MI MEDICAL DEVICE SUMMIT & SUPPLIER SHOWCASE

SEPTEMBER 20, 2022 - AGENDA

7:30 - 8:30 AM: Registration and Networking Breakfast

8:30 - 8:40 AM: Opening Remarks and Michigan's MedTech Industry

Stephen Rapundalo, PhD, MichBio, President and CEO

Dr. Rapundalo, has broad experience in the life sciences, with an extensive background in pharmaceutical research and development. Prior to joining MichBio in April 2006, he spent almost 20 years as a senior research scientist, project manager, and group leader with Parke-Davis Pharmaceutical Research and then Pfizer, Inc., primarily in the area of cardiovascular drug discovery.

Dr. Rapundalo also led a global interdisciplinary team that developed a strategic, operational and organizational change management program to improve Pfizer's worldwide R&D business processes. He has a strong background in innovation and is an internationally recognized expert in a number of technology areas including high-throughput screening and proteomics, among others.

Dr. Rapundalo has a superb record of scientific achievement with over 50 publications, book chapters, and monographs. He has served as a peer-reviewer for a variety of prominent scientific journals and national funding agencies. In addition, he continues to be active in a broad range of industry and governmental initiatives including intellectual property commercialization, talent recruitment and retention, science education and economic development.

Dr. Rapundalo has been a community advocate and civic leader for almost 20 years and formerly served as an elected member of the City Council in Ann Arbor, Michigan.

8:40 - 8:45 AM: Welcome

Rep. Julie Rogers, State Representative (D-Kalamazoo)

State Representative Julie Rogers is serving in her first term representing the 60th House District, which includes the City of Kalamazoo and portions of the City of Portage and Kalamazoo Township. She is a practicing physical therapist and served on the Kalamazoo County Commission for 8 years, including serving as Board Chair. She was appointed to serve as Assistant Democratic Floor Leader as well as the following committees: House Committee on Financial Services; Democratic Vice Chair to the House Committee on Military, Veterans and Homeland Security; House Appropriations Committee; House Appropriations Environment, Great Lakes and Energy subcommittee; and Democratic Caucus Committee on Diversity, Equity and Inclusion. She also serves as a co-chair for the Legislative Arts & Culture Caucus.

Rep. Rogers grew up in Kalamazoo County and is a proud graduate of public schools. She later attended Marquette University and earned a Master’s Degree in Physical Therapy. Her 22-year career as a physical therapist has led her to become a champion of public health, serving on the National Association of Counties Health Steering Committee for seven years. Rogers has been recognized for her work with a nomination to the Class of 2019 Women in Government, a national nonpartisan leadership program for women elected officials of all levels of government.

Rogers lives in Kalamazoo with her husband Dr. Ed Orloff, where they enjoy participating in community runs and triathlons.

8:45 - 9:40 AM: C-Suite Unplugged - Managing MedTech Company Growth During Extreme Uncertainty

Get the inside scoop from industry leaders across the spectrum of Michigan medical technology companies on conducting business in a continuing pandemic world, the impacts of changes in the healthcare delivery environment, barriers and entrance to new markets, access to talent and workforce, keeping up with innovation and disruptive technologies, and maintaining competitiveness.

Nate Folkert, Orchid Orthopedics, CEO

Nate joined Orchid in 2020 with 20 years of medical device experience and a deep understanding of the orthopedic implant end market. Prior to joining Orchid, he served as Vice President & General Manager for ConMed’s Orthopedics business, where he successfully accelerated growth through a customer-centric operating model with strong focus on accountability. Prior to ConMed, he served as President of Zimmer’s Trauma Division, preceded by several other executive roles at Zimmer and Stryker. Prior to joining Stryker, Mr. Folkert was a helicopter pilot in the United States Army, having graduated from the U.S. Military Academy at West Point.

Brad Saar, Stryker Medical, President

In his 29 years with Stryker, Brad Saar has served in numerous roles throughout the Medical division. He has distinguished himself as an excellent leader and has delivered exceptional results along the way.

