Case Study: International Medical Device Developer

Health Policy Associates Inc. recently completed a project with a European client engaged in the development of a novel implantable medical device that combines a wireless chip, signal processing software, and energy transmission in one device. The device has no predicate and is considered by many the most complex medical device ever developed. The client is venture funded with defined limits on internal resources.

The client’s fundamental need was to increase their valuation by achievement of short to mid-term milestones in the development process. The milestones included:

  • Development of a clinical and regulatory strategic plan capable of credible execution
  • Preparation of a Pre-IDE submission to obtain an FDA response that validates the European and US regulatory and clinical plans
  • Presentation of the company to the venture capital community
  • Positioning the company as the market leader in their field

In order to ensure the client met the key objective milestones, HPA Inc. assisted the company by:

  • Developing a comprehensive U.S. and European clinical and regulatory strategy capable of efficient execution
  • Developing Standard Operating Procedures necessary to ensure execution and compliance with Competent Authority and FDA standards and regulations
  • Assisting in both hiring expert operational and clinical personnel and training existing staff on SOPs, as well as GMP, GLP, and GCP requirements
  • Assisting company personnel in establishing new clinical sites, drafting a clinical protocol and managing a new clinical study designed for CE Mark and FDA requirements
  • Initiating US strategy for obtaining IDE/PMA approval by managing FDA communications, identifying key opinion leaders and clinical sites, hiring US staff and developing US/clinical budgets

Health Policy Associates Inc. involvement increases probability of success in both financing of and execution by privately financed companies.