Pat Baird works at Philips as a Sr. Regulatory Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs multiple committees related to artificial intelligence, is a sub-team lead for IMDRF AI committee, and current standards projects include risk management for ML systems and cybersecurity considerations for ML systems.

Vast experience of nearly 25 years in Quality, Regulatory, Processes Improvements, leading clinical studies and cross organization projects VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs. Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Kodak medical division)

Monika McDole-Russell is a regulatory affairs leader at Medtronic, a global leader in medical technology. She has over 17 years of experience in the medical device industry, spanning R&D, Regulatory Affairs, and Quality.

As a global regulatory affairs leader, Monika develops and executes regulatory strategies for devices within Medtronic’s Endoscopy portfolio, including SaMD and devices that incorporate artificial intelligence (AI) and machine learning (ML). She works with cross-functional teams, external partners, and regulatory agencies to ensure compliance with global regulations and standards. She also advises on regulatory best practices and emerging regulatory trends.

Monika is passionate about advancing medical device innovation and improving patient outcomes. She has presented on topics relating to leadership, AI/ML, and regulatory affairs at national and international conferences, workshops, and webinars.

Tarek Haddad is a Technical Fellow and Sr. Director of the AI Research Group at Medtronic, where he leads the development of AI/ML algorithms to improve patient outcomes and clinical efficiency. His team’s work on AccuRhythm AI has enhanced diagnostic accuracy for heart rhythm abnormalities in Medtronic’s implantable cardiac monitors, resulting in a 91% reduction in false alerts and 42% reduction in manual ECG review workload for clinics worldwide. This innovation has earned prestigious awards, including the Minnesota Tekne Award and MedTech Breakthrough Award in AI. Tarek has pioneered advancements in device reliability methods that have become standards for the Association for the Advancement of Medical Instrumentation (AAMI). He has also created Bayesian models used in major clinical trials, such as LEADR and Symplicity Spyral renal denervation (RDN), achieving combined cost reductions of millions of dollars. He spearheads regulatory innovations, including the Predetermined Change Control Plan, which facilitates continuous AI model updates, and Medtronic’s AI Compass program, which sets ethical standards for AI in healthcare. Tarek holds an MS in Biostatistics and a BA in Mathematics from the University of Minnesota, is a Master Black Belt in Design for Six Sigma, and holds numerous patents and publications in AI, reliability, and medical technology

Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions. Jennifer has over 25 years of Regulatory experience. She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device. She also facilitates a Regulatory Strategy Board, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program. Jennifer previously supported global strategies for some of Boston Scientific’s transcatheter aortic valve repair devices, left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons and guidewires, and vascular surgery grafts/fabrics. Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics).

Divya Raman, JD, MS, PMP, is the Sr Director of Quality and Regulatory Policy, Intelligence, and Strategy at Teleflex Inc. In this role Divya leads the regulations and standards management program, advocacy and policy program, and projects to support compliance to new regulations. Divya is well-versed in the area of program management and regulatory affairs and is passionate about how those two functions effectively support medical device lifecycle management. Divya has over 12 years of experience in the medical device field in multiple functional areas, such as technical communication, regulatory affairs, and medical affairs, and 6 years of experience in the legal field.

Is the co-founder and CEO of HabitAware. HabitAware created its Keen2 smart bracelet to help individuals like his wife and co-founder, Aneela, “retrain their brain” away from detrimental behaviors including hair pulling, skin picking and nail biting, to positive ones. HabitAware has received research grants from the NIH and NSF for research and to validate Keen2 as a treatment for these disorders. HabitAware was the Grand Prize winner of the Minnesota Cup and is a TIME Magazine Best Invention. Prior to founding HabitAware, Sameer was a professional investor at The Blackstone Group and worked in corporate strategy at Bain and Company and Ameriprise Financial.

