Synogen provides consulting services helping technology companies navigate from concept to market.

Synogen Team

Synogen helps young and growing companies succeed, bringing decades of experience as experts and entrepreneurs in the fields o f tech, medtech, greentech and biotech.

Synogen’s expertise comes from the success of its founders and principals. Unlike traditional consulting groups, Synogen team members have founded, run and been key principals in numerous companies operating in various markets, and have grown those companies through many different economic cycles, taking them to successful exits via acquisition or IPO. Our goal is always to complement the company's existing team, help the company speed up the development of their technology and gain unique advantages in the market.

Our goal is always to complement the company's existing team, and help the company accelerate the development of their technology and gain unique advantages in the market.

Jahangir (Jay) Ayub, M.S Biography

Jahangir (Jay) Ayub, M.S European & Asian Market Penetration; Life Science Marketing & Sales Training and Coaching; Microbiology & Laboratory Fields

Gary Fischman, Ph.D. Biography

Gary Fischman, Ph.D. Materials Development and Assessment; IP Assessment; Medical Device Hard Material Failure Analysis; Regulatory Assessment; Coatings Design and Expert Witness

David M. Gaisser, M.S. Biography

David M. Gaisser, M.S. Regulatory; Q/A; Quality Systems; Device Design; Product Design Control; FDA Regulatory Submissions; Biomaterials; Testing & Materials

Carl H. Jacobs, Ph.D. Biography

Carl H. Jacobs, Ph.D. Urology, Orthopedics, Cardiovascular Devices; Operational Systems; R&D, Technology Transfer; Q/A – Q/C; Radiation Sterilization; ISO/CE registration; Logistics; Metallic and Polymeric Bio-Materials; Device Failure Analysis; FDA Inspections and Responses

Michael N. Helmus, Ph.D. Biography

Michael N. Helmus, Ph.D. Combination & Biosensor Devices; Magnetic Nano-Particle Drug Delivery; Bioactive, Biocompatible & Thromboresistant Coatings; Electrospun & Injectable Therapeutic Polymers; Drug Eluting Stents; Heart Valves; Implants & Biomaterials in Orthopedic, Cardiovascular, Opthalmic & Wound Care Markets, Translation to Commercialization; IP and Litigation Expert

Louis G. Kessler, Ph.D. Biography

Louis G. Kessler, Ph.D. Intellectual Property; Technology Transfer; Licensing Negotiation; Pharmaceutical/Biotech Commercial Collaborations; Strategic & Product Development Planning; Life Sciences, Biotechnology and Drug Development

Mark Tanner Biography

Mark Tanner HIPAA Verification/Validation; Firmware & Embedded Systems; Web-based Systems Development; Software/Firmware/ Server-resident Architecture

Karl R. Zawoy, MS, RTTP Biography

Karl R. Zawoy, MS, RTTP Product Development; Technology Licensing; Medical Technology Commercialization; Video/Digital Content Production

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Jahangir (Jay) Ayub, M.S

Jahangir (Jay) Ayub, M.S

Jay holds an M.S. in Microbiology, and has leveraged his knowledge of life science and laboratory environments to guide companies in building and training their life science sales force, and in analyzing operations and supply chain, conducting price analyses and ensuring regulatory compliance. He has experience across Europe, especially in Denmark, Norway and Sweden. Born in Asia and a citizen of Denmark, proficient in 7 languages and having worked from France for many years, Mr. Ayub helps companies capitalize on international trade.

Over the years, he has launched and expanded the presence of enterprises across Western Europe, USA and the Indian subcontinent. He has successfully pioneered a company's presence in India, defining and executing the market entry strategy, identifying high-potential sales channels, and establishing initial sales with selected key accounts.

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Gary Fischman, Ph.D.

Gary Fischman, Ph.D.

