7:30 - 8:30 AM: Registration and Networking Breakfast
8:30 - 8:35 AM: Opening Remarks
8:35 - 9:15 AM: CEO's Unplugged: Navigating Today's Medtech Marketplace
The global healthcare marketplace continues to churn with plenty of opportunities for medtech business growth, but also headwinds that lead to worries. Hear candid commentary, insights, and expertise from leaders across Michigan’s medtech sector – OEMs, contract manufacturers, and start-up ventures – and what’s on their minds as they steer their companies against a backdrop of issues.
Sponsor:
9:20 - 10:00 AM: AI Powered Healthcare: Supercharging Devices, and Patient Monitoring
The application of Artificial intelligence (AI) in healthcare holds immense promise for enhancing patient care, increasing operational efficiency, and enabling early intervention. Learn from thought leaders on what the integration of generative AI means for remote, real-time patient monitoring, predictive analysis, product design, and user engagement and adherence.
10:00 - 10:25 AM: Networking Break
10:25 AM - 12:00 PM: Breakout Sessions
10:25 - 11:10 AM
Regulatory, Compliance, and Policy: Session 1
Cybersecurity Standards and Shared Risk Management
Cybersecurity has become mission-critical for medtech manufacturers to guarantee the safety and effectiveness of medical devices and preventing potential harm to patients. New standards and guidelines mean companies must satisfy key requirements like shared risk management, security architecture, testing and cybersecurity transparency. Get a better understanding on how to translate regulatory expectations into concrete design and development practices.
10:25 - 11:10 AM
Medtech Innovation: Session 1
Hard Lessons About MedTech Startups And Commercialization
The difficulty in building a medtech company is very much real, more so than in many other technology sectors –commercial reality, regulations, clinical validation, patient adoption, timelines, fundraising, and of course, the actual technology. Hear from startup founders and leaders talk about lessons learned and how to bulldoze one’s way through the obstacles when bringing an innovative medical technology to market.
Sponsor:
11:15 AM - 12:00 PM
Regulatory, Compliance and Policy: Session 2
Medical Device Product Biocompatability, Packaging, And Transit - Certification And Testing
The world of medical device manufacturing relies heavily on the crucial roles of biocompatibility, packaging and logistics. Required testing of such attributes ensures the product’s efficacy, reliability, integrity during storage and transit, and ultimately, patient use. This session seeks to bring clarity to the current complex landscape of regulatory requirements governing such safety testing.
Session Sponsor:
11:15 AM - 12:00 PM
Medtech Innovation: Session 2
Investment Trends in Medical Technology Innovation
The medtech investment landscape continues to evolve given technological advancements, shifts in healthcare delivery and marketplace, patient and provider expectations, among others. The intersection of healthcare and technology presents a myriad opportunities for growth and innovation. What are the key trends that are shaping medtech investments, where are the opportunities for growth and innovation, and what does all this mean for companies commercializing new medical products?
12:00 - 1:15 PM: Lunch and Keynote Plenary
Insights On Innovation And Practice Of Medtech Product Development
Session Sponsor:
1:15 - 3:30 PM: Breakout Sessions Continued
1:15 - 1:55 PM
Regulatory, Compliance and Policy: Session 3
Capitols' Review: Issues Facing the Medtech Sector in Congress and Michigan Legislature
Get the current briefing on all the relevant legislative, regulatory and political issues facing the medical device industry in Washington, DC and Lansing. Be updated on issues like the medical device “breakthrough” pathway, new rules governing ethylene oxide sterilization and forever chemicals, lab developed tests, CMS reimbursement for emerging technologies, data privacy, and more.
1:15 - 1:55 PM
Medtech Innovation: Session 3
Early Stage Medtech Technology Showcase
Meet Michigan companies that are developing transformative devices, diagnostics, instruments, and related technologies. Hear their emerging stories on how they’re trying to tackle unmet medical needs, disrupt healthcare delivery and improve patient lives.
