2004S-0233 - Solicitation of Comments on Stimulating Innovation in Medical Technologies
FDA Comment Number : EC2
Submitter : Mr. Ronald Peterson Date & Time: 06/10/2004 04:06:58
Organization : Three Arrows Capital Corp.
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
Technology transfer is the formal avenue for speeding commercialization of new medical technologies and it is there that your biggest obstacles lie. These offices are already funded but they are manned by the wrong disciplines. See "Technology Transfer in the Life Sciences" which is available as a free download at www.ThreeArrowsCapital.com
Questions
4. What forums should HHS use to survey constituents about obstacles in innovation (e.g., public meetings, contract research, focus groups)?
Concentrate on entrepreneurial forums to include graduate schools of business and networking opportunities. Studiously avoid scientific venues.
5. How can the portability of informaion between HHS agencies be optimized?
Initial attempts at commercialization plans for each innovation should be written and circulated to each agency for purposes of complementation and augmentation.
2. How can HHS help its agencies (e.g., NIH (and its grantees), FDA, CDC, and CMS) to work together more effectively to eliminate obstacles to development of medical technologies?
Insist that staffing of technology transfer offices be changed to minimize the role of attorneys and largely eliminate scientists. The latter category are not necessary since the science is already being done by the agency and having an additional scientific layer if reduntant. The staffing should emphasize commercial and business skills.
3. How can the HHS scientific and regulatory agencies work more effectively with CMS to eliminate obstacles to development?
The answer in commercialization and bringing new medical technologies to the marketplace is nearly always one of people and until such time as staffing is changed, you'll continue to realize precious little of your potential.
1. What strategies and approaches could HHS implement to accelerate the development and application of new medical technologies?
The technology transfer assumptions of most HHS offices are faulty and are premised on licensing out technologies to larger firms in order to commercialize those technologies. In truth, larger firms are often the least visionary in seeing the potential of new medical technologies (See Clayton Christensen's study in "The Innovator's Dilemma" and "The Innovator's Solution", both Harvard Business School books. Tech transfer offices are often staffed with attorneys and scientists, arguably the least capable business people imaginable. The solution lies in taking an
aggressive tack to staff these offices with people who can work with new enterprises to form viable new companies.
6. Which HHS policies and programs effectively spur innovation?
You're under federal law to promote commercialization so to the extent you do it poorly you're simply not implementing the law. The policies and programs that pose obstacles are the ones under which technology transfer offices remain manned by the wrong category of people.