Regulatory Strategy Case Study

Regulatory Affairs Support
CHALLENGE:
A large international medical diagnostic system equipment manufacturer was beginning to see the fruits of a technology development collaboration with Boston-area medical research institutions.

Having set up a subsidiary company in the US to commercialize these technologies the company needed:

  1. FDA regulatory experience in diagnostic imaging, especially considering the issuance of recent FDA guidances
  2. Medicare/health insurance reimbursement pathways for the new technologies
  3. A team with the technical know-how to understand and appreciate the products that would embody the underlying novel technologies


APPROACH:

AlvaMed proposed a project with:

  • A team of 2 experts with a total of 60 years of experience in the diagnostic imaging area and
  • A 2-phase approach where the initial phase provided an initial assessment and prioritization of the technologies and the second phase involved targeted in-depth assessments of the three most attractive technologies.

The 3 month $60,000 project assessed the regulatory pathway and reimbursement strategy for five technologies:

  1. Next generation molecular-microstructural arterial imaging system and catheter
  2. Ultaminiature endoscope
  3. Intracoronary laser speckle imaging
  4. Whole slide imaging to support pathology
  5. Combined FDNIRS/DCS system to monitor infant’s brain health


RESULTS:

Our client feedback rated our work as excellent and the results enabled our client to:

  • Have the justification to go to the parent company’s management and request additional funding to accelerate two highly attractive technologies
  • Maintain development funding of two others
  • Shelve the remaining technology