MEET THE Event Speakers
Monica Burt
Founder of MB&A
Monica Burt
Founder of MB&A
Monica Burt is the founder of MB&A and a pioneer in Audit Intelligence, a new category of AI-driven quality assurance that transforms compliance data into predictive business insight. With over 20 years of experience in the medical device sector, she has become a trusted partner to private equity firms, investors, and innovators, guiding them through the complex landscape of global regulatory strategy and operational excellence. Recognizing that traditional, manual auditing could no longer keep pace with the industry's rapid growth, Burt shifted her focus from simply managing quality systems to modernizing them. She now leads the development of AuditNova, the industry’s first Audit Intelligence platform designed to help manufacturers and suppliers move from reactive "snapshot" audits to continuous, data-driven risk monitoring. Prior to this, Burt built MB&A into a premier boutique consulting and recruiting firm, helping medtech companies worldwide navigate product commercialization, due diligence, and talent acquisition. Her work bridges the gap between quality and operations, helping leaders view compliance not as a cost center, but as a strategic asset for supply chain continuity and growth. To explore her work in Audit Intelligence and consulting, visit burtandassociates.com.
Patrick G. Fisher
President, Global Biologics and Limb Reconstruction at Orthofix
Patrick G. Fisher
President, Global Biologics and Limb Reconstruction at Orthofix
Patrick G. Fisher is a senior healthcare executive with 26 years of experience transforming and scaling global medical device businesses. He has a proven track record of driving profitable revenue growth, expanding EBITDA and operating income, leading complex M&A integrations, and building high-performing commercial and operational teams within publicly traded organizations. Fisher currently serves as president, Global Biologics and Limb Reconstruction at Orthofix, where he holds full P&L responsibility for the Biologics and Limb Reconstruction business units. He has successfully launched a new Limb Reconstruction category, exceeded revenue and EBITDA targets, and delivered double-digit U.S. growth. In January 2026, he assumed leadership of the $145M Global Biologics business. Previously, Fisher was vice president and general manager of Foot and Ankle at Stryker, managing a $972 million business within the Trauma and Extremities Division. He led the integration of Wright Medical following Stryker’s $5.4B acquisition—one of only four executives retained post-acquisition—and helped deliver sustained growth and margin expansion while transforming the commercial model from distributor-based to fully direct. Prior to Stryker, Fisher spent 18 years at Wright Medical Technology, ultimately serving as president of Lower Extremity and Biologics, where he improved EBITDA leverage, accelerated innovation-driven growth, and played a key role in increasing the company market capitalization by more than $4B. Fisher is known for his integrity-driven leadership style, candid team and board engagement, and commitment to talent development. He holds an MBA from the University of Memphis and a BA in International Studies from Rhodes College.
Anthony S. Freeman
President of A.S. Freeman Advisors LLC
Anthony S. Freeman
President of 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.
Chuck Hansford
Industry Consultant
Chuck Hansford
Industry Consultant
Chuck Hansford is a senior-level executive with over 40 years of R&D and manufacturing experience in both the medical and aerospace industries. He has spent the last 30 years growing the additive manufacturing business in both plastic and metal product applications. Hansford’s industry experience is highlighted by a 20-year career with Johnson & Johnson in the medical device industry, 10 years with Morris Technologies as VP of Medical, and 10 years in contract manufacturing with a focus on additive manufacturing of orthopedic implants and instruments. He has a broad technical focus in developing new and innovative products and process validation of emerging technologies, resulting in several issued patents in the medical market.
