February 6-8, 2018Anaheim Convention CenterAnaheim, CA

UBM ADVANCED MANUFACTURING MEDTECH CONFERENCES ADVISORY GROUP

The UBM Advanced Manufacturing Group has assembled a team of esteemed medical device and diagnostics industry experts to serve as the guiding force in ensuring the MD&M and BIOMEDevice conferences are valuable learning and networking experiences for attendees. The working group is comprised of experts across specialties such as design, R&D, product development, quality and regulatory affairs, and a range of technical topics. Their contributions are critical to the conference program and ensure the speakers and topics at our conference are of the highest quality and relevance to medtech professionals.

2018 Medtech Advisory Group Members

Principal Scientist, Medtronic

Dr. Caldwell is a principal scientist at the Medtronic Energy and Components Center focused on developing next generation rechargeable batteries for implanted medical devices. Prior to joining Medtronic, she was a lead scientist at Wildcat Discovery Technologies, developing new battery materials for industries including medical devices, consumer electronics, grid storage and electric vehicles. She leads projects that spanned topics including new cathode material development, solid state electrolyte technologies, and electrode level optimization for both primary and rechargeable batteries. Dr. Caldwell earned her Ph.D. in Chemistry from Stanford University.

Sr. Director, Engineering and Advanced Technology, Edwards Lifesciences

Dr. Hengchu Cao has over thirty years of research and development experience in medical device industry. At present, Dr. Cao is a Senior Director of Engineering in Advanced Technology at Edwards Lifesciences. Over the past decade, he has made substantial contribution to the development, regulatory approval, and commercialization of the break-through transcatheter heart valve technology. In particular, Dr. Cao developed an innovative approach to apply computer modeling and simulation technology to the design and life time prediction of the transcatheter heart valve structures.

Dr. Cao has made a personal commitment to excellence on medical device technology. He is the inventor of many implantable heart devices with nine patents. His industrial experience spans from startup to world’s largest and fastest growing heart valve company. His invention of a ceramic-based blood pump at a start-up company contributed significantly to the successful commercialization of the world’s first total suspended wearless ventricular assist device.

Dr. Cao is an active member of several professional organizations. He is a fellow of the American Institute for Medical and Biological Engineering. He served on the organizing committee for FDA/BMES Frontiers in Medical Device Modeling and Simulation. He was on the organizing committee for 1st FDA/ASME Frontiers in Medical Devices in 2013 as well on the National Academy BEMA roundtable for Medical Device In Vitro Evaluation in 2006. Dr. Cao holds a BS in chemical engineering from South China University of Technology, and a Ph.D. in materials science from University of California at Berkeley.

Regulatory Affairs Specialist, Microvention

Eri started her career as a Development Chemist for a very small electrophoresis product line that provided training on a broad spectrum of skills on the complete product life cycle. This training highlighted the key importance of managing documentation. The growing labeling knowledge sparked her interest in other parts of regulatory.

Working on the labeling requirements led to an opportunity to lead the Technical publications group in Brea. This in turn developed a detailed knowledge of world-wide IVD labeling requirements and the interplay with different standards..

Eri shifted her career to into Regulatory Affairs. She continues to expand her knowledge on global regulatory requirements. Different requirements such as chemical hazard communication, global registrations, import/export requirements, biological origin permitting and country of origin marking requirement were all interwoven into supporting a complete product life-cycle. Reinforcement of EU regulations were acquired by being an auditor for TUV SUD. The journey to acquire regulatory knowledge continues with MicroVention and working on their neurovascular medical devices.

Manager, Manufacturing Engineering, CeQur

Asmita Khanolkar has a Master's degree in Material Science & Engineering from Worcester Polytechnic Institute & Bachelor's degree in Polymer Science and Engineering. She has over 20 years of manufacturing experience specializing in the Medical Device Industry. She has managed device projects starting from concept to volume manufacturing launches. Her product portfolio includes devices in diabetes management, surgical devices, orthopedics, respiratory, cardio, patient safety and health monitoring devices, biomedical and cell regeneration devices, drug delivery, sports regenerative surgery, blood collection, pharmaceutical, diagnostics, needle protection and airway products. She has presented, chaired and participated in panel discussions at various medical polymers and device conferences on topics related to MEMS devices, Medical innovation, Wearable devices, Material Selection for Medical devices and Manufacturing technologies.

