Gold Sponsors

B Braun

Donatelle

Spectrum Plastics Group

Steri-Tek


Supporting Organizations

Colorado Advanced Manufacturing Association

Colorado BioScience Association

MDMA

Octane


Media Sponsors

Medtech Directory

Medtech Intelligence

Silver Sponsors

ARC Group Worldwide

Arthur G. Russell

Beaumont

Bentec Medical

Bihlermed

Biomedical Innovations

Cadence

Cyient

EG-GILERO

Eldon James

Forefront Medical Technology

IQMS

Isometric Micro Molding

Judson Smith

Laser Light Technologies

Medbio

MICRO

Micro Mold

MW Industries Medical Solutions

Parmatech

Plastikos

Qosina

Seisa

SigmaTron

Stradis Healthcare

STI

Tegra Medical

Teleflex Medical OEM

Trademark Plastics

Wytech


Bronze Sponsors

Eurofins

maxon motor

CNZFE

PMCF

QPC

Elyse Blazevich

Elyse Blazevich, COO & CFO, Securisyn Medical LLC
Elyse Blazevich co-founded Securisyn Medical 7 years ago at the age of 28 and has successfully led the company from concept to market ready. Under her leadership, Securisyn has advanced its mission to inspire the world to collaborate to make airway management safer. Later this year, the firm plans to obtain regulatory clearance to market SolidAIRity, the only integrated airway stabilization system designed and patented to significantly reduce, if not eliminate, preventable harm and deaths caused by unplanned extubation. As the company’s chief operating officer and chief financial officer, Blazevich is responsible for oversight of all business functions in the areas of supply chain, regulatory and quality compliance, financial management, human resources, marketing, and general operations. A Colorado native, Blazevich earned her Bachelor of Arts from Colorado College and her Master’s in Organizational Leadership with a specialization in Applied Business Management from CSU Global.

Natasha Bond

Natasha Bond, COO, Sana Health; Founder, Ikigai Medical Development
Natasha Bond is a proven leader in medical device program delivery with 20 years of experience integrating technical and commercial teams for success. She maintains a specific focus on moving small, often venture-funded medical device companies to commercialization efficiently and effectively. Currently, Bond is COO at Sana Health, a disruptive pain management device company, and also founder of Ikigai Medical Development, a firm assisting entrepreneurs with medical device development. Bond’s professional expertise is in medical device development from concept through to commercialization, regulatory submission support, regulatory compliance and quality system implementation, personnel management/teambuilding/client management, change management, project and program management, and due diligence and post-acquisition integration. She is also a chartered engineer in the UK and a Project Management Professional (PMP).

Rodney Brown

Rodney A. Brown, Senior Injection Molding Steward, Eli Lilly & Company
Rodney A. Brown provides expertise in plastic injection molding, mentoring numerous individuals and development of engineering best practices. Before joining Eli Lilly, he worked as a project manager for automotive components at Guide Corporation. He joined Lilly as a consultant engineer in 2006, bringing over 20 years of injection molding experience with him. Brown has been a key technical contributor to numerous delivery system projects critical to Lilly’s future. The outcome of some of the projects has brought significant return to Lilly’s injection-device-enabled business. He is also a recognized expert in plastic injection design and has worked with Lilly partners to ensure robust long-term supply of device components. Brown’s work not only improved existing products, but helped shape the next generation of Lilly devices.

Tom Burns

Thomas Burns, President & CEO, Resonetics
Tom Burns joined Resonetics in 2012 as president and CEO. In this six-year span, Resonetics has transformed from a single site, niche provider of polymer laser processing to a leading supplier working with a broad range of materials with seven manufacturing sites in three countries. Revenues have grown more than five-fold over that period with three acquisitions and strong organic growth. Prior to joining Resonetics, Burns was VP of business development at Tegra Medical, a diversified contract manufacturer providing precision metal machining services. Before Tegra, he was VP of sales and marketing at Web Industries, a contract converter serving the in vitro diagnostics, aerospace, and consumer products industries. Burns spent nine years in sales and marketing leadership roles at Accellent and two of the companies it acquired. For the first 11 years of his career, he worked in various sales and marketing roles at Genzyme, Edwards Lifesciences, and Johnson & Johnson. Burns graduated with honors from Northeastern University with a B.S. in Business Administration.