Vernon Hartdegen
Vice President of R&D for Trauma, CMF, Sports, and Extremities at DePuy Synthes
Vernon Hartdegen
Vice President of R&D for Trauma, CMF, Sports, and Extremities at DePuy Synthes
Vernon Hartdegen is a lifelong orthopedic professional. After completing his Bachelor’s Degree in Biomedical Engineering from Louisiana Tech, he joined Smith+Nephew Orthopedics as a product development engineer while simultaneously completing his master’s degree in Biomechanical Engineering from the University of Tennessee. In 2000, he moved to Wright Medical Technology, where he progressed through the ranks from engineer to senior director of product development. During his nine-year tenure at Wright, he oversaw the development of the total knee arthroplasty, upper extremity, and foot & ankle product portfolios. Hartdegen then moved into the start-up company environment with senior leadership roles at two companies before co-founding CrossRoads Extremity Systems in 2014. As president and CEO of CrossRoads Extremity Systems, Hartdegen successfully navigated the 2022 acquisition of CrossRoads by DePuy Synthes. He has continued with DePuy Synthes and is currently the vice president of R&D for the DePuy Synthes Trauma, Extremities, CMF, Animal and Sports franchise.
Michael Labadie
Executive Vice President of Sales & Marketing at Magno International LP
Michael Labadie
Executive Vice President of Sales & Marketing at Magno International LP
Michael Labadie is executive vice president of Sales & Marketing at Magno International LP, where he leads the company’s commercial strategy and market engagement across its integrated air, ocean, and ground transportation platform. In his role, Labadie works closely with customers to align logistics solutions with evolving supply-chain demands, with a strong focus on resilience, visibility, and end-to-end execution in highly regulated and disruption-prone environments.
Juan Mangual
Senior Director of Supply Chain at Smith+Nephew
Juan Mangual
Senior Director of Supply Chain at Smith+Nephew
Juan Mangual is a transformational leader and change agent with over 20 years of executive expertise in architecting resilient, end-to-end supply chains. Currently serving as the senior director of supply chain at Smith & Nephew, Mangual oversees strategic initiatives in the orthopedic medical device sector, where he has consistently set new benchmarks for delivery performance and inventory optimization. A graduate of the University of Notre Dame’s Mendoza College of Business (Executive MBA), he blends strategic vision with operational mastery. By integrating Six Sigma and Lean methodologies, he has successfully transitioned organizations from reactive "firefighting" to proactive, intelligence-driven management. His career spans high-stakes industries—including aerospace, automotive, and contract manufacturing—where he has a proven track record of turning underperforming operations into high-performing centers of excellence. Beyond technical metrics, Mangual is a dedicated culture-builder. He has led teams of over 70 employees, maintaining 90th percentile Gallup engagement scores while developing comprehensive supply chain playbooks. Whether forging collaborative supplier relationships or implementing advanced digital tools, he remains focused on a singular philosophy: be resilient, be a champion, and fear nothing. He continues to shape the future of the industry by turning global disruption into a sustainable opportunity.
Brian R. McLaughlin
Co-founder & CTO at ALM Ortho Inc.
Brian R. McLaughlin
Co-founder & CTO at ALM Ortho Inc.
Brian R. McLaughlin is the founder of ALM Ortho, Amplify Additive, and other companies focused on advancing orthopedic implant technologies through metal additive manufacturing. With decades of experience in orthopedic innovation, he has worked at the intersection of engineering, manufacturing, and clinical collaboration to develop next-generation implants and patient-matched devices. His work focuses on expanding the use of additive manufacturing and osseointegration technologies across orthopedic implant indications including limb reconstruction, extremities, spine, and large joint orthopedics.
Cowan Moore
President of MDCM / Adjunct Professor at University of Akron
Cowan Moore
President of MDCM / Adjunct Professor at University of Akron
Cowan Moore is president of a medical device contract manufacturing firm specializing in additive manufacturing implants, producing thousands annually. He holds patents in osseointegrative surfaces for total joint and spine applications. His current work focuses on application development for generative design, OI surfaces, and AM process optimization with QMSR. He also serves as an adjunct professor at the University of Akron, where he teaches and mentors engineering students.
Mark Morrison
Research Director at Smith+Nephew
Mark Morrison
Research Director at Smith+Nephew
For the past 20 years, Mark Morrison has worked in research at Smith+Nephew, a British medical-device company. With a Ph.D. in Materials Science from the University of Tennessee, Morrison manages a research group that focuses on materials and tribology as well as an Additive Manufacturing Center of Excellence that develops/supports AM products throughout the product lifecycle (from idea to obsolescence). He serves as an AM SME and an internal consultant to match business needs with AM solutions.