Brad joined Stryker as a sales representative in 1993 and progressed through numerous sales and marketing leadership roles before becoming President of the Medical division in 2008. Since that time, Brad has led the division through the global financial crisis, successful FDA inspections, consistent successful audit results for financial integrity and compliance and eight acquisitions in the last five years. In 2016, Stryker acquired Physio-Control and Sage Products, totaling $4 billion. Most recently, in 2022, Stryker acquired clinical communications leader, Vocera Communications for $3 billion. The Medical division now accounts for roughly 15% of Stryker Corporation’s overall sales.

Brad attended Penn State University and was a member of the 1982 football national championship team before finishing his playing career and graduating from Ball State University, majoring in Communications with a minor in Marketing. Brad has completed numerous executive leadership programs through Harvard Business School.

Brad’s leadership style is characterized by great execution, strategic thinking and exceptional relationship building skills. Talent is a strategy that Brad takes very seriously and he has a track record of building strong, engaged teams throughout his career. Medical’s employee engagement scores continue to be near the top of Stryker’s results. Brad is a champion of DE&I and is proud of the progress that has been made in this regard.

Eric Sklar, NuStep, President and CEO

Eric Sklar is President & CEO of NuStep, LLC, a global provider of recumbent cross trainers used in healthcare, senior living, and fitness settings. Eric previously served as President & CEO of A&E Medical Corporation, a global surgical implant company headquartered in Farmingdale, NJ, and prior to that he held senior executive positions at other medical product companies including Gelman Sciences, Pall Corporation, and Terumo Cardiovascular. With over 30 years of experience in the medical products sector and multiple patents to his name, he has a proven track record in new product development, sales, marketing, and channel development.

His educational background includes a BS from Michigan State University, an MS from Eastern Michigan University, and an MBA from Northwestern University’s Kellogg School of Management.

Kevin McLeod, C2Dx, President and CEO (Moderator)

Kevin McLeod is a dynamic CEO and entrepreneur with over 29 years of experience in the medical technology industry. He held executive leadership roles in marketing, sales, and business development at Stryker Corporation. During his tenure at Stryker, he demonstrated a history of success in portfolio and strategic development. In 2010, he launched the Michigan Medical Device Accelerator providing strategic direction for early-stage growth companies, including Impact Athletic, which he led until its successful acquisition by Rogers Athletic.

Kevin’s decades of medical and leadership experience led to the founding of C2Dx in 2019. He serves as president and CEO, leading the team on its mission to bring products to their fullest potential and provide patients and healthcare workers with tools they can rely on and service that makes them feel valued.

9:40 - 10:30 AM: Transformative MedTech - Developing Products for the Heathcare Market of the Future

Fundamental shifts in healthcare delivery are forcing the MedTech industry to change what products and services it develops and how value is created. In the past, new products entered the market successfully through innovative science and engineering, and little competition.

Today, disruptors are emphasizing customer discovery more, realizing that health systems, physicians, payers, and especially patients, have higher expectations for adoption, outcomes, customer experience, affordability, and accessibility. It’s imperative that Michigan MedTech companies, irrespective of size or focus, reexamine their business models and product development with an eye on how they innovate, develop, validate and manufacture to meet new market realities.

Sanjeev Aggarwal, MD, MBA, Abiomed Inc, Vice President, Global Clinical and Medical Affairs, Surgical Therapies

William Fluharty, Stryker Medical, Director of Design

Bill Fluharty is the director of Design for Stryker’s Medical Division. He is responsible for assuring the competencies of design and contemporary design process are integrated into Medical’s New Product Development Process. Bill has 37 years of new product development experience. Although technology is evolving fast, bringing the right technology to the industry at the right time becomes the challenge if we want to improve patient outcomes. Bill is not a Clinician but brings his experience in user-centered design practices to this panel.

