Panel:Biomaterial Based Regenerative Medical Product Commercialization hurdles

Timeslot: Wednesday, April 11, 2018 - 1:00pm to 3:00pm
Track: Career and Commercialization
Room: Grand Ballroom B


During the 2017 “Biomaterials and Medical Products Commercialization” Panel Discussions, some concerns were brought about the inconsistency in the common understanding between the Regulatory Agency (FDA), and the Reimbursement Agency (Medicare). It may be due the gap created by inadequate transfer of technical knowledge of such advanced biomaterial based devices. Specifically, in “biological skin substitutes”, Medicare (Center for Medicare and Medicaid Services) needs more guidance on Biomaterial sciences with respect to their reimbursement methods and assigning commercial values. However, we understand Medicare has its own limitations. There comes the duty of the Members of the Society for Biomaterials. SFB should take efforts to bring a common understanding in this matter. The Chair and the other panel members all from have also voiced their concerns in the need of a better co-ordination between the regulatory Organizations like FDA, Medicare, and the Medicare’s advisory entities such as the American Medical Association or the American Surgeons Association along with the Biomaterial Scientists. The purpose of the 2018 Group Panel Discussion is to enhance the awareness of the problem by increasing the number of Attendees and Scientific papers from the Device Industries, FDA, Medicare, and AMA which guide the CMS. In addition, the other Private and Government payers can participate for their unified understanding about advanced Biomaterials and their commercial valuation. The lead speakers consist of an Officer from CDRH, FDA (Dr. Sussman), an experienced biomaterials Scientist specialized in tissue regenerative products (Dr. Gunasekaran), a Gynecologist having experience in medical product usage and distribution thorough the Hospital Supply Chain system (Dr. Cox) and the end user of regenerative products who is the current President of Georgia Podiatric Medical Association (Dr. Gupta).


  • Our intention is to castigate and arrive at a solution for the following Hurdles:

  • 1. Clinician’s failure to understand the biomaterial science to define a bio medical device. This causes clinicians to mis-judge a quality product.

  • 2. Lack of communication between the device using clinicians and the payers resulting in delay or insufficient payments to the services rendered by the clinicians.

  • 3. Improper valuation of a biomaterial device due to lack of biomaterial knowledge by the CMS.

  • 4. The need for Biomaterial Science is ignored during the "decision tree process" of Medicare to evaluate a product, example the skin-substitutes doesn’t seem to have adequate scientific definition by CMS.

  • 5. Medical coding and billing methods are quite complicated which confuses the clinicians.

  • 6. Coding and billing methods are devised mainly by some Medical Associations without any feedback or involvement from the Society for Biomaterials that results in poor recognition and valuation of a product.