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Medical Device

Business Strategy

How Should MedTech Prepare for the Future?

In MedTech, are your company’s development, manufacturing, quality, and compliance processes keeping pace with your peers? We are researching MedTech processes for bringing new products and devices to market. The survey asks about top challenges and approaches to common processes based on your role. The survey also looks at the current status of digital health,…

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  • Survey Invitations

Michelle Boucher - December 16, 2025 - Filed Under: Research Invitations, Survey Invitations - Tagged With: Survey, Engineering, Product Development, Collaboration, MedTech, Quality, Digital Health, Medical Device, Regulation, Digital Thread, Case for Quality, Medical Device Manufacturing, Compliance

MedTech Buyer's Guide

Buyer’s Guide for MedTech

What will help MedTech companies stay competitive in an era marked by rapid innovation, rising regulatory complexity, and global disruption?  As the industry moves toward smarter, more personalized, and increasingly connected healthcare, MedTech manufacturers face mounting pressure to reduce time to market, improve patient outcomes, control costs, and ensure compliance without sacrificing quality or patient…

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  • Buyer's Guides

Michelle Boucher - September 17, 2025 - Filed Under: Published Research, Buyer's Guides, eBooks - Tagged With: PLM, ALM, Medical Device, MedTech, Regulatory Compliance, Buyer's Guide

MedTech ALM and PLM

MedTech: ALM and PLM Better Together

What should MedTech companies consider when integrating ALM and PLM? Software has become a crucial component in MedTech products. However, with software development managed in Application Lifecycle Management (ALM) and hardware managed in Product Lifecycle Management (PLM), the separate systems can create silos within the product development team. With increasing regulatory pressures and trends such…

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  • Webinars

Michelle Boucher - May 20, 2025 - Filed Under: Webinars, Presentations & Videos - Tagged With: Compliance, PLM, ALM, Digital Thread Integration, Medical Device, MedTech, Embedded Software, Digital Thread, Med Device

Medical Device Innovation

Enlil Focuses on Accelerating Medical Device Innovation with Compliance

We were recently alerted to a company we weren’t covering because a long-time business friend took a key position there. After a quick review of what they do, Julie Fraser and Jim Brown decided to team up on the briefing because we could already see a combination of QMS and PLM capabilities. We learned that…

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  • Insights

Jim Brown - May 12, 2025 - Filed Under: Insights, Insights & Activity - Tagged With: Product Innovation, Medical Device, Traceability, Approval, FDA, Compliance, MedTech, PLM, Class 2, Product Development, Class 3, Manufacturing, Clearance, NPD, Quality Management

Connected Medial Devices

How Connected Medical Devices Will Revolutionize Healthcare

Will connected medical devices make the Star Trek medical tricorders a reality in healthcare? A few decades ago, Star Trek’s tricorders were complete science fiction – only in the imagination could a device perform a simple scan and offer a full medical diagnosis of any ailment. While we may not be quite there yet, today’s…

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  • In the News

Michelle Boucher - June 11, 2024 - Filed Under: In the News, Insights & Activity - Tagged With: Product Innovation, Connected Devices, Medical Device, Healthcare, Life Sciences, Smart Products, IoT

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