Medical Innovation Exchange

Inga Hansen

New Cybersecurity Standards for Medical Applications

New Cybersecurity Standards for Medical Applications     An increasing number of pacemakers, insulin pumps and other medical devices incorporate software and can also connect to the Internet, hospital networks or smartphones. In this way, diagnostic data can be transmitted and evaluated in real time using for instance artificial intelligence (AI), thus allowing anomalies to be …

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PTC to Acquire SaaS Field Service Management Provider ServiceMax

PTC to Acquire SaaS Field Service Management Provider ServiceMax     PTC has signed a definitive agreement to acquire ServiceMax for approximately $1.46 billion. ServiceMax provides a suite of cloud-native, product-centric field service management (FSM) software and capabilities built on the Salesforce platform. These capabilities include managing all relevant information about serviced products—including product description, serial number, service history—creating and …

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Liver-Chip Successfully Identifies Drug Toxicity, Outperforms Animal and 3D Models

Liver-Chip Successfully Identifies Drug Toxicity, Outperforms Animal and 3D Models     Organ-on-chip technology can outperform animal models and could generate billions in increased R&D productivity, according to the outcomes of a study published in Communications Medicine (December 2022). For “Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology,” Lorna Ewert, et al, …

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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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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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MedTech Intelligence Announces 2023 Conference Series

MedTech Intelligence Announces 2023 Conference Series     Since 2010, MedTech Intelligence has produced valuable in-person conferences, and after three years of webinars, we are thrilled to bring back our in-person conference series to Washington, DC. The conference location brings in many high-level speakers from industry and FDA. Attendees can take advantage of networking opportunities, presentations …

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How MedTech Is Helping the Hearing Impaired

How MedTech Is Helping the Hearing Impaired     Hearing loss, both mild and severe, affects millions of people worldwide. The World Health Organization (WHO) suggests that around 2.5 billion people—or one in four—will live with some degree of hearing loss by 2050. With the help of technological innovations, medical professionals can now provide more people …

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FDA Highlights Exemptions for Real World Data-identified AEs

FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

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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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FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices

FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices     The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of Human Factors Information in Device Marketing Submissions” draft guidance offers a risk-based …

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