MPO Symposium Speakers


Tom Burns
VP, Sales & Marketing
Tegra Medical


Bio coming soon..


Ku Ho (Jonathan) Chong
Director, Business Development, Medical Products Vertical
TBM Consulting Group, Inc.








A former engineering and commodities manager with a solid background in lean and Six Sigma, Jonathan Chong came to TBM in 2004 after leading continuous improvement and product development efforts for 15 years for select Fortune 500 companies, such as IBM, Motorola, and Applied Materials.

At TBM, Jonathan has been one of the key leaders in the successful LeanSigma transformations of large multinational food and beverage companies, such as McCain Foods and Bunge, and of high-technology companies such as Freescale Semiconductors.

Jonathan also has been instrumental in utilizing LeanSigma tools to promote operational excellence and cultural transformation in large medical industry clients, such as Hill-Rom and Genzyme Corporation. His strengths are in using statistical tools to improve yield and process capabilities and in new product development.

Jonathan earned a Master’s degree in Aerospace Engineering and a Bachelor’s in Mechanical Engineering from Cornell University. He speaks fluent English, Korean, and Spanish.

Michael Cole
VP of Operations
Zoll Medical Corporation




As vice president of operations for Zoll Medical Corporation, Michael Cole oversees the manufacturing, purchasing, documentation control, shipping and receiving, and materials management for the company’s facility at its worldwide headquarters in Chelmsford, MA.
 
Mr. Cole brings nearly 20 years of operations management and oversight to Zoll®.  He joined the company in January 2010 from Harman International, Northridge, CA, where he served as senior vice president of operations and manufacturing of the consumer division since 2001. Previously he held various operational executive positions in global manufacturing and sourcing and supply chain management for  Black & Decker Corporation for 17 years.  Mr. Cole earned a B.S. in engineering technology from the State University of New York College of Technology in Utica. 


Christopher Donovan
Partner
McDermott Will & Emery LLP
Chris J. Donovan is a partner in the law firm McDermott Will & Emery LLP and is based in the firm's Boston office. He focuses his practice on advising companies and their investors and lenders in mergers and acquisition, recapitalizations, buyouts and restructurings. He has particular experience in leveraged buyouts involving heath care companies and health care real estate financing.

While in law school, Christopher was a member of the Boston College International Comparative Law Review.



Toby H. Kusmer, PC
Partner
McDermott Will & Emery LLP










Toby H. Kusmer is a partner in the law firm of McDermott Will & Emery LLP and is based in the firm's Boston office.  He focuses his practice on all aspects of intellectual property law, both U.S. and international, including ex parte and inter partes matters such as patent and trademark prosecution, opinions, licensing and contract work and related counseling and litigation.

Toby’s practice includes a diverse array of areas including optical, medical devices and instrumentation, imaging systems for both medical and security applications, antennas, process control equipment, telecommunications, semiconductor and electronic technology and devices, alternative energy technology including photovoltaic devices, information technology, nanotechnology, RFID technology, computers, networks, business methods, e-business and internet technologies, and computer software.

Toby is AV-rated in the Martindale-Hubbell Law Directory (highest peer related review).  He is also nationally recognized in The Legal 500 United States 2008-2010 editions for patent litigation support and a leading lawyer for patent prosecution:  utility and design patents.  From 1985 to 1990, he was an adjunct lecturer of law at Boston College, teaching the intellectual property course.  He also spent six years as a patent examiner in the U.S. Patent and Trademark Office.


Steve McKenna
Senior Quality Manager, Corporate Alliance Quality Management
Boston Scientific Corporation














Steve McKenna is Senior Manager at Boston Scientific for Corporate Alliance Quality Management in Natick MA, with overall responsibilities for Outsourced Manufacturing and Acquisition Quality Assurance.  Over the past 20 years Steve has continued to develop and refine supply management processes that are founded on identifying the real and true supply opportunity, including the suppliers themselves who can meet the needs of the business.  These methods include evaluating the manufacturing process to determine and control the risks involved in manufacturing the product within the supplier’s facility.  Processes such as REPACE and RBA, which will be explained in the talk, are cornerstone to the program.
 
