Conference Speakers

José Colucci Jr.
Director, Health & Wellness
IDEO

José Colucci's interests range from medical and scientific instruments to product strategy and trends in science and healthcare. Currently a member of the Health & Wellness Practice at IDEO, José has been with the company since 2000. He's authored many patents and written on topics from the biotech revolution to design innovation. Recently, he's been researching and speaking about aging and its implications to the design of products, services and society. Prior to joining IDEO José worked mostly for high-tech companies, including FUNBEC (General Manager, ten years developing medical and scientific instruments such as electrocardiographs, defibrillators, monitors, treadmills, insulin pumps, spectrophotometers, and ultrasound scanners), VisionMaker Canada (VP of R&D, five years: high-resolution pen-input video interface for computers), and a number of design consulting firms. Jose has training and experience in both Mechanical Engineering and Industrial Design. He also has a Ph.D. in Biomedical Engineering and was awarded the prestigious Fulbright Scholarship for academic excellence.

Brad Dawson
Practice Leader, Process Optimization Consulting
Quintiles

Brad Dawson is Practice Leader, Quality Systems Process Optimization, Consulting at Quintiles. Brad is a seasoned life science management consultant with extensive expertise leading strategic growth initiatives, process improvement, and quality systems optimization solutions for leading pharmaceutical, biotechnology, and medical device companies. He has firsthand experience delivering solutions focused on the transformation of core business and information management processes from preclinical API development through clinical trials, regulatory management, and commercial operations among global life science entities.

At Quintiles, Brad leads the design and implementation of strategic R&D transformation and process improvements initiatives, aligned with Quality by Design development strategies for the company's global biopharmaceutical clients. He and his team strive to develop novel and proven solutions to address key challenges faced by senior leadership including: the high costs of development, the complexity of meeting pipeline requirements to satisfy unmet medical needs, an industry-wide deficiency in innovation with increasing R&D productivity challenges, expanding global regulatory compliance challenges, and the need to adapt to an ever-changing competitive landscape in the New Health arena.

Prior to joining Quintiles, Brad led a CRADA with the FDA's Office of Pharmaceutical Sciences (OPS), CDER, focused on industry adoption of the Critical Path Initiatives, including Quality by Design development paradigms with an aim to improve development performance and improve quality.

Brad has a B.A. in Psychology, Public Health Epidemiology Focus, from the University of California, Los Angeles (UCLA).

David J. Dykeman
Shareholder & Patent Attorney
Greenberg Traurig LLP

David Dykeman is a registered patent attorney, shareholder, and co-chair of the IP Department in the Boston office of the international law firm Greenberg Traurig LLP. With over fifteen years experience in patents, intellectual property, and licensing, David's practice focuses on securing strategic worldwide intellectual property protection and related business strategy for high tech clients, with particular expertise in medical devices, healthcare IT and life sciences. David also performs patent due diligence to assess patent portfolios for venture capital investment, mergers and acquisitions, and licensing opportunities. A frequent author and lecturer on medical device and life sciences intellectual property, David also serves on the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), was appointed to the Massachusetts Life Sciences Collaborative Research, Innovation & Commercialization Task Force, and is a Contributing Editor of The Journal of BioLaw & Business. Recently, David was named one of the top 250 Patent and Technology Licensing Practitioners in the world by Intellectual Asset Management (IAM) Magazine.

Roman Fayerberg
Patent Attorney
Greenberg Traurig LLP

Roman Fayerberg is a registered patent attorney in the Boston office of the international law firm of Greenberg Traurig, LLP. Roman's practice focuses on preparation and prosecution of patent applications and counseling clients on patent issues relating to medical devices, biomaterials, and nanotechnology. Roman's patent practice builds on seven years of experience he gained as a research and development engineer at C.R. Bard and Boston Scientific Corporation.

Anura S. Fernando
Research Engineer
Underwriters Laboratories

Anura Fernando is a Research Engineer at Underwriters Laboratories Inc. He holds a Masters in Software Engineering and Graduate Certificate in Software Development Management from the University of Maryland as well as Bachelors degrees in Electrical Engineering and Biology / Chemistry from Purdue University and Indiana University respectively. During the course of his fourteen year career at UL, Anura has been involved with the certification of software in a variety of different product areas including industrial control, alternative energy, appliances, lighting, combustion control, elevator and escalators, and medical. He has also been involved with the development of software and Functional Safety requirements in these areas as a contributor in UL's Standards Technical Panels, as well as serving on several IEC, ISO, and ASME standards writing committees and serving as an IECEE technical expert and CB Scheme assessor for software.