Gary is a leader in the field of ceramics for medical applications. His experience included development of ceramics and coatings for medical devices, understanding, reviewing and assessing potential materials for medical device application as well as failure of materials for medical devices, assessing IP for ceramics and medical device materials. His career has included time as a tenured faculty member in Ceramic Engineering at the New York State College of Ceramics at Alfred University, Director of Biomaterials and Technology at the University of Illinois at Chicago, FDA scientific expert in the Center for Devices and Radiological Health (CDRH), founding member of Xylon Ceramics, a materials company that supplied orthopaedic materials. Gary was also a Board Director at the National Academies, Expert at NSF and CTO for a small coatings company. He has a Bachelors, Masters and PhD in Ceramic Engineering.

Gary has published and presented scientific papers internationally including 20 peer-reviewed publications. He has directed the development of reports of national and international significance and has been an active participant in the writing of both national and international standards and specifications dealing with materials for medical devices. He has served on the boards of the American Ceramic Society, ABET International, American Association of Engineering Societies, Edison Awards and the National Materials Advisory Board. He is the U.S. current voting member in TC 150 (Implants for Surgery) for ceramics and for coatings and is the Chairman of ASTM Subcommittee F04.13 (Ceramics for Medical Devices), a current member of the American Ceramic Society, the Materials Research Society, the ISO TC 194 TAG and a past member of the Society for Biomaterials, American Association of Dental Research.

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David M. Gaisser, M.S.

David M. Gaisser, M.S.

David began researching medical devices and materials while obtaining a B.S. in Ceramic Engineering in early 1980’s, studying under Dr. Eugene Monroe, the co-inventor of HA ceramics as bone graft materials. After earning an M.S. in Bioengineering, David worked at The Cleveland Clinic Foundation in orthopedic implant and material research.  In 1989 he began work in the dental industry, developing ceramics and glasses as synthetic bone graft materials. Initially with Calcitek, Inc. (now Zimmer Dental), David worked on new dental implant forms and HA glass-ceramic coating optimization, both in research and production. In 1997, he began 16 years with US Biomaterials, Inc./NovaBone Products, LLC, a manufacturer of synthetic bone graft devices for dental and orthopedic indications. The company’s base technology is centered on developing devices based on bioactive glass, a calcium-phospho-silicate material (Bioglass®) first developed by Dr. Larry Hench at the University of Florida.

David provides regulatory, quality assurance, and device design advice, including such areas as Quality System development, product design control, and the coordination, planning, and preparation of FDA regulatory submissions. He is currently a member of the Orthopedic Research Society, the Society for Biomaterials, the American Society for Quality, and the American Society for Testing and Materials.

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Carl H. Jacobs, Ph.D.

Carl H. Jacobs, Ph.D.

Carl has over 35 years of experience in the medical device industry, with organizations ranging in size from small scale start-ups through billion dollar multinationals in the areas of orthopedics, urology and cardiovascular devices in addition to collagen based materials and bioresorbable metals/polymers, ion-implantation technology and nanoscale interventional devices. He has a strong background in R&D, operations, logistics, Quality Control and Quality Assurance, ISO/CE registration and technology transfer. His expertise ranges from fundamental biomaterial research to full scale manufacturing.

Carl attended the University of Vermont where he received his Bachelor of Science in Mechanical Engineering, his Master’s and Doctoral Degrees. He holds several patents for novel medical devices. His industrial experience includes: Group Leader Material Science, Howmedica Research Center; Director of Research Laboratories and Director of Quality Assurance, Zimmer, Division of Bristol Myers; VP Operations, Orthomet; Director of Quality Assurance, Osteonics Division of Stryker; VP Operations, Collagen Products Division and Managing Director, Bioplex Medical, Datascope Corp.

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Michael N. Helmus, Ph.D.

Michael  N. Helmus, Ph.D.

