Conference Speakers

Evan Anderson received his BS in Biomedical Engineering with a concentration in Material Science and a minor in Psychology from Johns Hopkins University in 1998. While pursuing his MS degree in Biomedical Engineering at Case Western Reserve University, Evan performed research on the mechanics of heart valves at the Cleveland Clinic Foundation.   As an R&D engineer at Guidant Corporation (later becoming Boston Scientific) beginning in 2001, Evan worked on development of a next generation implant for Abdominal Aortic Aneurysms with catheter based delivery, development of a first generation proximal anastomosis clip for off-pump cardiac bypass surgery, next generation assist devices for off-pump epicardial ablation, and new epicardial ablation lesions for Atrial Fibrillation. Evan took a leave of absence in 2004 to do research in medical device innovation at the Stanford Biodesign Program and to work as a Biomedical Engineer at the FDA in the Medical Device Fellowship Program.  From September of 2005 until July of 2008 Evan led development at Boston Scientific (which later became Maquet Cardiovascular) of a minimally invasive valve product through chronic animal studies and up to design freeze for first in man.  After two years leading the development of the SNaPT device as R&D Manager at Spiracur, Evan has transitioned over to become the wound care startup''s 5th sales representative.

 

In his role as Co-Founder and Chief Innovation Officer for Ximedica, Aidan drives innovation in their core markets of healthcare delivery solutions, medical device development, and consumer healthcare.

With a passion for applying a human-centered approach to system and device development, Aidan has committed himself to advising and leading expert teams of researchers, human factors engineers and designers in collaboration with a global client base to co-create, implement, and measure solutions that form the leading edge of the industry.

Aidan has multiple published articles on Design Leadership and Industrial Design in the medical industry. He has spoken on development process, human factors and the implications of changing demographics on the medical industry.

He is an adjunct faculty member to the Industrial Design program at Rhode Island School of Design, teaching Design Leadership, and sits on the Foundation Board of the Massachusetts College of Art and Design.

 

Biography coming soon.

 

Dr. Cosgriff-Hernández received her B.S. in Biomedical Engineering and Ph.D. in Macromolecular Science and Engineering from Case Western Reserve University in Cleveland, Ohio. Her graduate research, under the guidance of Professors Anne Hiltner and James Anderson, elucidated key cell-material interactions and biodegradation mechanisms of biomedical polyurethane elastomers. She was awarded the UT-TORCH Postdoctoral Fellowship and conducted orthopaedic tissue engineering research with Professor Tony Mikos at Rice University. She joined the faculty of the Biomedical Engineering Department at Texas A&M in 2007. Her laboratory specializes in the development of hybrid material systems that combine the advantages of synthetic and natural polymers (e.g. collagen) to advance tissue engineering design. Biomaterial synthesis is complemented by the development of new fabrication strategies that improve our ability to manipulate 3D scaffold architecture. In addition to providing improved scaffolds for tissue repair, these innovative biomaterials and fabrication strategies provide new tools to probe the complex process of tissue remodeling in order to enhance the rational design of biomaterial scaffolds and guide tissue regeneration strategies. The primary applications currently under investigation include high porosity bone grafts, tissue engineered ligaments, and bioactive vascular grafts.

 

Mir Imran founded InCube Labs to focus on his passion: creating medical solutions that change the standard of care in critical healthcare markets. After attending medical school, Mir began his career as a healthcare entrepreneur in the late 1970's and has founded numerous game-changing companies since those early days. Over the decades, he has become one of the leading inventors and entrepreneurs in the field. Mir now holds more than 200 issued patents and is perhaps most well known for his pioneering contributions to the first FDA-approved Automatic Implantable Cardioverter Defibrillator. As an entrepreneur, Mir has founded more than 20 life sciences companies; 15 of his companies have seen "liquidity events" (IPO/Acquisition). Mir's expertise spans a wide range of clinical areas from interventional cardiology to chronic pain, obesity and CNS disorders. Mir actively collaborates with the nation''s top universities on research and development including Stanford, Rutgers, Johns Hopkins, UTSW, among others. Mir also founded InCube Ventures, a life sciences venture fund, where he has led investments in a range of promising ventures. Mir sits on Boards of several life sciences companies. He holds an M.S. in bioengineering and a B.S. in electrical engineering from Rutgers. He also attended CMDNJ/Rutgers Medical School.