Publications & Conferences:

  1. Medical Product Outsourcing magazine, New Tech Drivers – Advanced Molding Technologies, published June 2011 issue
  2. Speaker, "Material Selection for Medical Devices" International Medical Polymer Conference Sept 25-26, 2012
  3. Speaker "MEMS in Medical Devices" Wireless Connectivity in Medical Devices MEMS overview, East Coast, Nov 26-29, 2012
  4. Speaker - "Overcoming challenges of Integrating MEMS in Medical Device", Biomedical Device show Dec3-5 San Jose 2012
  5. Speaker - "Overcoming challenges of Integrating MEMS in Medical Device", M2M Summit Cambridge, Boston, May 9th, 2013
    Panel Discussion "Human Factors Engineering", MEMS in Medical Devices
  6. Speaker and Chair "Medical Polymer Conference", AMI Boston Sept, 2013 "Technological trends in materials and their applications, Medical devices"
  7. Speaker, Medical Device Summit, Feb 2014, Boston, "Medical Device Innovation" Mobile, Portable, Wearable Devices - Technology & Manufacturing
  8. Speaker, Medical Device Summit, Feb 2015, Boston, "Medical Device Innovation"
    An overview of market, technology, manufacturing trends, costs and new projected future for medical devices
  9. Speaker, "Medical Polymer Conference", AMI Boston Sept, 2015 "Medical Device Innovation"
  10. Speaker, Medical Device Summit, Feb 2016, Boston, "Medical Device Innovation and Manufacturing"

Vice President, Medical Robotics, Kinova Robotics

An intensely focused and accomplished leader, engineer and business development professional who leverages a strong foundation in research and product development to envision and shape medical device technology opportunities. Recognized for the ability to master complex and evolving science, engineering and medical applications.

Recent emphasis includes interaction with Key Opinion Leaders, Physicians, Healthcare Partners and device innovators towards the goal of product realization, conception and commercialization. Extensive experience leading traditional and virtual cross-functional teams throughout the entire product lifecycle. Currently, as a member of the Kinova Robotics Executive Management Team, Stuart principally leads the company's strategic roadmaps related to medical technology and affairs, as well as scientific research and innovation, all within the Medical Robotics Division. Additionally, Stuart oversees all quality assurance and regulatory affairs activities company-wide.

Prior to joining Kinova Robotics, Stuart headed up engineering, research and product development programs at CAE Healthcare, helping to focus teams on technological innovations for medical and surgical simulators. Prior to this, Stuart spent just over nine years with Medtronic Inc. (previously CryoCath Technologies Inc.), where he led programs in advanced research, product development and systems engineering, involving both cryoablation balloon catheters and steerable sheath introducer technologies, as well as acted as an advisor for core technology innovations throughout parts of Medtronic. He was one of the principal engineers that lead the Arctic Front and Arctic Front Advance cardiac cryoablation platform to market, both in the USA and several OUS countries, to combat recurrent symptomatic paroxysmal atrial fibrillation. During his tenure with Medtronic, Stuart was the recipient of two awards – the Research and Development Innovation and Total Execution Award (RADIATE), and the Medtronic Star of Excellence Award – both of which recognize leadership and advancement in product development & quality. He is a certified Green and Black Belt in "Design for Six Sigma" practices, and holds two design centric patents in medical device technology. Active in academia, Stuart represents local Medical Device and Biotechnology industry partners in Quebec, Canada as both an Industry Partner Ambassador and as a Guest lecturer to the newly created "Surgical Innovation Program", jointly offered by the Department of Surgery at McGill University, the John Molson School of Business at Concordia University, and the Department of Engineering at Ecole de techonologie supérieure (ETS). Stuart received both a B.Eng. and an M.A.Sc. in Mechanical & Materials Engineering from Concordia University in Montreal, Quebec, Canada.

Stuart's experience and expertise span multiple areas of concentration including electrophysiology, structural heart, cardiovascular, endovascular, pulmonary, gastrointestinal, and minimally invasive surgical devices.

