Boston MedTech Advisors’ Post

The journey to reimbursement for medtech devices is accelerated with expert advice - have you considered using an advisory board?

AdvaMed Applauds Bipartisan Senate Letter Urging CMS to Establish a Reimbursement Pathway for AI-Enabled Medical Devices Scott Whitaker, president and CEO of AdvaMed said: “Ensuring patients have access to innovative AI-enabled clinical technology requires a formalized Medicare reimbursement pathway to provide manufacturers the certainty to deploy technology and providers the ability to invest in it. AdvaMed applauds these Senators for their commitment to ensure seniors benefit from proven medical innovation and looks forward to working with the Congress and CMS to realize the promise that FDA cleared, AI-enabled clinical technology can have to improve patient care.”   Read more here: https://hubs.li/Q02CDX2f0 #advamedmember #advamed #AIDevices

Strategic consultation can help your clinical trials reach their full potential.  Learn how our experience solves patient recruiting and retention difficulties to provide strong results for medical device approval. Explore data-driven strategies and patient-centric approaches. Reach out to us and elevate your trial success! 📩 info@gcp-service.com #ClinicalTrialConsulting #MedicalInnovation #HealthcareStrategy #ClinicalTrials #ClinicalResearch #MedicalDeviceManufacturers

🚀 Accelerating Time-to-Market: Strategies for Medical Device Companies 🏥 In the fast-paced world of healthcare, the demand for innovative medical devices is constantly on the rise. To stay competitive and meet the evolving needs of patients and healthcare providers, medical device companies must focus on accelerating their time-to-market. A swift and efficient product development cycle not only ensures a competitive edge but also allows companies to address critical healthcare challenges in a timely manner. In our latest blog post, we explore strategies that can help medical device companies expedite their time-to-market processes. Check it out to learn more about how you can streamline your development cycle and make a significant impact on healthcare. https://lnkd.in/g8aE8QCH

Sharing my latest video covering the answer to a question that I am most frequently asked by clients...... ""What clinical evidence is required for a successful medical device reimbursement application?" Hope you found it useful. See video in post below ⬇ #clinicalevidence #marketaccess #medicaldevices #womeninstem #medtechniqueconsulting

Medical Device Recall Improvement Act. Congress has given a spotlight attention to an unmet need in the business! Specifically, the Medical Device Recall Improvement Act would: - Require FDA to establish an electronic format for medical device recall notifications; - Require medical device manufacturers to use the electronic format to contact FDA and hospitals and health providers; and - Require medical device manufacturers to include information in recall notifications about the risks of the recalled device, and instruct hospitals and health providers to distribute the information to patients.

In the medical industry, patient safety is paramount. That's why rigorous validation testing is important to ensure your medical devices perform as intended and meet strict regulatory standards.   MFG One's validation testing services safeguard your innovation, minimize risks, and build trust with healthcare professionals and patients.   Trust us to validate your medical device. Your patients deserve nothing less.   ---> https://lnkd.in/eYbqWkU8   #ValidationTesting #MedicalDeviceManufacturing #MFGOne

✨ Do’s and Don’ts for Crafting Medical Product Claims ✨ Do you want to elevate your medical product and succeed in the fast-moving healthcare market? Crafting meaningful, realistic, and evidence-based claims is essential for effectively marketing a medical product. But how do you ensure you are making the right claims? Check out the document for some key do’s and don’ts. This will help you ensure that your medical device claims are legally compliant, truthful, and effective in conveying the right message to healthcare professionals and patients alike. Want to know more? At xQlaim, we help MedTech companies develop and optimize their medical claims to meet customer needs, market trends, and regulatory standards. Contact us or visit our website: www.xqlaim.com. #Medtech #MedicalDevices #RegulatoryCompliance #EvidenceBased

The MDIC Commercial Payer Council's Q2 Key Insights Summary is now available! Dive into the latest discussions on the impact of Utilization Management on #healthequity and the influence of new #obesitydrugs on reimbursement and coverage in the medical device industry.  https://lnkd.in/ex3DGZPg Learn more about MDIC's Commercial Payer Council at https://lnkd.in/eC9HN6c3

The medical device landscape just shifted significantly. The Biden administration finalized a plan for Medicare to offer temporary coverage for cutting-edge devices, even while further research is conducted. This is a major win for patients, especially seniors, who will gain faster access to potentially life-altering technologies like AI-powered diagnostics and advanced implants. Effectively communicating this new pathway to patients will be critical, ensuring they understand both the potential benefits and the ongoing data collection process. Check out more from Axios https://lnkd.in/eefuraYH #MedTech #Medicare #HealthcareInnovation #HealthPolicy #MedicalDevices #Communication