Physician-owned companies

Abstract

Study design: The author relates his experience in the development of a spinal implant development company (K2M) that is significantly advised by physicians.

Objectives: To provide information about the development of a spinal implant company (K2M) advised by a group of professional spinal surgeons. To relate the federal laws (STARK and anti-kickback) as they pertain to surgeon-influenced companies. To discuss the role of a scientific advisory board.

Methods: A self-developed company was developed together with significant, but minority physician financial input and majority scientific advice.

Results: A privately owned spinal implant development corporation (K2M) was developed 3 years ago. Physician financial participation was less than 20% (Stark laws state no more than 40%). Users of product are greater than 60% non-investor physicians. The development of a large scientific advisory board has been very influential in product development.

Conclusions: A privately owned spinal implant company (K2M) has been developed strictly within Federal laws. Its board of scientific advisors that receives recompense commissurate only with effort significantly impacts the company policy.