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.
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.
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.
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.
Due to a shortage of radiologists and other imaging specialists, AI-enabled technologies are of significant interest—and hold particular promise—in medical imaging. In this article, Penny Pinnock of Siemens Financial Services (SFS), discusses the routes to investment available for healthcare organizations looking to acquire efficiency boosting technology while protecting their financial health.
Typically, costs are reduced by using less material and floor space, and eliminating any specialty equipment required for handling large or heavy parts. For miniature devices, the equation is reversed.
Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.
Embracing certification leads to enhanced product quality, innovation, and customer trust.
The new equity guide provides implementation steps to help developers and users implement the AHRQ Digital Healthcare Equity Framework to ensure new technologies ameliorate, rather than exacerbate, inequities in health care.
Information polarization affects public opinion. It can also affect investors. As we approach upcoming elections in different countries, it is crucial to understand how these political events could significantly reshape the landscape for MedTech investments. This article outlines an approach to help investors navigate and understand the interplay of political climates, cultural norms, and healthcare policies without getting emotionally attached to them. It emphasizes the importance of open dialogue, diversity, critical thinking, and cross-cultural collaborations to determine the true potential of MedTech innovations.
