MEET THE Event Speakers
Amy Beckley, Ph.D.
Founder and CEO of Proov
Amy Beckley, Ph.D.
Founder and CEO of Proov
Amy Beckley, Ph.D., created Proov after her battle with infertility and recurrent miscarriages (seven total) led her to discover the cause, which was low progesterone after ovulation. She has a Ph.D. in Pharmacology from the University of Colorado and an MBA from Kansas State University. She studied breast cancer progression, stress signaling, and vaccine development, but her passion to change the way infertility is diagnosed and treated was developed after her personal experience. Dr. Beckley created an innovative hormone testing platform that empowers women with information regarding their own fertility so they can advocate for themselves and get better care. Proov is dedicated to empowering women at every stage of life to track their own hormones quickly and easily at home. Dr. Beckley lives in Boulder, CO with her two kids (one born via in vitro fertilization and one natural progesterone miracle), her husband, a boy named Fozzy, a Russian Tortoise named Lazy, and a Chinchilla named Dash.
Elyse Blazevich
President and CEO of Colorado BioScience Association
Elyse Blazevich
President and CEO of Colorado BioScience Association
Elyse Blazevich leads CBSA’s work to create co-opportunity for Colorado’s life sciences community. With the CBSA Board of Directors, team, partners, sponsors, and members, she strategically advances CBSA’s efforts to build a collaborative environment for health innovation. Blazevich brings deep knowledge of life sciences company needs, CBSA as an organization, and Colorado’s business community to offer continuity, connections, and a clear vision for the future of CBSA and the ecosystem it represents. Before joining CBSA, she co-founded Securisyn Medical and led the organization as COO and CFO, transitioning the company from a founder-led startup to a professionally led, commercial-stage medical device company. She remains a member of the Securisyn Medical Board of Directors. Previously, Blazevich led investor relations for the South Metro Denver Chamber of Commerce. She has also served as a board member and leader for Project C.U.R.E. and the Blue Bench in addition to her board leadership role with CBSA. Born and raised in Colorado, Blazevich holds a B.A. in biology from Colorado College and earned her M.S. in organizational leadership from CSU Global. She is also a graduate of the Colorado BioScience Institute’s Executive Leadership program.
Frank Chan
President of Acute Care & Monitoring at Medtronic
Frank Chan
President of Acute Care & Monitoring at Medtronic
Frank Chan is a global healthcare technology business leader with proven experience in developing bold growth strategies, portfolio investments, and operating plans. Originally a biomedical engineer, Chan has successfully driven high organizational engagement and execution across complex matrixed organizations. As president of the Medtronic Acute Care & Monitoring (ACM) operating unit, Chan oversees airway management, breathing systems, temperature management, patient monitoring, and connected care technologies, helping clinicians reduce serious respiratory and perioperative complications across the continuum of care, inside and outside the hospital. As a partner to healthcare providers, he drives the development of innovative solutions that improve patient outcomes, reduce healthcare costs, and expand patient access to care. Chan is known for transforming businesses by aligning organizations to a common vision, creating a culture that enables innovation, and driving execution across global stakeholder groups. He strives to foster an inclusive, diverse, and equitable workplace where each employee can be their true self. He believes that a work culture rooted in trust and empathy translates to stronger relationships with customers and partners, which enables the delivery of better care for patients.
Ben Dunn
Managing Director at Covington Associates
Ben Dunn
Managing Director at Covington Associates
Ben Dunn is a managing director with the healthcare investment banking firm Covington Associates. For over 30 years, he has been providing strategic advisory services to medical technology companies and has orchestrated over 100 transactions on five continents. An early follower of the outsourced medical manufacturing industry, Dunn authored one of the first white papers on the industry in 2007. In addition to his transactional work, he has been an active investor, board member, and strategic advisor to numerous companies in this dynamic industry.
