How to take a medical device design through to manufacturing

31st March 2023
Kiera Sowery

Bringing a new medical device to market can be lengthy, complex, and expensive so it is vitally important to reduce risk as much as possible.

The ESCATEC Group is an integrated Electronics Manufacturing Services (EMS) provider with a long history of successfully bringing such products to market for its customers. ESCATEC has now condensed this experience into a free guide that provides a detailed overview for MedTech companies wanting to create such products.

ESCATEC’s Stefan Beer, Project Manager, explained: “The pace of new discoveries in this area keeps accelerating creating new product opportunities and to remain competitive, companies need to move fast to capitalise on them. A recent survey found that MedTech product cycles have become 50% faster over the past five years. However, regulations are becoming stricter to ensure safety and reduce product recalls as, in 2021, reportedly there were 2607 FDA product recalls affecting millions of units and costing manufacturers significant sums. That’s why we wrote this guide, so that companies understand how to launch a new device first and fast with minimal risk but, more importantly, one that is fully compliant with all the various complex regulations.”

The free guide covers how to choose a design partner for faster New Product Introductions (NPIs), the regulatory requirements for medical devices, variations in regulations around the world, and the various stages of design through to volume production.

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