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:
- FDA regulatory experience in diagnostic imaging, especially considering the issuance of recent FDA guidances
- Medicare/health insurance reimbursement pathways for the new technologies
- 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:
- Next generation molecular-microstructural arterial imaging system and catheter
- Ultraminiature endoscope
- Intracoronary laser speckle imaging
- Whole-slide imaging to support pathology
- 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