These processes have been successfully deployed in the medical device industry over the past 20 years, in an effort to improve product quality, reduce costs and help prevent field actions and supply interruptions. 
 
After taking up his first position in medical engineering in 1988, Steve has worked for some of the best known companies in the medical device and Pharmaceutical arena, companies including British Oxygen (BOC) Ohmeda medical systems division; Pfizer Pharmaceuticals and most recently Boston Scientific.  Steve has held a variety of different positions in Research and Development, Supply Management and Quality since 1988.
 
Steve attended the Metropolitan University of Leeds, England, graduating in Mechanical Engineering in 1985.  Later returning to complete his Master of Science degree in Manufacturing Systems Engineering at the same establishment in 1992.


Linda Meloro
Principal
PRTM










Linda is a Principal in the Healthcare Business Group at PRTM Management Consultants specializing in operational and supply chain optimization and innovation in the Medical Device Industry.  She has more than 18 years of consulting and industry experience and has led numerous teams in the design and implementation of operations and supply chain strategy and process improvement projects.  Her recent project work has ranged from helping several global medical device companies redesign their manufacturing and distribution networks to conducting a strategic sourcing engagement for a major medical equipment manufacturer.  Linda led the development of the “PRTM 2009 Medical Device & Diagnostics (MDD) Direct Material Sourcing Benchmark”.

Prior to joining PRTM, Linda managed a team in the consulting services group within UPS Supply Chain Solutions working with clients in the Life Sciences industry to develop and implement in-novative supply chain outsourcing solutions.  She also has experience as a Principal with Price-waterhouseCoopers. 

Linda earned a Master of Business Administration from Carnegie Mellon University and also holds a Bachelor of Science and Master of Science in materials engineering from Rensselaer Polytechnic Institute.


Susan Mucha
President
Powell-Mucha Consulting, Inc.








Susan Mucha is president of Powell-Mucha Consulting, Inc. PMCI focuses on a range of consulting activities for the electronics manufacturing services (EMS) market which include: strategic partner identification, organizational analysis, market positioning strategy development and training. Prior to founding PMCI in 2001, she spent 20 years in the EMS industry in sales and marketing management positions at several EMS companies. She has also served as adjunct faculty in both University of Phoenix’s undergraduate program and Webster University’s MBA program.
 
Ms. Mucha writes extensively in industry trade publications on EMS topics. She is the author of Find It. Book It. Grow It.: A Robust Process for Account Acquisition in Electronics Manufacturing Services. She is also a frequent presenter at electronics industry conferences on EMS industry business models and sourcing trends. In 1994, she was the recipient of the IPC's President's Award for her work in support of IPC's Electronics Manufacturing Services Industry (EMSI) Council. She holds a B.S. degree in journalism from the University of Florida and an MAS degree from the University of Alabama in Huntsville.


Tony Mulone
VP & GM
Covidien

Tony Mulone is responsible for directing the medical supplies OEM, veterinary, dental and consumer businesses. The medical OEM group focuses its efforts on providing custom solutions for pharmaceutical and medical device companies with primary attention to drug delivery, electrotherapy and hydrogel markets, through such brands as Monoject™, Ludlow™ and Uni-Patch™. The veterinary, dental and consumer group center their attention on promoting the Monoject™ and Kendall™ brands into these emerging markets. Mulone began his medical device career in 1981 and joined Kendall in 1988, holding management positions in both marketing and sales. Mulone holds a bachelor's degree in economics from Framingham State College (Mass.).

Larry Nichols
CEO
NUTEK, Corp.

Larry earned his bachelor of sciences in business management at Cal Poly in San Luis Obispo California.

Throughout the first half of his working career owned and operated various business that included a locksmith shop, four ice cream stores and a small chain of retail cartoon stores.  During the dot com era, he was the vice president of procurement for ActionAce until the dot com bust. For the past 15 years he has been in the medical device industry at NUTEK Corporation where he started as the business manager. Over the years he has rounded out his medical device experience as the manager of different department within the company that include quality, operations and business development before being promoted to the CEO.