Mike has extensive experience in all phases of managing medical device development projects from inception to market. He has led and managed the R&D of medical and controlled drug delivery devices, with a focus on developing commercialization strategies of potentially disruptive technologies. He has particularly strong expertise in due diligence, assessing products, incubating emergent technologies, and deep commercial experience with Drug Delivery, Stents, Heart Valves, Vascular Prostheses, Implants, Biomaterials, Biocompatibility and Nanoenabled materials. His work has crossed from the orthopedic, cardiovascular, and minimally invasive markets into wound care, opthalmic, and combination and biosensor devices. He has experience with magnetic nano-particle drug delivery, bioactive, biocompatible and thromboresistant coatings, electrospun polymers, injectable polymers, therapeutic NO and statin releasing polymers and biodegradable polymers.

Mike has 44 issued US Patents for medtech and drug delivery, including Drug Eluting Stents, Heart Valves, Implants, Biomaterials. He has over 80 publications and presentations. He has co-chaired the review National Nanotechnology Initiative. Mike's positions have included Sr. VP Biopharma, Advance Nanotech; VP Advanced Biomaterials and VP Materials Science & Technology, Boston Scientific Corporation (BSX); Director R&D, Materials & Tissue Technology, Edwards Lifesciences Heart Valve Therapy; Director R&D, Materials & Tissue Technology, Baxter CVS Heart Valve Therapy Division. Mike earned his Ph.D. in Biomedical Engineering from Case Western Reserve University.

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Louis G. Kessler, Ph.D.

Louis G. Kessler, Ph.D.

Lou was one of the founders of ChaoLogix, a chip/data security company which developed the world-class ChaoSecure data protection/security technology that provides hardware-based immunity to analysis attacks on encryption keys and data. Lou served as President of Chaologix for several years and is currently Executive Vice President of Intellectual Properties. Before co-founding ChaoLogix, Lou was VP of Corporate Development at Ixion, a development stage biotech company, and Director of Intellectual Properties and Technology Transfer at Nabi (Univax) Biopharmaceuticals, a drug development company.

Lou has served as science adviser to a Washington, D.C. law firm and as a patent examiner in the U.S. Patent and Trademark Office. Dr. Kessler received his Ph.D. in molecular genetics from the University of Georgia and completed a postdoctoral fellowship at The University of Texas Southwestern Medical Center at Dallas.

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Mark Tanner

Mark Tanner

Mark graduated cum laude from Yale with a double major in music and computer science. His work experience in the technology space began with work for Schlumberger and a career at IBM, but he has led an active musical career as well, performing as a guest cellist with numerous U.S. and international symphony orchestras. Mark was among the first Internet programmers, starting in 1978. His expertise is broad, ranging from embedded systems to computer forensics, and with almost 40 years of computer experience he now specializes in web-based application architecture and development. He created the HyMarks® reporting system used by HyGreen®, a compliance monitoring system used in hospitals worldwide, and the system architecture for Xhale’s SMART® breath-based medication adherence monitoring system. He architected the server/device/app system utilized in the Scout™ GPS/Cellular tracking & recording system. Mark is also a co-founder and chair of Emergent Growth Fund II, an angel investor fund, and also founded the Tropikordia Foundation to promote string playing around the world.

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Karl R. Zawoy, MS, RTTP

Karl R. Zawoy, MS, RTTP

Karl has over 30 years of experience working with executives, investors and entrepreneurs to develop, transfer, and commercialize products in the medical device and high technology markets. He has extensive experience working with diverse business and technical teams to communicate, build trust, and complete projects on time. Karl advises CEOs, entrepreneurs and inventors on ways to de-risk, develop and market technology to attract angel, institutional, and corporate investors, and provides video and digital media services to share company stories with investors, customers and the community at large. He has negotiated and closed over 150 licensing deals with corporations and startup companies.

Karl served as a Technology Licensing Officer for the University of Florida and was an Entrepreneur in Residence at the Florida Institute for the Commercialization of Public Research. Before coming to UF, Karl helped develop and launch products for companies such as Novoste, Johnson & Johnson, 2C Optics and Cordis Dow Medical, and Biofield Corp. Karl holds a Master of Science degree in Computer Science from NSU and a Bachelor of Science degree in Mechanical Engineering from the University of Florida. He is an inventor on 13 patents and a Registered Technology Transfer Professional.