Lisa Griffin Vincent Ph.D., has more than 30 years of experience in scientific, regulatory, and business leadership across the healthcare ecosystem within medical technology and combination products, payers, data analytics and population health, and management and diligence consulting. Her career began serving patients as a clinical and research nurse in neonatology, neurology, cardiovascular, and infectious diseases. Her current role is Chief Regulatory, Quality, Clinical at GT Metabolic Solutions, where she serves on the executive management team. GT Metabolic is the leader in development of magnetic compression anastomosis technologies, setting a new standard in minimally invasive surgery. Dr. Vincent has expertise leading and growing functional talent and organizations along the product lifecycle, including research, clinical, regulatory, health economics, reimbursement, medical affairs, and market access. In addition, she has served in business leadership roles including, as chief operating officer for two global research companies, and as president of an outcomes research division. Her industry trajectory includes early-stage companies, such as Seismed Instruments, and PatientPoint, and large multinational organizations, such as UnitedHealth Group (UHG), Medtronic, BD, and GE Healthcare. Dr. Vincent has significant experience in the policy area and was appointed in January 2022 as an industry representative to the U.S. Department of Health and Human Services (DHHS) CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Dr. Vincent holds a B.S. in nursing, M.A. in kinesiology, and Ph.D. in health services research and policy, all from the University of Minnesota. She was awarded full scholarships from the U.S. Agency for Health Care Policy and Research and DHHS for her doctoral training, and her dissertation focused on patient adherence to complex medical therapies to maximize health and economic efficiencies and reduce disease burden

Jason Neff has over 14 years of experience in the medical device and biotechnology spaces, and has worked with AtriCure, Johnson and Johnson, Boston Scientific, and the Broad Institute of MIT. He has authored numerous clinical evaluations for EUMDR and class III cardiac devices. Jason graduated from the University of Minnesota and lives in the Twin Cities area with his family.

Mac McKeen has 35 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices.  Recently retired Mac served as a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. In these roles Mac has prepared and submitted well over 500 submissions to FDA and global regulatory agencies.  For the last 16 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technology Leadership Institute on medical device development.  Throughout his career Mac has been and continues to be actively engaged in a wide range of industry and patient advocacy initiatives working directly with FDA, AdvaMed, RAPS, Medical Alley, MDIC, and the Smithsonian Institute.  Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and has been recognized as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S) and is currently serving on the RAPS RAC Board.

Al is the Vice President of Quality Assurance and Regulatory Affairs at CVRx.  He developed and implemented the quality system and was a key participant in all clinical and commercial regulatory submission work at CVRx for more than 19 years leading to European, FDA and Australian approvals for the quality system and devices.  In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts for many years.  Through this, CVRx has volunteered to pioneer new Case for Quality programs developed in conjunction with FDA to improve the quality of medical devices in general and the CVRx product line specifically, including pilots of FDA Critical to Quality assessments, maturity model assessments for the FDA Voluntary Improvement Program (VIP) and the Medical Device Information and Analysis Sharing (MDIAS) program as a co-chair of the Governing Committee.  Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the areas of quality and reliability.  Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Master of Business Administration degree from the University of Colorado.

Michelle Wetherby has 30 years’ experience in clinical trial execution and currently serves as Director of Clinical Research and Operations for Terumo Neuro. In this role she is responsible for the conduct studies for ischemic and hemorrhagic stroke. Prior to joining Terumo, she held several industry roles focused on the conduct of global medical device trials and led the development and implementation of a novel risk assessment tool and risk-based monitoring framework to support a novel monitoring approach. Ms. Wetherby is adept at assembling global teams to provide scalable central services to support critical clinical trials activities. She holds a MBA from St. Mary’s University and has presented and published on several topics.

David recently joined GlobalData’s medical devices consulting practice after 3 years providing guidance to some of the industry’s largest companies, working in a variety of segments including surgery, patient monitoring, oncology, neurology, orthopedics, artificial intelligence, augmented reality, care communications, and wound care.

With 25 years of experience in the medical device industry, David has held roles in Corporate Strategy, Mergers & Acquisitions, and finally as Director of Innovation, where he led a advanced technology initiatives for a global medical device company.

Among David’s areas of expertise is a unique combination of experience in innovation and intellectual property. As an attorney, David’s practice emphasized intellectual property, including patent law, and in his role as Director of Innovation for a large medical device company David was an inventor on over 100 patents.

David holds a JD from Willamette University of Law and a certificate in healthcare economics from the University of Washington.

