Medical Innovation Exchange
Event Registration
Menu

Focus Article

Successful Development, Approval and Deployment of Digital Health Solutions

Leave a Comment / Compliance Management, connected care, Digital Health, end user, Focus Article, Health Data, interoperability, Manufacturing Execution, Medical Device, MedTech, Quality/Regulatory, RC - Device Design & Manufacturing, regulatory compliance, software design / By

Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is …

Successful Development, Approval and Deployment of Digital Health Solutions Read More »

Reshaping of the Biotech M&A Landscape

Leave a Comment / biotech, Digital Health, Focus Article, Medical Device, MedTech, MedTech Economics, mergers and acquisitions, orphan drugs, patents / By

Reshaping of the Biotech M&A Landscape     The biotechnology industry has always been marked by innovation, rapid technological advancements and a drive to prevent, treat and cure disease. The prospect of mergers, acquisitions and joint collaboration deals with larger pharmaceutical giants has always served as fuel for the aspirations of small and mid-sized biotechnology companies. …

Reshaping of the Biotech M&A Landscape Read More »

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

Leave a Comment / aesthetics, breast implants, dermal fillers, EU MDR, Focus Article, intended use, lasers, Market Access, Medical Device, MedTech, Quality/Regulatory, RC - EU MDR and IVDR, RC - Medtech Regulatory Resource Center / By

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose     Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose Read More »

MedTech Marketing Pearls for FDA Clearance and Beyond

Leave a Comment / device marketing, digital media, Focus Article, Market Access, Medical Device, MedTech, MedTech Economics, new product introduction, opinion leaders, Soapbox / By

MedTech Marketing Pearls for FDA Clearance and Beyond      Product marketing touches every function of a MedTech organization. I often describe it as the central spoke of the wheel, or the business lead that directs and guides each function in critical ways. Marketing know-how keeps a company ahead of market trends and perceptions. These insights …

MedTech Marketing Pearls for FDA Clearance and Beyond Read More »

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi

Leave a Comment / enablement, Focus Article, Medical Device, MedTech, MedTech Economics, patent claims, patent law, PRALUENT, Product Design & Development, RC - Device Design & Manufacturing, REPATHA, scope, Thomas Edison, U.S. Supreme Court / By

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi     On May 18, 2023, biotech innovation suffered at least a temporary setback in Amgen v Sanofi in which a unanimous Supreme Court affirmed the rulings of the district court and the Court of Appeals for the Federal Circuit holding that Amgen’s challenged patent …

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi Read More »

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi

Leave a Comment / enablement, Focus Article, Medical Device, MedTech, MedTech Economics, patent claims, patent law, PRALUENT, Product Design & Development, RC - Device Design & Manufacturing, REPATHA, scope, Thomas Edison, U.S. Supreme Court / By

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi     On May 18, 2023, biotech innovation suffered at least a temporary setback in Amgen v Sanofi in which a unanimous Supreme Court affirmed the rulings of the district court and the Court of Appeals for the Federal Circuit holding that Amgen’s challenged patent …

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi Read More »

Partnering to Support Sustainability in the OR

Leave a Comment / environmental impact, Focus Article, HCPs, Medical Device, MedTech, MedTech Economics, or, packaging, Product Design & Development, RC - Device Design & Manufacturing, recycling, reuse, single-use devices, Sustainability, transportation, waste diversion / By

Partnering to Support Sustainability in the OR     A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President of U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how …

Partnering to Support Sustainability in the OR Read More »

The MDR Deadline Extension: Use the Time Wisely

Leave a Comment / Class II devices, EU MDR, Focus Article, Medical Device, MedTech, notified bodies, Product Design & Development, Quality/Regulatory, RC - EU MDR and IVDR, RC - Medtech Regulatory Resource Center, state of the art, testing / By

The MDR Deadline Extension: Use the Time Wisely     On March 15, 2023, the European Parliament amended the original Medical Device Regulation (MDR) to lengthen the compliance period for certain medical devices and in vitro diagnostic devices. The move provides device manufacturers with additional time to prepare their products for market and offers a buffer …

The MDR Deadline Extension: Use the Time Wisely Read More »

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

Leave a Comment / compliance, cybersecurity, Digital Health, Focus Article, ISA/IEC 62443, Medical Device, medical device software, MedTech, Product Design & Development, Quality/Regulatory, RC - Device Design & Manufacturing, RTA, SOBM / By

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials     In recent years, more and more medical device manufacturers (MDMs) have come to rely on software bill of materials, or SBOMs. Some do this to help track licensing while others do so as part of a product vulnerability management process. In …

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials Read More »

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

Leave a Comment / computer system validation, CSA, Digital Health, Focus Article, least burdensome approach, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, sostware testing, Therac-25, verification / By

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach     Now that the FDA guidance on computer software assurance (CSA) is available, life sciences companies that have struggled with traditional computer system validation (CSV) are eager to adopt it, and it’s easy to understand why. The modernized framework is designed to help manufacturers achieve CSV more …

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach Read More »

Quick links

MedTech Minds
FDA Courses
Forum
News
About
Contact
 
 

Newsletter

Linkedin Meetup Twitter Instagram

Quick Links

MedTech Minds
FDA Courses
Forum
News
About
Contact

Newsletter

Linkedin Meetup Twitter Instagram

 Medical Innovation Exchange @ Copywrite 2021. All Rights Reserved.