Representative Medical Technologies
Over more than four decades in medical device, diagnostic, biotechnology, pharmaceutical, and combination product development, I have worked with an exceptionally broad range of medical technologies across virtually every stage of the product lifecycle, including FDA regulatory strategy, product development, biomedical engineering, clinical investigations, quality systems, manufacturing, commercialization, due diligence, and expert witness consulting.
The technologies listed below are representative of projects on which I have provided professional services throughout my career. Organized by clinical specialty, they illustrate the breadth of technical experience available to clients while recognizing that many projects remain confidential. This portfolio is representative rather than exhaustive and will continue to expand as additional technologies are added.
Cardiovascular Devices
- Transcatheter Aortic Valve Replacement (TAVR) systems
- Implantable cardioverter defibrillators (ICDs)
- Cardiac pacemakers
- Artificial heart valves
- Inferior vena cava (IVC) filters
- Coronary and peripheral vascular stents
- Left ventricular assist devices (LVADs)
- Balloon angioplasty catheters
- Electrophysiology catheters
- Cardiac monitoring systems
- Cardiac biomarkers
- Cardiac risk assessment technologies
Diabetes & Metabolic Care
- Continuous glucose monitoring (CGM) systems
- Implanted glucose monitoring systems
- Blood glucose meters
- Portable insulin infusion pumps
- Automated insulin delivery systems
- Diabetic foot ulcer therapies
- Diabetes management software and mobile applications
General Surgery & Wound Management
- Surgical staplers
- Hemostatic dressings
- Topical hemostatic agents
- Surgical meshes
- Tissue sealants and adhesives
- Negative pressure wound therapy
- Drainage systems
- Gastrointestinal surgical devices
Orthopedics & Spine
- Total joint replacement systems
- Total disc replacement systems
- Spinal fixation systems
- Bone graft materials
- Orthopedic implants
- Bone growth technologies
Ophthalmology
- LASIK systems
- Corneal topography and diagnostic systems
- Automated field perimetry systems
- Ophthalmic diagnostic devices
- Ophthalmic surgical technologies
Neurology & Neurosurgery
- Intrathecal drug delivery systems
- Baclofen infusion pumps
- Neuromodulation technologies
- Neurodiagnostic systems
Women’s Health & Reproductive Medicine
- Breast implants
- Obstetrical fetal monitoring systems
- Gynecologic devices
- Fertility technologies
Respiratory & Critical Care
- Respiratory monitoring systems
- Pulse oximetry
- Oxygen delivery systems
- Patient monitoring technologies
Diagnostic & Laboratory Medicine
- Molecular diagnostics
- Polymerase chain reaction (PCR) systems
- Recombinase Polymerase Amplification (RPA) technologies
- Point-of-care diagnostics
- Clinical laboratory instruments
- Companion diagnostics
- Infectious disease testing
Biotechnology & Regenerative Medicine
- Cell therapies
- Stem cell technologies
- Tissue engineering products
- Regenerative medicine
- Human cellular and tissue-based products (HCT/Ps)
- Gene therapy platforms
- Biologic products
Drug Delivery & Combination Products
- Drug-device combination products
- Injectable drug delivery systems
- Epinephrine auto-injectors
- Controlled-release drug delivery
- Transdermal delivery systems
- Infusion technologies
Digital Health & Software
- Software as a Medical Device (SaMD)
- Clinical Decision Support (CDS) systems
- Mobile medical applications
- Cloud-connected medical devices
- Artificial intelligence applications
- Cybersecurity and connected devices
- Medical databases
- Telemedicine technologies
Robotics & Emerging Technologies
- Robotic-assisted medical systems
- Wearable medical devices
- Smart sensors
- Remote patient monitoring
- Internet-connected medical technologies
FDA Regulatory & Quality Systems
Representative experience includes:
- FDA 510(k)
- De Novo Classification Requests
- Premarket Approval (PMA)
- Investigational Device Exemptions (IDE)
- Breakthrough Device Designation
- Quality System Regulation (21 CFR Part 820)
- ISO 13485 Quality Management Systems
- ISO 14971 Risk Management
- Clinical investigations
- Design controls
- Failure investigations
- Corrective and Preventive Actions (CAPA)
- Product recalls
- FDA inspections
- Medical Device Reporting (MDR)
- MAUDE adverse event analysis
Representative Professional Services
Across these technologies I have provided:
- FDA regulatory strategy
- Product development
- Biomedical engineering
- Design controls
- Risk analysis
- Clinical study planning
- Quality systems
- Manufacturing support
- Failure analysis
- Product recalls
- Adverse event investigations
- Due diligence
- Commercialization strategy
- Expert witness services
- Technical and regulatory opinions
- Litigation support
This portfolio reflects the breadth of technologies encountered throughout a career spanning executive leadership, FDA regulatory consulting, product development, and expert witness services. While representative rather than exhaustive, it demonstrates the multidisciplinary experience brought to each client engagement and continues to expand as new technologies and litigation matters are undertaken. Additional technologies are added periodically as historic consulting projects are reviewed and documented.