Frank Saltiel, MD, Borgess Heart Institute, Chairman & Crossliner Inc, Chief Clinical Officer

Frank Saltiel, MD, FACC, FSAI is a board-certified interventional cardiologist with over 30 years
of experience. Dr Frank Saltiel is the Chairman of Ascension Borgess Heart Institute, Medical
Director of Cardiology of Ascension Borgess Health Systems, and co-director of the Ascension
Michigan Interventional Cardiology Council. He serves on the Ascension Michigan
Cardiovascular Executive Committee as well as the Cardiac Catheterization Services Standard
Advisory Committee for the State of Michigan.

Dr. Saltiel is a Co-founder and Chief of Clinical Affairs for CrossLiner, Inc., a medical device
company developing a broad platform of device and technology delivery systems for use in
endovascular medicine. He is also the Co-founder and a general partner for the Novus
Biotechnology Fund, a life sciences venture fund located in Kalamazoo, Mi.

Dr. Saltiel attended the University of Chicago obtaining his BA in Biology with Honors in June of
1984. Accepted into medical school, he attended Northwestern University School of Medicine
and received his Doctor of Medicine degree in June of 1988. Frank went on to postgraduate
studies at Stanford University School of Medicine completing his residency in Internal Medicine
in July 1991. He continued at Stanford University, completing a Cardiovascular Medicine
Fellowship in June of 1994, and finished with Interventional Cardiology Fellowship at Indiana
Heart Institute in June of 1995.

Frank’s medical career started in 1995 at the MacNeal Cardiology Group as an interventional
cardiologist. He joined a growing private practice, Illinois Heart and Vascular in Hinsdale, IL in
1996. and practiced with them until 2010. In 2001 he founded and served as President of the
Illinois Heart and Vascular Foundation, a 501c3 charitable and research foundation. He served
as the Director of Interventional Cardiology with Rooney Heart Program at Adventist Midwest
Health from 2002 to 2010. He joined the Heart Center for Excellence in Kalamazoo in 2010 and
has served in his Directorship roles with Borgess since 2011.

He has been active in new device innovation throughout his career. He was granted a United
States patent on an ostial stent positioning device, now commercially available as the Ostial
Pro™ sold by Merit Medical. He has several other patents under current prosecution with the
USPTO. He has had an active academic career and has served as a site principal investigator
on over twenty-five different medical research studies, and a sub-investigator on over fifteen
different medical research studies. He is an Associate Clinical Professor of Medicine at both the
Homer Stryker MD Western Michigan University School of Medicine as well as the Michigan
State University College of Human Medicine.

Timothy Durst, MBA, Accenture, Global Medical Technology Sector Lead (Moderator)

10:30 - 11:00 AM: Networking Break

11:00 AM - 12:00 PM: Breakout Sessions

Arcadia Ballroom: Best Kept Secret in Tech: Tax Incentives for MedTech Development and Manufacturing

Many companies in the medical device manufacturing sector are unaware that the federal government and many states, offer R&D tax credits and other incentives. Even companies in the know often fail to capture the full extent of the credits due to misconceptions about the types of business activities that qualify. The fact is that technology firms, OEM and contract manufacturers, suppliers, and others, can benefit. Get the complex area of R&D tax incentives demystified by an expert.

Michelle Cipa, Monetek LLC, Senior R&D Tax Specialist

Michelle has over a decade’s worth of experience in public and private accounting. She provides clients with valuable federal and state credits and incentives expertise, specializing in Research and Development tax credits and Employee Retention tax credits.

Michelle’s educational background includes a B.S. in Finance and a Masters of Business Administration.

She is passionate about learning new industries and how things work.

Robin LeBlanc, Monotek LLC, Senior Project Manager

Robin joined Monetek as R&D Tax Credit Associate in 2019 and brings over twenty-six years’ experience in accounting and client services. She assists on projects throughout the U.S., including on varying study phases, generation of related reports and communication of results and deliverables to clients.

Since joining Monetek, Robin has worked on hundreds of projects. She is instrumental in education outreach, and activities related to conferences, presentations and other educational modes of dissemination.

