Advances in 3D printing could make medtech mass customization a reality. Matt Sand, president of 3DEO, will discuss the role of 3D printing in medtech in the MD&M Minneapolis session, “3D Printing: The Journey from Prototyping to Production to Metal 3DP.” His October 31 talk will include five tips for moving from prototyping to production.

“Mass customization is the capability of producing in volume in an efficient manufacturing flow, instead of ‘one at a time,’ while still being able to offer options in color, size, and materials that differ from the core product offering,” Sand told MD+DI. “This could mean 90% of the part’s design is always the same, but the last 10% is customized for the person. For example, a hip implant design is always very similar, but with 3D printing, it can be customized for the specific patient’s body.”

Such customization coud better serve patients. “Every person’s body is different–no two parts should be exactly the same,” he said. “One generic implant may work perfectly for one patient but may be too big or uncomfortable for another. So why make generic sized parts when we can customize each part to the patient? With 3D printing, medical devices can be optimized to suit the needs of specific patients.”

Clinicians and healthcare providers could benefit, too. “Rather than buying pre-manufactured parts, today’s healthcare system can buy additively manufactured parts as needed–this is on-demand manufacturing,” he said. “Hospitals and surgeons can partner with 3D printing service bureaus like 3DEOto print medical devices on case by case basis. This gives them the flexibility to design custom parts on a short notice.”

During his MD&M Minneapolis presentation, Sand will share five steps for moving from prototyping to production. He offered the following preview of those steps to MD+DI:

• Design the product with a CAD software like Solidworks.
• Get first articles printed–these are 5-10 initial pieces used for prototyping and to improve the design.
• Iterate–revise the design as quickly as you’d like–with 3D printing. You can print parts faster than they can be redesigned so engineers can make design progress very quickly.
• Production–as soon as the design is set, you can move into production quantities. With on-demand manufacturing, you can order exactly what you need, when you need it (as opposed to minimum-order quantities).
• Maintain and improve the product over time by improving the design or material properties.

“The great thing about prototyping and production using the same technology is there is no re-qualification step,” he pointed out. “You can qualify first articles and that also counts for production orders. This can save engineers a tremendous amount of time. If the transition requires using different manufacturing technologies, this can cause problems with speed, (re)qualification, and cost. Understanding the 5 steps can help designers and engineers pick the technology that best fit their 

Image of a part breakout courtesy of 3DEO.

Sand said that technologies such as laser sintering, binder jetting, and what he calls “Intelligent Layering” each have “unique capabilities that may produce different results. This includes differences in surface finish, production volume capabilities, and complexity in design. It is important to understand these differences to find the best service bureau for a healthcare provider’s specific application. For example, surface roughness may be very bad for one application (for example, a hinge) but very beneficial in others (stimulating osteointegration).”

When asked whether medical device designers are familiar with metal 3DP, the process his firm offers, Sand said that many are unfamiliar with it. “The industry is constantly evolving, and 3DP companies are coming out with brand new technology. It’s a new challenge, and everyone’s trying to understand how to work with it,” he said. “Common questions [about metal 3DP] have to do with material properties and the quality of manufacturing, which are regulated by FDA. To answer these questions, it is important to note that approval by FDA is done on a case-by-case basis. This means that medical device designers need to understand what materials and quality suits their application best and find a metal 3DP service provider that can produce that.”