I am very excited to announce that this month, Innovative Health opened our new Research and Innovation Center in an office building in Scottsdale, Arizona. For years, medical device reprocessing has been stuck in a minimalist position regarding which technologies are reprocessable and which are not - and our innovation lab is challenging this status quo with new reprocessing technologies that make medical device re-use broader and more impactful for hospitals.
The Research and Innovation Center has been on the drawing board for a while, as we have known the barriers to reprocessing for several years. Its opening signals the “beginning of the end” to manufacturer demarcations of single-use, and I would like to explain how the innovation lab is getting there.
The core of the Research and Innovation Center is its Bioscience unit. For years, lab testing and advanced analysis of biocompatibility, total organic carbon residuals, etc., have been the domain of advanced labs. However, the reprocessing industry has advanced its knowledge of these areas to the point where we can bring these technologies and tests in-house. Frankly, the reprocessing industry is in some ways bypassing lab testing competencies in terms of bioscience and the reuse of medical devices. Clearly, ensuring that devices are clean and clear should be the marker for device re-use, and while others tested this for us for years, we are now ready to provide this scientific evidence ourselves. Our biomedical staff is growing – in numbers and in qualifications. Today, I am reluctant to think of sending out tests to show device re-use readiness as a proof of quality – as our technologists provide better and stronger results in our own labs.
Looking at how devices can be re-used means a lot more than ensuring devices are clean after reprocessing. It also involves discovering how devices can be tested and inspected, how device integrity can be maintained mechanically, how electronic functionalities are sustained, etc. Our team of Electrophysiology specialty reprocessing engineers look at these aspects of device re-use to demonstrate to FDA how EP devices can be safely reprocessed without losing any of their functionality or adding patient risk. We are getting pretty good at this as we continue to get clearances for EP devices that no other company can reprocess. However, Electrophysiology is one of the fastest growing and most expensive service lines in US hospitals, and their needs to reduce costs are a constant theme in our discussions with EP lab management. Therefore, it continues to be a priority for our engineers at the Research and Innovation Center to get clearance to reprocess even more devices used in EP procedures. And although we can now do all major mapping and diagnostic ultrasound catheters – along with most other devices used in EP procedures, there is still a lot of work to do. Our EP Speciality Reprocessing team has a track record of breaking down re-use barriers, and have several patents to show their results in developing new reprocessing technology – but there is still a lot of work to do.
Our results in Electrophysiology device re-use speak for themselves. However, other procedure areas have similar needs to reduce costs, and Innovative Health’s Emerging Technologies team works every day on developing new reprocessing technologies that can be applied in interventional cardiology, radiology, etc. to reduce procedure costs where it makes a difference for the hospital and the surgery center. Engineers on our Emerging Technologies team are some of the most brilliant in the medical device industry, and their development work challenges many of the strongest assumptions in medical device re-use. The reprocessing technologies they invent will translate into new FDA clearances and patents this year.
Our single-use device reprocessing solution dramatically reduces the cost of medical devices used in Electrophysiology procedures. Over the past 7 years, we have received FDA clearance to reprocess and sell a number of medical devices, gradually increasing the savings for our hospital partners. At this point, some of them use our devices to reduce procedure costs by up to $3,000. To be able to do this, research and development is critical. At Innovative Health, we invest heavily in research and development as well as in our regulatory process and our patented technologies. The work of our R&D team is not the first you think of when it comes to reprocessing single-use devices. You think of the savings the hospital can realize and the value of those savings in terms of being able to provide better care for more patients. But the work of this team is the backbone of a healthy reprocessing program. This is where reprocessing technology is born, where patented methods evolve - and where device savings begin. Our Research and Innovation Center is home to some of the best engineers and technologists in healthcare. And their work drive your savings. Several of them will be at the Heart Rhythm Society conference in San Francisco later this week. Come see them at our booth and discuss device re-use with them!