Theresa W. Fossum, DVM and PhD,
Texas A&M Institute for Preclinical Studies

Theresa (Terry) W. Fossum is a Professor of Surgery and holds the Tom and Joan Read Chair in Veterinary Surgery at Texas A&M University. She is a world renowned surgeon and serves as the Director for Cardiothoracic Surgery and Biomedical Devices in the Michael E. DeBakey Institute at TAMU. She was recently appointed Director of the new Texas A & M Institute for Preclinical Studies, a 70 million dollar venture at TAMU which will promote public-private partnerships to speed the development of medical devices and drugs. Dr. Fossum's leadership was integral in conceptualizing and funding this Institute.

Dr. Fossum graduated from Washington State University College of Veterinary Medicine in 1982. After completing an internship at Santa Cruz Veterinary Hospital the following year, she went on to do a surgery residency and Master's degree at the Ohio State University. She received board certification in Surgery (ACVS) in 1987 and joined the faculty at Texas A&M University later that year. In 1992, she completed a PhD in Veterinary Microbiology. Dr. Fossum's main interests are diseases of the respiratory and cardiovascular system, including cardiopulmonary bypass procedures. Dr. Fossum has authored numerous articles on chylothorax and other respiratory and surgical diseases. She is the principal investigator of numerous research projects including evaluation of the DeBakey Ventricular Assist Device in a calf model, evaluation of angiogenic factors for the treatment of cardiac ischemia, and vascular adaptations to hypertension. Dr. Fossum sits on the Board of Directors of the National Space Biomedical Research Institute and is the Chair of the Board of Directors for the Foundation for Biomedical Research. Dr. Fossum is a previous recipient of the Wiley Distinguished Professor of Veterinary Medicine Award and the Carl J. Norden Distinguished Teacher Award at Texas A&M University. In 2004, she received the Texas Society for Biomedical Research Award in recognition and appreciation for her many years of dedicated service to the science, research and medical communities in the State of Texas. Dr Fossum, along with Dr. Michael E. DeBakey, founded the CARE Foundation in 2004 in order to provide an infrastructure for veterinary medicine to perform research using animals with spontaneous disease. She serves as President of the organization.

Kristen Grumet
Principal, Medical Device Quality Systems
Quintiles

As the Director, Medical Device Quality Systems, Ms. Grumet is responsible for assisting with oversight of the Medical Device Quality Systems program at Quintiles Consulting. She provides oversight for Quintiles Consulting's medical device projects, serving in both a technical and executive oversight role. Ms. Grumet works with clients in the medical device and biotechnology industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations. She provides strategic regulatory consultation to the medical device industry. Ms. Grumet works with clients to develop and execute cost-effective gap analyses and corrective action plans in response to FDA 483s, Warning Letters, Consent Decrees and other regulatory actions.

Ms. Grumet has nine years of FDA experience as a field investigator specializing in the area of medical devices. She was a member of the FDA Design Control Inspection Strategy (DCIS) Team and the FDA Pacific Region Design Control Training Cadre, responsible for development and implementation of the DCIS questionnaire used during FDA medical device inspections, as well as training industry and FDA staff on design control requirements. Ms. Grumet was also a member of the first cadre of certified medical device investigators in FDA history, qualifying as a Phase II certified performance auditor in the area of medical devices. She served on the FDA foreign inspection cadre for six years, conducting numerous medical device inspections in Europe. In addition to her FDA expertise, Ms. Grumet has medical device industry expertise as both a Senior Quality Engineer and Manager of Quality Systems Compliance. In these roles, she was responsible for quality system execution as well as overseeing the corporate Quality Systems Compliance department, including Internal Audits, Management Action Plan, and Inspection Readiness programs.

Ms. Grumet received her B. A. in Environmental, Population, and Organismal Biology from the University of Colorado in Boulder.

Joseph A Heanue, Ph.D.
President
Triple Ring Technologies, Inc.

