Medical Innovation Exchange

Manufacturing Execution

Connected Care: Overcoming Roadblocks and Identifying Opportunities

Connected Care: Overcoming Roadblocks and Identifying Opportunities     What’s next—and what’s holding us back—on the road to a truly connected healthcare system? On March 14-15, leaders in digital health will come together at the ConnectedCare Summit East in Washington, DC, to look at best practices, pitfalls and what we’ve learned so far on the road …

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Intricon Launches Biosensors Center of Excellence

Intricon Launches Biosensors Center of Excellence     Intricon, a developer and manufacturer of medical devices powered by smart miniaturized electronics, has launched a new Biosensors Center of Excellence (CoE). The center combines the company’s biosensor device expertise and capabilities into a vertically integrated business unit focused exclusively on bringing biosensor devices to the medical market. “OEMs and …

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Sustainability: Lessons from the Frontlines of Health Care

Sustainability: Lessons from the Frontlines of Health Care     Healthcare leaders today face the complicated test of transforming existing systems to create a social and natural environment in which our patient’s and communities’ wellbeing can thrive, while improving health care outcomes and increasing equity of care. As the global community focuses on issues of sustainability …

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King Joins KMM Group as Healthcare Industry Advisor

King Joins KMM Group as Healthcare Industry Advisor     J. Mark King, a long-time healthcare executive is the new Non-Executive/Non-Owner Chairman of the Board and Healthcare Industry Advisor for KMM Group. King has held numerous executive leadership roles in the medical device Industry, both in branded product lines and in contract manufacturing. Most recently, he …

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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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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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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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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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