Chrysalis Incubator

Insightful comments on reimbursement from Jason Fontana at Medtronic: “The good news is when you’re designing the device around clinical efficacy and safety, those are the key things that payers are looking for as well,” he continued. “They want demonstration of efficacy. For renal denervation it’s blood pressure reduction and then does that blood pressure reduction lead to long-term positive impacts — reducing stroke and [myocardial infarction] — and is it safe? So they’re thinking about it from a population dynamic: When you put this device in my population, is the impact going to be positive?” “The advice I would give to folks that are designing new technology is to think about those three pieces,” he concluded. “Think about making sure you have a safe and effective device, making sure it’s got good short- and long-term clinical data, and then really thinking about how that clinical data impacts a broader population, because that’s going to be your payer dynamic.” Read more: https://lnkd.in/gFkVnz5K.

?? Bringing Medical Innovation to Market ?? Turning a groundbreaking medical device idea into a market-ready product requires strategic planning, regulatory know-how, and a solid IP and commercialization strategy. Join us on Wednesday, April 23rd at 12:00 PM CT for a complimentary webinar featuring industry experts who have successfully navigated this journey: ?? Darryl B. – CTO of Sonex Health & MedTech entrepreneur ?? Brendon Pittman – Chief Commercial Officer at Crossfire Medical ?? Mark Gardner, MBA, Esq. – Founder & Managing Partner of Gardner Law, and an FDA regulatory expert ?? Benjamin Tramm – Chair of the Electrical & Software Practice Group and Partner at Merchant & Gould P.C. Together, they’ll share insights on: ? Identifying unmet medical needs ? Building a strong IP strategy ? Creating a winning marketing plan ? Navigating regulatory & legal pathways Whether you're an innovator, entrepreneur, or investor, this is your chance to learn from the best! ?? Read more & Register: https://lnkd.in/gYgruxzT #MedicalDevices #MedTech #Innovation #StartupSuccess #IPStrategy #RegulatoryCompliance #Marketing #HealthcareTech

Recent developments at the FDA and HHS could impact your business. Here’s what you need to know:? - FDA Layoffs: Staffing cuts at the FDA, particularly in areas like medical devices and food safety, could lead to delays in reviews and inspections.? - RFK Jr. at HHS: With Robert F. Kennedy Jr. now leading HHS, expect potential shifts in FDA oversight, including stricter regulations on vaccines, clinical trials, and food additives.? - Dr. Marty Makary's Potential FDA Appointment: If confirmed as FDA Commissioner, Dr. Makary could push for more transparency and reform, particularly in medical device approvals and drug pricing.? - Government Shutdown Risk: A looming government shutdown could disrupt FDA operations, especially in inspections and compliance enforcement. Stay ahead of these changes and learn how they could affect your business. Read the full article for key insights: https://lnkd.in/g4uVi76d #FDALayoffs #RFKJr #FDALeadership #DrMartyMakary #RegulatoryChanges #MedicalDevices #Pharmaceuticals #Food #FDACompliance #HealthcareRegulations #GovernmentShutdown #FDAUpdates?

It's shaping up to be a busy year on the Medtech M&A front! https://lnkd.in/gHqqdP6P

We are thrilled to announce the launch of Chrysalis, a new MedTech-focused incubator dedicated to empowering inventors to turn their life-changing ideas into reality. ? At Chrysalis, we provide hands-on expertise to guide entrepreneurs through the intricate process of bringing their products to market. This includes early assessments of clinical needs, market potential, intellectual property (IP), and regulatory pathways. ? Together, we have successfully guided numerous MedTech startups to successful product launches and exits. We are excited to offer comprehensive support to inventors at every stage of their journey. Our exceptional team of founders and partners includes: ? Mark Gardner, MBA, Esq.: Founder and Managing Partner at Gardner Law, with extensive experience in guiding MedTech startups. Darryl B.,: Founder and CTO at Sonex Health, Inc. A physician-entrepreneur, executive, and inventor with over 20 patents, passionate about developing minimally invasive surgical solutions. Brendon Pittman, MBA: Marketing professional with extensive experience in product development and commercialization, having worked in both startups and large companies. Benjamin Tramm, Esq.: Partner at Merchant & Gould P.C. and intellectual property attorney with a proven track record of securing valuable IP, including hundreds of medical device patents. ? While we will continue to fulfill our current responsibilities, we are also excited to embark on this new venture. We are thrilled to take on both of these exciting challenges. ? Visit our website at?www.chrysalisincubator.com. #Medtech #Innovation #Healthcare #Startup #Incubator #Entrepreneurship