Officers

President:
Richard O’Brien

dobrien@meddevgroup.org

Richard “Dick” O’Brien is a business development consultant, working with clients in medical device and related life sciences fields as well as serving technology/scientific organizations. Mr. O’Brien works with management to increase revenues, secure clear focus and preemptive corporate identification, address and build client relationships, develop strategic approaches, plans, systems and resources for growth in business, and to improve profitable operations for the organization. Mr. O’Brien’s work includes preparing advisory boards for operating and emerging companies. He is an entrepreneur who holds an MBA from Babson College and retired as a captain in the U.S. Navy.

Vice President:
Mark Sears

msears@meddevgroup.org

Mark Sears was born in the UK and has spent the past 20-plus years serving companies that make products including many medical device manufactures. Mr. Sears is currently engaged in the startup community in Boston as an owner of 3D Ceramics Printing Company Figulo and an investor in other 3D printing technology companies and some medical device startup companies. He previously worked for Prime/Computervision, SolidWorks and was the owner of engineering services company SolidVision.

2leej@comcast.net

Number of years as MDG member: 6

Years in Medical Device/Technology Industry: >10

Education: University of Wisconsin, MS Industrial Technology (Manufacturing Management, Business, & Engineering)

Positions/Career path in Medical Device/Technology Industry: I have spent my entire career working for OEMs. These firms include AB Dick, Guardian Electric Mfg, Travenol Laboratories, Bausch & Lomb, GM Nameplate, and Dekko Medical Devices. I also have been a manufacturer’s representative for companies with a variety of manufacturing disciplines. At each stop I have had hands on experience in developing and bringing products to market on the component, subassembly, or finished goods levels.

Treasurer:
Peter Fuchs

pfuchs@meddevgroup.org

Peter Fuchs is currently the Director Finance, International for Smith & Nephew. His previous experience includes senior global financial positions with Conagra Foods, Gateway Computers and the Swatch group in Hong Kong. He began his career as a CPA with Price Waterhouse. Mr Fuchs has demonstrated expertise in budgeting, forecasting, turnarounds and acquisitions in fast growing entrepreneurial environments. Mr Fuchs received an MBA from UCLA and a BS in economics with Lehigh University.

At-Large Board Members

Richard Andrews

rich@richandrews.com

Number of years as MDG member: 3

Years in Medical Device/Technology Industry: 21

Education: Bachelor of Science Electrical Engineering, Northeastern University

Positions/Career path in Medical Device/Technology Industry: For more than 20 years Rich has helped medical device and instrumentation companies with product concept, design, and development.
He is president of Andrews Business Solutions a consulting practice specializing in bridging the gap between Engineering and Marketing in the medical device space.
Prior to starting his consulting business, Rich worked for Intertech Engineering Associates and Kollsman Manufacturing Company which are firms that specialize in the contract design and development of medical devices and instrumentation.
Rich has also worked for Infusaid developing implantable Class III infusion pumps.
His experience includes upstream marketing, product concept and development, systems engineering, requirements management, software quality assurance, and verification and validation.
He is a member of the Collaborative Care Technology Working Group an organization affiliated with Harvard Medical School whose purpose is to find solutions for improving primary care.

Robert Ezzell

rezzell@meddevgroup.org

Number of years as MDG member: 4

Years in Medical Device/Technology Industry: 24

Education: PhD - University of California, Berkeley; MBA - Northeastern University

Positions/Career path in Medical Device/Technology Industry: Robert (Bob) Ezzell is a Senior Regulatory Consultant at AlvaMed. Bob has over 24 years experience in biopharmaceutical and medical device industry. Most recently, he was Director of Product Development at RenaMed Biologics, which had a combination device in clinical trials to treat acute renal failure. Prior to joining RenaMed, he held senior positions at Argose (minimal invasive glucose monitoring) and Scient (Healthcare eBusiness Systems Integrator), and was a co-founder of Molecular Geodesics (MGI). Before founding MGI, Bob was an Assistant Professor at Harvard Medical School.

William Munger

wmunger@meddevgroup.org

Alan Raider

araider@meddevgroup.org

Number of years as MDG member: 3

Years in Medical Device/Technology Industry: 3

Education: BA – Speech Communication – Ithaca College, 1992

Positions/Career path in Medical Device/Technology Industry: Account Manager; Medical/Laboratory focus – Intertek. In this role I work primarily with medical device and laboratory equipment manufacturers in addressing their global market access requirements for testing and certification.

Lisa Sasso

lsasso@meddevgroup.org

Number of years as MDG member: 7

Years in Medical Device/Technology Industry: 17

Education: MBA in Management (with honors)- Bentley Graduate School of Business, BBA in Marketing and BA in Economics’ both from University of Massachusetts at Amherst

Positions/Career path in Medical Device/Technology Industry: President and CEO, Medical Development Partners, LLC (MDP) - Coach & Consultant to Medical Device Entrepreneurs & Executives. Co-Founder, Past President and CEO, Radi Medical Systems, Inc: built a profitable US Sales and Marketing subsidiary in the Cardiology space where I grew US revenue from inception to $28M in 5 years. I led the effort to bring a disruptive technology to market that improved patient outcomes and become an industry standard. Changed the perception of doctors, competitors and industry professionals through training, clinical studies and reimbursement. Prior to Radi, I was a Market Research Manager and worked in Product Management at USCI – CR Bard Cardiology.

