John Bobo

Background

About John Bobo

Medical Device Management of Research, Development, Animal Studies, Projects, Products and Personnel I am a senior level research scientist (Ph.D. Chemist) focused mainly on medical devices and adhesives. A few of the devices I have worked on are listed below -Medical Cyanoacrylate Device • Closure Medical-(J&J Ethicon) Omnex vascular sealant • Adhezion- FloraSeal surgical drape • H.B. Fuller – Confidential 3rd party skin adhesive -Bioabsorbable polymers • US Surgical- sutures: BioSyn and Polysorb • Micell- Mistent sirolimus eluting cardiovascular stent coating -Silicone Gel dressings • Advanced Chronic wound dressing • Negative pressure wound therapy (NPWT) System -Acrylic Adhesives for wearable devices • Multiple continuous glucose monitoring devices In my various roles I have taken products from inception to clinical trials and to regulatory (CE Mark and FDA) approval and many stages in between. To achieve these goals, I have: • Directed many stages of R&D: from inception to CE mark and FDA filings • Taken processes through validation, including OQ and PQ • Directed production of medical devices under GLP/GMP for animal trials and human clinical trials • Written SOPs and supporting documents for use in regulatory filings • Managed collaborations with outside testing facilities, including Animal Studies • Managed up to 10 R&D scientists in medical device development • Developed and ran ‘in-house’ wear studies to determine adhesive performance on the skin of human volunteers • Performed chemical R&D experiments • Developed methods of syntheses and analyses • Managed outsourcing of syntheses