Medical Innovation Exchange

Focus Article

Successful Development, Approval and Deployment of Digital Health Solutions

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 …

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Reshaping of the Biotech M&A Landscape

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. …

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

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 …

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MedTech Marketing Pearls for FDA Clearance and Beyond

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 …

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

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 …

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

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 …

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Partnering to Support Sustainability in the OR

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 …

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The MDR Deadline Extension: Use the Time Wisely

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 …

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

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 …

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Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

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 …

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