Minimus developed a novel injection treatment for patients with disc herniations. It's called Triojection, which is now licensed to SpinaFX. Based on existing data in the scientific literature, Triojection improves patient care and reduces cost. Here are a few of the things that we did at Minimus. • Created an investor group consisting of physicians and medical device executives from the US, Europe and Middle East. Including an investment from the State of Texas, Minimus raised approximately $3.75M.• Developed a dedicated, cross-functional team to develop, build and validate the product.• Filed and received numerous patents in the US and abroad.• Established an ISO 13485 Quality Management System that passed numerous audits.• CE Marked our product as a treatment for disc herniation.• Conducted a multi-center, randomized clinical study in three countries comparing Triojection to surgical discectomy (clincialtrials.gov NCT02525120). The data from that study are being written up for publication. • Currently seeking funds to continue operations or sell the technology.Keywords: angel investments, new business development, project management, , product development, CE Mark, ISO 13485, quality, spine, clinical trials, regulatory affairs, business analyst, FDA, statistics, technical writing, medical device

I can help you with design history files, clinical evaluation reports, regulatory submissions, labeling, manufacturing procedures, quality procedures, supplier audits, clinical trial design and execution, and early stage financing strategies. I'm not actively pursuing consulting work at this time, but if you want to talk about an interesting new medical idea, ping me. I have broad experience across the medical device industry. As founder of a small medical device company, I have completed early stage financing transactions and can bring an informed perspective to your new project. CQA certification through ASQ.

I consulted with BioSET, functioning as VP of Clinical Operations. BioSET developed a novel bone graft substitute involving a ceramic coated with a peptide, which was being studied in both spine and also foot and ankle. The company was acquired by Ferring Pharmaceuticals in early 2015. While at BioSET, I had the following responsibilities:•Managed a small, dynamic clinical team to complete several regulated, pilot studies of a novel synthetic bone graft applied to spine and orthopedic applications. These trials were conducted in the U.S. and Canada. • Negotiated clinical protocols and presented data to regulatory bodies• Led meetings of the Data Safety Monitoring Board• Compiled data for internal reports as well as peer reviewed publications and conference presentations• Participated in board meetings with executive management and investorsKeywords: clinical trials, regulatory affairs, FDA, spine, foot, ankle, start-up, CRO, clinical monitoring, medical device

• Member of Executive Team as the company sales grew from 28MM in 2002 to $85M in 2005. • Responsible for all clinical and regulatory affairs including departmental budgets and securing adequate resources to meet business objectives within financial restraints.• Involved in the selection and evaluation of companies being considered for strategic acquisition or partnering, including one strategic investment and one company acquisition. • Represented clinical, regulatory affairs and quality assurance during Abbott Laboratories’ due diligence process of Spinal Concepts (later Abbott Spine). Resulted in a deal valued at $170MM.• Represented the company during multiple on-site FDA inspections. • Built department through successful hires and personnel management.• Responsible for contracts with physician investigators and outside vendors. • Responsible for charting U.S. regulatory strategies for Class II and III devices. Introduction of product to foreign markets including European Union, Japan and Canada.• Design and execution of four IDE studies utilizing three investigational devices and over 40 clinical sites. Coordinated clinical, marketing and engineering efforts for Class III investigational products.• Wrote and reviewed numerous 510(k) clearances for various spinal products.• Trained clinical investigators and sales representatives on surgical techniques. • Successful public speaker, presenting to large and small groups, scientific and commercial.Keywords: clinical trials, regulatory affairs, quality assurance, FDA, ISO 13485, product development, team-building, business development, publics speaking, statistics, spine, medical device.