Rob Bodor, VP and GM of the Americas, Proto Labs

As suppliers to medtech manufacturers, we’ve had the opportunity to work with a variety of companies in this space—from large medical device OEMs to early-stage medtech firms—to help deliver transformative technologies and products to market.

This market is sizeable, and a fiercely competitive one. The United States remains, according to U.S. Department of Commerce statistics, the largest medical device market in the world, with revenues expected to reach $155 billion this year.

A number of industry trends are fueling this growth. Here are some of the key ones:

• The aging baby-boomer population that’s living longer, setting new life expectancy records, and driving up demands and costs on the health care system;
• The trend toward increased proof of product effectiveness by many health care systems;
• The constraints of existing regulatory requirements and anticipated future regulation and compliance issues;
• The impact of greater patient engagement and the correlating move to human-factor engineering or user-centered design; and
• The growing customization of medical devices, such as prostheses and implants.

Given the above trends and the opportunities they present, it’s not surprising that the medtech space has become an increasingly competitive one. So what can medtech companies do to stay ahead of the competition? One key enabler of competitiveness is an optimized product development and manufacturing supply chain.

Manufacturing gone digital

Depending on the product, medical device companies often use contract manufacturers for parts and components. Identifying suppliers that not only can provide a variety of manufacturing services but also understand the industry trends and its demands for accelerated product development cycles is an important success factor.

This is why an increasing number of medtech companies are turning to digital manufacturing providers who have the capacity, automation and ability to provide custom parts on-demand. It’s this kind of supply chain flexibility that enables iterative product design, validation, and, ultimately, market launch. In some cases it could even make or break a product, giving it a first mover advantage, or conversely, its absence could hinder or even cripple design and development.

Before this digitization of the manufacturing supply chain, a more traditional manufacturing approach meant, in many cases, a design-and-wait approach, with initial prototyping and one-at-a-time design iterations taking months to reach the engineering build phase.

Conversely, digital manufacturing, which can be applied across all manufacturing processes, including traditional manufacturing processes and additive manufacturing (3D printing), can have a transformative impact on product development. Here’s how:

• Drastic reduction in R&D spend by shortening development cycles from months to days;
• Improved product quality and adoption rate through multiple design iterations, reducing design risk and minimizing failure rate;
• An optimized supply chain with reduced lead-times, lower inventory, and better management of demand volatility.

Selecting the right digital manufacturing process

Although the digital manufacturing model, like the one at Proto Labs for example, offers a variety of manufacturing processes to choose from, not all processes are suitable for every medtech application.

Additive manufacturing processes, also known as 3D printing, can accommodate complex designs, work well to reduce multipart assemblies, and support customization of prostheses, dental implants and body parts. (Think tracheal implants and ribs, legs, joints and hands.) Companies can also use 3D printing to make microfluidics products, such as fluidically sealed devices like chips, sensor cartridges, connectors,and valves created on a sub-millimeter scale. 3D printed parts are ideal for physical testing and validation, including tests that digital simulation may miss, making them invaluable for early evaluation of new medical devices and components.

There are multiple 3D printing processes out there, but the most commonly used ones are stereolithography, selective laser sintering, direct metal laser sintering, fused deposition modeling, and polyjet technologies. Most are capable of producing parts in as fast as a day.

In addition to 3D printing, CNC machining also works well for prototyping, as well as short-runs of end-use parts. Material properties with machined parts are representative of injection-molded parts. Plus, high temperature-resistant plastics such as PEEK and PEI (Ultem) work well for sterilization, so manufacturers regularly use parts made of these plastics for medical applications. Parts can be manufactured through high-speed milling and turning techniques from a variety of plastic and metal materials.

Surgical instruments, implantable devices, bone screws, ventilator parts, and pump components are just a small sampling of components often prototyped with CNC machining. And with the digital manufacturing model, parts can be delivered in as little as one day as well.

Shifting to higher volumes

While 3D printing and machining provide repeatability and precision in lower quantities, neither is conducive for production runs into the tens of thousands or beyond. Medical device companies designing a product or device to take to market on that scale regularly move to injection-molded components, due to cost considerations.

Injection molding is a common production method used for medical components made from plastic and liquid silicone rubber (LSR), which is especially well-suited for medical products because of its thermal, chemical, and electrical resistance. LSR parts are also biocompatible, so they work well for products that have skin contact.

Examples abound of molded medical-device or medtech parts made rapidly: monitor shells, electronic housing, diabetes-testing equipment, eyeglass frames, actuators, bio-absorbable fasteners, operating room equipment, hand-held devices, and so forth. The digital manufacturing model, when applied to injection molding, produces a tool in 15 days or less, so rapid manufacturing is possible—even with some of the traditional manufacturing processes like injection molding.

Ultimately, staying competitive in a growing and increasingly fragmented market space is made easier when medtech providers adopt and start leveraging some of the digital manufacturing strategies mentioned above.

Rob Bodor is currently VP and GM of the Americas at Proto Labs, an online and technology-enabled digital manufacturer of rapid prototypes and on-demand production parts. At Proto Labs, he has also held roles as CTO and director of business development. Prior to joining Proto Labs, Bodor held leadership roles at Honeywell and McKinsey & Company, and has been on the executive team of two early-stage software companies in the Twin Cities. He holds B.S., M.S., and Ph.D. degrees in engineering and computer science.