Joe Heanue is the president and co-founder of Triple Ring Technologies, a firm that provides R&D services and advanced technology to the MedTech, Homeland Security and Defense, and CleanTech industries. Joe has significant leadership experience in device and instrumentation research & development within interdisciplinary environments. He has served as Vice President of Engineering at NexRay and Signature BioScience. At NexRay, Joe led the development of a low-dose x-ray imaging system for interventional cardiology. At Signature, he headed a group that delivered prototype RF and microwave spectroscopy instruments to a major instrument partner; the first of these instruments was launched in 2005 by MDS Sciex. Joe holds a number of patents for medical devices and instruments, including a patent for a medical system imaging architecture that is licensed to a major medical equipment manufacturer. He received a BS in Physics from the Massachusetts Institute of Technology and earned his Ph.D. in Electrical Engineering and Computer Science from the University of California at Berkeley. Joe was a postdoctoral researcher at Xerox PARC, and he has completed the Stanford University Executive Program for Growing Companies.

Barb Huibregtse
Vice President Preclinical Sciences
Boston Scientific Corporation

Dr. Barbara Huibregtse received her DVM degree from the University of Minnesota, College of Veterinary Medicine, and completed her post-doctoral work at Case Western Reserve University in the United States, researching animal models for use in tissue engineering for orthopedic and cardiac applications. She has been a Senior Scientist at Genzyme Corporation, evaluating cell replacement therapy for orthopedic applications from 1997 until 2002 when she joined Boston Scientific. Her primary area of research has been development of methods and models for the evaluation of vascular response to stents and balloons in coronary and peripheral applications. She has been an author on multiple papers and abstracts related to models for evaluation of devices and tissue-engineering therapies, and is Vice-President of Preclinical Sciences.

Sameer Jaiswal
Mgr, Enterprise Software Quality Assurance, Global Quality Systems
Boston Scientific Incorporated

Sameer Jaiswal is the Manager of Enterprise Software Quality Assurance at Boston Scientific. Sameer holds an MSc in MIS and a BSc in Accounting from the University of Illinois.

Sameer worked in the banking industry in the UK before moving to the US and the healthcare industry in 1998. During his career in healthcare, Sameer has worked at both Abbott Laboratories and Boston Scientific.

Sameer was at Abbott Labs for 11 years where he helped Abbott Labs develop and implement SDLC's and had global responsibility for several of Abbott's core software systems. In 2008, Sameer moved from Abbott to his current position at BSC. As manager of ESQA, Sameer is responsible for the regulatory compliance of all enterprise non-product, quality systems as well as providing training, consulting and support to BSC site software quality assurance departments around the world.

Mary Beth Kossuth, Ph.D.,
Senior Staff Research Scientist
Abbott Vascular

Mary Beth Kossuth is a Senior Staff Research Scientist at Abbott Vascular, where she has been working for the last three years on developing the AbsorbTM Bioresorbable Vascular Scaffold. Her expertise is in polymer physics and structure/property relationships. Prior to joining Abbott Vascular, she worked at Symyx Technologies, where she contributed to high-throughput materials discovery programs across the fields of commodity polymers, performance materials, and life sciences. She received her Ph.D. in Materials Science and Engineering from the University of Minnesota-Twin Cities, and her B.S. in Materials Science and Engineering from M.I.T.

Mark Leimbeck, P.E.
Program Manager, Health Sciences
Underwriters Laboratories

Mark Leimbeck is Underwriters Laboratories' Quality and Training Program Manager for Medical Certifications. His current responsibilities include development of an overarching Certification Model for medical devices, encompassing both Regulatory and Safety, as well as coordinating implementation of the model globally.

Mark has more than 30 years of experience at UL working in a variety of roles, including Operations Manager, Principal Engineer for a variety of product categories and representative on US National and International Standards writing committees. He is currently serving as a UL delegate to the IECEE (CB Scheme) Risk Management Task Force.

Mark has served as Project Manager for multiple process improvement initiatives. He led development of, and has contributed to, several training and development programs at UL including quality, technical and management training courses. He has authored and co-authored numerous technical articles, and recently joined the editorial review board for Medical Devices and Diagnostic Industry magazine.

