Sponsored by Innovatus Imaging
By Ted Lucidi, CBET
We’re often asked, “How did you get in the business of repairing ultrasound probes and MRI coils?” It’s actually a very interesting story. To keep it simple … as a former manufacturer of MRI coils and current FDA registered manufacturer of ultrasound probes, Innovatus Imaging has the in-house engineering talent, proprietary fixturing and instruments, and expertise to fully understand the technology we repair. Innovatus is both an original equipment manufacturer (OEM), and an independent service organization (ISO). It’s quite unique in the HTM industry. Let’s look at ultrasound probes as an example.
Innovatus maintains two facilities dedicated to ultrasound probes: An FDA-registered Center of Excellence for Design and Manufacturing in Denver, Colorado, and a Center of Excellence for Ultrasound Repair in Tulsa, Oklahoma, which together combine to address the entire life cycle of ultrasound probes … design, engineering, manufacturing and, finally, providing repair solutions that meet OEM form, fit and function as well as safety and efficacy.
Bringing a Device to Life
Like any medical device, an ultrasound probe begins its design life cycle as a series of user needs, intended uses, requirements (or design inputs) and ultimately ends as a finished medical device. There is a tremendous amount of effort, years of planning and continual testing that occurs in-between. Some of the major requirements include electrical, mechanical, acoustic and chemical verifications and validations. Other seemingly minor requirements might be the color of the probe housing, its shape and the degree of protection from fluid and dust intrusion (IPX-rating).
Our Denver facility manufactures ultrasound probes from concept to production and must follow FDA regulations every step of the way. Every device manufacturer needs to prove that they are manufacturing a safe and effective product. Two important questions that need to be answered by every device manufacturer are:
- “Does the output equal the input (or design specifications)?”, or “Did I make the product correctly?”
- Just as important is answering the question, “Does the product meet the user’s needs and intended uses?”, or “Did I make the correct product?”
Applying OEM Expertise to ISO Repair Operations
Many of the same FDA current Good Manufacturing Practices (cGMPs) and philosophies are transferred and implemented when we engineer solutions for your products in our repair centers. The goal in our repair operations is to return a product, whether a probe or a coil, to OEM form, fit and function and not alter safety, performance or intended use. Because Innovatus is a manufacturer, we have all the necessary instruments, knowledge, training and processes to ensure this outcome. We’re also able to design and manufacture proprietary test and repair fixtures based on the design of the various OEM makes and models.
Let’s look at a common failure on an ultrasound probe, intermittent or broken wiring in the system cable. There are several solutions available to independent service providers and one that is definitely not. OEMs of ultrasound probes will not sell components to ISOs.
Solution 1: There are one-size-fits-all cable replacement solutions available in the aftermarket space, but there are many electrical parameters to consider (characteristic impedance, DC resistance, capacitance, shielding) and physical characteristics (length, diameter, color) which differ for almost every probe model.
Solution 2: Re-termination involves cutting-back a cable past the point of damage and then re-terminating it to the probe. Although this practice is widely used in the repair industry, cutting-back too much of a cable, or splicing individual micro-coaxial wires, can alter the electrical properties of the OEMs design, ultimately affecting performance.
Solution 3: Harvesting used cables to replace the cable on your probe. There is a risk to re-using an already worn, potentially over-flexed cable. The repair provider is betting that his solution will outlast his warranty period.
Solution 4: Fabrication of a replacement cable. Using sophisticated instruments, Innovatus benchmarks new OEM cables (by probe model) to determine their specifications and then designs to those specifications. The cables are then stress tested using customized “torture” devices as well as undergoing electrical and acoustic verification. In fact, we currently manufacture over 90 different wiring harnesses and cables to ensure performance consistent with OEM design.
Replacing plastics and lenses may seem simple until you research the hundreds of OEM recommended cleaners and disinfectants for the hundreds of probe models we restore. All materials used by Innovatus must not only be compatible with recommended cleaners and disinfectants but also ISO 10993 compliant (biocompatible).
Once our Design and Manufacturing Center completes and approves a material or process, it then transfers to our ISO 13485:2016 registered Ultrasound Repair Center to be implemented into our probe repair processes. This is a continuous, evergreen, process as new devices enter the market, as each model will have different characteristics and unique designs which we have to engineer.
What Does All of This Mean to You
As mentioned above, our single goal is to restore safety, performance and OEM design intent to the products that your clinical teams use every day – not just getting it working again … and do so at a highly competitive price. There are no short-cuts taken to save costs, yet Innovatus provides OEM quality at ISO pricing. We encourage potential clients to perform a true apples-to-apples comparison between providers. You’ll find that, for the same level of and approach to repair, Innovatus actually provides greater longevity and long-term value to your facilities.
As an OEM, we understand the entire life cycle of the products we support. After more than 180,000 probe repairs and 40,000 MRI coil repairs, we understand not only how they fail but how to restore them to provide many additional years of patient care. Learn more at innovatusimaging.com.
Ted Lucidi, CBET, is the director of commercial operations and business analytics at Innovatus Imaging.