Project examples

Each of the following examples is an amalgam of projects that were completed for several clients. 

Clients: Start-up, pre-revenue and mid-size post-revenue companies.

Technologies: Biomaterials (collagen, hyaluronate, tricalcium phosphate, human tissue), recombinant protein, animal-derived growth factors.

Medical fields: Wound repair; spine fusion; osteoarthritis; bone void filler

Services provided and value added: 

• Led effective approach to product development including preclinical planning, design control, manufacturing and/or FDA presubmission
• Value added: Effective development of a locked design that supported the value proposition; mitigated regulatory risks and/or risks involved in novel manufacturing; directed methods of manufacturing that resulted in new products and sales

Clients: Large and small orthopedic and spine companies; privately held and public; post-revenue.

Technologies: Class II and III hardware medical devices; Section 361 human tissue

Medical fields: Spine fusion; foot and ankle arthrodesis; spine disc arthroplasty/ artificial disc replacement

Services provided: 

• Clinical study strategy, protocol writing, IRB approvals, site initiation visits, monitoring, data collection and analysis, and manuscript writing; led Surgeon Advisory Board
• Value added: Substantial support for evidence-based marketing including white papers, abstracts presented at conferences and peer-reviewed publications in prominent journals (see Publications tab)

Clients: Large orthopedic and spine companies; public; post-revenue.

Technologies: Knee and hip arthroplasty; spine fusion

Services provided: 

• Wrote all sections of CER
• Provide responses to Notified Body deficiencies
• Senior reviewer for MDR compliance
• Value added: CE Mark certification under MDR which allowed uninterrupted sales in the EU for the highest selling product

Clients: Cell therapy and biomaterial companies; Public, private.

Technologies: Cell therapy, bone graft and collagen medical device

Services provided: 

• Gap analysis, recommendations for additional validations and wrote CMC CTD Module 2.3 and 3
• Wrote comprehensive Master File and submitted to FDA
• PreSubmissions to FDA
• Clinical strategy for a Phase II IND study; wrote protocol and Investigator's brochure and clinical and preclinical section of CTD for IND
• Value added: Efficient regulatory approvals without deficiencies or clinical holds; decreased cost of clinical study due to efficient design; more effective product development planning and regulatory approvals with FDA feedback