Medical Innovation Exchange

Soapbox

Tackling Go-To-Market Challenges

Tackling Go-To-Market Challenges     The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …

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Risk Management Is More Than a Spreadsheet

Risk Management Is More Than a Spreadsheet     In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …

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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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Pharma Needs a New Class of CRM Solutions

Pharma Needs a New Class of CRM Solutions     Today’s pharma companies face three primary challenges in their efforts to engage with their customers. There are more ways than ever before to engage—and as the response to the pandemic showed, digital engagements play an increasingly vital role. There are more stakeholders to engage than ever …

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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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Life Sciences Labeling for Patient Safety

Life Sciences Labeling for Patient Safety     Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …

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Improving Image Integrity in Clinical Research

Improving Image Integrity in Clinical Research     Clinical research is the foundation upon which breakthroughs in medical devices and pharmaceuticals are built. To bring a novel therapy to market, researchers must collect data and publish sufficient evidence proving that the product meets its intended purpose. The evidence shared in clinical research must be accurate, or …

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A Single Source of Truth Helps Regulatory Teams

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step of bringing a medical device or drug to market. Because of the essential role they play, these teams need advanced tools to keep pace with the latest regulatory bodies and standards. Legacy technology that siloes data across different pillars isn’t …

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Prognosis: Medical Device Security Needs Improvement

Prognosis: Medical Device Security Needs Improvement     The Internet of Things (IoT) has brought many improvements to the healthcare industry. Connected devices make it easier to track hospital resources, transfer critical data and enable telemedicine, but the industry’s increased reliance on these tools raises new concerns. Most notably, device developers, hospitals and regulators have fallen …

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AI Applications

AI Applications     Of all the healthcare data available, medical imaging is among the richest. In terms of clinical indicators, imaging data contains a tremendous amount of valuable information that’s easily identifiable, as well as so much that’s not visible to the human eye. And because most patient’s healthcare journeys begin with a diagnostic image …

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