2:00 - 2:40 PM
Regulatory, Compliance and Policy: Session 4
Perspectives on the Future of Medical Device Sterilization
Sterilization is a critical step in the manufacturing process for many medical devices with ethylene oxide (EtO) employed as the most common method. What are the likely consequences of recent regulatory restrictions on EtO sterilization in terms of supply chain concerns, timelines to implement alternative technologies, product compatibility and effectiveness, and operational burdens.
2:00 - 2:40 PM
Medtech Innovation: Session 4
Working with Healthcare Providers: Navigating Access, Validation, and Value Adoption
Joshua Kooistra, DO, is Senior Vice President, Chief Medical Officer, Hospital Care, Corewell Health West.. In his role, Joshua is focused on enhancing the value of care delivered by improving quality, clinical standardization, eliminating inefficiencies and appropriately reducing our length of stay. Joshua also leads acute health, cardiovascular health, provider fulfillment, informatics, research and graduate medical education, clinical pathways and supports our elected medical staff leadership. He has been instrumental in the collaboration between the emergency departments, inpatient floors and intensive care units to develop protocols and improve care coordination and communication throughout the COVID-19 pandemic. He also serves as an Associate Dean for the College of Human Medicine at Michigan State University.
One of the biggest challenges in medtech product development is accessing the healthcare provider to substantiate the technology concept, medical need and economic value. Hear what approaches providers take when evaluating, validating and adopting new device technologies, and what informs their product adoption decision-making.
2:45 - 3:30 PM
Regulatory, Compliance and Policy: Session 5
An Update on the FDA's Premarket Review Programs
Heather Rosecrans brings more than 40 years of public health, and particularly medical device experience, to MDMA and ELIQUENT Life Sciences.Navigating the complex landscape of the US Food and Drug Administration's (FDA's) Center for Devices and Radiological Health's (CDRH's) premarket submissions can be a daunting task for device firms. Hear the latest on changes the agency has instituted to strengthen and modernize the programs, as well as tips to help ensure predictability and improve expectations when working with CDRH.
2:45 - 3:30 PM
Medtech Innovation: Session 5
Protecting Your Medtech IP Assets: Strategies and Updates
Tom is a patent attorney with over 30 years of experience in domestic and international patent and trademark portfolio development and enforcement as well as in IP licensing. A partner with the Dykema firm, Tom works primarily in the biochemical arts. He has represented foreign companies in China since the 1980’s. He was a Fulbright Scholar in China and was a foreign advisor to China’s patent office. Tom was a legal expert for an IP office in Taiwan and taught IP law in Vietnam.
Dr. Ashley Sloat is a USPTO-registered patent practitioner who specializes in the development and management of patent portfolios for startup ventures and emerging growth companies. She takes a hands-on approach with each client, partnering with Engineering and Management teams to intimately understand each client’s business, competition, and product vision. Armed with this knowledge, Ashley is able to increase the value of her clients’ patent portfolios while reducing overall legal costs.
Intellectual property (IP) strategy plays a pivotal role in the commercialization of innovative medical technologies and products. It encompasses a range of legal, business, and tactical decisions aimed at maximizing the value of intangible assets. Hear from legal and IP strategy experts on the latest legal updates and best practices to safeguard your breakthrough advancements, develop a strong market position, and ensure commercialization success.
3:30 - 3:45 PM: Networking Break
3:45 - 4:45 PM: FDA Town Hall
David Gasparovich is a Consumer Safety Officer within the Office of Medical Device and Radiological Health Operations/Division 1 (East). He has been with the FDA for almost ten years. Mr. Gasparovich conducts both domestic and international medical device inspections. Prior to joining the FDA, Mr. Gasparovich spent three years conducting clinical research studies.
A unique opportunity to hear from key FDA officials who lead medical device inspection and compliance activities. The session will cover a lot of important issues, including updates on new FDA initiatives and priorities, implementation of QMSR to ISO 13485, how to address device inspection citations, responding to 483s and warning letters, recalls, and so much more.
4:45 - 5:00 PM: Final Remarks: Future of Michigan's Medical Device Cluster
5:00 - 6:30 PM: Networking Reception
MEDC - Here to Help
