The latest advances in medical devices and equipment are changing the way the medical community and patients manage health and disease. For patients waiting for results from blood tests or nasal swabs, highly-complex fluid analysis equipment provides results faster than ever, which is critical for containing infectious diseases like COVID-19 or identifying and treating other illnesses. When it comes to cancer detection, the latest medical imaging equipment utilizes sophisticated imaging technology to quickly and accurately detect disease, so that doctors and patients can focus on treatment options.
Just like many other electronic devices we rely on every day, all of these complex medical products require repair and updated parts over time. In 2020, the global medical equipment maintenance market was valued at $35.3 billion and is expected to expand at a compound annual growth rate (CAGR) of 7.9 percent from 2021 to 2027. Smarter medical devices, a rise in life threatening diseases that require regular monitoring and increased demand for repaired/refurbished medical equipment are fueling this growth.
Many of these high tech products cost several thousands to several millions of dollars, so simply buying a new machine to replace a broken one isn’t a viable solution. The products are becoming increasingly technical, with multilayered printed circuit boards, complex circuitry and smaller, lightweight, sensitive components that require great skill in electro-mechanicals and electronics to repair.
When it comes to ensuring quality during the repair of these products, the stakes are high since any type of failure could put a patient’s health and safety at risk. Engineers and technicians that fix or upgrade these medical devices must have extensive knowledge and training across several disciplines and the ability to comply with the latest regulatory requirements. Factories that handle these capabilities must also have achieved several industry certifications across medical and electronic disciplines.
Sanmina Fort Mill Facility: Critical Medical Device Repair Hub
Located in the Charlotte metroplex, Sanmina’s facility in Fort Mill, South Carolina is a critical repair hub for products from major U.S. medical companies. Established in 2007, it was one of Sanmina’s first medical repair centers and is part of the larger Sanmina Global Services (SGS) division that provides a wide range of integration and fulfillment, field support, aftermarket services and lifecycle management services around the world.
When medical equipment malfunctions, defective components or entire systems are sent to the Ft. Mill team to be fixed. The repaired parts then go back into stock and are used on demand, facilitating an efficient and cost effective means of reusing valuable and complex electronics.
Refurbishing some of this medical equipment involves stripping it right down to a metal frame, repairing electromechanical components and reassembling the product. From there, it takes several days of testing, documentation and certification to ensure the product will function properly in an external environment.
In addition to having the standard ISO9001 factory certification, the Ft. Mill site has an ISO13485 medical certification and has attained several levels of IPC standards that ensure the quality of repair for electronic circuit boards, including an onsite IPC instructor to speed up the training and certification process for engineers.
Ft. Mill also handles returns, logistics and kitting, so that when new equipment is being installed or repaired at a medical facility or some other setting, technicians have a kit at their fingertips that contains all the components they need to complete the work without having to order and wait for new parts.
Deep Engineering Expertise and Institutional Knowledge
The extensive capabilities offered at the Ft. Mill facility wouldn’t be possible without a strong engineering team. They are well versed in clinical chemistry and medical imaging, including radiology, magnetic resonance, nuclear medicine, computer tomography and ultrasound. Engineers are also are fully trained in radiology, isotope handling, laboratory reagents and have a deep understanding of photometrics, electromechanical tests, schematics, engineering drawings, technical specs and electronic and mechanical test equipment.
Many of the engineers and technicians on the factory floor have been with Ft. Mill for several years and some of them have more than thirty years of institutional knowledge. They have invaluable experience about multiple generations of imaging equipment and blood handling machines that often goes well beyond what the medical customer has retained about its own products.
A few years ago, the team began repairing a very sophisticated multimillion dollar PET scanner used to identify cancer. The repair process involved 200 pages of certification and a deep proficiency in the analysis of picture quality, a very complex skill that Sanmina engineers mastered. They also came up with an innovative way to remotely adjust the scanner image display via the internet, saving the customer time and money. Now, whenever the customer has questions about image quality, they turn to the Ft. Mill team for advice.
One Stop Shop
Exciting as recent developments in the medical device industry may seem, this is just the tip of the iceberg. Breakthroughs in science, medicine and technology will continue to facilitate more innovation in medical devices and equipment for years to come. The Ft. Mill facility has become a one stop shop for companies looking for a full suite of services that include manufacturing integration, distribution, returns and repair, as well as refurbishment. The team love what they do and are very proud of the impact their work has on medical communities, patients and consumers. They are poised and ready to take on new challenges as the industry comes up with new ways to diagnose disease and manage health.