Mark is a member of the American Society for Quality, Regulatory Affairs Professionals Society and is a Registered Professional Engineer. He earned a Bachelor's Degree in Electrical Engineering Technology from Southern Illinois University and a Master's Degree in Business Administration from the University of Chicago.

Shana Leonard
Editor-In-Chief, QMED/MPMN
UBM Canon

Shana Leonard joined the editorial staff of Medical Product Manufacturing News in 2005 and has served as editor-in-chief of the brand since 2008. In April 2011, Shana also accepted the position of editor-in-chief of Qmed.com. As the editorial leader of these two medical brands, Shana works with her team to optimize content for medical device OEMs and to provide extensive information on the components, materials, equipment, and services they need to design and develop a finished medical device. She holds a BS in Journalism from Boston University.

Lawrence T. Levine, P.E.
Partner
Creative Services

Founded in 1967, Creative Services is an independent engineering consulting firm that assists suppliers and marketers throughout the product cycle, including: development, technical design and redesign, product testing, and safety.

Larry has over twenty-five years of experience testing and analyzing materials and mechanical/electromechanical components and devices. Areas of concentration include: risk analysis, test program design, quasi-static and lifecycle test fixtures and system development, failure analysis, and safety certifications.

Larry holds mechanical engineering degrees from the University of Pennsylvania (B.S.) and Cornell University (M.S.), with a concentration in biomechanics. He is a registered professional engineer with the State of Connecticut and has been awarded utility patents for a wide range of mechanical and electromechanical products.

He is also a member of several Standards Technical Panels of Underwriters Laboratories, Inc.; assisting in the development of industry Standards. Larry is a past president of the Inventors' Association of Connecticut and a long-time judge for the Southern Connecticut Invitational Science & Engineering Fair.

Vicki R. Lewis, PhD,
Scientific Director, National Center for Human Factors Engineering in Healthcare
MedStar Institute for Innovation, MedStar Health Research Institute

Dr. Vicki Lewis is the Scientific Director at the MedStar Health Center for Human Factors Engineering in Healthcare and the Director of the Center's Usability Division. Dr. Lewis received her Ph.D. in Industrial and Systems Engineering/Human Factors Engineering from Virginia Tech. She has 20 years experience conducting research in the areas of Human Systems Integration (HSI), human-factors engineering, training, and user interface design and evaluation. She previously served as Director of the Center for Vehicle-Infrastructure Safety at Virginia Tech. While there, Dr. Lewis applied skills to the issues of driver fatigue, driver distraction, and the evaluation of in-vehicle information and warning systems. Prior to her work at Virginia Tech, Dr. Lewis developed training systems for the Federal Aviation Administration and the Occupational Safety and Health Administration, and designed documents and computer interfaces for various applications and organizations. She has authored more than 90 scientific articles, technical reports, and book chapters, in addition to two published transportation-related safety standards.

Ron Litke
Senior Project Engineer
Orchid Design

Ron's role at Orchid Design is as a project manager and a design engineer for medical devices with a focus on orthopedics. With expertise in the design and development of mechanical systems and mechanisms, Ron has strong CAE experience coupled with solid manufacturing process expertise and is also certified as a Senior Level GD&T Professional. Previously employed by Cannondale Bicycles and NextRnd where he designed power assist wheelchairs, Ron has 15 years of Engineering experience and a BS and MS Degree in Mechanical Engineering from the University of Connecticut.

Milenko Masic
Principal Research Engineer
Covidien

Milenko Masic is a Principal R&D Engineer/Scientist with Advanced Technology Development group of Covidien/Puritan Bennett's center for mechanical ventilation excellence in Carlsbad, CA. Dr Masic has been leading the development of new mechanical ventilation technologies addressing unmet clinical need, including technologies that promote improved patient ventilator synchrony. He specializes in application of systems theory, dynamic systems control, signal processing, algorithm development, statistical and process improvement methodologies in medical devices development. Dr Masic is certified Design for Six Sigma Black Belt and Project Management Professional (PMP). He is the inventor and author of several patents related to core mechanical ventilation technologies.

Covidien is a $12 billion global healthcare products leader dedicated to innovation and long-term growth. Covidien creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.