Christopher Gates
Director of Product Security at Velentium
Christopher Gates
Director of Product Security at Velentium
Christopher Gates has over 50 years of experience developing and securing medical devices for numerous industry-leading device manufacturers and frequently collaborates with regulatory and standard bodies including the CISA, HSCC, OWASP, Bluetooth SIG, IEEE, and the SBOM Forum to present, define, and codify tools, techniques, and processes that enable the creation of secure medical devices. Everywhere he goes, Gates promotes the concepts of a secure total product lifecycle, an approach that eases the burden on developers and ensures high-quality products that work as intended to save and improve lives without putting patients at risk. In 2020, he co-authored the first book on medical device security, entitled “Medical Device Cybersecurity for Engineers and Manufacturers,” and is currently finishing the second edition of this bestselling, and award-winning book. Gates graduated from California State University Northridge with a B.S. in Computer Science and worked in various roles as a software/firmware engineer, systems engineer, project manager, and cybersecurity architect. He joined Velentium in 2017 because he had previously collaborated with Velentium as a contractor and had seen firsthand that its values are exemplified by its founders. Gates currently lives in Las Vegas with his wife of 42 years along with their Siberian Husky.
Mark Ginestro
Principal at EY-Parthenon Life Sciences
Mark Ginestro
Principal at EY-Parthenon Life Sciences
Mark Ginestro is a partner in EY-Parthenon Strategy Practice, focusing on healthcare and life sciences. He has over 25 years of experience in growth strategy, portfolio strategy, M&A strategy, M&A diligence, acquisition integration and divestiture carve-out, brand strategy, pricing strategy, performance improvement, and organizational effectiveness. Ginestro has been involved in over 100 M&A transactions in life sciences throughout his career. He has experience in all aspects of life sciences, including medical devices, diagnostics, and healthcare distribution. He's authored many whitepapers and articles on various aspects of life sciences and is a frequent speaker at life sciences conferences.
Tim Gooch
Technical Director, Knowledge at SGS Life Sciences Management Systems and Supply Chain
Tim Gooch
Technical Director, Knowledge at SGS Life Sciences Management Systems and Supply Chain
Tim Gooch has over 40 years of experience in medical devices, including the design and development of surgical implants for the neck and above, active implantable devices, and audiological active devices. He has served the testing, inspection, and certification business since 2012 including as global manager for MDSAP at SGS. His current role as technical director includes quality system certifications for medical devices, cosmetics, and pharmaceuticals.
Christopher Lueken
Principal Technical Lead—Cybersecurity at CSA Group
Christopher Lueken
Principal Technical Lead—Cybersecurity at CSA Group
Christopher Lueken currently serves as the principal technical lead at CSA Group, overseeing cybersecurity evaluation and testing services for industrial, medical, and commercial products. These services verify that our clients’ solutions conform to the stringent technical requirements of applicable government regulations and industry standards. Prior to joining CSA Group, Lueken amassed over 20 years of experience supporting cybersecurity engineering activities on critical infrastructure and classified systems across multiple U.S. government agencies. He also retired from the U.S. Navy Reserve after 20 years of service as a cryptologic warfare officer supporting Cyberspace Operations. Lueken holds a Master of Science in Management Information Systems Security at Colorado Technical University and a Bachelor of Science in Computer Science at Hawaii Pacific University. Additionally, he has earned eight certifications in cybersecurity, project management, and cloud services.
Kimberly Muller, M.Sc., J.D.
General Partner at CU Healthcare Innovation Fund; Executive Director at CU Innovations; and Co-Founder of the UCHealth CARE Innovation Center
Kimberly Muller, M.Sc., J.D.
General Partner at CU Healthcare Innovation Fund; Executive Director at CU Innovations; and Co-Founder of the UCHealth CARE Innovation Center
Kimberly Muller is the executive director of CU Innovations where she leads innovation for the University of Colorado Anschutz Medical Campus. Her business development responsibilities include investing, company creation, innovation management, forming key strategic industry partnerships, and licensing. Large-scale industry collaborations have been established in areas such as AI and drug development. Muller also manages several investment funds, including a $10 million innovation grant fund, a $50 million early-stage venture fund, a $75 million follow-on fund, and partners with UCHealth on a $100 million growth-stage fund. Muller has a graduate degree in Genetics and received her law degree with highest honors from the University of Connecticut School of Law.