Dawn Norman, MS
Partner at MRC Global
Dawn Norman, MS
Partner at MRC Global
As a partner, Dawn Norman’s expertise and leadership have been a significant part of MRC Global’s continued growth as a leading regulatory and compliance consulting firm highly respected throughout the medical device industry. With an extensive background of over 25 years in the medical device and biologics industry that includes VC-funded startups to fortune 10 device manufacturers, Norman’s depth of experience allows her to develop custom client solutions, regulatory submission, go-to-market and clinical study strategies, and a client-focused risk-based approach related to regulatory and quality systems. With a focus on regulatory strategy and submissions, along with clinical study design and study execution, Norman has been directly involved with the early development and market entry of numerous, leading edge medical innovations, such as: AI/ML diagnostic aides, neurovascular- and cardiovascular-based interventional catheters and implants, electrophysiological mapping and novel cardiac ablation, recombinant protein and growth factor-based combination devices, orthopedic trauma, spinal systems, infusion pumps and vascular access accessories, robotic systems, implantable stimulators, light based technologies, dental implants and orthodontia appliances, and advanced imaging technologies, to name a few. Norman received a Bachelor of Arts in Biological Sciences and Chemistry, and a Master of Science in Biomedical Sciences from Southern Illinois University at Edwardsville. She is also a certified ISO 13485 lead auditor. As a regulatory, quality, and clinical study design expert, Norman is a sought-after consultant and speaker for the medical device industry.
Melanie Prevost
Associate Director, ZBX ASC Solutions, at Zimmer Biomet
Melanie Prevost
Associate Director, ZBX ASC Solutions, at Zimmer Biomet
Melanie Prevost’s career in the healthcare industry is truly in her DNA. With more than two decades of experience in marketing and advertising, she has seamlessly navigated both sides of the industry—working within the healthcare sector itself and the advertising agencies that serve it. She began a career in communications at Medtronic Spine & Biologics, where she gained firsthand insight into the inner workings of the healthcare landscape. She later transitioned back into the agency side, stepping into a pivotal leadership role in which she oversaw multiple industry verticals and led integrated campaigns that deeply resonated with audiences. After 12 years, Prevost embarked on a new academic chapter at Arkansas State University, earning a Master of Science in Strategic Communications and further strengthening her expertise. Today, she leads ZBX ASC Solutions at Zimmer Biomet, shaping strategies that advance the industry and deliver measurable impact. She oversees the go-to-market strategy for this comprehensive solutions portfolio, partnering with surgeons and healthcare administrators to communicate meaningful clinical and operational value. Her unwavering commitment to excellence in health care marketing communications defines her work and positions her as a respected industry leader.
Trey Rodgers
Research Principal Engineer in Zimmer Biomet's Advanced Technology Research group
Trey Rodgers
Research Principal Engineer in Zimmer Biomet's Advanced Technology Research group
Trey Rodgers is a Research Principal Engineer in Zimmer Biomet's Advanced Technology Research group, where he develops orthopedic biomaterial and advanced manufacturing technologies to improve patient outcomes. With nearly 14 years at the company, he brings deep expertise across materials science, manufacturing, and regulatory affairs, and currently serves as Zimmer Biomet's subject matter expert for additive manufacturing and porous metals for biological fixation.
