Don’t Miss the Michigan Medical Device Summit!

Join us at the pinnacle event for Michigan’s medtech community, Monday, Sept. 23, 2024. Dive into the latest medical device technologies, regulations, and market trends, and discover what makes Michigan a hub for medical innovation. Hear from the state’s top thought leaders as they share their insights on current topics.

Network with a diverse group of professionals, including medtech sector experts, academic researchers, healthcare providers, suppliers, contract manufacturers, investors, business leaders, and government officials. Don’t miss this unique opportunity to connect, learn, and collaborate with innovators across all growth stages.

More Information to come!

Michigan's Bio-Industry Strategic Roadmap to be Updated

MichBio, Michigan’s biosciences association, announced at the 2024 Mackinac Policy Conference that it will update the Michigan Bio-Industry Roadmap for Success. Originally released in 2016, the updated strategic plan aims to position Michigan as a global leader in biosciences. The new roadmap will focus on expanding sectors like pharmaceuticals, medical technologies, and agricultural biotechnology while improving innovation, business climate, and talent development. Outreach efforts will include a statewide listening tour and stakeholder engagement to refine strategies and identify growth opportunities. Read the full press release on our website for more details.

Independent Contractor or Employee? Time to Reassess

The U.S. Department of Labor (DOL) has implemented a new rule that changes how workers are classified under the Fair Labor Standards Act (FLSA). Effective March 11, 2024, this rule aims to ensure more workers receive proper classification and thus, appropriate wages and protections.

Key highlights from the new rule include the adoption of a six-factor "totality-of-the-circumstances analysis" to determine worker status. This shift may result in fewer workers being classified as independent contractors.

Misclassifying employees can lead to significant penalties, including back pay for unpaid overtime, double damages, and additional legal fees. Employers are urged to reassess their worker classifications and contracts to comply with the new regulations.

For a detailed analysis, read the full article by Melvin J. Muskovitz, Esq., counsel at Dykema on our website.

MichBio Welcomes New Team Member

MichBio welcomes Jamie Krajny (left)  as the new Director of Marketing and Industry Engagement! With 18 years of experience in marketing, communications, and public relations, Jamie has a proven track record of driving industry engagement through innovative strategies and compelling storytelling.

Her background includes notable roles at two statewide member-based associations in Michigan, where she showcased her commitment to fostering community participation and amplifying organizational missions. She can be reached at jamie@michbio.org

Join the MichBio Board as Secretary or Treasurer

MichBio is seeking committed individuals for two non-voting Officer roles: Secretary and Treasurer. This is a unique chance to drive our mission forward and shape MichBio's future. Both roles require attendance at quarterly Board meetings and relevant Committee meetings, typically held virtually. Terms last one calendar year with no re-appointment limits.

Interested? Contact stephen@michbio.org with your background and non-profit experience. Feel free to share this opportunity with your network!

Updated Biosecure Act Draft Clears House Committee

Revised legislation that would restrict US organizations from contracting with some Chinese biotech providers has been passed by a House of Representatives committee.

First introduced in January, the original bipartisan BIOSECURE Act singled out various Chinese biotech companies, including genomics specialist BGI Group and its subsidiary companies MGI and Complete Genomics, as well as contract development and manufacturing organization WuXi Apptec, describing them as “foreign adversary biotech companies.” The wording of the BIOSECURE Act claims that China is seeking to dominate biotechnology as an industry of the future.

The House has backed an updated version of the bill that includes a later deadline of January 31, 2032, for US companies to cut their ties with companies cited in the legislation, which include WuXi AppTec, BGI Group, MGI/Complete Genomics, and now WuXi Biologics, which was added in the latest draft. It would prohibit the purchase of equipment or contracting of services from the companies.

According to BIO CEO John Crowley, the new BIOSECURE legislation “highlights a key vulnerability in our global supply chain and provides a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing. It ensures during this transition that important biomedical research will not be slowed and that patients will have unimpeded access to life-saving medicines.”

The context here is that the results from a BIO survey of 124 biopharma companies found that 79% have at least one contract or product with a China-based or China-owned CDMO/CMO, and they’ll need up to eight years to switch manufacturing partners.

Life sciences companies doing business with WuXi AppTec, BGI Group, MGI, or Complete Genomics (entities specifically named in the legislation) as well as other potential biotechnology companies of concern (e.g., companies with ties to the governments of China, Russia, North Korea, or Iran), will want to monitor the developments of this legislation and assess in advance how to mitigate its potential effects.

Stay tuned…depending on the legislation’s final form and implementation, a range of companies could be forced to choose between forgoing relationships with biotechnology companies of concern or forgoing relationships with the federal government.