Robin is an essential team member supporting Monetek’s studies and client relationships.

Prairies Room: MedTech Workforce Recruitment and Retention Solutions in a Challenging Labor Market

The COVID-19 pandemic reshaped the medical device market to an unprecedented degree and placed inordinate challenges on company workforces – among them, difficulty in finding the right workers to meeting high demand without increasing costs.

Learn how Michigan companies are addressing some of their labor issues and rethinking workforce strategies as they try to sustain productivity and efficiency.

Kate Bekasiak, Stryker Medical, Vice President, Human Resources

Kate Bekasiak is the Vice President of Human Resources, Medical at Stryker Medical after having held progressive HR positions within the organization for more than 13 years. As an HR leader Ms. Bekasiak brings business strategy together with empathy to lead with policies that enable the organization to meet its business objectives while providing a sought-after work environment.

Ms. Bekasiak earned her Masters of Business Administration from Wayne State University and her Bachelors of Business Administration from the University of Windsor. Ms. Bekasiak lives with her husband JP and her two children.

Zack Brown, Epredia, Human Resources

Zack Brown serves as the Director of Human Resource Operations at Epredia and has more than a decade of progressive human resources experience with Eaton Corporation, Whirlpool, and Epredia. Mr. Brown has significant experience providing direct and indirect support to the recruiting process at all levels of the organizations – including his current role where he develops organizational HR strategy and oversees the operational mechanisms required for implementation.

Mr. Brown received his Masters in Human Resource Management from the University of Colorado Global and his Bachelors in Human Resource Development from Oakland University.

Angie Rohrer, Orchid Orthopedic Solutions, Chief Human Resources Officer

Angie has spent her entire career in medical devices. She joined Orchid in 2020 as Chief Human Resource Officer. During her time at Orchid, she has put in numerous programs focused on employee engagement and development. Prior to joining Orchid, she spent 19 years at Stryker, where she held roles in Regulatory, Compliance, Supply Chain, Operations Management, and Human Resources.

Angie has a passion for people, driving engagement and developing talent. She earned her bachelor’s degree in Human Biology from Michigan State University in East Lansing, Michigan. In her free time, Angie enjoys running and working out. When she is not working, she can often be found at an ice rink or baseball field watching her boys play sports.

Patrick Emerson, Kelly Science & Clinical, Regional Account Executive (Moderator)

Patrick Emerson is a Principal Workforce Consultant, Biomanufacturing at Kelly where he is responsible for business development as it pertains to workforce solutions within Life Science, Medical Device, and Pharmaceutical organizations. Equipped with a variety of industrial experience, Patrick applies his skill sets through a consultative approach. This consists of integrating with clients to acquire, retain, and, grow top scientific talent.

12:00 - 1:15 PM: Networking Lunch

1:15 - 2:10 PM: Breakout Sessions

Arcadia Ballroom: MedAccred - Raising the Quality Bar in MedTech Manufacturing

The MedAccred certification and the supporting MedMMAP program – Medical Manufacturers MedAccred® Accreditation Pathway (MedMMAP) – may help accelerate business growth in the medical device sector while improving your critical processes. OEMs are increasingly requiring the MedAccred certification from their supply chains to maximize patient safety and improve quality.

Hear what the certification entails and how suppliers can improve operations and product quality, and strengthen business opportunities.

Robert Jenkins, Michigan Manufacturing Technology Center, Quality Programs Manager

Bob Jenkins is a Quality Program Manager at the Michigan Manufacturing Technology Center. In his role, he manages and delivers training and implementation assistance to organizations in the field of quality improvements. As an Exemplar Global Certified Auditor, Bob assists clients with Quality Management System implementations such as ISO 9001:2015 and IATF 16949. He provides internal auditor training and consulting services for various groups, including production, production management and corporate management, in disciplines involving the automotive core tools of quality systems consisting of FMEA, PPAP, APQP, SPC, MSA, and Root Cause Analysis/Problem Solving. His ongoing growth in Quality continued to Medical Devices through gaining certification as a Lead Assessor in ISO 13485. Since joining the pilot program for MedAccred (sponsored by NIST), Bob has become pre-assessment certified by PRI as an SME in Plastics, Mechanical Assembly and PCBA.

