Medical Innovation Exchange

Focus Article

How AI Can Advance Breast Cancer Detection and Treatment

How AI Can Advance Breast Cancer Detection and Treatment     In recent years, the synergy between technology and healthcare has ushered in an era of unprecedented progress, reshaping the landscape of disease detection and treatment in ways previously deemed unimaginable. Among the myriad of ailments, breast cancer stands as a formidable adversary, affecting women and …

How AI Can Advance Breast Cancer Detection and Treatment Read More »

Companion Diagnostics Regulations are Evolving in Asia

Companion Diagnostics Regulations are Evolving in Asia     Personalized medicine is experiencing a global surge in popularity, with Companion Diagnostics (CDx) products playing a pivotal role in facilitating this expansion. While CDx products are being used frequently in the West for personalized medicine, in the future, providers in Asia will also use more CDx products …

Companion Diagnostics Regulations are Evolving in Asia Read More »

Bringing Digital Health Products to the Global Market

Bringing Digital Health Products to the Global Market     In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …

Bringing Digital Health Products to the Global Market Read More »

Access Management Strategies: Best Practices and Emerging Trends for Cyber Security Teams

Access Management Strategies: Best Practices and Emerging Trends for Cyber Security Teams     Access management is an essential facet of cybersecurity and is quickly adapting to counteract the continuously shifting cyber threats. For cybersecurity professionals working in the medtech arena, staying updated on the latest trends in access management empowers them to make better choices …

Access Management Strategies: Best Practices and Emerging Trends for Cyber Security Teams Read More »

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 …

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

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. …

Reshaping of the Biotech M&A Landscape Read More »

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 …

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

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 …

MedTech Marketing Pearls for FDA Clearance and Beyond Read More »

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 …

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

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 …

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