Elizabeth Engler Modic, Editor

If there’s one thing the last 18 months has highlighted for manufacturers it’s that design and manufacturing projects need to be optimized from the beginning for consistent success. As some facilities slowed production of their typical product lines, many pivoted to producing a range of personal protective equipment (PPE) and other medical devices and equipment that were (and still are) in demand. It was also a time when companies took a close look at their current processes to determine where improvements could be made, what new technology they should add, and how best to implement these changes for more streamlined production as demand returned.

The U.S. Food and Drug Administration’s (FDA) stringent requirements for safety in medical devices and equipment require the production process be approved, but determining how is key to efficiently manufacture everything from face masks to surgical equipment. These decisions go beyond what machine to use, encompassing everything from design to material choice, components, testing, production, software, and the process; and traceability from start to finish.

This issue is filled with insights regarding where and how to optimize design and manufacturing, starting with the cover story. Alan Levine, managing director at Open Mind Technologies USA dives into how medical manufacturers can successfully manage the tools in their manufacturing workflow. The answer is using optimized NC programs that offer an extensive database for users to manage tools of all types – from drills and milling cutters to complex turning tools – which can all be mapped virtually and linked with data.

It’s also necessary to consider what process to use, discussed by Nigel Flowers, UK managing director of Sumitomo (SHI) Demag, as he examines additive manufacturing (AM) and injection molding, noting how each has distinct advantages and when used for the right application, they complement each other nicely.

EOS’ Global Medical Development Manager Laura Gilmour and Global Key Account Manager Fabian Krauss weigh in on producing products via AM and consider material choices. EOS’ patented 3D-printed flexible lattice, Digital Foam, delivers fine-turned, customized products – from orthotics to prosthetics and more. But how do you know if the material and approach is the right fit? Don’t just attempt it by using a file for subtractive and applying it to AM; testing it on a new project can lead to the best success.

What components can help the Internet of Medical Things (IoMT) achieve full potential? InnoPhase’s Talaria TWO platform delivers low-power Wi-Fi, extended battery life, and direct-to-cloud connectivity, enabling design engineers to add more intelligence and functionality to IoMT devices.

Enterprise resource planning (ERP) systems are the backbone of operational excellence – so turn to page 18 to learn the six key capabilities medical device manufacturers should look for in their ERP systems to support shifting business models and requirements.

Staying current on the best available machine, software, components, materials, and other solutions is essential to continually produce the safest medical devices in the most efficient manner.