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Medical Manufacturing Gets Personal

Medical Manufacturing

Personalized care—via patient-specific medical devices, for example—is driving innovation in medical product design and manufacturing. But now is not the time to lose sight of what you need from your suppliers.

Mark Shortt
Editorial Director
Design-2-Part Magazine

Technology is bringing big changes to the medical industry, and it's happening fast. Consumer electronics are making their presence felt in the medical device industry by giving individuals more control over their healthcare and making personal health information immediately accessible to healthcare professionals in real time. Efforts to improve diagnosis are fueling a push toward the development of cutting-edge molecular diagnostics devices that will enable more precise, accurate, and sensitive testing for mutations, diseases, and conditions. And a number of technologies are contributing to the growing use of 3D printing to make patient-specific medical devices that replace “one-size fits all” products with solutions individually tailored to a patient's unique needs.

One of the most transformative changes sweeping the industry today is the “consumerization” of healthcare, evidenced by the medical industry's growing adoption of consumer electronics technologies in an effort to give patients a more active role in managing their own health. Mobile devices are morphing into mobile health (mHealth) devices as wireless technologies enable healthcare professionals to remotely monitor patients via their smartphone or other connected devices, which enable real-time views of a person's health status. The aim is to provide better treatments based on timely, patient-specific information. We're really only seeing the beginning of mobile health devices, which Lux Research estimates will grow from a $5.1 billion market in 2013 to $41.8 billion in 2023.

The demand for—and successful delivery of—individually customized medical devices, including patient-specific implants for the hip, knee, face, spine, foot, and ankle, is also gaining momentum. Major enablers of patient-specific medical implants include software tools that allow designers to do freeform modeling beyond the confines of traditional CAD, so that they're able to work with organic shapes that more closely mimic the natural shapes and contours of the human body; haptic interface and force feedback tools tied to CAD; and 3D printing in biocompatible metals, including titanium and various titanium alloys, cobalt chrome, and some stainless steels.

But as products with new design challenges emerge, medical device OEMs aren't changing their requirements for quality, functionality, and aesthetics—or for shorter lead times. At a time when technology brings constant change, some things—like face to face interaction, attentive customer service and support, continuous improvement, and deep technical knowledge and experience—haven't gone out of style. Nor have Design for Manufacturability or the need for high-level engineering.

John Zeis, president of the Plastics and Single Use Disposables Business at Foundry Medical Innovations, Carlsbad, Calif., said in an interview that the development of diagnostics products, as well as other devices, brings with it a number of technical and regulatory challenges, as well as the need to maintain open lines of communication and interaction among different stakeholders.

“You've got the scientists that are developing the assay in the diagnostic product, and then the engineers that are developing the device, and there are a lot of interactions that have to go on between the two groups,” he said. “And then you've got the user that's going to end up using the device. There's always going to be this whole trade-off between the science, the engineering, and the user that needs to go on continuously during development. If you don't have that, it's not going to be the optimal way to develop the product, and you might not develop the best product. So it's very important that the whole group is always available to each other.”

Compliance with regulatory requirements is an absolute must-have. The RoHS and REACH regulations, for example, challenge manufacturers to understand the substances contained in their products. Whether the regulations restrict certain hazardous substances (RoHS) in electrical and electronic equipment, or require registration, evaluation, and authorization of chemicals (REACH), you should work with suppliers who have in-depth knowledge of, and the ability to help meet regulatory requirements.

The need to carefully select a manufacturing partner or supplier has never been greater. Here's a sampling of things to consider when choosing a company — whether a product design firm or a manufacturing services provider — that can meet your strictest requirements for quality, short lead times, and cost-competitive services.

10 Key Things to Look for in a Supplier

Quality certifications: ISO 9001:2008, ISO 13485:2003

Ability to meet regulatory requirements

History of making parts for the medical industry; deep knowledge and experience

Short lead times

Convenient location; opportunities for face-to-face interaction

High-level design and engineering in-house

In-house toolmaking

Vertically integrated, single source supplier that offers turnkey service

Compliance with regulatory requirements, including those for product safety

High level of customer service and support

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