Christine Scifert
Founder and Partner of MRC Global
Christine Scifert
Founder and Partner of MRC Global
As founder and partner of MRC Global, Christine Scifert’s vision is the driving force behind the company’s continued growth. MRC Global is a regulatory and quality systems consulting firm supporting companies in the medical device industry. Scifert continues to support small and large medical device companies to identify regulatory hurdles, develop strategy, write submissions, implement quality systems, and expedite time to market while taking a risk-based approach. Scifert has been consulting for over 15 years (previously MRC-X and Memphis Regulatory Consulting). Prior to consulting, she spent nine years at Medtronic Spinal and Biologics, directing the regulatory department. As senior director, she set regulatory strategy, oversaw global submissions, and assisted in the development of a design control process. Scifert interfaced directly with the FDA and notified bodies, overseeing submissions and regulatory compliance while performing due diligence activities for potential acquisitions. Prior to Medtronic, Scifert performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents. Scifert received a Bachelor of Science in Physics from Hamline University and a Master of Science in Biomedical Engineering from the University of Iowa. She also completed a Master’s in Engineering Management from Christian Brothers University. Scifert has been an adjunct professor at Christian Brothers University, teaching regulatory affairs courses.
David Sheppard
Co-Founder and Managing Director at MedWorld Advisors
David Sheppard
Co-Founder and Managing Director at MedWorld Advisors
Dave Sheppard is co-founder and managing director of MedWorld Advisors, a global M&A advisory firm focused exclusively on the digital health tech, medical device, medtech, healthcare services, and outsourced manufacturing sectors. With more than a decade of experience advising founder-led businesses, private equity groups, and strategic acquirers, Sheppard specializes in sell-side transactions across orthopedics, enabling technologies, digital health, and medical CDMOs. He is widely recognized for his deep industry insight and ability to connect innovation trends with capital strategy. He regularly advises boards and executive teams on positioning their businesses for premium valuations and strategic exits. In addition to his advisory work, Sheppard is a recurring columnist for both Medical Product Outsourcing (MPO) Magazine and Orthopedic Design & Technology (ODT) Magazine, where he co-authors the “C-Suite” and “Orthopedic Insights” columns. His writing explores M&A trends, enabling technologies, and the evolving role of OEM suppliers in shaping patient outcomes.
Matt Stekier
Principal at Plante Moran
Matt Stekier
Principal at Plante Moran
Matt Stekier is a principal at Plante Moran with nearly 30 years of experience helping organizations transform their supply chain and operations. He has spent 10 years in industry, followed by almost two decades in consulting, working extensively in the medical device sector. Stekier’s expertise spans supply chain, manufacturing operations, SIOP, inventory optimization, logistics, and organizational transformation, with a track record of guiding companies through complexity to achieve sustainable growth and improved margins. He is passionate about simplifying and optimizing supply chains and leveraging innovation to help businesses compete in a rapidly changing environment. Over his career, Stekier has partnered with clients across sectors such as automotive, life sciences, and healthcare to deliver practical solutions that drive measurable results. He holds a degree in Supply Chain Management and an MBA focused on organizational change. Stekier is also certified as a Six Sigma Green Belt and trained in Theory of Constraints and Lean Manufacturing.
Janelle Swanson
President of Cretex Medical | QTS
Janelle Swanson
President of Cretex Medical | QTS
Since 2023, Janelle Swanson has been president of Cretex Medical | QTS, a leader in the medical device outsourcing sector. Specializing in several disciplines, including assembly, kitting, packaging, and sterilization services, QTS prides itself on accelerating products to patients while achieving a strong industry reputation for quality and safety. Swanson is a strategic, results-driven president known for elevating organizational performance, developing high-impact teams, and steering companies through growth, transformation, and operational excellence. Throughout her tenure, Swanson has built a reputation for aligning business strategy with measurable outcomes. She excels at turning complex challenges into focused initiatives, strengthening internal processes, and fostering a culture of continuous improvement. Before becoming president, Swanson helped triple sales as a business unit director while earning a reputation as a trusted leader who inspired her team to achieve extraordinary results. Her business development and executive sales leadership experience comes from a variety of industries. She spent seven years with St. Croix, a promotional products distributor, as vice president of sales and marketing and in other sales management roles, leading both internal and external sales efforts. Swanson also has operational management experience from her time with UPS. She has a bachelor's degree in Education and Business Management with a minor in Coaching from the University of Wisconsin, River Falls.
