How many of us have actually been taught how to innovate? We may have been taught to engineer or design, but likely, relatively few in research, development, and design have really been taught how to innovate. Innovation happens when research and development teams produce a new and valuable product. Innovation in healthcare requires a cooperative relationship between physicians and professionals in the medical-device industry. But what is a medical innovation, really?

Dr. Tom Fogarty, a physician, entrepreneur, and inductee into the Inventor's Hall of Fame describes medical-device innovation this way: “Science is the activity of proving or disproving a theory. Technology is the application of science that is already proven.”

The term “innovate” comes from the Latin in novare, “to make new.” Fogarty adds that “clinical utility” is what a successful medical innovation must have, or where a device meets and solves a clinical need and embodies the right amount of technology.

Linus Pauling had insights that lead to innovations. “The best way to have a good idea is to have a lot of ideas,” he said. However, ideas not acted or executed on are worthless. Time is also working against you. If you are working in a field populated with other smart people. You can be sure they are looking at the same problems and data and may be converging on similar solutions. The only consistent competitive advantage is to connect the dots first and execute on the idea first. So get the idea out of your head, into a notebook, into a prototype, and into reality. A strategy for someone who must innovate might be to observe, prototype, experiment, test, and repeat.

It is a skill to generate and capture ideas, connect concepts, and develop them. Like any skill it can be learned. Innovating by generating and capturing good ideas, cultivating, iterating, and permutating them is an art that takes practice and time to develop. So start now.

Medicine first, thenbusiness

Dr. Lanny Johnson, a pioneering orthopedic surgeon and coinventor of an arthroscopic shaver, recently presented a keynote address titled “The Business of Medicine: Medicine First then Business.” The title helps set the tone for medical-device innovation. In his talk, Johnson noted: “The foundation of business is innovation, and its foundation in medicine is clinical observation.” Hence, finding clinical needs and developing innovative solutions requires a cooperative arrangement between physicians and professionals in the medical-device industry. Gathering clinical observations as a professional will be the subject of a future article.

Barriers to innovation:Conflicts of interest

This issue and legislation such as Federal Anti Kickback laws, “Stark Laws” (after Pete Stark D-CA), and recent actions by the U.S. DOJ against the orthopedic industry have had a noticeable effect on physician-industry relationships. The “Stark Laws” are aimed at preventing physicians from making referrals to facilities or prescribing devices or drugs in which they have a financial interest. For more information see: http://en.wikipedia.org/wiki/Stark_Law.

Healthcare innovation is complex and risky enough without the threat of government prosecution and restrictions from legislators. (By the way, if some form of socialized medicine takes hold in the United States, the relationship between medicine and industry may grow even more complicated and restrictive than it already is.)

To advance innovative ideas in healthcare, industry must be able to solicit and develop ideas from physicians, and both must fairly share in the success. The ethical bar on this issue has been raised, and industry innovators working with physician innovators must be aware of these issues. Two useful resources are the AdvaMed Code of Ethics www.advamed.org/MemberPortal/About/code/ and the AAOS Standards of Professionalism www5.aaos.org/industryrelationships/standards.cfm.

To wrap up, here are a few steps for developing an innovative medical device:

• Start with a clear clinical need based on clinical observation

• Gather data on the need and learn everything you can about it from wherever you can and from everyone you can (but be careful about confidentiality). Capture and keep the data in an organized, systematic form. Then highlight, annotate, and cross-reference the information.

• Learn from the data and develop solutions. Answers to problems often appear in pieces and need positioning, like puzzle pieces arranged into a picture. Generate as many ideas and potential solutions as possible, and defer judgment on them. Capture, record, and date these ideas as you generate them. Look at different dimensions of the problem, such as technological, ease-of-use, how the design affects patients, affordability, and economic impact.

• Prototype and test these solutions in vitro (“in glass” i.e. on the bench) and in vivo preclinically and clinically “in life.” Prototype and test early and often. Systematically record your observations and use what you learn to generate new ideas and converge on a solution.

• Apply just the amount of technology needed to do the job. Keep costs low and ease-of-use high. Get to a proof-of-concept-level solution.

• Test the solutions in the hands of real doctors in real clinical settings, and let clinical observations guide you to a best real-world solution. Solicit honest feedback.

RECOMMENDED READING

Several good general-purpose resources are available on the subject of innovation. One is Clayton Christensen's “The Innovators Solution” and “Seeing What's Next.” Christensen popularized the term “disruptive innovation.”

“The Essential Drucker” has some of the best ideas from Peter Drucker, a leader in business thinking. Another useful read is “The Myths of Innovation” by Scott Berkun.