It’s a Complex Time for Medical Device Manufacturers
With the ongoing supply chain difficulties and ever-changing pandemic, as well as the impact of the Russo-Ukrainian War and the many sanctions surrounding it, the production and distribution of medical devices on an international scale is difficult to navigate. While companies producing these devices are required under humanitarian law to continue providing devices to countries that have been sanctioned, the demand for these devices as well as medicines is increasing — to say nothing of increasing demand domestically.
Because of this, organizations producing important medical devices may find themselves struggling to keep up. Not only do companies have to manage production in addition to ordering parts and components to create their devices, but they must also be assembled, kitted, and distributed. Now more than ever, a medical device assembly and fulfillment partner should be high on companies’ priorities.
Advantages of a Medical Device Assembly and Fulfillment Partner
Critical Components Are Produced and Handled by a Single Company
While your equipment may have parts produced by more than one company, the foundational components such as printed circuit board assemblies and other components can be produced by a single electronics manufacturer — providing you with a single point of contact that makes managing production overall easier, more efficient, and cost-effective. The ideal partner will provide all of the technology and capabilities needed to support your device — ranging from surface mount technology and automatic optical inspection (AOI) to environmental storage. Working with a single partner for the manufacturing of your medical device components saves your team a wealth of time in managing multiple relationships and multiple communication streams.
Components Are Gathered from a Centralized Location and Assembled
Medical device assembly partners will offer inventory management programs to store all of your PCBAs and other components needed to produce a complete product. The key advantage here is that your employees don’t need to be weighed down with this responsibility, allowing them to focus on higher priority tasks and goals instead of processing parts and putting the final product together. It takes a lot of time to manage and process these parts for final assembly — if your team took this on during a period of increased demand, it could reduce their productivity and lead to reduced revenue.
Kitting and Distribution Are Managed by an Expert Third Party
Closely related to the above is the value a medical device assembly partner can provide in terms of kitting. If your devices are part of a larger kit, or if they include multiple devices, many of your customers or distributors will want all of those elements in a single kit that’s ready to go when it arrives or when it’s shipped to its next destination. If your team doesn’t have to manage the kitting process, they’ll be able to spend more time on achieving their production goals, the various costs of in-house kitting are mitigated, and customer service improves because your team isn’t rushed trying to get devices into customers’ hands.
Industry Compliance is Maintained at All Times
The right medical device assembly partner will uphold a variety of industry compliance requirements and standards to ensure that the products they’re assembling and managing on your behalf meet the most stringent of expectations. These include ISO 13485:2016 (quality management system for consumer medical devices), IPC-A-610 (applies to organizations responsible for the quality and reliability of electronics assemblies), and even registration with the Food and Drug Administration (FDA) for companies working with medical devices.
Now is the Time to Work with a Medical Device Assembly Partner You Can Trust
South Dakota Partners has been supporting medical device manufacturers with component production, assembly, kitting, quality control, testing, and even repair and rework services for years. We work with a variety of industries on all of their electronics needs but have great specialization in medical devices.
By working with a single partner for all of these electronics requirements, our customers have been able to mitigate the many supply chain and production risks that come by managing multiple suppliers or handling this important work in-house. In many cases, we’re able to make a significant impact on our customers’ bottom lines. Our team delivers measurable impact, attested by one of our case studies. Explore how our team helped one medical device manufacturer reduce their warranty claims by 70 percent simply by providing design expertise.
And to ensure that the work and products you receive from our efforts are of the utmost quality, our team uses a variety of processes and best practices in all that we do. We are also strategically located near some of the best technical schools and talent in the country — ensuring that you have qualified, educated technicians and specialists working on your medical device assembly program at all times.
Ready to learn more about our medical device assembly capabilities? Connect with our team here to learn more and to request a quote.