 

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Richard R. Allen

Richard R. Allen

Richard has co-founded multiple successful companies, including four companies that are on or part of the Nasdaq: RTI Surgical (Nasdaq:RTIX), Axogen (Nasdaq:AXGN), ViewRay (Nasdaq:VRAY) and OrthoHelix (subsidiary of Nasdaq:WMGI). Although the four public companies are all in medical technology markets, his background includes mechanical engineering, electronics and manufacturing, including co-founding BluAzu, the company behind the Scout™ GPS tracking system, and co-founding with Jamie Grooms and Lou Kessler Chaologix, with computer chip security technology.

Richard has held executive leadership roles with Sabine (pro-audio electronics), Pulstar (solar energy) and Heat-Pipe Technologies (NASA-licensed mechanical engineering technology). His medical technology experience includes RTIX (tissue implants and regeneration), OrthoHelix (orthopedic surgical implants), Optima Neuroscience (neural monitoring technology), Axogen (peripheral nerve implants), ViewRay (MRI-guided radiation therapy) and Xhale (breath-based electronic medical technologies). Richard serves on several boards, has two degrees from the University of Florida, is a CPA, is co-author of Vital Business Secrets for Young & Growing Companies (1989-Dow Jones-Irwin), and is co-founder of Sustainable Cambodia, a nonprofit with more than 20 schools in rural Cambodia.

 

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Jamie M. Grooms

Jamie M. Grooms

Jamie has 20+ years of experience as a successful entrepreneur in medical technology. He was co-founder with Richard Allen – and served as CEO – of RTI Surgical (Nasdaq:RTIX), where he developed the concepts for the tissue implants and regenerative technologies on which the company was founded. Jamie is also co-founder and current Chairman of the Board of Synogen portfolio company Axogen (Nasdaq:AXGN), a peripheral nerve regeneration company. He also co-founded Synogen's portfolio company Chaologix (computer chip security). He is also Chairman of the Board of NeXtGen Biologics, and until recently served as CEO of the State of Florida's Institute for the Commercialization of Public Research, which provides funding and support to companies that are commercializing technology developed at Florida’s universities and research institutions.

Jamie's background includes various positions of leadership at the Virginia Tissue Bank (now LifeNet Health), Osteotech(Nasdaq:OSTE) and CryoLife (NYSE:CRY). In addition to his executive management experience, he has extensive experience in all areas of operations of med-tech business, including Research and Development, as well as laboratory and manufacturing operations. He has developed state-of-the-art medical processing and manufacturing systems and other technological innovations. Jamie holds a degree in biology from Old Dominion University.

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David C. Greenspan, Ph.D.

David C. Greenspan, Ph.D.

David has 39 years of experience in the medical device industry in numerous capacities.  He has served as V.P. Product Development for Tutogen Medical and RTI Biologics, Chief Technical Officer and co-founder of NovaMin Technologies, and VP Research and Development and co-founder of US Biomaterials. He began his career with Howmedica, an orthopedic implant manufacturer. His experience includes R&D in synthetic and allograft biomaterials including nanomaterials, bioactive ceramics, materials characterization, corporate management, quality and regulatory affairs. He is co-inventor of the NovaMin technology, along with numerous patents for application of bioactive glasses in medicine and composite materials. His educational background includes a B.S. in Glass Science from Alfred University and a Ph.D. in Materials Science from the University of Florida.

David holds 36 U.S. and International patents and has published and presented scientific papers, with 45 peer-reviewed publications and more than 65 presentations at international conferences. He is a member of the ASTM F-4 Committee on Medical Devices, as well as a past member of ISO TC 150 and 194.  He served as Chairman of the External Advisory Board for the Department of Materials Science and Engineering at Pennsylvania State University and has also served on the External Advisory Boards of both Biomedical Engineering and Materials Science and Engineering at the University of Florida and Florida Institute of Technology.