Medical Device Repair: What to Look for in a Partner - South Dakota Partners – Printed Circuit Board Assembly Services

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Medical Device Repair: What to Look for in a Partner

The Pressure is On to Keep Medical Devices Operable as Demand for Care Grows Nationwide

When it comes to medical devices and other electronics within a hospital or medical setting, maintaining performance and functionality is of the utmost importance. There has never been a more critical time for medical organizations and manufacturers to do all they can to ensure the equipment that physicians and staff need to provide care for patients and maintain operations is working properly — and to rely on rapid, efficient medical device repair partners when the need arises.

It’s no secret that facilities are struggling with medical device repair and have been for some time. Spikes in COVID-19 and Delta variant cases have made the situation direr as well. Medical professionals and equipment manufacturers have been working together on solutions to get broken or malfunctioning equipment up and running faster, but it’s not always possible for manufacturers to open up equipment for hospital repair technicians (biomeds) to repair themselves. That, and the technicians may not have the expertise, equipment, or materials needed for medical device repair itself.

Despite continued progress in getting technicians the access and support they need, it’s evident that a reliable medical device repair partner is paramount — whether you’re a medical facility in need of support or a manufacturer looking for expanded technical expertise for your products. However, it’s equally important to look for a company that brings quality, extensive repair capabilities, and additional services to the table to ensure you have all that you need to sustain the growing demand for care nationwide.

Key Attributes and Capabilities of a Medical Device Repair Company

1. Repair Services That Go Beyond Repair Alone

First and foremost, the ideal medical device repair partner should have the necessary repair and rework capabilities needed to service a broad array of equipment and component types — from pain relief tools and shockwave therapy systems to continuous motion devices and iontophoresis systems. Depending on the issue, however, repair work may be needed at a much deeper level — such as circuit boards and various components. The ideal partner should be able to conduct troubleshooting at this deeper level to not only identify the issue and resolve it rapidly but also to provide the necessary documentation, such as problem cause and recommended solutions.

Depending on the nature of the problem and the frequency of the repairs for that device type, your partner should be able to provide trending information. This helps facilities and manufacturers understand if there is a bigger issue at hand or if something else is responsible for the repair frequency, such as consistently incorrect usage that might indicate further training is needed on the part of users. Your partner should also be able to utilize your existing systems — such as Oracle, Salesforce, and others — to make the process streamlined and efficient.

2. A Commitment to Quality and the Certifications to Back It

Your medical equipment is far too important to entrust to just any repair services provider. Every component and detail must be carefully assessed to ensure the equipment performs properly and reliably. To that end, it’s important to work with a partner that maintains appropriate industry certifications and quality commitments. Applying to both repair and manufacturing, certification with Institute for Printed Circuits (IPC) standards ensures that your partner’s workforce adheres to absolute excellence. A key certification to look for is IPC-A-610 — acceptability to electronic assembly.

Another quality consideration for the ideal partner is ISO certification. A key certification to look for is ISO 13485:2016, which ensures adherence to a quality management system for the design and manufacturing of medical devices. Additional quality certifications and processes will demonstrate a relentless commitment to providing exceptional medical device repair services on your valuable and essential equipment. Last but not least, working with a company that holds certification with the Food and Drug Administration (FDA) gives you peace of mind in knowing that you’re working with a service provider skilled in the medical industry.

3. Service That Continues When the Repair Work Ends

Depending on your specific equipment and repair needs, managing the repair process can quickly become taxing. And with today’s labor shortages and supply chain challenges, it’s essential to work with a company that can provide an extra layer of support. If you’ll have a high volume of medical devices that need repair, consider partnering with a company that will manage shipping and logistics for you. Medical devices vary widely in size. Depending on the number being sent in for repair (and eventually back to your facility), you may have a need for less-than-truckload (LTL) or full-truckload (FTL) freight. Work with a company that will manage this process for you so you can focus on your own strategic goals.

Case in point: Learn how we helped a major medical device manufacturer reduce their warranty claims by 70% while serving as a true solutions provider. Download the case study.

Work with South Dakota Partners for Medical Device Repair

At South Dakota Partners, serving the medical device industry is part of who we are — in fact, it’s in our mission statement. Our on-site repair center at our Clear Lake, South Dakota headquarters has been serving the medical device industry for more than 10 years and is staffed by highly trained, certified, and deeply motivated technicians that handle warranty and non-warranty work for countless manufacturers. We even handle the repair work for some of our clients under DBA, serving as a key part of their overall service function.

With component-level troubleshooting and full documentation capabilities for each repair, as well as analysis services for trending issues and end-user complaints, we’re the medical device repair partner you’ve been looking for to maintain your equipment and operations. We are ISO 13485:2016 certified, FDA registered as a contract manufacturer, have an IPC-certified team, and undergo a variety of internal audits and external inspections to meet rigorous quality standards. And as your repair partner, we’ll assist you with shipping and logistics for all your repair needs — ensuring you have the equipment you need without skipping a beat.

Connect with our team today to learn more about our medical device repair capabilities.

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