 

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.

 

Mr. Dinger has over 25 years experience ranging from product engineering to corporate management, including executive positions in research & development and company operations. His expertise has been applied to both large and small companies that were in need of significant change or complete turnaround. He is currently the President and Chief Executive Officer for ENTrigue Surgical, Inc. Prior to ENTrigue, Mr. Dinger served as President and Chief Executive Officer of C2M Medical, Inc.; President and Chief Executive Officer of OsteoBiologics, Inc.; Vice President and Chief Operating Officer of A-Med Systems, Inc.; Vice President, Research & Development for Xomed Surgical Products, Inc.; Vice President, Research & Development for Linvatec Corporation; and Supervising Engineer in the Space and Strategic Avionics Division of Honeywell, Inc. Mr. Dinger earned a Bachelor of Science in Mechanical Engineering from Cornell University and a Master of Science in Engineering Management from University of South Florida. He holds numerous device and method patents as inventor and serves on the board of directors for several privately held medical device companies and a faith based charity.

 

Dr. Stone is Chief Scientific Officer and a Director of Remeditex Ventures. He joined Remeditex from UT Southwestern Medical Center (UTSW) where he was Professor of Internal Medicine, Physiology, and Biochemistry. He served as the Vice President of Technology Development since 1998. In that role, he directed licensing operations as well as the biotechnology development initiative taking place at UTSW and was the liaison with pharmaceutical and biotechnology companies interested in partnership with UTSW scientists. During his tenure, Dr. Stone and his team created over $120M in revenue and launched six start-up biotechnology companies that collectively have raised over $500 million in financing. Dr. Stone has participated on the board of directors of Eliance Biotechnology, Inc., Myogen, Inc., miRagen Therapeutics, Inc., MacroGenics, Inc., and Reata Pharmaceuticals, Inc. In addition, he served as the chairman of the U.T. Regents' Technology Transfer Commission and was vice chairman of the board of the Texas Emerging Technology Fund's Life Science Commercialization Center. Dr. Stone received his undergraduate training in the Plan II Program at The University of Texas at Austin and his medical degree from UTSW.

 

Dr. Anderson is a California-based management consultant who specializes in seminars, workshops, and consulting on Design for Manufacturability, Concurrent Engineering, and Lean Production, Mass Customization, and Build-to-Order.

He wrote the definitive book on DFM: "Design for Manufacturability & Concurrent Engineering; How to Design for Low Cost, Design in High Quality, Design for Lean Manufacture, and Design Quickly for Fast Production," (2010, CIM Press, 456 pages). He also wrote the opening chapter in the SME handbook on DFM (TMEH, Vol 6), and the chapter on DFM and Mass Customization in the Quality Function Deployment Handbook (Wiley, 1998). His DFM book is now in its fourteenth printing and is in use in more than 450 companies. Hewlett-Packard, United Technologies, and Loral each ordered more than 100 copies.

Dr. Anderson has authored web-site on Half Cost Products, www.HalfCostProducts.com. He also wrote the 2008 book "Build-to-Order & Mass Customization; The Ultimate Supply Chain Management and Lean Manufacturing Strategy for Low-Cost On-Demand Production without Forecast or Inventory." In 1997 he wrote the book, "Agile Product Development for Mass Customization, Niche Markets, JIT, Build-to-Order, and Flexible Manufacturing" (McGraw-Hill, 1997). He was the guest editor for the Mass Customization issue of the Agility Forum’s journal in 1998.

At the Haas Graduate School of Business at the University of California at Berkeley, he created and twice taught the course "New Product Development, the Management and Design of Manufacturable Products" as part of the Management of Technology Program. He has taught "Spontaneous Build-to-Order" twice for AME before plant tours of Hoffman Engineering, who build a $30,000,000 plant to build on-demand a wide variety of standard and mass-customized sheetmetal enclosures to order.