Professional Experience
Bob has more than 30 years of experience in quality, manufacturing and management with Ford Motor Company, serving in plant engineering as well as corporate staff. During his time as a corporate staff member, he assisted global locations in solving difficult problems during launches. Bob worked as an internal staff consultant at Automotive Components Division at Ford, rising to the position of Global New and Emerging Markets Quality Manager. In this capacity, Bob established quality systems in new facilities all over the world and assisted in the recovery of failing systems. Post Ford/Visteon, Bob established his own consulting firm that served clients throughout North America. As a Group Quality Manager at Cooper Standard, Bob led 10+ plants to achieve ever-improving quality performance.

Bob worked directly with GM, Ford, FCA, Nissan and BMW serving in capacities such as Quality Coordinator, Quality Supervisor, Quality Engineer, Process Engineer, SPC Coordinator, Best Practices Auditor/Manager, Quality Assurance Manager and Group Quality Leader. While working in the various industries mentioned, he had liaison responsibilities with such customers as GM, Ford, Chrysler (FCA), MBUSA, VW, Nissan, BMW and various Tier 1 suppliers.

Bob first studied quality under W. Edwards Deming in the 1980s. This led to certification as a quality engineer and quality manager prior to him completing AIAG Lead Assessor training and becoming certified as an assessor by Exemplar Global in ISO 9001 and ISO 14001. Bob also teaches blueprint reading and is developing skills in GD&T.

Education
Bob has a BA in Interdisciplinary Studies from Wayne State University and an MBA from the University of Michigan with a concentration in International Business.

Justin McCabe, MedAccred Performance Review Institute, Operations Manager

Justin has over 10 years’ experience developing and managing the MedAccred program for the medical device industry. MedAccred is an industry-managed supply chain oversight program for critical manufacturing processes to reduce risk to patient safety, assure quality products, and verify compliance with requirements. Subscribers to the program include Baxter, Boston Scientific, BD, Bausch Health, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics, and Stryker.

Prairies Room: Strategies on Building a Strong MedTech IP Portfolio

Hear from seasoned intellectual property (IP) practitioners as they discuss best practices for building effective and practical portfolios, both at home and abroad. Topics focusing on the domestic portfolio include timing and scope of provisional patent applications, the importance of those first 12 months, and using US continuation practice to gain a competitive edge.

Then the conversation shifts to protecting IP in other countries with topics addressing what to file, where to file and how to file in order to achieve the right balance in your company’s international IP portfolio.

Thomas Moga, Dykema, Member

Thomas T. Moga is a partner with the law firm of Dykema Gossett and has over 30 years of experience in domestic and international intellectual property portfolio development and enforcement. He is an experienced patent prosecutor in the mechanical, chemical, biochemical, and pharmaceutical arts and has been qualified and has testified as an expert witness in patent disputes.

As an intellectual property portfolio developer, Mr. Moga’s experience includes the development of domestic and foreign patent portfolios, the acquisition of registrations for trademarks and copyrights, licensing, and policy development.

In the arena of intellectual property rights enforcement, Mr. Moga manages patent enforcement and anti-counterfeiting actions in Asia, including overseeing initial counterfeit product investigation, selecting and working with local investigators, selecting and working with local counsel, preparing administrative and judicial documents, and participating in raids.

A pioneer in protecting and enforcing intellectual property rights in China, Mr. Moga has represented foreign companies in that country since the 1980’s. He was a Fulbright Scholar in China where he taught patent law at Jilin University and acted as a foreign advisor to China’s patent office. Mr. Moga was a visiting foreign expert in law at Xiamen University, China, and worked as a foreign legal expert for a patent and trademark law office in Taipei.