Dr. Hatice Bilgic Lim is a leader in medical device clinical development and regulatory writing with over 25 years of experience in research, strategy, and communication. She has held senior positions at leading MedTech companies, including Medtronic, Becton Dickinson, and Philips, where she led cross-functional teams in creating high-impact clinical and regulatory strategies that facilitated global product approvals. Her expertise lies in developing and executing effective clinical trials for innovative technologies that enhance access to care across diverse global markets.

In addition to her industry experience, Dr. Bilgic Lim has a background in academia and nonprofit leadership, emphasizing the advancement of healthcare through research, communication, and training. She is the founder of Academy HBL, where she mentors students and professionals in scientific communication and career development, and she serves as a board member for various academic nonprofits.

At the OCT Medical Devices USA 2025 conference, Dr. Bilgic Lim will lead a roundtable discussion titled "Strategic Leadership in MedTech Clinical Development: Creating Agile, High-Impact Trial Strategies." This session will draw on her hands-on experience in designing streamlined, globally aligned clinical programs that not only meet regulatory milestones but also accelerate innovation.

As an executive in R&D, Technology, Innovation, Product Development and Engineering, I specialize in leading high-impact teams, driving breakthrough product innovation, and transforming cutting-edge research into commercially successful solutions.

With 20+ years of experience, I have scaled multi-million-dollar R&D operations, launched AI-powered products, and led cross-functional teams of engineers, IT, data scientists, and clinicians to bring transformative technologies to market.

Executive Expertise & Leadership Impact:
- AI & Data Strategy – Driving AI, real-world data (RWD), and digital innovations to enhance clinical outcomes.
- R&D Leadership & Innovation – Led end-to-end development of Class II & III medical devices, in-vitro diagnostics, digital health, digital therapeutics, and drug-device combination products.
- Regulatory & Market Access – Deep expertise in FDA, MDR, ISO 13485, ensuring faster product approvals & go-to-market execution.
-  Product Commercialization – Managed $3B+ product portfolios, driving market adoption & revenue growth.
- Strategic Partnerships & GTM Strategy – Spearheading alliances with biopharma, payers, and AI-driven startups.
- Led World Wide Product & Technology Planning that aligned with corporate strategy and goals, by involving cross-

At MED Institute, Samantha leads and supports clinical projects and strategies. She has over 30 years of experience in the medical field, including clinical research, medical education, regulatory affairs, sterile processing, materials management, and surgical technology. She is certified as a Surgical Technologist, Surgical First Assistant, and Clinical Research Professional. She holds a BS in Career and Technical Education from Indiana State University, an AAS in Surgical Technology from Ivy Tech Community College, and is currently pursuing an MPH degree from Purdue Global University.

Chems Hachani is a seasoned clinical trial professional with over 10 years of experience in the medtech, pharma, and CRO industries. As the founder of Eclevar Medtech, a tech-enabled CRO, Chems Hachani spearheads innovation in clinical trials with MILO, a cutting-edge platform that accelerates patient identification through GenAI and enhances site effectiveness.

Catherine Tyner brings 27 years of clinical research experience with a focus on Oversight Group Management for Clinical Endpoint Committees, Data Monitoring Committees, and other operations. Throughout her career, Ms. Tyner has led and developed oversight departments at Quintiles (now IQVIA), Novella Clinical, and Covance (now Fortrea), providing strategic management for over 500 clinical trials, including complex megatrials across diverse therapeutic areas. A recognized thought leader in endpoint adjudication best practices, Ms. Tyner has authored the industry's seminal guidance on adjudication operations and best practice. In her new role at AG Mednet, Ms. Tyner will work to expand and tailor the value jointly created with new and existing CROs Trial Sponsors, Core Labs, and Academic Research Organizations, working closely to optimize the future of clinical process efficiency.

Mark Voigt, Director of Sales at Greenlight Guru, brings over 20 years of experience in software sales. Throughout his career, Mark has focused on understanding and addressing the unique problems and challenges faced by companies, driving solutions that lead to tangible improvements. At Greenlight Guru — the leading provider of quality management and clinical data solutions for medical device companies — Mark helps medical device companies streamline clinical trial data management and bring safer, higher-quality products to market faster.