Accumold is showcasing micro moulding innovation at this year’s Med-Tech Innovation Expo.
The medical device industry is constantly looking for smaller products and components with ever more exacting and often micron-level tolerances. The industry demands absolute precision, totally repeatable manufacturing processes, and zero failure rates for products that are frequently used in safety-critical applications. As such they must work alongside and partner with micro moulding experts that are working at the cutting-edge of advanced design and manufacture.
For medical device OEMs, design for micro moulding (DfMM) is complicated, as the “norm” in terms of geometric complexity and material performance are different from moulding larger scale products. Working with micro moulding experts early in the product development cycle and at design reviews is important as they can offer vital insight into issues such as design for tolerance achievement, optimal gate locations, accounting for flash and mismatch, advice on prioritising and limiting critical dimensions, and material selection for optimal outcomes.
At Med-Tech Innovation Expo, Accumold will be displaying a range of medical parts and components that it has manufactured over a long relationship with the medical device sector globally and through an innate understanding of DfMM. The company is truly vertically integrated, and as such it can operate as a one-stop partner in the development and manufacture of medical devices and components. Under one roof, Accumold offers design and material assistance, micro tool fabrication, proprietary micro moulding services, cutting-edge metrology, assembly, and automation. This facilitates the streamlining of customer’s medical product development process, and the attainment of optimal outcomes in terms of timeliness, cost, and accuracy.
Aaron Johnson, VP of marketing and customer strategy at Accumold, said: “We are proud to say that we have partnered with countless leading medical device manufacturers across the world, and with each we operate strategically to ensure that the product development process is as efficient as possible. Our over 30-year association with micro moulding and micro manufacturing really gives us the edge, and we are not only the most experienced micro moulder in the world, but also the largest. This affords our customers with the reassurance of working with a robust and secure company that can provide efficiencies that lead to affordable production, and one that has the capacity and infrastructure to ramp up to full mass volume manufacture. We are also ISO 13485 accredited, the stringent and internationally recognised quality management system for medical devices.”
Micro moulding for medical device OEMs is an art form honed after years of expertise and troubleshooting, and it is vital that micro moulders have the business culture, personnel, and equipment in place to provide the service necessary to ensure a successful project outcome.
Micro moulders for medical device OEMs will be dealing with low, medium, and high volume runs in a variety of different materials, all requiring different levels of validation. They must also have the expertise in handling, storing, and processing often extremely expensive and sensitive materials that in many instances will be used in critical implantable applications.
Johnson added: “The regulatory environment is one that is becoming more and more important for medical device OEMs and ensuring a partnership with a micro moulder that has an understanding of this environment is disproportionately important. Much of the focus today is on the 510(k) approval process, which seemingly changes week to week. In general, medical agencies the world over have toughened up in the area of product approval, and have started to request information from medical device OEMs never previously required. This has meant that the percentage of first-round 510(k) submissions requiring more information has gone up dramatically, often resulting in time-to-market delays and expense. Engaging a micro moulder with an innate understanding of the vagaries of the 510(k) process can save enormous amounts of time and effort.”
Accumold wants to engage with any medical OEMs that will be at Med-Tech Innovation Expo and looks forward to meeting everyone at one of the first face-to-face events the company has exhibited at since the COVID-19 pandemic and will be located at stand D18.
Med-Tech Innovation Expo takes place on 28-29th September at the NEC, Birmingham. Register at med-techexpo.com.
