Bridging Regulatory & Reimbursement

Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success

By Christy Sheehy, PhD, Jenny Levinson
Bridging Regulatory & Reimbursement

As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.

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Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus
Post-market surveillance

As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.

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Nicole Coustier

Reimbursement Déjà Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry

By Nicole Coustier
Nicole Coustier

Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.

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Healthcare Technology

The Role of EPSS in Prioritizing IoMT Security Threats

By Shankar Somasundaram
Healthcare Technology

The Exploit Prediction Scoring System (EPSS) can help healthcare organizations prioritize security vulnerabilities, but it has limitations in IoMT environments. While EPSS provides valuable data-driven prioritization, it should be combined with other risk assessments, cybersecurity frameworks, and strategies to more comprehensively secure healthcare systems’ IoMT devices.

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Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff
Errol Weiss

Information Sharing and Analysis Centers (ISACs), developed to help critical infrastructure industries prevent and become more resilient to cyber and physical security attacks, are expanding their strategies to meet ever-evolving threats. Errol Weiss, Chief Security Officer of the Health-ISAC, discusses how these groups work to protect industry, emerging threats and how device developers and healthcare organizations are working together to protect patients.

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