Stephen McCarthy
Chairman, Polymer, Sciences and Biomaterials
Umass Lowell

Professor McCarthy is a Full Professor in the Plastics Engineering Department at the University of Massachusetts Lowell. He is currently the Director of the Biodegradable Polymer Research Center where he is conducting research into Biodegradable Polymers and Blends and Co-director of the Massachusetts Medical Device Development Center (M2D2)at U. Mass. Lowell. He is currently the Editor for the Journal of Polymers and the Environment. He received his Masters in Chemical Engineering from Princeton University, and a Ph.D. in Macromolecular Science from Case Western.

Rich Nass
Director of Content, Medical Devices Group
UBM Canon

Nass is the Director of Content, Medical Devices Group for UBM Canon. His key responsibilities include setting the editorial direction for all properties within the Medical Devices Group at UBM Canon. This includes MD+DI, QMED, MED, EMDM, CMDT, MPMN, and OrthoTec, as well the global DesignMED Conferences, and all custom properties and events. Nass has been in the Medical/Electronics OEM industry for over 20 years. Before taking on the his current role, he held a similar position at EE Times Group, handling the Embedded and Custom groups and the TechOnline DesignLine network of design engineering web sites. Nass holds a BSEE degree from the New Jersey Institute of Technology. For the MDEA program, Nass helps manage the judging process. He also coordinates MDEA coverage in MD+DI, which is the publication sponsor of the awards, and assists in coordinating the MDEA ceremony held in conjunction with MD&M East (www.MDMEast.com) at the Pennsylvania Convention Center in Philadelphia.

Vinny Sastri, Ph.D.
President
Winovia LLC

Vinny Sastri, Ph.D., is the President of WINOVIA LLC. His firm provides customized, sustainable solutions, strategies and training in new product development, quality management and high performance materials for medical device companies. His areas of expertise include design controls, process validation, and FDA and ISO Quality Systems for Medical devices, quality systems and Design for Six Sigma. He consults with medical device companies in designing, developing and manufacturing innovative new products with validated processes and in the implementation of effective quality systems. Prior to starting his own consulting firm, Dr. Sastri has held positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and General Electric Plastics. Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute. He was also an Adjunct Professor at Virginia Commonwealth University in Richmond, Vi rginia. He has published articles in the Medical Device and Diagnostic Industry trade journal, and has given workshops and training on the integration of product development, Design for Six Sigma and the FDA Quality System Regulation in the United States, Europe and Asia.

Max Shurgalin
Senior Staff R&D Engineer
OmniGuide, Inc

Dr. Max Shurgalin is the senior staff engineer at Omniguide Inc. (Cambridge, MA). He received his PhD in Physics from Griffith University (Brisbane, Australia) for his experimental work in fundamental science on electron scattering from laser-excited atoms. He also worked on the development of copper-bromide lasers for medical applications at Norseld Pty. Ltd. (Brisbane, Australia). Prior to joining Omniguide Inc. Max worked for 2.5 years at Harvard-Smithsonian Center for Astrophysics (Cambridge, MA), leading experimental section of a 2.5-year research project of interest to lighting applications in collaboration with OSRAM Sylvania Inc. R&D. At Omniguide Inc. Max led many technology development projects and more recently surgical fiber product development and fiber assembly process and tooling designs. Max made significant contributions to establishing Omniguide Quality System. He authored and co-authored over 30 publications in peer-reviewed journals, books and conference presentations and holds 11 patents issued in US, Europe and Australia. He is a member of American Physics Society and a reviewer for Institute of Physics journals.

Thomas J. Sommer
President
Massachusetts Medical Device Industry Council (MassMEDIC)

Tom Sommer was named the first president of the Massachusetts Medical Device Industry Council (MassMEDIC) in October 1996. Since that time, Sommer has served as the association's chief executive officer, managing its daily operations and working with medical device industry executives in developing its policy agenda. Since its establishment, MassMEDIC has grown to over 375 member companies.

Ryan Sproul
Global Operations Supplier Quality & Director of Global Mfg Quality
Smiths Medical

Ryan Sproul is a graduate of Rochester Institute of Technology's Engineering Technology program. He is an experienced subject matter expert for supplier qualifications including validation and supplier evaluations. Ryan currently resides with his wife and daughter in Keene, NH.