Regulatory Strategy

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REGULATORY STRATEGY CASE STUDY


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 be developed from underlying novel technologies


APPROACH:

AlvaMed proposed a project with:

  • A team of 2 experts with a total of 60 years combined experience in the diagnostic imaging area
  • A 2-phase approach, where the initial phase provided an 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. Ultraminiature 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:

Client feedback rated AlvaMed’s work excellent and the results enabled the 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 for two other technologies
  • Shelve the remaining technology 

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