Director, Quality & Regulatory Affairs, BD

Frank Pokrop has worked in the drug and medical device industries for more than 20 years and has obtained these certifications: CSQE, CISA, CPGP and RAC. Frank is a director of quality and regulatory affairs for CareFusion (now BD) where he manages the global auditing of quality management systems at 48 sites; he manages the standards program, performs internal investigations and implements corporate policies. His background includes worldwide submissions, recall management, product launches, vigilance reporting, and manufacturing operations for drugs and devices. He has been a member of MD&DI's Editorial Advisory Board since 2006, he volunteers at UCSD on the "B" IRB, he has volunteered for SDRAN since 2010 and lives in Carlsbad with his wife, two daughters, and a female chocolate lab.

Senior Principal Scientist, Medtronic

Prabhakar Tamirisa is a Senior Principal Scientist in the Battery Research & Technology group at the Medtronic Energy and Component Center (MECC). At Medtronic, he serves as technical lead on early stage Technology projects focused on developing primary and secondary power sources for implanted medical devices. Prabhakar has a Ph.D. in Chemical Engineering from The Georgia Institute of Technology. He has authored peer reviewed publications, invited book chapters, and has multiple patents in various stages of prosecution. He has been an invited speaker at medical device and battery conferences, and has given several presentations at Medtronic's internal conferences. Prabhakar has served as President and Secretary of the Twin Cities section of The Electrochemical Society.

Vice President, R&D, Infection Prevention, BD

Jennifer Raeder-Devens has 20+ years of drug, medical device and combination product development experience, working in 60-person to 60,000 person companies. Since 2008 she has held the title of Vice President, R&D, Infection Prevention at three succeeding companies through spin-offs and acquisitions: Cardinal Health, CareFusion and Becton Dickinson. During her tenure at these companies, she has launched medical devices, combination products and pharmaceutical products chiefly focused in the Infection Prevention market space. Jennifer has successfully built high performing, cross-functional R&D teams through personal leadership and mentoring, and by maintaining strong linkages between the R&D pipeline and evolving needs in infection prevention. She supervises a group of 60+ scientists and engineers developing products ranging from 510(k) line extensions to new Drug Applications. Prior to joining Becton Dickinson, she held positions at Medtronic, 3M and Schneider USA/Boston Scientific. She has a BS from MIT and a MS from Stanford University, both in Chemical Engineering.

Jennifer resides in Saint Paul, MN, and in her spare time likes to cook and garden, and to camp and canoe in the BWCA with her husband and two daughters.

Director, User Experience Design, BD

Gia Rozells is an HCI pioneer who drove the integration of customer-centered thinking into the core values and processes at Intuit. She was the first Director of User Experience at Intuit and grew the UXD community to over 200 research and design experts. Gia authored the first version of Turbotax Online, developed the Innovation Catalyst program, and helped create the Design for Delight method that drives innovation at Intuit. Currently, Gia is the Director of User Experience for Becton Dickinson where she’s implementing a new innovation process and expanding the UXD function.

Senior Human Factors Design Engineer, Medtronic

Drew Seils is a Sr. Human Factors Design Engineer for Medtronic’s Surgical Innovations business (formerly Covidien) in North Haven, CT. Drew has a B.S and M.S. in Biomedical Engineering from the University of Connecticut, with a research focus in Human Biomechanics and Ergonomics. Prior to employment with Medtronic, Drew was a research assistant within the UConn Health Center, Occupational Medicine Biodynamics Laboratory. Drew is currently pursuing a certification in professional ergonomics while at Medtronic.

Senior Director, Quality & Regulatory Affairs, Nihon Kohden

Marcelo Trevino is an Experienced Senior Director with Nihon Kohden America, one of the fastest growing manufacturers of Patient Monitoring equipment in the U.S. with a large global footprint. Marcelo directs the Quality and Regulatory Affairs initiatives at the Corporate Headquarters in Irvine, CA. The product lines include Enterprise Patient Monitoring as well as Neurology and Cardiology equipment. Prior to Nihon Kohden America, Marcelo led Quality Systems and Regulatory Compliance initiatives for several years as a Senior Manager at Medtronic's Heart Valve manufacturing Center of Excellence.

