Innovative Health LLC
Innovative Health is an advanced, FDA regulated reprocessing company focused on Electrophysiology devices. This means we gain FDA clearance to reprocess and sell back FDA single-use cardiology devices that have been used one or more times. Innovative Health’s mission is to enable hospitals, manufacturers, and physicians to provide better care for cardiology patients through significant device cost savings, which lead to reduced procedure costs and the ability to access new technology and improve patient care.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 2014
- Employees:
- 101-1000
This company also provides solutions for other industrial applications.
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History
Around 2000, FDA became aware that to reduce costs, many hospitals were re-using devices labeled “single use”, thereby increasing patient risk. As a result, FDA regulated the practice of single-use device reprocessing, so that only advanced reprocessing companies with clearances from FDA could reprocess single-use devices. This meant that the practice was taken away from the hospitals and placed in a safe, regulated environment.
To be able to reprocess a single-use device, reprocessors must submit an application to FDA that demonstrates that the reprocessed device is substantially equivalent to a brand new device. To achieve this, reprocessors must reverse engineer the device, understand how to clean it, inspect it, and test it, and do extensive tests that prove the device functions the same way as a new device. The process is similar to the process original manufacturers must follow to launch a new device. Same agency, same requirements, same functionality, and same safety.
Initially, many physicians were hesitant to use reprocessed single-use devices. However, as evidence grew that these devices actually functioned the same way and failed even less frequently than new devices, more and more physicians adopted the use of these devices. Many of them have increasingly backed hospitals’ efforts to reduce costs, and prefer the less expensive devices – although they may not feel exactly the same as a new device, using them enables us to reduce the cost of care. Today, reprocessing is a widely celebrated key supply chain strategy utilized in all the US News & World Report’s top hospitals.*
Around 2010, the largest reprocessors were acquired by large original manufacturers who did not invest in reprocessing technology that could drive higher savings. As a response, Innovative Health was formed in 2015 to deliver a focused, dedicated technology effort that could significantly increase savings, specifically in cardiology, where the most expensive devices are used.
It is our philosophy that reprocessing is not about buying inexpensive devices. Reprocessing is about enabling hospitals to provide better care through savings. Ever-increasing device costs is a very real problem for Electrophysiology labs. When device costs go up, hospitals must reduce service and patients lose. Managing reprocessing programs for maximum impact makes it possible for the hospital to better control supply costs and provide better care.
Reprocessing single-use devices is smart business and responsible healthcare. Innovative Health takes reprocessing into the future by helping hospitals control their supply costs and aggressively pursuing new technologies.
Innovative Health
Innovative Health is an advanced, FDA regulated device economics company that helps Cardiology (Electrophysiology) labs reduce procedure costs, so they can adopt newer and better technology, improve patient care, and offer their services to more patients. We reduce procedure costs by offering reprocessed single-use devices at a significantly reduced price. Our focus is on Electrophysiology devices, which are among the most expensive medical devices used. Other reprocessors offer electrophysiology and cardiology products. However, as a specialty reprocessor, Innovative Health is focused entirely in cardiology . This means we focus our investment in new reprocessing technologies and FDA clearances in this area only. As a result, we get more clearances to reprocess still more complex technologies which means hospitals can achieve higher savings.
Innovative Health was founded in 2015 by a team of reprocessing pioneers to push the boundaries of the industry and provide higher savings to hospitals in North America. Given the strategy, the company is highly R&D focused and our team of engineers as well as regulatory and quality experts have deep scientific and clinical knowledge about Electrophysiology technology. We work with many of the leading hospitals in the United States, and several of these have become our research partners.
Healthcare Needs New Answers
Hospitals in the US are financially fragile and the pandemic has brought many to the verge of bankruptcy. Meanwhile, advancements in pharmaceuticals and medical technology carry the promise of better patient care – and a hefty price tag that threatens the hospitals’ financial and clinical sustainability.
Healthcare needs a different type of solution: Products and services that reduce the cost of care while improving patient outcome. Healthcare needs pharmaceutical and medical technology companies to stand up, take responsibility and partner with hospitals to enable better care at a lower cost. This is not happening.
In cardiology, few initiatives are available that significantly reduce costs while allowing hospitals to improve the quality of care. Single-use device reprocessing has the potential to reduce medical device costs in some cardiology procedures by 30% without adding risk, freeing resources for hospitals to invest in better care.
Innovative Health is leading the development of new reprocessing technologies that help hospitals reduce cardiology costs significantly.
Atrial Fibrillation Is A Challenge For U.S. Healthcare
Healthcare Needs New Answers
Electrophysiology has made it possible for healthcare providers to offer an alternative to lifetime medication with severe quality of life costs to patients with Atrial Fibrillation (AFib), one of the fastest growing disease areas in the country. As a consequence, the number of AFib Electrophysiology procedures is growing rapidly.
There will be an expected 240,000 Atrial Fibrillation procedures in the US in 2020, using some of the most advanced technology available in healthcare. We will spend more than $2.5B on medical devices in these procedures.
Because reimbursement cannot always cover the cost of expensive technologies, these procedures are not offered to all that could benefit for them, and many hospitals will be losing money on the procedures – or they will use outdated, inadequate technology. About half of the procedures will be successful.*
Device Costs Drive Economic Constraints
The economic and clinical limitations in Electrophysiology are a major challenge, and it’s all about the cost per procedure of medical devices.
Many hospitals depend on elective procedures like AFib procedures to offset losses on other service lines. Therefore, procedure profitability is financially critical. However, manufacturers constantly launch new, more expensive technologies in Electrophysiology, driving up the per-procedure costs, often without demonstrable improvement in outcome.
In most AFib procedures hospitals will spend more than $10,500 on medical devices. Almost all devices are designated “single-use” by the manufacturer, so they do not come with cleaning instructions, and the expectation is that the device will be discarded after one use. However, the manufacturer does not need to provide a rationale for why the device should only be used once. Some individual catheters cost more than $4,000.
Hospitals used to clean and re-use these devices to reduce costs. For patient safety reasons, this is no longer possible.
Reprocessing: Safe and Economical Device Utilization
Innovative Health is an advanced, FDA regulated reprocessing company focused on Electrophysiology devices. This means we gain FDA clearance to reprocess and sell back FDA single-use cardiology devices that have been used one or more times.
FDA’s granting of an FDA clearance for a reprocessed device means that FDA has determined, based on data submitted by Innovative Health, that the reprocessed product is substantially equivalent to the new device (it functions the same way) and does not represent added risk to the patient. Over the years, physicians and lab managers have come to appreciate the FDA clearance process for reprocessed devices and have found that they are safe and effective.
Using reprocessed devices instead of new ones reduces the device costs per procedure significantly. A $2,500 device becomes a $1,300 device, for example. Based on Innovative Health’s clearances, an Electrophysiology lab can reduce the device costs of an AFib procedure by 30% or more than $3,000.
This means procedures become more profitable and the hospital can acquire new technology and potentially treat more patients.
Advanced, Specialty EP Reprocessing
Other reprocessors offer electrophysiology and cardiology products. However, as a specialty reprocessor, Innovative Health is focused entirely in cardiology. This means we focus our investment in new reprocessing technologies and FDA clearances in this area only. As a result, we get more clearances to reprocess still more complex technologies. This means hospitals can achieve higher savings.
Today, Innovative Health has FDA clearance to reprocess several complex mapping catheters, diagnostic catheters, and other electrophysiology devices that no other reprocessor can offer. As a result, regardless of what technology the physicians prefer, we can deliver lower cost solutions.
On average, this means saving more than $1,000 more per procedure than with our leading competitors.