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MichBio | BioLink – July 2022

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Michigan Medical Device Summit Registration is Now Open!
NEW THIS YEAR – SUPPLIER SHOWCASE
 
The Michigan Medical Device Summit is the annual gathering of the statewide medtech community. It is designed for attendees to learn about the latest in medical device technologies, regulations, and marketplace, and especially what Michigan’s cluster has to offer to those developing and manufacturing innovative medical products. Hear the state’s most outstanding medtech and related thought leaders share their perspectives on topics of the day.
 
Meet and network with medtech sector professionals, academic researchers, healthcare providers and clinicians, suppliers and contract manufacturers, professional services firms, investors, business leaders, government officials, and disruptive companies across all growth stages.
 
The Summit is intended to better connect and raise the visibility of Michigan’s large medtech cluster including its significant innovation and supply chain assets that are contributing to its steady growth and economic impact. New in 2022 is a showcase of Michigan firms supplying and serving the medtech community.
 
AGENDA INFORMATION IS COMING SOON!
Small Business Opportunities from the NIH
SBIR/STTR AWARD ASSESSMENT, FUNDING OPPORTUNITY & COMMERCIALIZATION PROGRAMMING
 
Phase I Technical and Business Assistance (TABA) Program Launches for 2022-2023: Request a Needs Assessment Report for Your SBIR or STTR Award
The NIH TABA Program helps small businesses identify and address their most pressing product development needs. And now, if eligible, you can submit a request for a FREE Needs Assessment Report that provides a third party, unbiased assessment of your project’s progress in four technical and business areas that are critical to success in the competitive healthcare marketplace.
 
Your company is eligible to participate if your Phase I NIH SBIR or STTR (grant, contract, or Fast-Track) 
  • is active or was active within the past two years, AND 
  • was not awarded TABA funding within the Phase I award budget, AND
  • has not already received a TABA Needs Assessment Report or NICHE Assessment for the same Phase I project.
Selection will be made on a first come, first serve basis.
 
Questions? Email the NHLBI Small Business Team at nhlbi_sbir@mail.nih.gov. To learn more, visit the NIH TABA Needs Assessment Website
 
Concept to Clinic: Commercializing Innovation (C3i) Program
Medical device innovators with active NHLBI small business grants are invited to apply to the National Institute for Biomedical Imaging and Bioengineering (NIBIB) C3i program! The 24-week C3i program provides participants with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Participants will learn how to:
  • Evaluate whether a compelling unmet market need exists for their proposed solution
  • Assess whether there is a viable business opportunity that can be built to meet this need
  • Build a compelling pitch presentation to secure support from potential investors and other business partners.
The teams will be guided through a series of lectures and interactive exercises, where they will pressure-test the commercial viability of ideas using universal business criteria as well as the unique requirements of medical device commercialization. Participants also work with experienced business advisors and subject matter experts who provide insights into the market sector, intellectual property, regulatory, and reimbursement requirements specific to their projects.
 
Applications for this year’s C3i cohort are due August 5th, 2022. For more information, visit the NIBIB C3i Program website
 
Administrative Supplements for Providing Technical and Business Assistance (TABA) Funding to SBIR/STTR Awardees (NOT-OD-21-062)
All NHLBI grantees with an active Phase I (R41/R43) small business award or a Fast-Track (R42/R44) award in the Phase I stage are now eligible to request up to $6,500 to support subcontracts or consultants that provide specific TABA services. Normally, small businesses include this budget request as part of the application and provide a detailed budget justification. However, small businesses may become aware of technical or business needs after receiving their Notice of Award that necessitate requesting TABA Funding through an Administrative Supplement.
 
Examples of technical and business services that can be supported by TABA Funding include, but are not limited to:
  • Assistance with product sales
  • Intellectual property protections
  • Market research and/or validation
  • Development of regulatory plans
  • Development of manufacturing plans
Eligibility is limited to grantees whose awards are not in a no-cost extension and did not already request TABA funding through their grant application.
 
Grantees who are interested in requesting an administrative supplement through NOT-OD-21-062 are strongly encouraged to contact Dr. Stephanie Davis at nhlbi_sbir@mail.nih.gov before applying.
 
 
New Funding Opportunity from the NIH: Small Business Transition Grant For Early Career Scientists
SIGN UP NOW
 
The National Cancer Institute (NCI) recently released a new funding opportunity for biotech companies and university researchers! The new Small Business Transition Grant funds the translation of technology from university to small business, as well as the transition of early career researchers from academia to industry. This award uses the Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) funding mechanisms, so you must be a small business concern at the time of application. If you are not familiar with the mechanisms, please refer to the attached overview factsheet for information on the two mechanisms.
If you are interested in applying for this Fast-track opportunity with a budget of up to $2.4 million, sign up for an informational webinar on July 21, 2022. READ MORE
 
 
 
 
 
 
 
 
 
 
 
 
FEDERAL ADVOCACY NEWS
 
UFAs Advance Slowly
Reauthorization of the FDA user fee agreement (UFA) package – that sets terms, conditions and costs for review of prescription drug (PDUFA), medical device (MDUFA), generic drug (GDUFA), and biosimilar (BsUFA) applications – is inching forward in Congress. In addition to codifying the agreements, these bills are often vehicles for other FDA policy changes. READ MORE
 
Senate Committee Advances PBM Transparency Legislation
The Senate Commerce Committee passed legislation, Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) , that is designed to address how PBMs control drug prices and can potentially reduce the amount independent pharmacies and consumers pay for medicine. READ MORE
 
Cybersecurity Front and Center for Feds
Congress is considering several pieces of legislation requiring the FDA to regularly update cybersecurity guidance and better coordinate efforts with other agencies to better safeguard of medical and healthcare technologies from digital threats.
 

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