Flexible, Creative Strategies
Today’s diverse and competitive medical device marketplace requires that companies remain flexible and embrace complex and creative clinical and regulatory strategies. The downstream effects of an early regulatory strategy can be significant. It is at this point, more than any other in the product development cycle, that a well thought out multi-prong approach can make the difference between product approval and acceptance and failure to commercialize in a timely and/or cost efficient manner.
BioMDg provides a wide range of scientific and marketing support solutions for a range of medical devices, combination products, and gene and stem cell therapeutics. Specific areas of medical research expertise include: cardiovascular, metabolic, neurological, ophthalmic and orthopedic.
Concept Evaluation
BioMDg offers the following services to successfully evaluate a new product concept:
- Scientific Business Plans – Tailored to a specified audience from the well educated/knowledgeable investor to clinicians and scientists in the same field of practice
- Regulatory strategy development – Determine optimal regulatory pathway for US, Canada, and European product approval
- Due diligence and valuation of new technologies
- Evaluate existing technical and clinical data
- Provide liaison with Notified Bodies and Competent Authorities
- Communicate and meet with FDA for strategic discussions
- Determination meetings with FDA (pre-IDE / pre-IND, EOP II)
- Determine pre-clinical and clinical requirements
- Down-classification petitions
- Orphan designation
Pre-Clinical & Clinical Testing
- Determine which consensus standards/FDA guidance documents may apply to product
- Determine the optimal/cost effective animal model to use (when applicable)
- Packaging/sterilization/biocompatibility Risk analysis (FMEA)
- Determine bench testing requirements
Marketing Approvals
Clinical – upon study completion:
- 510(k) – Premarket notifications – traditional, special, abbreviated
- Design Dossiers and Technical Files for CE Marking
- PMA / PDP – Premarket approval applications, amendments and supplements
- BLA / NDA – Biologic License Application / New Drug Application
- Breakthrough Designation
- Canadian Device License Applications
- Write clinical report
- Regulatory Submissions
- Panel preparation
- 100 Day Meetings
- Analyze data
Clinical Development
Develop clinical testing programs to support safety and effectiveness and claims:
- Site selection IRB / IBC / Ethics Committee submission materials and informed consent documents
- Regulatory – make appropriate submissions
- Case report form development including electronic data capture (EDC)
- Clinical database design
- Investigator agreements
- Investigator brochures
- Protocol writing
- Clinical trial oversight (full CRO services)
- Master File
- HUD/HDE and Orphan Designation Requests
- IDE
- IND
Early Marketing Initiatives
- Distribution chain management (domestic/international)
- Early Revenue Generation
- Post market surveillance
- International marketing
- Post marketing studies
- Regulatory / Clinical
- Expanded indications
- Strategic planning
Training
BioMDg has developed training programs based on our experience with the regulatory process and with frequently asked questions regarding regulatory issues. We can also design training programs for specific clients upon request. All courses can be presented privately at locations and on dates convenient to the individual client.
Courses are available for:
- Medical devices and their Regulation (US & Europe)
- QSR – quality system regulation (GMPs)
- Good clinical practices
- Risk Management