Julia S. Rasor, MS
Medical Device Strategist and Entrepreneur
Rasor Consulting Group















Julia S. Rasor, MS is a strategic, multidisciplinary medical device entrepreneur with an extensive track record of leading very successful solutions for business, clinical, or regulatory roadblocks as well as technical hurdles. She uses a combination of science, business, and regulatory savvy and tools developed from a 60-company experience to 'Fast Track' companies reducing cost and risk thus seizing the competitive advantage. Julia is inventor of a $100M/year revenue medical product ECHOVIST®, Schering AG, the first commercial ultrasonic contrast agent; CEO and Founder of Entrovita, Inc. and Inventor of its devices to fight nosocomial infection; Former CEO Founder of CAPNIA, Inc., a drug delivery company that closed $38M to date; Member of 6 Scientific Advisory Boards; Inventor of 17 patents; Founder of Rasor Consulting Group celebrating over 25 years of success for clients and providing Julia with an equity portfolio of 13 companies, www.MedicalDevice.com; Author of 30 publications and 20 White Papers yielding multi-million dollar venture funding, increased sales, and reversal of FDA’s previously stated decisions; Author and originator of highly successful newsletter Rasor Resource, circulation to 2,500 medical device executives plus download of archived newsletters and author’s talk presentation slides now at 900 per month from her www.MedicalDevice.com website.

Julia often works as an interim Chief Strategy Officer (CSO) and provides the required practicum via internships in her start-ups for university MBA and Masters of Science Degree candidates. She holds an MS degree in Human Physiology from UC, Davis, a Professional Certificate in Engineering Management from UC San Diego, and is a formally educated medical writer with a Multidisciplinary Medical Communications Certificate, a 2-year medical writer’s certificate, from the American Medical Writers Association (AMWA, Founded in 1940).


Gil Reich
VP, Sales and Marketing
The MedTech Group, Inc.

Gil Reich is vice president of sales and marketing. Gil holds an engineering degree from Rutgers University. With over 20 years of service at MedTech, Gil has served in various engineering, sales and marketing roles.







Dave Robson
Vice President, Development
Ximedica

Dave is the primary point of contact for many of Ximedica's clients and works closely with development teams to scope complex technical development programs for the most effective and efficient outcome. Dave's extensive experience in medical device product development, in both capital equipment and sterile disposables, includes positions with Genzyme Biosurgery, Deknatel, Niche Medical, and DHD Healthcare. Dave holds a BSME degree from the University of Rochester.

 

Derek Sakata, MD
Associate Professor, Medical Director for Anesthesia Services
John A. Moran Eye Center,
Department of Anesthesiology,
University of Utah





Derek Sakata, MD received his bachelor’s degree in electrical engineering from the University of California, Irvine and completed medical school at Loma Linda University, CA. Dr. Sakata interned at Arrowhead Regional Medical Center, San Bernardino, CA. and continued his residency in anesthesiology for 3 years at the University of Utah. 

During his last year of residency Dr. Sakata worked on a concept to expedite the reversal of inhaled anesthetics.  After his residency, he continued his work as a clinical instructor at the University of Utah collaborating with Drs. Orr and Westenskow through Korr Medical.  Through this collaboration, the concept became a patentable device.  Anecare Laboratories was founded as a home for this device, the QED-100 were Dr. Sakata served as director for medical affairs for this company.  The device underwent 510k FDA clearance and has been on the market.  Dr. Sakata is currently an associate professor of anesthesiology, and Medical Director for Anesthesia Services at the John A. Moran Eye Center and holds the Leland O. Avanelle W. Learned Endowed Professorship in Anesthesiology.


Thomas Taylor
President
Roush Life Sciences

























Thomas F. Taylor is President of Roush Life Sciences (RLS), a division of Roush Enterprises, Inc., a five hundred million dollar company, which holdings include Roush Fenway Racing, Roush Performance products, and Roush Manufacturing.  RLS designs and develops laboratory research products and medical devices. 
 