He is a member of the Industry Trade Advisory Committee on Intellectual Property Rights (ITAC 14), a trade advisory committee co-administered by the Office of the United States Trade Representative and the U.S. Department of Commerce. Additionally, Mr. Moga is past board member of the American Intellectual Property Law Association, the Fulbright Association, and the Fulbright Academy. Mr. Moga is the author of "Patent Practice and Policy in the Pacific Rim” (Thomson Reuters), a multi-volume treatise on patent law and practice in Asia, and "China’s Utility Model Patent System: Innovation Driver or Deterrent" (U.S. Chamber of Commerce). Mr. Moga is an adviser to both Equalize Health, a not-for-profit medical technology company, and the Association Internationale pour le Développement de la Propriété Intellectuelle (ADALPI).

Kristen Pursley, Dobrusin Law, Managing Shareholder

As managing shareholder of The Dobrusin Law Firm, Kristen Pursley is dedicated to achieving the objectives and vision of the firm and its clients, and in bringing out the best in those around her. Her steadfast belief in the exceptional work provided by the firm and her fellow shareholders supports her in leading important development initiatives that result in increased client loyalty and satisfaction.

Listed among the top lawyers practicing today in such publications as Michigan Lawyers Weekly, SuperLawyers, and Best Lawyers in Patent Law, Kristen is also a DBusiness Top Lawyer and Oakland County Executive 40 Under 40 honoree. Notably, Kristen is also a graduate of Leadership Oakland and an Oakland County Bar Foundation fellow.

In her private practice, Kristen advises on patent, trademark, and copyright prosecution and agreements. She is appreciated for her practical approach to problem-solving and drive to exceed client expectations on every matter, every day. Among Kristen’s clients are tier-one suppliers for the automotive industry, medical diagnostic and device manufacturers, and consumer product and packaging producers, with whom Kristen communicates at all levels of sophistication.

Kristen understands even the most complicated aspects of R&D and speaks the language of both engineers and business professionals. She is appreciated for her seemingly innate ability to render legal counsel that not only safeguards IP portfolios but also offers the potential for market expansion and product exclusivity in the future.

A leader valued for being balanced and fair and for cultivating buy-in and innovation at all levels of operation, Kristen views management decisions from the standpoint of enhancing the client experience. As a result, she focuses on developing programs and approaches to problem-solving that maximize creativity and peak performance from everyone involved.

A thought-innovator who strives to make a difference in everything she does, Kristen is a past president of the Women Lawyers Association of Michigan, a past president of the Women’s Bar Association, and the immediate past president of the Michigan Intellectual Property American Inn of Court. She provides pro bono legal services through the Michigan Women’s Foundation volunteer network and SpringGR and is a member of the MichBio IP & Legal Affairs Committee. Kristen also sits on the board for the Encore Performing Arts Center, which oversees the Flagstar Strand Theater in Pontiac, and serves as the chair for the Women Lawyers Association of Michigan Foundation.

2:10 - 3:05 PM: Breakout Sessions

Arcadia Ballroom: Investing in MedTech: Current State and Future Outlook

The lingering headwinds of the Covid pandemic continue to create uncertainty for medical technology companies, large and small. Predicting patient demand, product sales, provider access, supply chain disruptions, and workforce shortages have become futile as Covid remains a risk and new variants emerge, and let alone other market forces.

So, what does all this look like from an investor's point of view? Hear expert insights from across the funding spectrum on what the markets are saying for early-stage, growth-stage investment, and M&A activity.