Dr. Patrick Toy
Board-Certified Orthopedic Surgeon
Dr. Patrick Toy
Board-Certified Orthopedic Surgeon
Dr. Patrick Toy is a board-certified orthopedic surgeon with over 17 years of experience dedicated to advancing the field of joint replacement. Based in Collierville, Tennessee, he practices at OrthoOne Sports and Orthopaedics, where he specializes in anterior approach hip replacement, robotic-assisted total knee replacement, and complex revision hip and knee surgery. He completed his residency at the prestigious Campbell Clinic Orthopaedics and went on to pursue fellowship training in orthopedic oncology at the University of Florida, where he developed a strong foundation in complex musculoskeletal care. What sets Dr. Toy apart is the rare combination of clinical excellence and business acumen. He holds an MBA from the University of North Carolina and brings a keen interest in the business and investment side of medicine. Beyond his clinical work, he is passionate about supporting healthcare initiatives and startups developing products that have the potential to meaningfully improve patient outcomes and the delivery of care—bridging the gap between the operating room and the boardroom in a way few surgeons can. A pragmatic adopter of technology, Dr. Toy embraces innovation when it meaningfully improves clinical outcomes—making him well-suited to speak to the evolving role of tools and techniques in today's ASC environment. An early pioneer in outpatient joint replacement, Dr. Toy performed his first ambulatory surgery center (ASC) case in 2013—well ahead of the curve—and has since completed thousands of hip and knee replacements in the ASC setting.
Tim Turner
Strategic Account Manager at Precera Medical
Tim Turner
Strategic Account Manager at Precera Medical
With more than two decades in the medical device industry, Tim Turner has built his career at the intersection of engineering, operations, and commercial leadership. He began as a manufacturing engineer in the orthopedic industry with Onyx Medical, now Elos Medtech, working hands-on with CNC Swiss-turning, grinding, and production systems. Early on, he developed a deep appreciation for the complexity behind implant and instrument manufacturing—from process control and scheduling to operating within highly regulated quality environments. That technical foundation shaped his practical, execution-focused approach to leadership. Four years into his career, Turner transitioned to the commercial side of the business, taking on business development and customer service responsibilities. Leveraging his engineering background, he partnered closely with OEM customers to translate design concepts into manufacturable, scalable solutions. During this period, the business experienced steady growth, doubling approximately every five years. In 2020, Turner returned to operations as managing director of the Memphis production site and later vice president of operations. He led the organization through the challenges of the post-COVID environment while doubling output in just two and a half years, maintaining strong performance metrics. In 2023, Turner moved back into commercial leadership as vice president of sales and business development, leading a global team across sales, customer service, and project management to help OEM partners bring new products from concept through launch and into sustainable production. He recently joined Precera Medical, formed in late 2025 following SK Capital Partners’ acquisition of the medical division of Lisi Group, where he is focused on strengthening Precera’s role as a strategic extension of its customers’ engineering and development teams—accelerating advanced medical technologies from concept to scalable production while safeguarding patient outcomes and reliability.
Paul Vasta, Ph.D.
Co-Founder and Chief Technology Officer at Gramercy Extremity Orthopedics
Paul Vasta, Ph.D.
Co-Founder and Chief Technology Officer at Gramercy Extremity Orthopedics
Dr. Paul Vasta is co-founder and chief technology officer at Gramercy Extremity Orthopedics, bringing over 25 years of medical device industry experience to strategic make vs. buy decisions. As a Ph.D. Biomedical Engineer, he has successfully navigated the complexities of determining optimal outsourcing strategies across diverse R&D projects, including implant systems, surgical instruments, electronics, and software platforms. Having held leadership positions at both resource-constrained startups and larger established companies, Dr. Vasta brings a broad perspective on how company size, stage, and capabilities fundamentally shape make vs. buy decisions. His experiences span product design and development, manufacturing engineering, and process optimization, providing a comprehensive view of evaluating internal capabilities against contracted partnerships.
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