Irena Cantrall

Irena Cantrall, Principal, Red Line Consulting
Irena Cantrall was most recently director of innovation at Medtronic, where she enjoyed a 10-year tenure with positions of increasing responsibilities in marketing and business development. At Medtronic, she was responsible for identifying and commercializing new growth engines for the $5B Surgical Innovations business. Earlier in her career, Cantrall gained extensive experience in marketing, business development, and venture capital with GlaxoSmithKline, KensaGroup, and GNS Healthcare where she raised $7M in funding through government grants. She is presently with Red Line Consulting, guiding clients through market assessments, go-to-market strategy, and revenue forecasts. Cantrall holds a combined Bachelor’s and Master’s degree in Biotechnology Engineering from University of Chemical Technology of Russia; a Master’s degree in Chemical Engineering from Tufts University; and an MBA from Cornell University.

John Carlson

John Carlson, President—Health Solutions, Flex
John Carlson is the president of the Health Solutions group at Flex Ltd., where he has led the transition of the medical business from a primarily manufacturing focus to a Sketch-to-Scale solutions focus that extends from human-factors-based user needs definition through innovation and design, to ramp up, full scale production, and supply chain management. The Health Solutions group is able to leverage technology, expertise, and scale across Flex industries to offer unique and better solutions to its customers. Prior to Flex, Carlson spent 15 years in leadership roles at Johnson & Johnson in research and development, most recently as VP of the Innovation portfolio, where he led research and development activities across the pharmaceutical, medical device, and consumer health segments of the company and identified new growth areas. He also served as worldwide VP of R&D for the Ethicon Endo Surgery group, and for the Diabetes Care franchise. Carlson also held previous research and development positions with medical device startup companies in the San Jose, Calif., area. 

David A. Durfee

David A. Durfee, Ph.D., CEO & Chief Scientist, Bay Computer Associates
David A. Durfee, Ph.D., is the CEO and chief scientist at Bay Computer Associates (BCA), a company he’s been with since 1989. BCA specializes in the contract design of electronics and software. Products developed at BCA have been for customers ranging from Fortune 500 firms to startups. In addition, Dr. Durfee is an adjunct professor at Brown University School of Engineering and also works with the school’s brain science research group. He is on the advisory board of the Slater Technology Fund and the University of Rhode Island biomedical engineering department. He is a past adjunct professor for the Computer Science Department of the University of Rhode Island. Dr. Durfee earned a degree in electrical engineering from Brown University in 1980. He then went on to work as a systems design engineer for several companies, before completing his graduate studies at Brown University in 1992, when he received a Master’s degree in computer science and a Ph.D. for studies in EE/CS.

Anthony S. Freeman

Anthony S. Freeman, President, A.S. Freeman Advisors LLC
Tony Freeman leads A. S. Freeman Advisors, a transaction advisory firm focused on the precision manufacturing and specialty materials industries. With a focus on supply chain companies, Freeman Advisors offers buy-side and sell-side services as well as strategic consulting on market selection and value enhancement. Clients range from Fortune 500 firms to small, privately held companies in the life sciences, aerospace, electronics, and specialty chemical industries. Freeman also serves as executive director of mdmX, an industry organization for medical supply chain executives. He is a regular contributor to MPO and other industry publications. He holds a BA from the University of Chicago and an MBA from Columbia University.

Christian L. Haller

Christian L. Haller, Chief Executive Officer, The RavenOye Group
Christian Haller is the founder of The RavenOye Group, a strategic advisory practice dedicated to accelerating transformative technologies into the marketplace. In the past 30 years, he has assisted more than 300 startup companies with successful commercialization, funding, market entry, and acquisition in the areas of medical devices, diagnostic devices, pharmaceuticals, and clean energy. In addition to his advisory services, Haller is also an angel investor in early stage companies, where he’s held postions including chairman, director, CEO, CTO, COO, chief engineer, VP of business development, and VP of engineering. In addition, Haller is the founder of AdvaMed’s Entrepreneur’s Boot Camp.

