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Physician-owned companies.

John P Kostuik1

  • 1Department of Orthopaedic/Neurosurgery, Johns Hopkins Hospital, Baltimore, MD, USA. jkostuik@k2m.com

Spine
|May 15, 2007
PubMed
Summary

A privately held spinal implant company, K2M, was successfully established with physician investment and scientific guidance, adhering strictly to federal laws. Its scientific advisory board plays a crucial role in shaping company policy and product development.

Area of Science:

  • Biomedical Engineering
  • Medical Device Development
  • Orthopedic Surgery

Background:

  • Physician-influenced medical device companies require careful navigation of federal regulations, including Stark Law and anti-kickback statutes.
  • Establishing a successful spinal implant company necessitates balancing financial investment with scientific expertise and ethical considerations.

Purpose of the Study:

  • To detail the development of K2M, a privately owned spinal implant company.
  • To examine the legal framework governing surgeon-influenced medical device companies.
  • To illustrate the impact of a scientific advisory board on company strategy and product innovation.

Main Methods:

  • A company was founded with minority physician financial input (less than 20%) and substantial scientific advice.

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  • Compliance with federal regulations, such as Stark Law (which permits up to 40% physician investment), was maintained.
  • A diverse scientific advisory board was established to guide product development.

    • Main Results:

    • K2M, a privately owned spinal implant company, was established within three years.
    • Over 60% of K2M's product users are non-investor physicians, ensuring broad market acceptance.
    • The scientific advisory board significantly influenced product development and company policy.

    Conclusions:

    • K2M's development demonstrates a model for creating a compliant, physician-advised spinal implant company.
    • A recompensed scientific advisory board, compensated for effort, can effectively guide company policy and innovation.
    • Adherence to federal laws is paramount for surgeon-influenced medical device ventures.