Mr. Trevino has an extensive knowledge of medical device management systems (ISO 13485:2003) and international medical device regulations for the United States (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 and Canadian Medical Devices Conformity Assessment System), Japan (Pharmaceutical Affairs Law), and Europe (93/42/EEC Medical Device Directives). He holds a B.S. degree in Industrial and Systems engineering from ITESM in Mexico and an MBA in Supply Chain Management from the W.P. Carey School of Business at Arizona State University. He is also a certified Quality Management Systems Lead Auditor by Exemplar Global and has consulted with several corporate executives in medical device firms to implement different process and quality improvement projects. Additionally, he is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and holds Certificates in Environmental & Sustainability Management Regulatory Affairs Management from University of California, Irvine.

Marcelo has experience working on Lean Six Sigma Projects and many Quality/Regulatory Compliance initiatives the medical device industry in the US and around the world. He has conducted Third Party Audits and has written several articles to assist corporations in their quest for quality and service excellence.

Senior Director, Software Engineering, Tandem Diabetes Care

Since its inception, Tom has been responsible for all medical device software at Tandem Diabetes Care where he is helping develop the next generation of ambulatory insulin pumps for treating Type 1 and Type 2 Diabetes. Tom has spent the past 31 years developing real time embedded software for life critical mechanical systems for both the Aviation and Medical industries. Additionally, Tom has over 20 years of experience with engineering leadership and management. Tom studied engineering at the University of California, Irvine as a Regents Scholar and graduated Magna Cum Laude with a Bachelors of Science degree. Later he earned a Masters of Science degree in Engineering, also at UC Irvine. Tom was an adjunct member of the computer science faculty at Orange Coast College in Costa Mesa, California for six years. Tom currently serves as adjunct faculty for two colleges in Kenya and in addition to working at Tandem, he is a full time Ph.D. student in Organizational Leadership at Regent University. His goal is to develop material to help engineers make the transition from individual contributor to manager.

Passionate about global causes, Tom has founded two software companies in Nairobi, Kenya as an alternative to unsustainable charity. These companies perform, with excellence, formal software validation and verification activities for companies operating in the aviation and medical industries.

Tom holds eleven US patents with several more pending.

Cofounder, Chemical Angel Network

Dr. Vreeke is a cofounder of the Chemical Angel Network. The Chemical Angel Network provides a source of capital for early stage firms that converge with the chemical sector in the materials, measurement and manufacturing space.

Previously, Dr. Vreeke served as vice president of R&D for Rational Biotechnology, a Rational Systems spin-off. Rational Biotech’s mission was to speed the adoption of personalized medicine through the development of combined IVD and drug therapy products. Rational Biotech identified a novel route to the delivery of personalized therapy without the requirement of massive clinical trials. He also served as the Senior VP of R&D at Pepex Biomedical (St. Louis, MO). Pepex is an early stage medical device company specializing in developing, manufacturing and marketing disposable miniaturized electrochemical biosensors.

Earlier in his career, Dr. Vreeke held research positions at TheraSense. At TheraSense he contributed to the successful transfer of glucose sensor technology from the University of Texas. This was one of the most profitable technology transfer plays for any university outside of the drug space. The company was originally funded through the SBIR program and can be counted as one of the SBIR program’s biggest successes.

He graduated from Calvin College with a BS in chemistry and went on to receive a Ph.D. in analytical chemistry from the University of Texas at Austin. He is currently a member of the editorial advisory board of IVD Technology and is a visiting professor in the chemical engineering department at the Universitat Rovira i Virgili (Tarragona, Spain). He sits on several academic, industry, and corporate boards. Academic honors include a Dow Scholar, Welch Fellow and Woodrow Wilson Fellow.

Head of Upstream Marketing, Zoll

George Walls is the Head of Upstream Marketing for ZOLL San Jose. George's focus is circulation and temperature management products including the world’s only intravascular temperature management system and an innovative and automated ECMO platform. His leadership roles include global strategy, product development, market development, reimbursement, and new product launch. Some of his prior product work includes the MDEA award-winning Merlin.net a pioneering IoT system and the SpeedBlocks Head Immobilizer – systems now available and used for over a million patients to date. George has an extensive background in new product planning, product definition, product development, sales and marketing management.

Prior to joining ZOLL George worked at St. Jude and Laerdal Medical in leadership functions that included Product Innovation, New Product Planning, and Sales. George is a prior MDEA Juror, award winner, and holds five medical device patents. George holds a BS/BA in Management and Finance from the University of Dayton and an Executive MBA from the University of Houston. His passion is lifesaving innovation.

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