Jerry Shapiro

jshapiro@meddevgroup.org

Number of years as MDG member: 9

Years in Medical Device/Technology Industry: 42

Education:

Positions/Career path in Medical Device/Technology Industry: President and CEO, Fem-Medical LLC; President, Floelle Inc.; COO, Hemetrics Development Corp.; Director of Operations, Spectrum Medical Technologies Inc.; Director of Engineering, Optical Micro Systems; Ophthalmology Program Manager, Candela Laser; Associate Professor of Medicine, Surgery, and Ophthalmology, Boston University School of Medicine; Cofounder, Dept. of Biomedical Engineering, Boston University; Principal Investigator, University of Michigan School of Medicine. Jerry developed more than a dozen surgical devices, invented and patented four diagnostic devices, specialized in fast-track development of concepts into products and now works to relieve the suffering of 450 million women afflicted with an embarrassing condition.

Maria Shepherd

mshepherd@meddevgroup.org

Committee Chairs

Alliances
Alan Kivnik, Co-Chair

akivnik@meddevgroup.org

Marketing

Membership
and Education
Coordinator

Networking
Bob Ezzell

bezzell@meddevgroup.org

Event Operations
David Ennen

dennen@meddevgroup.org

David Ennen has extensive design and development experience in systems and software for medical devices, in vitro diagnostics, imaging, analytical instruments, and robotic-based distributed process control. Recently, David has consulted in the areas of: software development, risk management and standards certifications. He has served diverse roles, including functional manager, program manager, technical lead, software engineer, software architect, systems engineer, and real-time embedded system designer. Currently working as a consultant in regulated device development, David has held engineering positions with Foliage, Boston Scientific, Hologic, Physiometrix, Waters, Zymark, and Advanced NMR. He holds a B.S. in Physics from the University of Cincinnati and an M.S. in Biomedical engineering from the University of Michigan.

Sponsorship

Entrepreneurial SIG
Marty Sklar

msklar@meddevgroup.org

Marty Sklar was the first president of Medical Development Group (“MDG”) and one of its co-founders, doing so in 2001, and currently serves on the MDG Board. He is also a founder and CTO of Medical Development Partners (MDP). In 1992, he founded Automated Medical Instruments, Inc. to develop remote-controlled and automated surgical devices. In 2002, with MDG colleagues, he co-founded AlvaMed, LLC, a Quality and Regulatory consulting company. In 2004, also with MDG colleagues, he co-founded MDP.

Martin has over twenty five years of successful experience in business development, project management, invention, design/development engineering, analysis, quality, regulatory, manufacturing engineering and product introduction of various medical products. He has experience in surgical, image guidance, automated laboratory, implant and other medical devices and systems. These products have been utilized for diagnostic and therapeutic applications in cardiology, orthopedics, neurology, and other key areas.

Earlier commercial experience includes work with Corning Glass Works, Dade Behring, Hewlett Packard, Johnson & Johnson, Millipore Corporation, Orion Research, Visualization Technology, Inc. (now part of GE Medical). More recent work has included development of micro technologies for drug delivery and pain management devices. Martin’s work has led to approximately $800 million in revenues for employers and clients. He continues to search for and develop new business opportunities, product concepts, and intellectual property to satisfy unmet medical needs, which will also provide an optimal ROI.

Marketing & Sales SIG
John Knott, Chair

johnk@jdtechsales.com

John Knott is founder / owner of JD Technologies LLC a field sales company that provides premium sales and marketing services to a group of high quality, complementary manufacturers of engineered services and products who serve the industrial, aerospace, military & defense and medical industries. JD Technologies, LLC develops long term relationships with key customers who value the consultative style of selling and who wish to interface with sales professionals of high integrity. Our approach is to use proven consultative selling techniques. Consultative selling is a collaborative process that leads customers/prospects through an analysis of their current situation to a resulting improvement.

Marketing & Sales SIG
David Hamacher, Co-Chair

davidh@getbettersales.com

Product Development & Manufacturing Outsourcing SIG
Michael Aprea, Chair

maprea-sdw@cox.net

Michael Aprea, founder and President of Sakonnet DesignWorks, Inc., is an engineer, entrepreneur, and inventor designing consumer, industrial, accessory and medical products. His company’s success is founded on persistence, resourcefulness, and strategic relationships to solve product design, development, and manufacturing challenges.

Kevin has over 30 years of experience in the field of materials testing.

He started his career as a Metallurgical Technician involved in materials testing and failure analysis. This was followed by 14-years as a Metallurgical Laboratory Supervisor of a materials testing laboratory that served the Aerospace, Medical Device, and other commercial manufacturing industries.

He is presently the Sales and Marketing Manager at Massachusetts Materials Research, Inc. A materials testing and engineering company serving a number of different industries to include; Medical Device companies, Aerospace Manufactures, Department of Defense, Law Firms and Insurance companies, the Power Generation industry, Municipalities, and variety of commercial manufacturing industries.

Software SIG
Tony Raymond

traymond@meddevgroup.org

Tony Raymond, Director of Quality at Sunrise Labs, honed his leadership in several high tech companies including Corning, Honeywell Medical, Compaq, and Hewlett Packard where he led efforts in software development, quality assurance, software and hardware testing, program management, platform integration, customer satisfaction, and supplier management in the U.S, Europe and Asia. Prior to joining Sunrise in 2011, Tony founded New Harbor SQA, providing expertise in the software development lifecycle with specific knowledge of and execution of software quality assurance within the regulatory environment. These include: Design controls, Risk management, Verification & Validation and computer system validation for Device Development, Laboratories, and Manufacturing.