The Healing Innovation (HI) blog has spent the last year making the case for greater collaboration between the medical device industry and clinicians. HI, however, has also blogged extensively about the conflicts of interests created by clinicians becoming PR mouthpieces for new products and clinical trial results.
Although medical device companies spend large sums of money paying “Key Opinion Leaders” (KOL’s) for their thoughts on the future of medicine and products in specific clinical indications, this should not be mistaken for collaboration.
KOL’s are typically driven by the marketing function within an organization, with larger companies having more specialized strategic marketing resources responsible for coaxing prognostications out of leading clinicians in a field. Whether these doctors provide technically accurate responses is of little consequence since their opinions are assumed to become self-fulfilling prophecies.
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Healing Innovation Website Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
KOL’s are chosen because they are either on “the tour” (i.e. speaking at most scientific conferences) and influencing their peers or are large volume buyers and can move the needle with their own actions. Either way, medical device companies go out of their way to make these KOL members feel privileged and influential. That is not to say that these leading clinicians are actually aiding the development of products, just providing critique and conjecture.
So, why aren’t more medical device companies searching for the actual lead-users that can drive innovation and actively collaborate on product development? Let’s start with hypothetical perspectives for four key medical device company functional areas:
- Strategic Marketing: more concerned with being in conversations with perceived leaders in a field than finding the actual innovators; establishing relationships of influence is primary.
- R&D: doctors are great at identifying clinical needs, but “we (engineers) are the experts on solving problems”. Note: the actions of R&D teams are often reflective of a “Not Invented Here (NIH) Syndrome”.
- Business Development: doctor’s don’t understand that a product has to be financially viable and do not spend effort flushing-out a business case. Let someone create a start-up company around the idea to flush-out most of the risk before we get involved.
- Legal (patent counsel): there is too much risk to allow engineers to be exposed to ideas from clinicians before they file for patents; the company could be working in an area that then gets contaminated and the company is vulnerable to suit from a jilted doctor.
Like a comedian’s joke, there is an essence of truth in each of the four stereotypical responses above. Additionally, there exists a large swath of doctors who don’t have the time, patience or passion for medical device product development despite their curiosity. So, what is the answer?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Here are three suggestions:
- Separate clinical trial investigators who present data at scientific conferences from lead-users that contribute to the product development process. Avoid involving KOL advisors in clinical trials to prevent the perception of influence peddling.
- Start using Internet-based tools that provide greater exposure to more clinician input in a controlled and documented fashion, protecting intellectual property without the current rigid constraints. Make more clinicians a part of the development process. Better tools will enable greater collaborative freedom.
- Stop pretending that doctor inventors have to be experts in all facets of product development to contribute to the process, or have to be marginalized to providing thumbs up/down input or solely clinical needs. If a physician has expertise in a clinical specialty and is creative, that doctor has the ability to be an innovator and work with other technical and business resources to drive new medical devices development. There is a role for a physician innovator in almost all medical device product development teams.
- Ensure that clinicians share in the risk-reward of the innovation process without letting the relationship be co-opted for marketing purposes.
Physician innovators are valuable resources that are under utilized and misappropriated. New collaboration tools and approaches are needed to make medical device development more efficient and effective.
Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