Dr. Anderson has over 35 years of industrial experience and has presented dozens of public classes on Design for Manufacturability & Concurrent Engineering and hundreds of in-house DFM seminars at many leading companies including several divisions of Hewlett-Packard, Emerson Electric, Boeing, GE, NCR, FMC, BAE Systems, Smiths Aerospace (now GE Aircraft), John Deere, United Technologies, Loral, Freightliner, Korea’s LG Group, and many others. When he was Manager of Flexible Manufacturing at Intel’s Systems Group, he initiated successful programs for Design For Manufacturability (DFM) and standardization of parts and tooling for electronics. He has presented dozens of speeches at DFM conferences on product development and mass customization topics and at internal corporate conferences and summits at Hewlett-Packard, EDS consulting (now A.T. Kearney), Emerson Electric, and Schlumberger. He has been a panelist at forums at Caterpillar and Johnson Controls.

From 1977 to 1983, his company, Anderson Automation, Inc., generated design studies and built special production equipment and tooling for companies such as IBM, Clorox, and Optical Coating Labs. He also did concept studies for SRI International and two divisions of FMC. As the ultimate concurrent engineering experience, he personally built the equipment he designed and is proficient at machining and welding.

Dr. Anderson is a Fellow of ASME (American Society of Mechanical Engineers) and has been certified as a Certified Management Consultant (CMC) by the Institute of Management Consultants. He holds professional registrations in Mechanical, Industrial, and Manufacturing Engineering and a Doctorate in Mechanical Engineering from UC, Berkeley.

 

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.

 

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.

 

Cindy has over fifteen years of experience in medical device regulatory affairs, with a focus on drug delivery systems – large volume infusion pumps for intravenous and parenteral routes of administration, diabetes management technologies including insulin delivery devices, glucose monitoring technologies, and stand-alone software products for blood glucose control. She supports manufacturers of these systems in assurance case preparation, non-clinical test design and the development of usability assessment programs that meet current FDA expectations. She has authored 510(k) premarket notifications for a range of complex medical device products and systems including drug delivery systems, stand-alone software products, software-controlled instrumentation, implantable devices, infection control products and tissue engineered products. Cindy is a member of the Regulatory Affairs Professionals Society, the Association for the Advancement of Medical Instrumentation, and the North Carolina Regulatory Affairs Forum. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University. She is Regulatory Affairs Certified.

 

Walt Murray has worked in many capacities including management positions, in QE consulting and within private industry. He is a certified lead auditor in the QMS standards and has developed, trained and audited companies in the aerospace, automotive, pharma and medical device sectors as well as traditional manufacturing. Most recently, his tenure was as a Senior Quality Analyst and Director of Quality for two nutritional supplement companies in the state of Utah. Walt has performed in operations management using lean manufacturing implementation. Walt is versed in several regulations including 21 CFR (110, 111, 210, 820, 40 CFR, 29 CFR, CAA, CWA and the harmonized guidance for these FDA and EPA equivalents. He has authored training courseware for the ISO 14971 as well as other key elements of the quality standards (CAPA, Auditing, SPC/SQC, Risk Analysis, and others). He is certified and has assisted countless companies in process improvement using critical thinking skills and rational process and project management. At MasterControl, Walt enjoys the dynamic flexibility of the company and getting to know the employees he works with. Walt also enjoys working with MasterControl customers. "Seeing our clients grasp and deploy the vision at MasterControl is a very gratifying experience."

 

Kevin Marcus is a quality systems professional with more than 25 years’ experience in the medical device and pharmaceutical industries. His experience includes the understanding, development and maintenance of quality systems to ensure regulatory compliance, including FDA cGMP/QSR; ISO-13485:2003; European Medical Device Directives (MDD); and the Canadian CMDR. His professional experience includes serving as director of quality at Edwards Lifesciences, VP of quality at Research Medical, Inc.; product compliant manager at Pfizer Hospital Products Group; and quality assurance positions with Dow Corning Opthalmics and Alcon Optics. Marcus has extensive auditing background with an emphasis on developing and administering quality systems compliant to ISO-9000, ISO-13485, MDD, CMDR and FDA device and drug regulations, and cGMP/QSR, as evidenced by internal and external audit results. His bachelor’s degree is from California State University at Long Beach and he is a senior member of ASQ and a past board member of the Intermountain Biomedical Association.