Accumold - supporting the medical device community

Accumold - supporting the…

This week, Accumold would have been proudly exhibiting at the MedTec Live event in Nuremberg, Germany. Obviously, as is the case with many spring and summer events, MedTec Live has been postponed due to the global response to Covid 19, and we look forward to being in Germany on the revised dates of June 30 - July 2nd 2020 if this is possible.

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 molding experts that are working at the cutting-edge of advanced design and manufacture.

At the MedTec Live event, Accumold would have been displaying an array of medical parts and components that it has manufactured over a long relationship with the medical device sector globally.

The company is unique in that it is truly vertically integrated, and as such it is able to 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 molding services, cutting-edge metrology, assembly, and automation, and this facilitates the streamlining of customer’s medical product development process, and the attainment of optimal outcomes in terms of timeliness, cost, and accuracy.

Roger Hargens, President at Accumold says, “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 molding and micro manufacturing really gives us the edge, and we are not only the most experienced micro molder 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 also 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 recognized quality management system for medical devices.”

Micro molding for medical device OEMs is an art form honed after years of expertise and trouble-shooting, and it is vital that micro molders have the business culture, personnel, and equipment in place to provide the service necessary to ensure a successful project outcome. Micro molders 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.

Hargens says, “The regulatory environment is one that is becoming more and more important for medical device OEMs, and ensuring a partnership with a micro molder 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 molder 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 would have attended MedTec Live this week to ensure that there is a continuity of service and engagement over the next few months, and looks forward to meeting everyone at the newly scheduled show and into the future. Accumold remains ready to stand by any OEMs as we all navigate these temporarily choppy waters.