Rob Ball, Genesis Innovation Group, CEO

Eli Thomssen, Adlore Inc, President and CEO

Jeff Wesley, Red Cedar Ventures, Executive Director

Jeff Wesley serves as the Executive Director of Spartan Innovations, Red Cedar Ventures and Michigan Rise. All these entities are subsidiaries of the Michigan State University Foundation (MSUF). Prior to joining MSUF, in 2018, Mr. Wesley was the CEO of Two Men and Truck International, the largest international franchise moving company. During his tenure he and the company received an A plus ranking by Franchise grade, 93 CEO Glassdoor rating, “Crain's Detroit Business Coolest Places to Work”, Inc. 5000 award winner, recognized nationally as a leading franchise system, a leading innovation franchise system, Franchise Times Top 200 Franchise System and Mr. Wesley received national recognition as a top franchise executive.

Mr. Wesley also has served as the President of Accu Bite Dental Supply, an Inc. 100 company, that was acquired by a Fortune 500 company. Mr. Wesley led this early startup to a recognized leading national full-service dental distributor. Mr. Wesley began his career as an Audit Manager at Deloitte.

Mr. Wesley has had significant experience in leading and scaling private companies to record success. Mr. Wesley has contributed to several startups throughout the state providing mentorship, coaching, operational experience and startup capital. Mr. Wesley has also been an Angel Investor for over 15 years and was a member of the Capital Community Angels and the Michigan Angel Fund. Mr. Wesley is a prior Vice Chairman for the Lansing Economic Area Partnership and has served on various economic and community boards.

Mr. Wesley is currently an observer and Board Member of several boards including Greenmark BioMedical, AvidHrt, and AR Utility to name a few. Mr. Wesley is a frequent judge and speaker at events related to leadership, franchising and startups.

Jason Gorak, JPMorgan Chase & Co, Relationship Executive - Life Sciences (Moderator)

Jason is an Executive Director, Relationship Executive for J.P. Morgan’s Commercial Banking Life Sciences team, helping companies grow revenues and protect assets. In this role, Jason provides financial solutions to companies across the Midwest in the Life Sciences industry. The Life Sciences industry includes companies at every stage of growth from early stage to full commercialization. Life Sciences companies' primary objective is creating new healthcare products regulated by the Food and Drug Administration (FDA). These companies often require significant upfront research and development investment. In addition, they often require assistance/advice for raising capital, financing mergers and acquisitions, investment management for raised capital as well as international banking and foreign exchange at all stages of development.

Jason has over 20 years of banking experience at JP Morgan Chase as a trusted adviser to both clients and his network. He delivers the firm by leading a team of experts in the field of traditional credit, venture debt, international banking, foreign exchange, treasury services, fraud protection, 401k, capital markets, and personal wealth management.

Jason was born and raised in the south suburbs of Chicago and has spent the majority of his life living in the City of Chicago. Jason currently lives in Wicker Park with his wife Monica and his Labrador retriever, Charlie. Jason participates in a number of groups, both internal to the organization and external, in support of the community. In his spare time Jason loves to travel, golf, and spend time with family and friends. Jason is a fanatic sports fan and his favorite pastime is following the Chicago Bears and Cubs on the road.

Prairies Room: Proposed Changes to 21 CFR 820 Quality Management System Regulation - Practical Considerations

The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820 Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016 “Medical Devices - Quality Management Systems – Requirements for Regulatory Purpose”.

The FDA wishes to align its current regulatory framework “to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.” What does all this mean for the medical device manufacturer?

Mark Durivage, Quality Systems Compliance, Managing Principal Consultant and Member

Mark Allen Durivage has worked as a practitioner, educator, and consultant. He is Managing Principal Consultant at Quality Systems Compliance LLC, ASQ Fellow, SRE Fellow, and an Expert Faculty Member for AAMI. He holds several certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS. Durivage has written several books available through ASQ Quality Press, published articles in Quality Progress, and is a frequent contributor to Life Science Connect.

Mark primarily works with companies in the FDA regulated industries (medical devices, human tissue, animal tissue, and pharmaceuticals) focusing on quality management system implementation, integration, updates, and training. Additionally, he assists companies by providing internal and external audit support as well as FDA 483 and Warning Letter response and remediation services.

