Manufacturing Tool Kit for the Medical Industry

Prototypes help design teams make more informed decisions by obtaining invaluable data from the performance of, and the reaction to, those prototypes. The more data gathered at the design stage of the product development cycle, the better the chances of preventing product or manufacturing issues down the road.

Indeed accelerated prototyping has always been important in medical development, and especially now during the COVID-19 crisis as designers and engineers create critical medical products to fight the pandemic (see sidebar).

At Protolabs, we produce prototypes for a range of medical devices and other medtech products and assemblies. A well thought out manufacturing strategy greatly increases the chances that a product will pass strict regulatory and compliance standards, launch to the market on time, be accepted, perform reliably, and be profitable. Our services and quality processes ensure you get there faster by leveraging our decades of experience in medical device product development combined with the ability to quickly iterate on designs with our accelerated manufacturing processes. 

Here are eight ways we can help improve your parts during medical device product development.

1. Use Design for Manufacturability Analysis

A common manufacturing method for end-use medical parts and components is low-volume injection moulding, although functional medtech prototypes are also 3D printed and machined. At Protolabs, our moulding process starts with an online quote. Each quote comes with a free, automated, interactive design for manufacturability (DFM) analysis. Beyond the online interactive analysis, we have dedicated design review teams for free design consultation for all four of our manufacturing services: moulding, machining, industrial-grade 3D printing (additive manufacturing), and sheet metal fabrication. Everything starts with your uploaded CAD model.

Additionally, regarding moulding in the medtech world, sometimes you may find that a part that was originally designed to be 3D printed or CNC machined may need to be redesigned for injection moulding. Our applications engineers are available for consultation on these types of redesigns. For customers who may need more support in the design process, Protolabs offers Consultative Design for Manufacturability, a consultative deep-dive into your product design with recommendations and insight on how to improve geometries to maximise function.

Our goal is to help save time and money—even if you need to make modifications you didn’t plan for—to avoid designs that are not manufacturable.

The next section dives deeper into moulding for medical device and medtech parts and products.

2. Leverage Injection Moulding for Medical Applications

In the highly regulated world of medicine and medical products, our medical moulding service moves part and component design rapidly from prototype to production. This is especially important in this industry, where products need to pass rigorous testing from the development phase through commercialisation. Our high-quality aluminium tooling, combined with automated DFM analysis, can quickly cut product development time, taking just days to cut a tool vs. steel tooling.

Along these lines, our quality control and tooling items include:

• Process validation, which may be achievable by a standardised qualification package, industry-accepted protocol, or customer-defined

Additionally, on the topic of tooling, our software program for mould flow analysis can help improve a medical part’s overall design through a number of ways, such as: aiding in the positioning of the gate or gates on your part; showing the position of knit lines, which allows you to improve your part’s cosmetic and physical properties; locating trouble spots that are hard to fill within your part; and identifying the proper material for your design.

At Protolabs, companies have turned to us for recent medical-related projects such as:

• Lower volume or difficult-to-forecast products
• Early-in-development parts and products
• Components requiring complicated supply chains
• Projects in which design flexibility is needed all the way through development
• Parts in which early process lessons can benefit in a transfer to production
• Design verification testing, clinical trial submissions, and regulatory-body submissions.

3. Iterate Prototypes Rapidly with Multi-Cavity Tooling

Developing parts and devices for the medical industry is challenging because things move so quickly. This is especially true now during the COVID-19 crisis. Accordingly, you can take advantage of our family and multi-cavity tooling in injection moulding so you can mould, in final, end-use material, multiple versions of the same prototype, then test those multiple versions, and move forward with the prototype version that succeeds.

In addition to the benefit of rapid iterations, using multi-cavity moulds can also be an efficient way to boost production volume and reduce part cost. We have a design tip on multi-cavity moulds that goes into more detail.

Metal 3D printing with DMLS delivers complex, high-resolution parts for medical applications.

4. Consider 3D Printing in Metal for Complex Medical Parts

Direct metal laser sintering (DMLS) is a frequently used metal additive manufacturing technology with applications for the medical industry. There are several benefits to DMLS—including printing high-resolution parts to support metal instrumentation design, for example. Materials include stainless steel (17-4 PH & 316L), aluminium (AlSi10Mg), cobalt chrome (CoCr), Inconel (IN718), copper (CuNi2SiCr), and titanium (Ti-6Al-4V).

Consider surgical tools with ultrafine features and medical components with organic shapes. These devices may be designed for metal injection moluding or casting, both of which have relatively high tooling costs and lead times that can span weeks. With DMLS, you can print a prototype surgical hand tool at the exact weight and strength of the final product and have it in a surgeon’s hands within days.

For DMLS projects, check out our design guidelines.

5. Choose Finishing Options for Moulded Medical Parts

Medtech companies often leverage post-processing options for their moulded medical parts. We offer a wide selection of finishing options for moulding that strengthen parts, improve cosmetic appearance, and provide customization, among other benefits. These finishing processes include:

• Threaded inserts
• Pad printing
• Heat Staking
• Laser Engraving
• Basic Assembly                                    

Medical device company Hemosonics, for example, recently turned to Protolabs for finishing options in addition to using our injection moulding, 3D printing, and machining services. The company used heat staking and pad printing for its Quantra System blood analysis machine.

6. Use the Right Material for Medtech Parts

We have suitable, medical-grade material for most injection moulding or 3D printing projects. Choosing the best material for your project means that your prototypes will match final parts as closely as possible.

Customers with proprietary materials for final production, common in the medical industry, often want to select a material as similar as possible to their in-house material by providing a close match in elasticity, hardness, strength, and other critical characteristics.

For help deciding which material or colour will work best for your job, you can also consult with one of our applications engineers.