Getting a new medical device from concept through approval and to manufacture to the deadlines that you and your team expect is a real challenge. Yet something that the recent pandemic has taught us is that it is possible to innovate and achieve production quickly when it is really needed.
There are several steps to getting it right and how you shrink the development time between each can make a real difference to your deadlines. Often the innovators of new devices understand the clinical needs, but that does not mean that they have all of the skills needed to see it through the development cycle quickly.
While the concept may be sound and the clinical need very real, you need to translate that idea into a CAD design that you can manufacture using your chosen production technology. Then you need to test it for function and finally you may need to produce low volumes for clinical trials before you move onto mass manufacture.
Traditionally we all assumed that this process could take months if not years but since Covid, our expectations for faster turnarounds have grown. And using the full power of digital manufacturing it is possible to get through the prototyping stages to final production faster than many thought was possible.
Let’s go through the development cycle one step at a time to see how you save time and ensure a successful outcome.
From concept to design
If you have your CAD the first thing to check is whether that design can actually be manufactured using your final production process – whether it’s injection moulding, CNC machining or 3D printing.
At Protolabs we have automated this design for manufacturability analysis stage. When you submit your design, you will get an analysis back alongside your quote in just a few hours. If needed it will highlight areas where you have to change your design to meet the realities of production plus also areas where it would be advisable to do so.
It’s a useful sense check to see if your design will work in practice. If you need some help after this first stage, and many do to move the development through, then you can contact us to take advantage of our consultative design service for injection moulding – there is no charge for those who have already uploaded their CAD.
Prototyping
When you know that your design will work in theory, the next step is to test the part for form, function and fit. In practice you may need to go through a few prototype iterations before you are happy to commit a design to manufacture. You may also start off with prototypes produced using a different technology from your final production process.
A common example is to use 3D printing to produce plastic or resin parts for testing even though you will be using injection moulding as the final production process. This is because this process can produce parts in typically a few days, or even a day if it’s really urgent.
At this stage it’s important to use a supplier who understands both technologies so that the prototype that you design and use in testing from 3D printing can actually be manufactured using injection moulding. That link between design, prototyping and production is vital.
If your supplier offers both the prototyping technology and the final production capability then their engineers will have that knowledge and not lose sight of the final goal.
Read our whitepaper on which technologies to use for different stages of prototyping here.
Low volume production for clinical testing
When you are happy with the product there comes a time when you need to commit and get it clinically tested to ensure compliance with regulations and standards. At this stage you need to produce the final version that ideally uses the same production technology that it will be manufactured in.
For low volume production of specialist items, you may actually use 3D printing throughout the entire process and even plan to produce the product using this technology. The same is true if CNC machining is your chosen technology. This may be ideal if your production volumes are likely to number in the hundreds or a couple of thousand spread over time.
If your device is set for mass manufacture or production numbering in the thousands then there could still be rapid low volume manufacturing options for you at this stage that will save you both money and time.
Take injection moulding. Traditionally you can expect to wait 10 to 12 weeks for your steel moulds before you can produce a small number for clinical trials.
A better option to shorten that timeline is to find a manufacturer who produces moulds using aluminium which helps to shorten that time frame to about 10 days or even as fast as a day.
From clinical trials to production
Having got your concept through clinical trials you will be keen to get your product onto the market as soon as possible. Again, there are options to speed up this process. For low volumes you can probably use 3D printing or CNC machining.
If you need higher volumes numbering in the thousands or even hundreds of thousands then you will be exploring different production technologies.
Even here there are answers that will speed up the process. Remember we spoke about using aluminium moulds for faster turnaround in injection moulding, well you might be able to use these for production. For volumes of up to say 50,000 parts this might be your final solution.
Even if you are planning mass production beyond these numbers you could still use aluminium moulds to bridge the production gap until your final steel tooling is ready and save yourself waiting 2 or 3 months. Take a look at our on demand manufacturing service for example.
The pandemic has taught us that product development for medical devices can be far shorter than we excepted as the norm before. At Protolabs we have experience of helping medical manufacturers shorten their development cycles – read about how we helped develop a CPAP device for emergency ventilation for example.
We can help you achieve your deadlines faster. Put us to the test.
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