7:30 - 8:30 AM: Registration and Networking Breakfast
8:30 - 8:40 AM: Opening Remarks and Michigan's MedTech Industry
8:40 - 8:45 AM: Welcome
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.
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.
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.
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.
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.
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.
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.
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?
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?
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.