Dawn Lissy

Dawn A. Lissy, President & Founder, Empirical
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.

Greg Lusardi

Greg Lusardi, Worldwide Molding Leader, Becton Dickinson
Greg Lusardi has spent nearly thirty years in various roles in the injection molding industry, of which, more than the past twenty has been at BD. He currently holds the position of worldwide molding leader responsible for best practice implementation and operational excellence in over 50 manufacturing sites globally. Throughout his career, Lusardi has held roles that include a focus in processing, tooling, hot runner technology, R&D, validation, new product development, and vendor and operations management. He has worked in various industries, including medical device, consumer goods, electronics, industrial, and automotive. Lusardi has completed the RJG Master Molder I and II certification courses.

Laura McGuire

Laura McGuire, Chief Operating Officer, VineaGroup
Laura McGuire is co-founder of VineaGroup. She is a successful entrepreneur, having established four other B2B marketing service and technology companies. McGuire is an innovator and a nationally-recognized sales lead management expert with many industry and client citations to her credit. She is a lifelong resident of Colorado and has proudly served on the boards of state and local civic, non-profit and faith-based organizations. She is a five-time technology entrepreneur and nationally recognized expert in B2B prospect engagement, customer acquisition, and sales lead management. Her companies have pioneered innovative ways to identify, capture, communicate, and evolve relationships with any constituent group whether they are prospects, customers, members, donors, patients, suppliers, voters, or citizens.

Palani Palaniappan

Palani Palaniappan, Ph.D., Exec. VP—Innovation & Development, Terumo BCT
Palani Palaniappan, Ph.D., is currently the executive vice president of Global Innovation and Development at Terumo BCT ($900M). In this role, he oversees a global team of more than 700 associates. He has team members based in the U.S., Europe, Japan, and India, working in the areas of research and development; manufacturing technologies/process engineering; clinical; scientific; quality; regulatory affairs; and program management office. Since joining the company in May 2013, Palaniappan and his team have introduced several new Terumo BCT products and several new protocols for existing platforms. These developments have been approved for clinical use globally. Prior to joining Terumo BCT, Palaniappan was a vice president at Life Technologies—a legacy Thermo Fisher corporate. There he led the R&D unit focused on cellular analysis for eight years. During his tenure, the team introduced several innovative products in the field of microscopy, flow cytometry, and clinical pathology, and generated over 50 patents. While in this role, he also served as a board member for two nonprofit biotechnology organizations, creating new economic opportunities for the state of Oregon. Palaniappan completed his Ph.D. in Biological Sciences at Northern Illinois University, in DeKalb, IL, in 1993, followed by a post-doctoral program at the University of Rochester, Rochester, NY in the field of HIV biology from 1993-1998.

Maureen Reitman

Maureen Reitman, ScD, PE, Principal Engineer, Director of Polymer Science and Materials Chemistry, and Corporate Vice President, Exponent
Maureen Reitman, ScD, PE is a principal engineer, director of Polymer Science and Materials Chemistry, and a corporate vice president at Exponent, a scientific and engineering consulting firm. She works across the supply chain to help business leaders and technical teams bring new products to market, support continuous improvement, address risk, understand service life, and facilitate innovation in many industries, including the medical device sector. Dr. Reitman earned her SB and ScD at MIT. She then worked at 3M in technology and product development roles before joining Exponent in 2002. She is a Fellow of the Society of Plastics Engineers, and has served in leadership positions in SPE’s Medical Plastics Division, Failure Analysis and Prevention SIG, and the New Technology Forum Committee.

Paul Robinson

Paul Robinson, Vice President of Operations, Quality Systems Consulting Services
Paul Robinson is an accomplished quality executive with over 25 years of domestic and international experience. His career has been built on a solid foundation in quality, engineering, and manufacturing through progressive positions focused on quality systems, design assurance, and operational excellence with companies such as Covidien, Boston Scientific, and BARD. Robinson is a recognized QA/RA leader, having maintained over 20 manufacturing plants worldwide that produced various products including plastics, electronics, pharmaceuticals, biologics, and woven/non-woven materials. As an operational excellence head, he conceived and launched an organization-wide effort that realized over $260 million in three years. Currently, Robinson is the vice president of operations for Quality Systems Consulting Services (QSCS). QSCS offers the unique value proposition of delivering regulatory compliance essentially free by integrating operational excellence principles.

