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MedTech Intelligence

Volume 15 Issue No. 21


Developing Sustainable Medical DevicesDeveloping Sustainable Medical Devices

By MedTech Intelligence Staff

At Device Talks Boston in May, Ronald Kurz, Sr. Director and GM at Canon Virginia, Kathryn Unger, Sr. Mgr. of Global ESG Communications at Boston Scientific, and David Ettl, COO at Gradian Health System, addressed the question, how can we make medical products sustainable?


Critical Manufacturing - MES & Industry 4.0 | September 7-8, 2023

Featured Articles


Wearable Design Challenge:
Stick-to-Skin Adhesion

By Bret Ludwig, Ph.D., 3M

An adhesive developer explains why skin is so challenging to adhere to, why it’s never too early to explore skin-adhesive options for your wearable device, and recent milestones in stick-to-skin adhesive longevity.


Rimsys Regulatory Management SoftwareRegulatory Strategy as Competitive Advantage

Sponsored By Rimsys Regulatory Management Software

Most MedTech companies treat regulatory affairs as an operational cost center, which prevents them from realizing the potential of a bigger-picture regulatory strategy and creates friction between regulatory and go-to-market teams. In this webinar, Bruce McKean, Director of Regulatory, and James Gianoutsos, Founder and CEO, of Rimsys Regulatory Management Software, share how improved regulatory performance can speed time to market, reduce operational costs and help companies capture market share when new regulations are implemented.

Stream Now!

FDA CDRH Portal Now Offers Tracking of Pre-Submissions

By MedTech Intelligence Staff

The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.

Rimsys - 2023 MedTech Regulatory Performance Report

Process and Planning Are Key to Successful EU MDR PMS Compliance

By Jonathan Ripley, IMed Consultancy

In spite of continuing delays to implementation deadlines for EU MDR/IVDR, post-market surveillance requirements are currently in force. Hence, manufacturers need to urgently establish a PMS system to identify potential nonconformances and safeguard users and patients.

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly, Keysight Technologies

Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.

MedTech Library

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech ResearchTerumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Sponsored By Veeva Medtech

Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business.

Drive Healthcare Transformation with Enterprise-Level InfrastructureDrive Healthcare Transformation with Enterprise-Level Infrastructure

Sponsored By Arrow and Dell Technologies

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM Solutions portfolio can match any healthcare need.

2023 MedTech Regulatory Performance Report2023 MedTech Regulatory Performance Report

Sponsored By Rimsys

The 2023 MedTech Regulatory Performance Report provides insights and process benchmarks from a survey of 200 medtech regulatory professionals across North America and Europe. The report explores regulatory staffing and team size, workload and average times to complete regulatory projects, compliance issues and costs, and the role of technology and digital transformation.

All Available Resources
Upcoming Events & Webinars

MedTech Intelligence 2023 Washington DC Conferences

More info at MedTechIntelligence.com

November 7-8
MedTech Intelligence Advanced Manufacturing Conference
Join leading MedTech engineers and manufacturers as we take an in-depth look at the use of advanced manufacturing technologies in quality improvement, speeding time to market and combating labor shortages, and share insights on what’s working, implementation challenges and strategies for successful adoption.

November 8-9
MedTech Supply Chain Intelligence Summit
Gain insight and strategies from procurement professionals, device manufacturers and regulators on how to assess and mitigate risks to the supply chain, improve logistics, and build and maintain a sustainable, resilient supply chain.

November 13-14
MedTech Regulatory Intelligence Summit
The MedTech Regulatory Intelligence Summit brings together RA/QA professionals, device developers and regulators to share experiences and best practices, and find solutions to the key pain points in achieving regulatory compliance throughout the product lifecycle.

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