Consultants & Partners

20+ years of translational research experience

Medical device company experience (start-up to mid-size)

Rachel’s passion is looking at all the interconnectivities of translational science and giving medical technologies strategies and pathways to advance medicine.She loves the extra challenge of start-up timelines and budgets.

Successful track record of medical device development from prototype to approval

Education

• 18 years industry medical device
• 18 years clinical
• 20+ years molecular/preclinical
• 15+ years regulatory
• Clinical operations, R&D, and regulatory
• Ranged from start-up to mid-size
• Translational experience and strategic expertise maximizes testing, time, and cost efficiencies

Duke University
Pratt School of Engineering, Biomedical Engineering
Post-Graduate studies: advanced biomaterial design, fluid mechanics, molecular biology & genetics
Fuqua School of Business: managerial effectiveness
Harvard University Medical School – certifications

Dr. Spotnitz is an academic Board Certified general and thoracic and cardiovascular surgeon with expertise in research including surgical devices and clinical trials. He is the founder and Director of the Surgical Therapeutic Advancement Center at the University of Virginia, a clinical trials research and education group. He has advised many corporate collaborators on the topic of surgical hemostats, sealants, and adhesives and has published more than 90 papers in this area. He is also an expert on myocardial contrast echocardiography.
His expertise has allowed him to advise company collaborators about device characteristics, design, and development as well as the appropriate design of clinical trials and strategy for commercial registration. The addition of an M.B.A. degree has also facilitated his ability to provide advice with respect to finance, marketing, and sales.
He is an internationally recognized clinical expert with over ninety publications in the field, he has played a leading role in pioneering research and development of fibrin sealant tissue adhesives in the U.S. He is the author or co-author of 200 publications, 98 of which are on hemostats, sealants, and adhesives.

Education

• BA, Chemistry, Harvard University
• MD, Surgery – Columbia University
• MBA, Executive – University of Florida

35+ years of translational research experience

It is my fundamental belief that steadfast, concerted research efforts via a multidisciplinary approach will build upon the scientific and clinical knowledge base - improving the surgical care and quality of life for patients.

Medical device company experience

Education

Academic Appointments

• Orthopedic and neurosurgical science
• Clinical research
• 200+ peer-reviewed articles
• 20+ book chapters
• 500+ abstracts/presentations
• R&D, specializing in surgical development (8,000+ surgical cases)
• SME for regulatory agency meetings & submissions
• Clinical research
• Ranged from start-up to large

Johns Hopkins, MS Neuroscience
School of Medical Science, Griffith University
PhD Neuroscience

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

25+ years of medical device experience

Medical device development expertise

Expertise in multiple product categories

Surgical specialties

• Marketing & business development
• Global sales & operations
• US and International market development
• Class II and Class III product launches
• Product launch strategy & implementation
• Competitive product positioning
• DTC marketing campaigns & influencer collaborations
• Commercial team development
• Sales strategy & training
• Investor relations

Hemostats, sealants, and adhesives
Including trauma – former US Marine
Advanced energy devices
Regenerative medicine

Cardiac, vascular, thoracic, GYN/ONC, OB/GYN/women’s health, plastic surgery, neurosurgery, general surgery, podiatry, ENT

20+ years of medical device & biologics experience

Medical device development expertise

Expertise in multiple product categories

Surgical Specialties

• Market access
• Quality
• Regulatory
• Class II and Class III product launches
• Product launch strategy & implementation
• Competitive product positioning
• DTC marketing campaigns & influencer collaborations
• Commercial team development
• Sales strategy & training
• Investor relations
• Hemostats, sealants, and adhesives
• Including trauma – former US Marine
• Advanced energy devices
• Regenerative medicine

Cardiac, vascular, thoracic, GYN/ONC, OB/GYN/women’s health, plastic surgery, neurosurgery, general surgery, podiatry, ENT

9 years regulatory experience

Therapeutic areas and geographies

Education & certifications

• Expert in medical device and device-drug combination products
• Integrates regulatory into translational research, including GMP, Risk Management, Quality Assurance
• Pre-submissions, IDE applications, 510(k) notifications, De Novo requests, PMA Applications, EU MDR technical dossiers
• Cardiovascular, dental, dermal, ENT, gastroenterology, general & plastic surgery, hematology & pathology, neurology, OB/GYN, ophthalmology, orthopedics, radiology, respiratory, urology
• Software (SiMD, SaMD, AI/ML)
• United States, EU (MDR), Japan
• MS in Regulatory Affairs
• Graduate certification in International Regulatory Affairs, St. Cloud University
• US-RAC certification
• Medical Device certificate through Regulatory Affairs Professional Society

18+ years life science consulting

Broad range of therapeutic areas and clients supported

Education

• 15+ years market insights & strategies
• Medical device innovation from preclinical through commercial
• Market assessments, primary & secondary market research, competitive positioning, indication/market prioritization
• Meeting and KOL/SME management
• Value analysis strategy/HEOR planning
• Biosurgery, cardiovascular, gastroenterology, general surgery, orthopedics, spine/neuro, robotics/MIS, dermatology, diagnostics, emergency medicine/trauma
• US and global clients for US market
• Specialize in start-ups seeking successful exit and/or commercial launch
• VC/PE investment decision support

BA Biology/Biochemistry, University of Delaware
Post-graduate studies: molecular biology, neurodegenerative diseases, leadership

Lauren has a passion for seeing medical innovations to market by bringing data driven market insights to creative and strategic thinking.

20+ years preclinical experience

Expertise

• 15,000+ hours of surgical and interventional experience
• Bench-top, animal, and cadaver models
• Support US and OUS studies
• Integration of pre-clinical studies with the development program
• Regulatory requirements
• Sales and end user training
• Surgical, toxicological, biocompatibility
• GLP compliance

Osiris blends our preclinical/R&D background with our multifunctional team expertise to help developers drive progress in an efficient and forward thinking manner.

• Veterinary professionals with extensive surgical and protocol development experience
• GLP studies
• FDA submissions
• Veterinary surgeons
• Study directors
• Board-certified pathologists

BAYSIDE PRECLINICAL

PARTNER - PENDING

We collaborate with companies to optimize animal models, methodologies, evaluation criteria, and pathology endpoints. We are dedicated to supporting the success of technologies through meticulous planning, expert execution, and comprehensive analysis with our translational research team.

Custom Storytelling for Companies That Build the Future Synched Studios helps innovators, founders, and technical teams tell their stories clearly, creatively, and memorably. We translate complex ideas into websites, engaging videos, music, and visual storytelling. We specialize in making brilliant people feel human, approachable, and unforgettable