Before joining Roush in 2008, Taylor was President of Nypro Life Sciences, a division of Nypro Inc., a billion dollar global manufacturer of custom plastics offering integrated contract manufacturing.  He also held several other senior management positions including Vice President of Global Marketing and Business Development for Nypro’s 250 million dollar healthcare market segment, President of Nypro Medical Products Group, responsible for initiatives on new proprietary medical products and technologies, and Vice President of Business Development,  where he was responsible for M&A and instrumental in the acquisition of a new line of medical filtration devices for NP Medical Inc., a wholly owned company of Nypro. He also assisted in opening Nihon Nypro in Tokyo, which sells disposable OEM medical devices in Japan and Asia.  He also served as a board member on Nypro-Forbes India company, a Nypro joint venture contract manufacturing company, Radius Product Development, a Nypro joint venture design firm and NPA, a Nypro joint venture contract manufacturing company located in Mexico. 
 
Prior to Nypro in 2003, Taylor was Vice President of the OEM Healthcare Business Unit at Millipore Corporation, where he led sales, marketing, research and development for all polymer membranes and medical devices for the global medical and diagnostic market. He also held positions with Pall, Fisher Price and General Motors early in his career.  Taylor has extensive experience and background in developing and marketing disposable medical, diagnostic, laboratory research products for the global life sciences market. Taylor is a graduate of Ferris State University with a degree in Plastics Engineering and holds an MBA from New Hampshire College.

An authority on practices and trends in the medical device market, Thomas serves on a number of association boards, industry advisory panels and editorial boards including MassMEDIC, Medical Products Outsourcing, and Emerging Life Sciences Alliance. In addition, he has written several articles on plastics, medical products, and outsourcing.


Tom Vassallo
Executive Vice President,
Global Business Development
Helix Medical

























Thomas M. Vassallo is the executive vice president, global business development for Helix Medical, LLC. a full service contract medical device manufacturer with facilities located in Carpinteria, Cali., Baldwin Park, Cali., Gloucester, Mass., Shenzhen, China, Kaiserslautern, Germany and Carrick-on Shannon, Ireland. His responsibilities include all commercial aspects for the health care business of Freudenberg & Co., Weinheim, Germany.

Vassallo’s career spans 40 years in the medical device markets. He began as a sales representative for Pharmaseal Laboratories, a division of American Hospital Supply Corporation (AHSC) and progressed in two years to special markets manager for the OR and anesthesia specialties at the national level.

He next served as the marketing manager of the OR/anesthesia division and had global marketing responsibilities for $25M of products ranging from disposable surgeons gloves to single use trays for surgical procedures.

In 1978 Vassallo accepted the opportunity to become the vice president of sales and marketing for Heyer-Schulte Corporation in Santa Barbara, Calif. Heyer-Schulte was a newly acquired division of American Hospital Supply Corporation focusing on implantable silicone products for specialty surgical markets including neurosurgery, urology, ophthalmology, plastic and reconstructive surgery, wound drainage and gastroenterology. During his leadership Heyer-Schulte grew organically from $35M to more than $100M over a five-year period.

In 1984 Vassallo joined the newly established contract medical device manufacturer Helix Medical, Inc. in Santa Barbara, Cali., as its chief marketing, sales and business development officer. He served in that position until the company was acquired by Freudenberg-NOK in October of 2006.

The two founders of Helix Medical, Inc. retired at the time of acquisition and Vassallo stayed on to assist the new Helix Medical, LLC in it’s strategic growth to its present well-respected and successful position within the global medical device community.

Vassallo earned a bachelors of science degree with dual majors in chemistry and biological sciences from Kent State University, Kent Ohio.


Marcia Weinstein
Director of Marketing
Arc-Tronics



Marcia Weinstein is the director of marketing for Arc-Tronics, Inc.  Arc-Tronics is a family run Electronic Manufacturing Services (EMS) company founded by Conrad Goeringer, in 1972.  Arc-Tronics specializes in low to medium volume manufacturing focusing on the high end military, medical, aerospace, and life sciences markets.  Arc-Tronics has been certified to ISO 9001:2008 and ISO 13485 standards and is in the process of AS9100 certification.  Arc-Tronics is an ITAR registered organization.

Marcia Weinstein began working on the assembly line after high school while attending college where she received degree as a paralegal. While continuing to work her way thru all aspects of the business at Arc-Tronics, she finally settled in sales and marketing.  A bachelors degree from Roosevelt University followed in 1999 with a major in marketing.