Dhirti Roy
Dhirti Roy

Ask the Expert: Benefits and Challenges of the eStar Submission Process

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

Continue reading

Stu Johnson
Stu Johnson
Soapbox

The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation

By Stu Johnson

As with most industries experiencing steady growth, the medtech market faces several challenges, including supply chain issues, price inflation on materials and energy, labor shortages and increasing regulations. Adopting cloud-based digital solutions can help address these challenges. For companies investigating new solutions, the State of Manufacturing Technology survey can serve as a valuable benchmarking tool.

Continue reading

Warren Lesack
Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack

EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

Continue reading

Doug Donahue
Doug Donahue

Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico

The growth of the medical device industry brings increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. In this column, Doug Donahue, Director of Foreign Direct Investment and Manufacturing for Guanajuato’s Medical Device Cluster and co-managing partner of Entrada Group, discusses the benefits, challenges and opportunities available for companies investigating Mexico as a manufacturing site.

Continue reading

Renée Bailey
Renée Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By Renée Bailey

Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.

Continue reading