Medical Innovation Exchange

Focus Article

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

How Real-World Evidence Helps Medical Device Manufacturers Drive Value     Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used …

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Best Practices and Pitfalls When Going from Concept to Commercialization

Best Practices and Pitfalls When Going from Concept to Commercialization     MedTech Internet of things (IoT) start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position …

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Connecting More Patients to Clinical Trials

Connecting More Patients to Clinical Trials     Improving diversity in clinical trials is a top priority in the life sciences industry, and rightly so. One-to-one representation of the population intending to use an investigational therapeutic is not just morally right, but also fundamental to its effectiveness. One of the biggest barriers to trials for underrepresented …

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Laying the Groundwork for an AI Breakthrough

Laying the Groundwork for an AI Breakthrough     Big data and artificial intelligence (AI) have been billed as “the next big thing” for more than a decade. Theoretically, these approaches present R&D groups in the medical device industry with enormous prospects. Realistically, many organizations have trouble realizing their full potential. Some businesses have resisted or …

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Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1     In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …

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Microbattery Advancements Will Unlock a New Wave of MedTech Innovation

Microbattery Advancements Will Unlock a New Wave of MedTech Innovation     Over-the-Counter (OTC) hearing aids are just one example of the disruptive changes underway in the world of hearables and medical remote-monitoring and fitness-tracking wearables. As of October, hearing aids are now available to buy in retail stores without a medical prescription throughout the U.S. …

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How Health Tech Can Combat the High Cost of Lifestyle Choices

How Health Tech Can Combat the High Cost of Lifestyle Choices     Lifestyle choices can be costly to patients, their insurance companies and to the American healthcare system in general. For instance, obesity-related healthcare costs top $190 billion each year, while inactivity adds another $117 billion to our annual bill. Even things we generally take …

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From Art to Science:  How Machine Learning Is Changing the Surgical Landscape

From Art to Science:  How Machine Learning Is Changing the Surgical Landscape     Robotic surgery has already proven its value in improving surgical outcomes. The next frontier is using data collection and artificial intelligence to help guide surgeons in the OR and develop surgical simulators that can expand and enhance training opportunities. We spoke with …

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Why Human Factors Engineering Matters in Medical Device Packaging

Why Human Factors Engineering Matters in Medical Device Packaging     Human Factors Engineering (HFE), also referred to as Usability Engineering (UE), is the application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users that are applied to the design of medical devices. These characteristics include mechanical and software-driven user interfaces, …

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Nudging Towards Safer Decision Making

Nudging Towards Safer Decision Making     In recent years, the impact of evidence-based decision-making on patient safety has been under close examination. Despite technological advances, the gap between theory and practice remains a challenge to both clinicians and allied health professionals. Due to the complexity and dynamics of health systems, ‘doing the right thing’ is …

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