Meet the all-stars in medtech from North America and Canada
With the launch of MPN North American only a few months away, Lu Rahman selects some of the expertise coming out of this region throughout the last year
It’s been a fruitful year on MPN - as we approach the end of the year we're currently planning the launch of a North American issue. The magazine has always had a strong connection with our audience in this region which has grown steadily year on year. With that in mind, the time’s right to offer these readers a dedicated publication of their own. The MPN team is very excited about this launch and we’re looking forward to hearing more news from our audience in North America and the work being carried out in the medical plastics sector.
We've had some great stories and innovation from North American based companies over the last year. As always Accumold is at the forefront of the micro-moulding sector. In the summer the company looked at the future of medical device design and the role that micro-moulding has to play. The company’s Aaron Johnson recognised the “growing convergence between medical device and consumer electronics”. He outlined the way that in addition to this bringing innovation to the end user “it has also brought an interesting kind of pressure to the design and manufacturing world. The general population of the modern world has come to expect that all of their devices, medical or not, be ‘smart’ in some way”.
The growth of digital health has been well documented on MPN. Johnson highlighted: “The growing expectation that a devices built for a special purpose now function in multiple and sometimes in completely foreign ways. It wasn’t a stretch to accept that a hearing aid could double as Bluetooth connection between a mobile phone or television, but what if it also took your temperature, measured your heart-rate or counted your steps? It’s already connected to your body so why not? Think of all of the items worn by individuals that could have multiple functions. Any one of them could function as a medical device (or quasi-medical device) - many of which already do. So what’s next?”
And within this sits micro-moulding which Johnson rightly points out is one of the key technological innovations that enables the design and manufacture of the next generation of medical devices.
As always material selection is a key consideration in the design of medical plastic devices. Bing Carbone, Modern Plastics is a wealth of expertise when it comes to choosing the right material.
According to Carbone: “Device manufacturers have a number of criteria to consider when selecting plastic materials. High-performance plastics are the natural choice not just a single reason, but a combination of features and benefits. These plastics should be selected during the design process due to their ability to meet the application requirements, quality of the device, productivity and/or save costs.”
From selecting the right performance plastics, sterilisation methods to advice on medical plastics distributors, Carbone offered words of wisdom.
In the May / June issue of the magazine Peter Galland, Teknor Apex Company looked at plasticisers and the key factors that need to be considered when choosing between trioctyl trimellitate (TOTM) and Dioctyl Terephthalate (DOTP). This included cost, purity, toxicology, performance and REACH status. Known for its manufacture of medical-grade PVC compounds, the company also produces plasticisers and Galland outlined how to determine the best alternative to DEHP for PVC medical devices.
Earlier in the year Galland, along with Ross Van Royen looked at the challenges in compounding medical polymers. As well as a dedicated processing lines, the authors described the need for sophisticated process controls and production monitoring systems to meet “stringent codes and critical performance requirements as well as to provide device manufacturers with lot to lot documentation.”
Galland and Van Royen examined PVC compounds and TPEs. They noted that “a major challenge confronting PVC device manufacturers today is that of issues involving ortho-phthalate plasticisers, particularly DEHP, which is widely used in medical-grade PVC and has decades of application history” and that “selecting alternative plasticisers for use in producing medical compounds is not a simple matter, since most alternatives now available entail some compromise in cost or performance in comparison with DEHP, and since different device applications pose different plasticising requirements”.
They also brought to attention that fact that, “TPEs bring unique capabilities to the medical device industry, and in some cases these benefits represent valuable cost/performance advantages over conventional incumbent materials such as PVC and thermoset rubber”.
Two of the challenges facing compounders of medical-grade TPEs are developing a range of compounds broad enough to match the diversity of requirements in the many well-established applications dominated by conventional materials and perfecting the TPE compounds not just in terms of properties to be found on data sheets but in terms of real-world requirements.
One of the most popular stories of the year came from Berman Innovations. Owner Stephanie Berman’s POP by The Semenette unites a sex toy with a device that aids conception.
Berman said: “The Semenette was invented by combining my knowledge and expertise in women’s reproductive health, along with my hope of conceiving a child with my wife, which we were able to do with our prototype. Three years later we have successfully launched the second iteration of the toy, which we were able to use to conceive our second child! In those three years, we have found there are many other markets for which POP is ideal; the new version of the toy reflects those applications.”
J-Pac Medical’s Jeff Barrett outlined the company’s plans for MPN at the start of the year. Known for its capabilities in sterile packaging, Barrett revealed that the business would be investing heavily in medical device capabilities and expanding its existing manufacturing services for devices in orthopaedic, sports medicine and cardiovascular fields.
Always keen to share its expertise with MPN, Polymer Solutions’ Jason Smith looked at hydrogels in the March April issue . With common uses for this molecular sponge-like material including wound care management, drug delivery, cartilage replacement and as a material for contact lenses, the use of these substances is on the rise as the industry understands them more. Smith outlined the way that hydrogels are poised to improve quality of life and better patient outcomes. However, this can only happen if it’s supported by analytical science and proper lab techniques.
Later in the year the company’s Caitlyn Scaggs outlined the key aspects when choosing an independent testing lab. She pointed out: “You wouldn’t trust your health and well being to a physician that didn’t pass their medical boards—why would you trust high-consequence laboratory testing to a company that lacks proper accreditation? If you’re developing a product that will have end use within the medical industry you need assurance that the results supporting your product are reliable.”