Founder & President
As a Mechanical Engineer with 24 years of experience in the medical device field and 3 years in sports trauma research, Mr. Ettlinger developed numerous general & minimally invasive surgical instruments, various implants, and drug delivery devices with applications in arthroscopy, orthopedic trauma & spinal fusion, cardiology, oncology, urology, laparoscopy, endoscopy, brachytherapy, wound treatment, cosmetic and cardiac surgery. Along the way, Mr. Ettlinger designed and fabricated most of the test fixtures and manufacturing tooling necessary for bringing new devices from inception through Verification / Validation, FDA clearance (510(k) & PMA) to market release. Mark is an inventor on 8 patents and 5 pending applications. The products he developed for client and assignee companies earn them in excess of $250MM annually.
Mr. Ettlinger has worked with over 20 medical technology companies (as consultant, contract engineer and employee) including Smith & Nephew Dyonics, ACT Medical, C.R. Bard [BARD Access Systems, BARD Interventional, USCI, and DAVOL], Byron Medical (Mentor), Catheter Innovations (Boston Scientific), Innerdyne (TYCO/USSC), Hewlett Packard (Phillips), Hydrocision, Uromed, NDO Surgical, Mitralign, CardioSolutions and STD Manufacturing (STDMED).
Mr. Ettlinger is a co-founder of the Med Development Group (mdgboston.org) and served this non-profit company as Vice President, Program Director and Board Member. As well as being a co-founder of two consulting companies, AlvaMed and Medical Development Partners, Mark was a co-founder of Angiolink (Medtronic), Anodose Urology, Medical Animation & Design and CardioVantage.
Organizations: ASTM: Committee F04 on Medical and Surgical Materials and Devices (Subcommittees: F04.15 Material Test Methods, F04.21 Osteosynthesis, F04.22 Arthroplasty, F04.25 on Spinal Devices, F04.33 Medical/Surgical Instruments) ISO Technical Committee: TC150 SC4 Bone and Joint Replacements Medical Development Group (mdgBoston.org) New England Healthcare Executive Network MIT Enterprise
Forum Presentations & Publications:
1. Report for ASTM F04.42 Subcommittee for Biomaterials and Biomolecules; Toronto 2014; Title: Evaluation of Proposed Standards for Absorbable Metallic Materials
2. ORTHOTEC 2012: Title: Prototyping using RP & Additive Manufacturing Materials Medical Product Manufacturing News, July/August 2005: The Future of Medical Devices; 2025 A.D.
Hahnen, Collaborating Executive
Mr. Hahnen has over twenty-five years of industry experience and was a Principal Advisor with the National Institutes of Health Commercialization Assistance Program. The nationwide program provides commercialization assistance to NIH SBIR Phase II Awardees in which Kevin mentored over 40 companies.
His previous start-up ventures (The Innovation Factory, AcuFocus, Symbiosis, Haemacure, KeraVision, Embol-X, CardioVantage) have focused in the fields of Ophthalmology, Cardiology, Orthopedics, Wound Management, Minimally Invasive Cardiac Surgery and Stroke Treatment & Prevention. Larger company experience includes Boston Scientific, Cordis (Johnson & Johnson), American Home Products and General Electric.
Mr. Hahnen's background encompasses many disciplines including Business Development, Product Development, Due Diligence, Funding Exploration, Quality Systems, Intellectual Property, Manufacturing, Operations, Strategic Alliance Negotiations and Research & Development.
Ms. Kwiatkowski has over 14 years of Regulatory Affairs and Compliance leadership Director and Manager Levels at Fortune 500 and start-up companies. Janet Kwiatkowski is experienced at creating regulatory and compliance strategies that span both domestic and international markets. She has successfully gained market approval for US companies in the US and international markets as well as with international companies gain access to US markets. She has led Regulatory Affairs and Compliance organizational transformations, successfully implemented regulatory strategies, developed international business markets through regulatory affairs, and created and conducted leadership and diversity training programs.