Reimbursement Report

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD

More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

Soapbox

The Turing Test is Dead

By Ravi Komatireddy, M.D., Daytona Health

The world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” When we look at the growth of AI in health care, I say let’s also include a 21st-century addendum, “Do not deceive.”

The Med Tech Supply Chain:
Challenges and Strategies

Sponsored By Rootstock Software

Mark Benson, VP of Medical Device Supply Chain at Johnson & Johnson, Steve Chakrabarty, MBA, Global Supply Chain, BD, and Raj Badarinath of Rootstock Software discuss the implications for global supply chains, just-in-time inventory management and their shortcomings in the face of disaster, as well as strategic changes medical device companies are making to build robust and resilient supply chains without sacrificing economy and efficiency.

Stream Now!

Connecting More Patients to Clinical Trials

By Andrew Mackinnon, Medable

Connected sensors are a key component to improving patient access to and patient retention in clinical trials. Following are considerations for developers and sponsors when designing and selecting sensors for use in trials.

FDA Issues Final Guidance on Surveying, Leveling,
and Alignment Laser Products

By MedTech Intelligence Staff

The guidance defines SLA and non-SLA laser and provides information on how to request a variance or exemption from SLA class limits.

Cleeland Joins Francis Medical Board of Directors

By MedTech Intelligence Staff

“Francis Medical has a powerfully simple and differentiated technology, supported by an outstanding team. I’m excited to add my knowledge and experience to the group and make a meaningful impact as we strive to bring this transformational technology to urologists and their patients.”

Featured Quote

In the case of a new manufacturing plant, or a new production line within an existing plant, Annex 1 requires that companies apply the latest cleanroom technology and that human intervention is removed wherever possible.

— Anna Cluet - Rephine

Supplier Quality as Competitive Advantage:
Perspectives from PwC, Cardinal Health, and Veeva

Sponsored By Veeva Medtech

To address today’s supply chain challenges and ensure quality products it’s critical to have a robust quality management system. Download this article featuring PwC and Cardinal Health for insights on building a business case and supporting digital transformation goals.

AI Medical Device Software Under the MDR

Sponsored By DNV

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

The Post-Market Gambit: After EU MDR and IVDR:
A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.