Consultants & Partners

20+ years of translational research experience

• 15+ years regulatory
• 18 years clinical research
• 20+ preclinical

Medical device company experience

• Start-up to mid-size organizations
• Clinical operations, regulatory, and R&D

CRO leadership

• Research program director (nonclinical – regulatory – clinical) – NAMSA
• Global Head of Medical Device & Diagnostics – Syneos Health

Education

• Duke University, Pratt School of Engineering – biomedical engineering
• Harvard University, School of Medicine – post-graduate certifications

35+ years of industry research experience

• Advisement on device characteristics, design, and development
• Clinical study design
• MBA facilitates ability to incorporate finance, marketing, and sales
• Over 90 publications of hemostats, sealants, and adhesives
• Pioneered development of fibrin sealants

Clinical expertise

• Founder and Director of the Surgical Therapeutic Advancement Center at the University of Virginia
• Cardiac and Thoracic Surgical Division Chief at Temple University and the University of Florida

Education

• Harvard University – chemistry
• Columbia University, School of Medicine – MD, surgery
• University of Florida, Warrington College of Business – MBA

35+ years of translational research experience

• Orthopedic and neurosurgical science & clinical research
• 200+ peer-reviewed articles
• 20+ book chapters
• 500+ abstracts/presentations

Medical device company experience

• Start-up to large-size organizations
• 8,000+ surgical cases to support R&D
• SME for regulatory agency meetings and submissions
• Translation of R&D learnings to clinical research

Academic appointments

• Professor, Orthopedic Surgery – Georgetown University
• Adjunct Professor, Orthopedic Surgery – Menzies Health Institute, Queensland

Education

• Johns Hopkins – MS, neuroscience
• Griffith University, School of Medical Science – PhD, neuroscience

20+ years in healthcare research & development

• 20+ years medical device & diagnostics
• 19 years clinical research, including 4 years of clinical site management

Industry experience

• 14 years CRO and 7 years industry product development
• Medical device (Class II and III) and diagnostics
• Product development, scientific marketing, clinical operations
• Manufacturers from start-up to large size

Clinical research leadership

• Feasibility through post-marketing trials
• Expert in pivotal trials and pre-market agency interactions

25+ years medical device experience

• Marketing & business development
• Global sales & operations
• US and international market development
• Class II and III product launches

Development and marketing expertise

• Product launch strategy & implementation
• Competitive product positioning
• DTC marketing campaigns & influencer collaborations
• Commercial team development
• Sales strategy & training
• Investor relations

Therapeutic and technology expertise

• Hemostats, sealants, and adhesives; includes trauma – former US Marine
• Advanced energy devices
• Regenerative medicine
• Surgical specialties: cardiac, vascular, thoracic, GYN/ONC/women’s health, plastic surgery, neurosurgery, general surgery, podiatry, ENT

20+ years medical device and biologics experience

• Market access and regulatory strategy & submissions
• Quality management
• Class II and III product launches

Regulatory affairs expertise

• Regulatory submissions to access new markets or expand indications – US and OUS (510(k), PMA, CE Marking, Health Canada, Australia)
• RAPS regulatory certification
• Due diligence
• Integration with product development, quality, Good Manufacturing Practices, and risk management

Quality management expertise

• EU MDR and IVDR
• 21 CFR 820, 21, and CFR 1271
• ISO 13485:2016 certified auditor
• Medical Device Single Audit Program (MDSAP) lead auditor

18+ years of life science consulting and translational development

• 15+ years market insights & strategies
• Medical device innovation from preclinical through commercial

Market insights expertise

• Market assessments, primary & secondary market research
• Competitive landscape & positioning
• Indication/market prioritization
• Meeting and KOL/SME management
• Value analysis strategy; health economics outcomes research
• Specialize in start-ups seeking successful exit and/or commercial launch
• VC/PE investment decision support

Therapeutic areas

• Biosurgery, cardiovascular, gastroenterology, general surgery, orthopedics, spine/neuro, robotics/MIS, dermatology, diagnostics, emergency medicine/trauma

Education

• University of Delaware – biology/biochemistry
• Post-graduate studies – molecular biology, neurodegenerative diseases

20+ years of preclinical experience

• 15,000+ hours of surgical and interventional experience
• Bench-top, animal, and cadaver models
• US and OUS

Expertise

• Integration of preclinical studies with product development program
• Regulatory interactions for preclinical study design and results
• Sales and end user training
• Surgical, toxicological, and biocompatibility studies
• Good Laboratory Practice (21 CFR Part 58, GLP) compliance

20+ years of preclinical experience

• Surgical and large-animal models
• Integrated surgical, veterinary, and board-certified pathology expertise under one roof
• Full-service contract research laboratory for feasibility, pilot, and pivotal GLP studies

Charles Sylvia Jr., DVM, MS

Director of veterinary research

• 25 years research experience at 3 different research facilities and companies
• Directed 75+ GLP studies, most achieving successful FDA submission
• Education: University of California, Davis – DVM
• Education: San Jose State University – MS, physiology

Taylor Spangler, DVM, DACVP

Board-certified veterinary pathologist with industry-leading expertise and timelines

• Education: University of Illinois – DVM
• Education: UC Davis School of Veterinary Medicine – residency in anatomic pathology

18+ years biotech industry experience

• Medical device & diagnostics spanning almost all therapeutic areas
• Pharmaceuticals
• Diagnostics development for respiratory rapid visual tests
• Medical device development
• Preclinical and clinical study designs
• Data management and biostatistics through medical writing
• Agency interactions and FDA panel meetings

Expertise

• Global CRO biostatistics experience (PPD, Paraxel, NAMSA)
• Author/co-author of 40+ peer-reviewed publications in statistics and medicine

Education

• University of Georgia – MS, statistics
• Capital Medical University – MD

21+ years of regulatory and translational experience

• Regulatory guidance throughout entire product lifecycle
• Global RAC
• US and OUS regulatory strategies and submissions

Expertise

• Development strategy
• Integration of quality systems and risk management
• Audits and remediation
• Submissions and agency interactions for FDA approvals and CE marking

17+ years industry experience

• Product design
• Development of manufacturing processes from innovation to scale-up qualification and execution
• Proven track record of timely program launches

Technical expertise

• Process development
• Technical program management
• Product design and testing
• Process scale-up and process optimization
• Continuous improvement and risk management

Education

• University of Michigan – chemical engineering