Tony Mulone
Head of OEM Strategy at Baxter International
Tony Mulone
Head of OEM Strategy at Baxter International
Tony Mulone, is currently head of OEM Strategy for Baxter International where he is focused on assessing Baxter’s capabilities to service the B2B market. He also serves as chairman of the board for Signati Medical Inc., a vessel sealing start-up focused on innovating the vasectomy market through bipolar energy. Focused on medical device, Mulone was the general manager for the Custom Product Solutions (CPS) division of Covidien, a 12 billion dollar medical device company. He was responsible for directing the strategic growth into non-hospital markets, which included medical and pharma OEM, animal health, dental, and rehabilitation. The CPS division focused its efforts on providing custom solutions centering its attention on promoting Covidien product brands in these emerging markets. Mulone began his medical device career with Instrumentation Laboratories and then joined Kendall/Tyco Healthcare/Covidien/Medtronic, holding increasing management positions in manufacturing, sales/marketing, and senior leadership as a member of the ELT. He holds a bachelor's degree in economics from Framingham State University (Mass.). He also holds a USGC Masters Captains license.
Paul Orlando
Global Operations Business Development Lead at OLYMPUS SURGICAL TECHNOLOGIES AMERICA
Paul Orlando
Global Operations Business Development Lead at OLYMPUS SURGICAL TECHNOLOGIES AMERICA
Paul Orlando is currently the global operations leader in support of M&A strategies for Olympus. During the past 10 years at Olympus, he also served as vice president of procurement, where he oversaw the discovery, assessment, selection, and management of external solution providers including finish devices, components, and design services. Orlando was also the executive director of supply chain. He is a Boston native with more than 40 years of manufacturing, operations, supply chain, and engineering experience. Orlando has held various operations, plant, engineering, business unit, and product development leadership positions with Motorola, Johnson & Johnson, and Vention Medical. He has an Industrial Engineering degree from Northeastern University.
Jeremy Rogers
Director, Global Supply Chain at Tecomet Inc.
Jeremy Rogers
Director, Global Supply Chain at Tecomet Inc.
Jeremy Rogers has more than 20 years of experience in supply chain management in both the medical device and automotive industries. He maintained a heavy focus on contract negotiations, purchasing, production planning, and international logistics. Rogers obtained an MBA in business.
James B. Schultz
Vice President of Customer Solutions at ECA Medical
James B. Schultz
Vice President of Customer Solutions at ECA Medical
Jim Schultz has been the VP of customer solutions at ECA Medical for the past 12 years. He has positioned ECA as the leading designer and manufacturer of single-procedure precision torque-limiting instruments and complete sterile packed, surgery-ready procedural kits for the medical device implant industry including expansion into the ortho and spine market. ECA collaborates with medical implant firms to help them gain clinical and economic value and competitive advantage with surgery-ready instrumentation and procedural kits, which convert cost centers into profit centers. ECA products allow hospitals and outpatient surgery centers to reduce cost per surgery while improving OR efficiency and turnover, curbing SSI risk and providing perfect fixation of every implant. Before joining ECA Medical, Schultz was VP of sales & marketing at PBS Biotech, which develops innovative, lab-to-production, single-use bioreactors for producing large molecule/biomolecular drugs and vaccines. Earlier, he was EVP and GM of Jabil, heading the global power electronics business with operations in the U.S., India, China, and Europe. Over the past 30 years, he’s held a variety of senior executive positions at start-ups to Fortune 500 software, hi-tech, defense, and international trading companies including Whittaker Corporation, MSC Software, Peninsula Int’l Trading, and EOS Corp. He was also with the Dept of Defense and other U.S. agencies where he worked on America’s military space programs, was instrumental in creating Space Command (now Space Force), and helped make Navstar GPS a household name. He is an Air Force veteran and a senior member of IEEE.
