Sponsored by Innovatus Imaging
By Ted Lucidi, CBET
Health care clinicians using evidence-based medicine for diagnosis and treatment have been improving quality outcomes and reducing costs for years. Data-driven protocols enable clinicians to eliminate guess work and provide treatment at higher confidence levels.
The same applies to medical device service and depot-based repair. When providers base repair processes on scientifically valid research and methodology, they are able to increase consistency, reliability, operational efficiencies and, ultimately, device longevity, all while decreasing costs. Yet few repair providers in today’s price-driven market have the resources to continually test and develop these methodologies. Doing so requires high levels of:
Health care clinicians using evidence-based medicine for diagnosis and treatment have been improving quality outcomes and reducing costs for years. Data-driven protocols enable clinicians to eliminate guess work and provide treatment at higher confidence levels.
The same applies to medical device service and depot-based repair. When providers base repair processes on scientifically valid research and methodology, they are able to increase consistency, reliability, operational efficiencies and, ultimately, device longevity, all while decreasing costs. Yet few repair providers in today’s price-driven market have the resources to continually test and develop these methodologies. Doing so requires high levels of:
- Clinical and technical expertise and judgement
- Valid evidence
- Ability to execute efficiently and affordably
- Sophisticated instruments and test devices
Having the above requires more than what a typical repair shop with skilled technicians can provide. It requires engineering depth, research and testing capabilities, and leadership that understands what to test, and how to identify valid evidence around which to build best practices. Relying on scientifically valid evidence and data-driven analytics to guide repair procedures is critical for results that enable devices to perform as originally intended while positively impacting operational efficiencies and financial goals. At Innovatus Imaging, we call this Data-Driven Repair (DDR). Following are three benefits of Data-Driven Repair that can help you maximize device life cycle while providing performance consistent with OEM intent and clinician expectations.
1. Data-driven processes for problem resolution and repairs that last
Repair providers face increasing pressure to resolve problems quickly and cheaply, yet doing so without valid data for best practices can have consequences. Those that engage in multiple types and levels of testing are more prepared to solve problems right the first time and achieve optimal outcomes.
It’s important to ask providers what data they use to back up their practices. Is the data backed by high-level evidence from very well controlled trials … or low-level evidence such as personal experience and opinion. While low-level evidence can be impactful, the strongest evidence for building best practices and optimal outcomes comes from controlled testing and trials.
With more than 180,000 successful probe repairs and 40,000 MRI coil repairs, and the longest warranty periods in the industry, Innovatus Imaging continues to collect and apply proprietary evidence for repair methodologies used in its operations. Ongoing testing programs help gather evidence and identify thresholds at which efficacy diminishes further impacting quality outcomes.
2. Advanced Testing
While advanced testing capabilities are not always necessary for immediate favorable outcomes, providers that engage in high level testing programs can build proprietary DDR methods and provide in-depth information about your devices. For ultrasound probe repairs, acoustic testing (hydrophone measurements and radiation force balance) is a good example. OEMs design their probes, in conjunction with their systems, to deliver a specific level of acoustic energy to the patient. Acoustic testing measures the amount of energy delivered to the patient. Innovatus utilizes hydrophone testing of OEM new probes to enable engineers to benchmark and document acoustic performance and uses the data to build an acoustic profile for a given probe model. As a result, DDR can provide clients with confidence that Innovatus’ repaired probes perform as originally intended.
3. Accountability and Documentation
Accountability and documentation are another benefit of DDR. Now, more than ever, guidance from an ISO 13485:2016 certified Quality Management System (QMS) should be the minimal criteria when seeking potential repair providers for a medical device. Organizations that adhere to the globally accepted 13485:2016 standard and understand medical device manufacturing will, by design, produce outcomes containing many key elements necessary for safe, effective and reliable repairs. It’s important for providers to supply documentation that supports the work performed on their clients’ devices as well as the testing criteria used to release the devices back into clinical use. Not only does Innovatus provide a comprehensive pre-repair assessment, but also supplies a post-repair Certificate of Conformance which is consistent with OEM production. In this manner, Innovatus clients know what deficiencies were identified and what processes were used to restore safety, functionality, efficacy and OEM intended design.
Summary
In an industry with so much at stake, quick fixes and lowest-cost options are no longer valid qualifiers for choosing a repair provider. The choice needs to be backed up by evidence, not just personal experience as to what will work fast, keep a budget in-line and get a device working again. DDR represents methodologies developed over 30 years of proprietary research, testing and experience which guide our manufacturing and repair of ultrasound probes and MRI coils. It also integrates insights and methodologies from scientific studies, quality management systems, globally recognized performance standards and exclusive analytics from more than 180,000 successful probe and 40,000 coil repairs.
For more information on data driven repair and how it can help re-define your ultrasound probe and MRI coil service strategy, reach out to TedL@innovatusimaging.com.
Ted Lucidi, CBET, is the director of commercial operations and business analytics at Innovatus Imaging.
