How have medtech launches and prototyping evolved with 3D printing?

Here are three basic ways that 3D printing can help you get your medical device project off the ground.

Jim Medsker, Keystone Solutions Group

Additive manufacturing, commonly referred to as 3D printing, began to surface in the 1980s. Since then, the technology has quickly become a valuable tool for creating plastic prototype parts in a rapid fashion. Like many emerging technologies, however, the early days of 3D printing had drawbacks.

The equipment and materials were prohibitively expensive for most companies, thus creating the initial demand for 3D printing service firms. Many of the first printers on the market came with a price tag close to $300,000. Further, the parts created were primarily for visual purposes only and typically did not have the surface finish, strength or other properties necessary to make them a fully functional part.

Roll the clock forward to the present day and the technology is not only capable of creating fully functional parts in many applications, it’s also accessible for small companies and hobbyists. Today there are several 3D printer options in the sub-$1,000 range, and many in the $3,000–$10,000 range, that produce high-quality, structurally capable parts.

In the early days of the technology, materials were limited to specialized plastics with limited mechanical and thermal properties. Today materials, processes and resulting parts are wide-ranging, including:

• Many plastic resins;
• Elastic and dual durometer components;
• Metals;
• Fabrics;
• Biocompatible scaffold materials to promote tissue growth;
• Synthetic food products.

This advance led to the capability to produce everything from organ tissue to full-size vehicles and just about anything one can imagine in between.

For medical device startups, this means additive manufacturing is now a key asset for not only creating parts, but also in launching companies. The following provides a few brief examples of how this technology can help you get your medical device project off the ground:

1. Design cycle frequency

Many additive manufacturing processes produce parts with near net shape and physical properties that parallel components made with standard production processes. This allows the 3D-printed parts to go beyond boardroom presentation and into the lab for testing. At times, they can even go into the field for voice-of-customer and validation studies.

Data from the lab and feedback from the field can then be fed back to the design team and the next iteration design can be produced quickly. This means project schedules and budgets are minimized and design integrity is optimized.

2. Funding

Funding is often the primary barrier for entrepreneurs and department heads when it comes to getting ideas off the ground. While PowerPoint presentations and detailed pro formas can be impactful in the fundraising effort, there is nothing like a production-intent product in the hands of investors to help close the deal.

With today’s additive manufacturing technologies, this is not only possible – it’s becoming an expectation in many cases. High-quality prototypes deliver the message effectively and increase investor confidence.

3. Production

Moving to full-scale production often requires a significant capital outlay for tooling, fixturing and minimum volume commitments – potentially meaning months of lead time. The cost as well as the time required for custom tooling often puts the program’s finances and schedule at high risk. Fortunately, with the production quality output of many of today’s additive manufacturing processes and materials, many companies are forgoing the burden of expensive tooling and are now using 3D printing for production runs.

Depending on the product, using 3D printing for production may be limited to the initial pilot runs. However, it is becoming increasingly common to use this technology for long-term ongoing production.

The exciting news is that the technology continues to evolve and progress at an amazing pace. As the quality of parts and variety of materials produced with additive manufacturing continues to improve, the equipment and material costs continue to fall. These combined advancements and improved accessibility will undoubtedly help an ever-increasing number of initiatives get off the ground.

Jim Medsker founded Keystone Solutions Group (Kalamazoo, Mich.)  in 1998 with the vision of creating a turnkey resource for helping people and companies with product ideas get their products commercialized.