3:05 - 3:35 PM: Networking Break

3:35 - 4:30 PM: Building the Future - A Resilient MedTech Manufacturing and Supply Chain Ecosystem

Michigan’s MedTech cluster has grown increasingly by offering extraordinary capabilities ranging from R&D to contract manufacturing, logistics and aftermarket service. But is the state’s ecosystem doing all it can to support every phase of company growth, help create successful new ventures and advance the continued success of established companies?

What needs to be done to better connect the regional MedTech ecosystem, expand opportunities for technology partnerships, develop a resilient supply chain, ensure a strong talent pipeline, and promote a visible brand, among other necessary building blocks? In short, how does Michigan become a top tier MedTech cluster through our collective stakeholder efforts?

Josh Kaplan, SLI Medical, CEO

Josh Kaplan is the Founder and CEO of the SLI Group. SLI has two primary divisions -- medical and automotive -- and acts as a supply chain problem solver for both sectors. Founded in 2013 and headquartered in Novi, Michigan, the business has grown to include facilities across the country with 36 employees and an annual revenue of over $150 million. Josh has built a strong, diversified supply chain with countless direct-to-manufacturer relationships globally. This has allowed SLI to deliver quality medical supplies to institutions large and small on time and at a reasonable cost.

Throughout the Covid-19 pandemic, Josh leveraged his supply chain and logistics expertise to solve problems for large hospitals, states, and federal contractors. SLI's ability to execute during the pandemic has resulted in repeat orders from these clients. Josh serves as a thought leader to elected officials, international institutions, and industry colleagues. Josh sits on the advisory board of Kids Kicking Cancer, an international nonprofit dedicated to teaching mind body techniques to ill and at-risk youth. He lives in West Bloomfield with his wife Danielle and son Elliot.

Jim Medsker, Keystone Development, President and CEO

Jim Medsker is the owner and president of Keystone Solutions Group, a turn-key medical device development and contract manufacturing company located in Kalamazoo, MI. The Keystone journey began in 1998 and over the last 24+ years the company has helped launch a wide range of Class I and Class II devices in wound care, imaging, diagnostics, and many other areas. Jim also serves as an advisor and board member for a number of companies and non-profit organizations and holds a Master of Science degree in Mechanical Engineering from Western Michigan University.

Tom O'Mara, Autocam Medical, Vice President

Tom O’Mara, Executive Vice President at Autocam Medical, began his career with the Autocam Corporation in 1989. In 2007, he took over leadership of business development for Autocam Medical, a division of Autocam Corporation, and led the medical device manufacturer’s growth from $15 million in 2007 to an expected $170 million in 2022. He planned and executed the market strategy to expand Autocam Medical beyond a single market of ophthalmology to include orthopedics and other Med Device segments. O’Mara has a proven knowledge of customer driven management, entrepreneurial leadership, and long-range planning. Although O’Mara will retire at the end of this year, he plans to stay on in an advisory capacity with Autocam Medical, as well as serve on various boards. O’Mara lives in West Michigan and enjoys spending time with his wife and family.

Gene Parunak, in2being, Managing Director

Gene is the Managing Director of in2being, LLC. Prior to founding in2being in 2010, Gene was part of two successfully acquired med tech startups, including the wildly successful University of Michigan spinout, HandyLab, Inc. With 24 issued patents and a passion for educating stakeholders with a holistic view of the medical device development process, Gene loves to cut through complexity to get right to the heart of the challenges being faced by today's hottest med tech startups. Gene resides with his wife and eight children near Ann Arbor, MI, and has the somewhat dubious distinction of being the first person to successfully fly a powered paraglider coast-to-coast across the state of Michigan.

Mark Ignash, Michigan Economic Development Corporation (MEDC), Sector Development Director (Moderator)

4:30 - 5:00 PM: Working Together - Strengthening Michigan's MedTech Cluster

Key ideas for action, benchmarking efforts, priorities and follow-up deliberation in an interactive format.

Stephen Rapundalo, PhD, MichBio, President and CEO. Dr. Rapundalo's bio is above with the Welcome.