Mark Ettlinger,
Founder & President
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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.
Kevin
Hahnen, Collaborating Executive
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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.
Janet Kwiatkowski,
Collaborating Executive
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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.
