New medical product introduction (NPI) can be challenging for any company, even for established businesses or high-tech start-up organisations that have a leadership team familiar with bringing new products to market. That is why working with suppliers who have technical expertise and know-how in designing for manufacture and making market ready products makes commercial sense.
An area that requires a very specific set of skills in NPI is medical plastic injection moulding. An important part of medical component production is choosing specialist medical injection moulding companies that can help a start-up or established producer to:
- Engineer out the problems.
- Increase production efficiencies.
- Improve quality and consistency.
Let’s take a moment to look at medical device start-up, NeuPulse. The company had a leadership team that was knowledgeable in NPI but they still experienced a range of benefits working with a supplier that was used to creating medical moulded products.
The challenge
NeuPulse is a new UK company that has created a device that helps reduce both the severity and frequency of tics in individuals with Tourette syndrome. In a UK-wide double-blind sham-controlled clinical trial, the company has established the positive impact of its wearable device and accompanying App, and is now awaiting regulatory approval, to ensure it meets all relevant safety, quality and regulatory requirements.
To take the wearable device, similar in look to a smartwatch, from clinical trial to the mass production phase, NeuPulse needed to refine the prototype for manufacturing. Although the senior management team leading the company has a lot of combined experience in NPI, they weren’t used to fulfilling the process as a start-up. Also, this was the academic research team’s first foray in bringing such a product to market. With this in mind, NeuPulse decided to collaborate with OGM to make the most of the company’s medical device injection moulding expertise.
The benefits of working with an experienced medical injection moulding company:
Reviewing and re-evaluating the design – What product designers specify and what can be moulded efficiently and effectively to produce the most precise and best quality component can differ. OGM helped with design for manufacture by discussing how to re-work the design to deliver a more cost effective but high-quality product for volume manufacturing.
Material and supplier advice – NeuPulse set the requirements for the material on the wearable device and then OGM recommended suitable and trusted suppliers to work with, based on their years of technical knowledge and having worked on similar projects.
Driving efficiency – A finished computer generated image isn’t the same as a workable mould. OGM ensured that the mould tool wouldn’t be overly complex to drive efficiency and minimise dwell time on the plastic injection mould line.
Tool production management – OGM is managing production of the tool to ensure all deadlines are met.
Problem solving – Further design changes were recommended by OGM to remove unnecessary post-moulding manufacturing processes. Originally the device was to be joined using an O-ring or sealant. However, thanks to OGM’s suggestion of a two-part moulding process, they were able to influence the design so that the seal has now become part of the moulded part, removing a potentially time-consuming, messy and less aesthetically pleasing alternative.
Mould tool qualification – OGM is well used to qualifying mould tools to ensure repeatable parts are achieved quickly and efficiently.
Paul Cable, NeuPulse, CEO, comments: “This wearable device and self-managing treatment could change the lives of people living with Tourette’s. So, it’s vitally important that we get this product right. Part of making the project commercially viable was to ensure that the design was optimised for large-scale production. We needed a moulding partner to help us through the process and educate us where we needed education. We are very pleased with our choice. OGM has played an invaluable role in critiquing the mould design, material selection and advising us on the best material suppliers to use, as well as offering suggestions that will save us time and money in the long run.”
“In the past, I have been used to handing a design over to the production team and waiting for the ‘magic part’ to appear. As a start-up, however, we have had to lean much more heavily on the experience of our suppliers. OGM is an ISO 13485 certified manufacturer skilled in developing technical components for injection moulded medical devices, this expertise and OGM’s professional approach to our NPI project has helped us ensure our product can be produced efficiently and effectively.”
There are many benefits of bringing a new product to market with an experienced plastic injection moulding company. Why not find out how an expert plastic injection moulding partner like OGM will be able to advise you on your next NPI?