Time travel: How 3D printing improves medical device manufacturing lead times
Amith Belawadi, The Tech Group, examines how 3D printing is being used in medical device contract manufacture and the benefits that improve lead times from concept to development and validation.
Bringing new products rapidly from development and into full-scale production in today’s environment has never been more demanding. Market pressures on new and potential customers require the development, scale-up, and transfer to full-scale manufacturing be done faster, better, cheaper. The Tech Group, West’s global contract manufacturing solutions provider, leverages multiple types of technology to aid in all project phases.
One such leveraged technology is the in-house 3D printing capability, also referred to as desktop fabrication or additive manufacturing. Over the course of the past 20 years, 3D printing has gone from being cumbersome and complicated to a valuable, real-life product design and manufacturing solution. One of the most significant applications of 3D printing is in the medical industry. Today this technology is helping medical device companies in a variety of industries realise their design ideas at every stage – from concept to commercialisation and saving time and money in the process.
Making ideas tangible in the conceptual design stage
For CMs working with medical device companies, the primary means of communicating early design concepts is typically by CAD files and 2D drawings. This sometimes leads to design misinterpretation due to the virtual nature of the data. By using 3D rapid prototyping methodology, designers are able to create physical models of multiple of design iterations allowing them to ‘test’ which design will work best. Through trial and error, designers discover which device features and functions are most effective, manufacturable and user-friendly.
Preparing functional prototypes
Having the actual, tangible component or components is proving itself to be invaluable when engaging with our customers. Traditionally, manufacturers were using 3D printing early in the design process stage to generate inexpensive, yet accurate prototypes allowing manufactures and engineers to check form, fit function without committing a significant amount of capital. It also allowed them the flexibility to gauge customer response and compare design iterations within days. What used to take weeks or months, could now be accomplished in days or hours. As a Proof of Principle however, the capability does not end in the development phase. 3D printing has also proved beneficial in mould design, metrology fixture design and end-of arm tooling reviews.
Aiding in mould design
Once a part design is agreed upon, there is the opportunity to use 3D printing in creating a mould for the selected design. A 3D printed mould provides prototype parts moulded from production intent material in a matter of days rather than weeks. By moulding parts from the same material we are able to match performance characteristics of the part as designed. This step also helps in gaining valuable knowledge in mould design early on which can then be implemented when production moulds are made. It also provides a great opportunity in trying advanced cooling methods like conformal cooling and custom cooling channel geometry which might not be possible in traditional mould-making methods.
Although 3D printed parts provide a quick way to check form and fit it lacks the ability to replicate properties like strength and performance during cyclic assembly. Parts from 3D printed moulds are the closest match to actual production parts; providing strength, look and feel and performance using the same resin intended during production. This is the fastest method yet, to provide true ‘working’ prototype samples.
Creating fixtures for validation and metrology
Typically, design and manufacturing of an inspection fixture for CMM or Vision system could take upwards of four to six weeks and depending on complexity could be costly. With the advancements in precision and repeatability, 3D printing can be used to improving the total lead-time to < one week.
The process of fixture design has not changed. The major design consideration is to hold and orient the part for inspection measurements. Medical devices are in nature, complex in design and shape. Traditional machining methods are cumbersome, time consuming and costly. 3D printing allows designers to easily replicate the shapes and nuances that are needed for the part to be properly nested in the fixture. Printing a metrology fixture, EOAT (end of arm tool) grippers or tooling mounts/ plates in short order allows development teams to test designs prior to manufacturing the final version.
Whether it’s a fixture to hold one part or eight parts, the fixture can be scaled up as production volumes increase. Additionally, duplicate fixture can easily and quickly be produced for another department, customer, or even third party. Our customers have been intrigued by the price and advantages of 3D printed fixtures. Costs are on average, more than 50% cheaper than traditional hard-tooling fixtures. This allows both the medical device and CM to utilise replicates of the same fixture in turn reducing errors due to differences in measurement related to fixture variability.
3D printing technology has enabled the Tech Group to reduce project timelines, for both internal and external customers. With a 3D printed fixture, as well as 3D printed parts, metrology can begin inspection routines, before the tool is completed. Metrology can complete a gage R&R study, prior to mould acceptance. Completing these activities early, enables the development team readiness and response first off inspection of product produced during tooling FAT, process development and validation. This method of in-parallel manufacturing provides significantly shorter project timelines.
Overall, The Tech Group uses advanced in-house technology to reduce overall cost and time for our customers ensuring a reduced risk and speed-to-market solution. The Tech Group utilises 3D printing in the early stages of concept and design, to refine the design with 3D printed moulds and producing parts from the specified material. Through the development stage, using 3D printed fixtures for inspections and measurements. By planning and executing these tasks in parallel with each other, overall timelines to validation are reduced. Fully utilising 3D printing in all areas results in REAL benefits for our customers.