Access is Key

1. What are some of the challenges associated with repairing medical devices in the third-party repair industry?

Some of the largest barriers to overcome are related access to documentation, specifications, and quality replacement parts. MRI coils and ultrasound probes, as expensive as they are, might be considered accessory devices and, typically, OEMs do not provide access to any of this intellectual property. Items such as schematic diagrams, input/output specifications, material lists, parts listings, and assembly instructions simply just don’t exist. It’s up to each individual provider to determine the manner in which they choose to service the devices they support.

2. You mentioned not having access to replacement parts.

That is a huge challenge to overcome. Repair providers have several options for replacement parts. Traditionally, repair providers will harvest broken or scrapped products and use these in place of new, uncompromised parts. This model is not sustainable as no repair provider can assure a continual supply of every part for every model they support. Lack of parts can add delays to the repair process in that providers may have to source scrapped products from which they’ll harvest parts for your repair. A provider may be able to offer repair today, but not next week or next month.

3. Won’t using harvested parts affect performance?

Yes and No. There are some parts that just can’t be (or shouldn’t be) harvested and re-used. For example, the lens, seals, and strain reliefs on ultrasound probes can’t be harvested. Providers need to manufacture these solutions. Housings and circuit boards have expected lifecycles and can also be tested, but a common item of wear on almost any device is the cable or wiring harness. This single component is flexed thousands of times. It’s commonly run-over, pinched, and pulled, adding additional stress and strain, leading to a shorter-than-expected lifecycle, and ultimately affecting performance. Harvesting and re-using cables is common in the industry and providers are betting on their cable outlasting their warranty period.

4. How does Innovatus face the challenge of accessing replacement parts?

Our leaders identified this issue decades ago and invested in in-house talent and state-of-the-art machine shops at our Centers of Excellence. These investments have enabled our team to fabricate replacement parts as needed, keeping repair processes moving forward and, in most cases, getting devices back to imaging departments quickly. At our Center of Excellence for MRI Coil Repair in Pittsburgh, Pennsylvania, we have engineers and technicians skilled in mechanical design, rapid prototyping, parts fabrication, 3D printing and custom painting. These capabilities stem from our heritage as an MRI coil manufacturer and they enable us to quickly repair and restore the coils we receive for repair – which often arrive in multiple pieces, sometimes in as many as 10 for a single coil. At the Center of Excellence for Ultrasound Probe Repair in Tulsa, Oklahoma, in-house personnel are skilled in rapid prototyping, injection molding, and precision machining. Parts produced onsite are used for in-house repair processes and for new specialty devices manufactured at our FDA-registered Denver, Colorado facility and all Innovatus sites utilize an ISO 13485:2016 certified quality management system.

5. Cables still wear out. How does Innovatus deal with worn and damaged cables and wiring?

Our goal is to recover and re-use as much of the customer’s original device as possible. If need arises, Innovatus can provide full cable repair / replacement solutions which perform as the OEM intended.  From engineers, to sourcing specialists, and wiring techs, we have teams in each facility dedicated to cable repair. Model dependent, device lifecycles are no longer limited to the lifespan of or variables which affect cable performance. Innovatus can restore cable performance and put the device lifecycle back on track. Full cable repair and replacement solutions are available on over 100 ultrasound probe and over 800 MRI coil models.

6. What does this mean for customers and, ultimately, patient care?

Patient care is at the heart of all we do. No matter the product line, our teams focus on returning the customer’s product to the OEMs original intended design. While we’re proud of the vision and legacy from the leaders of Innovatus Imaging regarding parts fabrication, we’re most proud of what it means for our clients. Having access to a virtually fully internalized supply chain for replacement parts means quicker repairs, sustainable quality and the ability to keep imaging devices operating when patients need them most, which is nothing short of 24/7. As health care facilities still scramble to have all the capacity and equipment they need to care for COVID-19 patients along with patients with other illnesses and injuries, we believe it is important for all support companies, including all of us in the repair and service industry, to constantly innovate new methods, processes and outcomes. By doing so, we can keep our industry moving forward at a critical time for patients and providers alike. We can assure patient access to the diagnostic services they need to move forward.