David Robson

David C. Robson, Principal, Robson Advisors
David C. Robson, a principal at Robson Advisors, has spent 30 years concentrating on the development of medical devices. Seventeen of those years were spent working for a full-service product development firm where he interacted with both large and small medical device companies and reviewed statements of work and requests for quotation, wrote proposals, and negotiated hundreds of work agreements. Robson and his partners now offer product development guidance and advocacy to early-stage medical device clients.

Jake Rost

Jake Rost, Principal, See Level Consulting
Jake Rost, principal with See Level Consulting, has spent over 25 years in leadership positions advancing sophisticated capital equipment for the medical, biotech, and commercial industries. During this time, he has been a part of 100s of proposals and contracts in addition to being involved in two sell-side and eight buy-side M&A transactions. Rost now provides start, scale, and exit strategies for manufacturing and design executives, physician entrepreneurs, and inventors.

Christopher Scott

Christopher Scott, Vice President, Eurofins Medical Device Testing
Christopher Scott has spent nearly 30 years in the medical device industry working for prominent global organizations, as well as running several start-ups. He has worked across a range of sectors including cardiovascular, orthopedics, general surgery, dental, and robotics. Currently, Scott is vice president for Eurofins Medical Device Testing, an organization with 16 laboratories around the world providing a broad portfolio of testing services focused on the needs of medical device companies.

Scott Scully

Scott Scully, Corporate Director, Terumo Cardiovascular Systems
Scott Scully is a plastics veteran of 39 years, working the last 17 years at Terumo Cardiovascular Systems. He has Master Molder II, Six Sigma Green Belt, and World Class Manufacturing and Project Management certifications. He was an apprentice, journeyman, mold designer, business owner, medical molding engineering chief, business unit manager, and now a corporate director with Terumo. Scully has a solid foundation in project management, tooling, processing, Six Sigma, and Lean Manufacturing through progressive positions, proper training, and being a constant seeker of new information. He focuses on using new technologies to improve quality, throughput, and cost. Scully is involved with project management at a dozen sites at any given time both domestically and internationally. Conceived and launched project initiatives that have saved the company over $2.5 million per annum. He created a validation/troubleshooting team to assist suppliers in educating and developing validation procedures that are compliant and cost-effective.

Maria Shepherd

Maria Shepherd, President and CEO, Medi-Vantage
Maria Shepherd has more than 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. After her industry career, including her role as VP of marketing for Oridion Medical where she boosted the company valuation prior to its acquisition by Covidien/Medtronic, director of marketing for Philips Medical, and senior management roles at Boston Scientific Corp., she founded Medi-Vantage. Medi-Vantage provides marketing and business strategy as well as innovation research for the medical device industry. The firm quantitatively and qualitatively sizes and segments opportunities, evaluates new technologies, provides marketing services, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses and is a member of the Aligo Medtech Investment Committee.

James Shore

James Shore, Chief Quality Officer, Quality Lean Solutions
James “Gunny” Shore is the chief quality officer of Quality Lean Solutions, which provides medical device companies with support in compliance, quality systems, operational and Lean principles. He has 25 years of quality and supplier management experience working in medical devices, semiconductor, aerospace, and defense (Boston Scientific, Aspect Medical, ACMI (Olympus), Brooks Automation, and Raytheon). His professional certifications include ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Manager/Operations Excellence, Certified Quality Auditor and Certified Mechanical Inspector, and ASQ Senior Member. Shore is the co-author of the book entitled “Proactive Supplier Quality Management in the Medical Device Industry,” which is published by Quality Press. All of the royalties from the book are donated to Veteran service organizations. Shore served in the United States Marine Corps for 15 years and was Honorably Discharged at the rank of Gunnery Sergeant (E-7).