MichBio Helps Host Bio's Big Bold Idea 2025 Town Hall

MichBio helped host one of BIO’s (Biotechnology Innovation Organization) regional Town Halls as part of their Big Bold Idea 2025 Initiative. Held at the offices of Ann Arbor-based ONL Therapeutics (a member of both BIO and MichBio), some twenty emerging company and industry leaders from across Michigan gathered to share perspectives and solutions to the biggest challenges facing biotech and how to shape the future of the ecosystem.

Topics revolved around FDA and regulatory issues (real-world evidence, clinical trial innovation, digital health), capital formation and investment, access to medicines and payment models, intellectual property protection, and workforce development.

Feedback from such Town Halls will be used to create and promote a new, effective, forward-facing policy and advocacy platform in 2025.

MichBio Visits Capitol Hill for Bio Fly-In

MichBio traveled to Capitol Hill in mid-April under the auspices of the Biotechnology Innovation Organization (BIO) and its Council of State Bioscience Associations (CSBA, a consortium of state and regional trade associations representing their local biotech/pharma clusters). Representatives from Interactome Bio, Dykema, and NSF International joined MichBio in visiting offices of the Michigan Congressional Delegation to discuss the challenges and opportunities that their companies—and the whole life sciences ecosystem across the country—are currently confronting. 

Discussions focused on topics below among a few others.

1. The impact that changes in the R&D Expensing Rules (i.e., IRC Section 174) are having on Michigan businesses and the importance of changing back to the previous rule allowing 100% expensing in one year versus the current requirement to expense over 5 years.
2. Addressing the disparity in how small and large molecule therapeutics are treated by the price-focused provisions of the Inflation Reduction Act (IRA) and how the law currently disincentivizes the pursuit of secondary indications for orphan drugs.
3. How invoking march-in rights would imperil U.S. innovation and development of life-saving products (see separate section on Bayh-Dole).

Bayh-Dole Coalition Releases Video on Perils of Exploiting March-In

The Bayh-Dole Coalition, of which MichBio is a member, released a video to articulate the importance and efficacy of the Bayh-Dole Act. The video includes interviews with a variety of directors of technology transfer at leading biomedical research universities, including Johns Hopkins University, Washington University in St. Louis, Emory University, Duke University, Wake Forest University, Dartmouth College, Florida State University as well as the Association of American Universities.

The Biden Administration and others have been advocating for invoking march-in rights under the Bayh-Dole Act as a means to control the purported high cost of pharmaceuticals.

To view and share this video, click here.

FDA Issues Final Guidance on Device Remanufacturing

The FDA published final guidance that clarifies how companies can determine when their activities are remanufacturing, as opposed to servicing or repairs, and affirms remanufacturers may face agency inspections and other requirements imposed on device makers. A new section was added that lays out the regulatory requirements that apply to remanufacturers, aimed at entities less experienced with medical device regulation, including those who may consider themselves service providers.

Nevertheless, questions remain. For example, servicers will have to determine themselves whether their activities constitute remanufacturing. This might be difficult as they don’t typically have access to original equipment makers’ (OEMs) confidential data. Additionally, since device servicers are not required to register with the FDA, they will not be subject to routine inspections. Without access to OEMs’ confidential information about devices’ design, servicers may not be able to accurately self-assess whether they are conducting remanufacturing. Thus, it’s unclear how effective the agency’s oversight will truly be.

Medicaid Drug Rebate Program (MDRP) Proposed Rule is No Longer

The Centers for Medicare & Medicaid Services (CMS) announced, following input on the proposed rule for the Medicaid Drug Rebate Program (MDRP), that it will not be finalizing the proposal associated with stacking. The proposed MDRP rule would have required manufactures to “stack” all price concessions across the entire supply chain for a single unit of a medication, potentially increasing Medicaid rebate liabilities with inevitable broader ramifications for the 340B program and commercial markets.

To read the CMS statement, click here. The proposed change would likely have resulted in significantly increased rebate liability for pharmaceutical manufacturers.

While CMS has decided at this time not to finalize the proposed best price stacking rule, that does not mean it will not do so in the future – it plans to work with pharmaceutical manufacturers to collect additional information related to best price stacking methodologies to better understand and inform future rulemaking. 

Seed Fund Road Tour July 15, 2024

East Lansing, MI

Great Lakes Dates: July 15 - 19, 2025

America’s Seed Fund Road Tour is a national outreach effort to connect innovators and entrepreneurs to non-dilutive, technology funding opportunities provided through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, known as “America’s Seed Fund”.

MedTech Conference October 15-17

Toronto, Canada

Medical devices, diagnostics and digital technologies are making a significant impact on the lives of people around the globe. These advances are being made by scientists, entrepreneurs, academics, investors, and an entire community of medtech leaders and innovators. The MedTech Conference brings the community together and facilitates collaboration through panel sessions and inclusive networking events, providing the perfect setting for critical conversations.