Jodi Scott
Partner, Global Regulatory at Hogan Lovells
Jodi Scott
Partner, Global Regulatory at Hogan Lovells
Jodi Scott developed and honed her practical, real-world sensibility and business acumen during the time she spent as an in-house FDA counsel with Medtronic PLC, the world’s largest medical device manufacturer. Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses), developing digital health technology, and securing the necessary state medical device manufacturer and distributor licenses. Scott assists the medical device industry in navigating complex requirements to maintain compliance with the U.S. Food and Drug Administration’s (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.
Dalip Sethi, Ph.D., MBA, MSc
Commercial Leader, Cell Therapy Technologies, North America, at Terumo Blood and Cell Technologies
Dalip Sethi, Ph.D., MBA, MSc
Commercial Leader, Cell Therapy Technologies, North America, at Terumo Blood and Cell Technologies
As an innovative and transformational leader, Dalip Sethi currently serves as the commercial lead for Terumo BCT's Cell Therapy Technologies portfolio in North America. He holds a doctorate and conducted post-doctoral studies at Thomas Jefferson University, School of Medicine. Throughout his career in academia and industry, Sethi has been engaged in developing technologies and methods for use in cell therapy applications. He has authored multiple scientific publications and is a co-inventor on several patents and patent applications. Sethi is passionate about mentoring and workforce development. He is a CBSA board member. In addition, Sethi is also an ISCT member and participates in committees focused on cold chain, particulates, and process analytical technologies.
Matt Stekier
Principal—Supply Chain & Operations Consulting at Plante Moran
Matt Stekier
Principal—Supply Chain & Operations Consulting at Plante Moran
Matt Stekier serves clients throughout the supply chain continuum by quickly identifying improvement opportunities that deliver tangible results and lower costs in a variety of industries, including the medical device, food and beverage, footwear and apparel, military vehicle, and automotive manufacturing sectors. He earned his Bachelor’s in supply chain management from Central Michigan University and a Master’s in business administration from Wayne State University. Stekier also has obtained certifications as a Six Sigma Green Belt and in Theory of Constraints. A 10-year veteran of Plante Moran, he previously served in supply chain roles at Mercedes-Benz Technology and Ford Motor Company.
Nick Traggis
Strategic advisor to the medical device industry
Nick Traggis
Strategic advisor to the medical device industry
Nick Traggis, is a serial entrepreneur focused on manufacturing and technology development companies. He most recently served as the CEO of Lightdeck Diagnostics, where he negotiated the successful sale of the company to Heska (now part of Antech Diagnostics) in 2023. Before that he worked as the general manager of Precision Photonics; ultimately selling to IDEX Corporation, where he remained as the chief technology officer. He also holds several advisory roles, working with private companies and investment groups, focused on M&A, due diligence, and technology licensing and transfer. Traggis is also an Entrepreneur in Residence at Boulder Ventures (Boulder Ventures Ltd.), and the founder of Ambrosia Biosciences—a small molecule drug development company focused on developing orally available GLP1 and other incretin-based therapeutics.
Daniel S. Wittenberg
Partner at Snell & Wilmer
Daniel S. Wittenberg
Partner at Snell & Wilmer
Dan Wittenberg’s practice is concentrated on representing manufacturers and distributors of products across a vast array of industry sectors including: life sciences, medical technologies, pharmaceuticals, consumer products, appliances, fall protection, food, cosmetics, dietary supplements, healthcare products, heavy equipment, oral and personal care products, power generation, and timber. He regularly defends these companies in product liability litigation as well as counsels these businesses on agreements, risk avoidance/management strategies, labeling and marketing materials, instructions for use, as well as recalls and regulatory matters, including those involving the FDA and CPSC. Wittenberg has served as national counsel for major medical device manufacturing concerns and regional as well as local counsel in mass tort cases. He has attained certification as a Global Regulatory Affairs Compliance Professional (GRACP). Wittenberg also works with entities in technology transfer and intellectual property matters including university technology commercialization, litigation, licensing, and agreement negotiations. He also represents individuals and companies in commercial litigation.
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