Matt Therrien

Matt Therrien, Business Development Manager—Medical, RJG Inc.
Matt Therrien is the business development manager—medical, for RJG Inc. with 28 years of experience focusing on promoting customer success. Strategies include a strong consultative approach, with an emphasis on driving results and developing innovative solutions to a broad range of customer concerns, as well as client education. He has completed the RJG Master Molder I Certificate Program. Therrien is a BSME graduate of the University of Massachusetts, Amherst, and his experience is drawn from technical and commercial management positions at the global companies of Nypro, Husky Injection Molding Systems, MoldMasters Inc., and UPG/MedPlast. He has implemented successful business models across all market segments, with the last 15 years focused on medical device/assembly manufacturing.

Kim Trautman

Kim Trautman, Executive Vice President—Medical Device International Services, NSF International
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program, which includes NSF Health Sciences Certification, NSF International’s authorized Medical Device Single Audit Program (MDSAP) Auditing Organization, as well as NSF Certification Ireland, which is currently applying for designation as a notified body under the new EU Medical Device and In Vitro Diagnostic Regulations. Trautman was previously associate director for international affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. Her experience includes leading the conception and development of MDSAP, writing the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and leading the implementation, rollout and training associated with the QS regulation. She also led continuing harmonization efforts for ISO 13485 since its inception in 1994, where she is an international delegate to ISO/TC 210, author of ISO 13485, and the U.S. Technical Advisory Group co-chair for ISO/TC 210.

Ed Valley

Ed Valley, Director of Engineering & Program Management, Nypro Healthcare
Ed Valley is a senior plastics professional with more than 20 years of experience in several areas including operations, engineering, and program management. He is a proven technical leader of tooling, process, and project engineering teams within the healthcare, consumer, and automotive industries. Valley is skilled in scientific injection molding, design for manufacturing, tool design, project management, new product introduction, LSS principles, and validation of automation and plastic injection molds. He has obtained certifications in Program Management, Design of Experiments, Master Molder I, and Master Molder II.

Ben Walker

Ben Walker, Executive Director—Life Sciences, Innosphere
Ben Walker is the executive director of the Life Sciences program at the Innosphere. The Innosphere is an incubator with offices in Fort Collins, Boulder, and Denver, and focuses on serving both startup and scaleup companies. Walker has been involved with several startup companies and spent 28 years with Hewlett-Packard as a director level marketing manager with multiple product lines and worked for HP Corporate in the Mergers and Acquisitions office. He has a passion for commercialization and downhill skiing.

Ken Ward

Kenneth L. Ward, President and Founder, TeraSTRAT Consulting
Kenneth L. Ward has 40 years of experience in operations and supply chain leadership within the manufacturing industry. As director of supply chain and machine shop operations at Varian Medical Systems, he achieved inventory accuracy of 99 percent, supplier OTD of 98 percent, supplier quality of 99.98 percent, while improving customer OTD by 47 percent. Later, he founded TeraSTRAT, a firm dedicated to creating and executing strategies to significantly improve manufacturing operations and the total supply chain. Ward holds an Executive MBA from the University of Utah, is APICS certified in production and inventory control at the “fellow” level, is certified in “Integrated Resource Management,” and serves as an advisor to the Salt Lake Chapter of APICS. He also holds a certification as a lean/six-sigma green belt through Lockheed-Martin.

Craig Weinberg

Craig Weinberg, Ph.D., President & CEO, BDC Laboratories
Under Craig Weinberg’s direct leadership, BDC Laboratories transitioned from a small consulting and testing service laboratory to a premier, international cardiovascular device support organization with multiple divisions, including consulting, accredited testing services, test equipment and silicone mock vessels, and anatomical solutions. As an active member in the ISO and ASTM committees developing the standards and guidance documents for assessment of vascular and endovascular prostheses, cardiac valves, valve repair technologies, and cardiac occluders, Weinberg has (and continues to help) set industry standards for device evaluation alongside regulatory authorities and other experts in the endovascular and cardiac fields. Weinberg is an inventor on a number of patents including accelerated durability test systems and RF energy surgical tools. Weinberg earned his doctorate degree in mechanical engineering with a focus in cardiovascular fluid dynamics from the University of Colorado at Boulder.