a large
number of organizations. This is reflected in the rapidly increasing number
of human factors professionals employed in this domain. In fact, for many
companies it is difficult to find sufficient numbers of qualified human factors
professionals to meet their organizational needs.
These developments point to the increasingly important role of human
factors within medical device companies. Human factors is vital for
discovering, designing, developing, & deploying medical devices that are
safe, effective, usable, and innovative. But, it can’t do it alone. Instead, it
must successfully collaborate with numerous roles on the medical device
development team.
KEY TAKEAWAYS
1. Human factors educational programs often do not instill the necessary
knowledge, skills, and abilities to adequately prepare for working in cross-
functional teams. Much of it is learned on the job.
2. Clearly identify the responsibilities of human factors and the other team
members. Role confusion leads to unnecessary team conflict.
3. Identify opportunities to get each of the medical device development team roles
“out of the building” to see your products in use.
4. Be an advocate for the user; but maintain humility. Human factors does not have
all the answers.
5. Lastly: Be Nice!
DESIGN
• Clearly define roles and responsibilities between human factors and
design (interaction, user information, industrial, etc.).
• Partner with design early in the medical device development lifecycle.
• Participate in brainstorming sessions. Keep an open mind and positively
contribute to the generation of ideas.
ENGINEERING
• Work closely with systems engineering. They often are your primary
engineering contact.
• Ensure human factors is invited to the key weekly meetings; not just the
major gate reviews. Attend the meetings.
• Invite engineering to watch formative evaluations & human factors
validation testing.
CLINICAL
• Seek out opportunities to work with clinical. They typically understand
the product better than human factors.
• Clarify the purpose and what features will be tested by each group.
• Identify when both groups are testing to minimize recruits confusion
from overlapping testing weeks – or to leverage testing opportunities.
REGULATORY
• Make sure human factors and regulatory are in complete alignment with
the proposed regulatory strategy.
• Include them in meetings early in the medical device development
lifecycle.
• Keep them apprised of forthcoming standards and guidance documents.
MARKETING
• Seek out opportunities to collaborate with marketing. For instance,
funding studies and/or attending tradeshows.
• Identify marketing-specific questions that can be incorporated into
formative evaluations.
• Share study findings with them.
PROJECT MANAGEMENT
• Collaborate to identify acceptable timelines of key deliverables.
• Provide weekly updates on the progress of key deliverables.
• Communicate about potential blockers preventing timely completion.
with Medical Device Development Teams
Eric F. Shaver, PhD
Strategies for Successful Human Factors Collaborations
CONCLUSIONS
The recent history of human factors is replete with examples of
positive contributions made within medical device companies. But we
can’t do it alone. Instead, it requires a committed, cross-functional
team to develop safe, effective, usable, and innovative medical
devices. Thus, it require human factors professionals that are able to
successfully collaborate with a variety of diverse roles.
As we progress further into the 21st century, the importance of human
factors in medical device companies will continue to increase, but its’
role will likely continue to transform in order to maximize its’
effectiveness and rise to the needs of the time. While some might
consider this a threat, in reality, it’s a significant opportunity for the
individuals, their teams, and the companies they represent. If our
members can embrace this opportunity, the future of human factors
in medical devices companies will be bright!
Additional ideas? Please fill out a
card and put it in the envelope.
CONTACT INFORMATION
Eric F Shaver, PhD
Director of Human Factors
Human Factors MD
eric@humanfactorsmd.com
www.humanfactorsmd.com
1.800.639.7941
HUMAN FACTORS CONSULTANTS
• Use consultants to supplement team expertise.
• Provide introductions to key stakeholders of the medical device
development team and clarify their role and responsibilities.
• Afford them the freedom to work with team members in both a group
and individual basis.