2603_ICE_INNOVATUS

MAGAZINE

IMAGING PROFESSIONALS

CORPORATE PROFILE

PROVIDING DECADES OF SERVICE EXCELLENCE FOR ULTRASOUND PROBES, MRI COILS AND DESIGN & MANUFACTURING

In novatus Imaging’s Center of Excellence for Ultrasound Probe Repair was founded on a 40-year heritage leveraging the expertise and vision of Dennis Wulf, who remains on the Board of Directors today. Wulf pioneered ultrasound probe repair in the mid-1980s, years before others entered the industry. In those early days, many independent service organizations (ISOs) outsourced their repairs to Wulf’s facility in Tulsa, OK. Having performed over 195,000 repairs since 2000, Innovatus is recognized as the premier ultrasound probe repair provider and is a trusted partner of OEMs, ISOs, asset managers and healthcare facilities worldwide.

On a similar timeline began the legacy of Innovatus’ MRI Coil Center of Excellence. Once an FDA registered contract manufacturer and service center of MRI coils for multiple OEMs, the company expanded to include multi-vendor service of MRI coils. With over 50,000 coil repairs, Innovatus remains a service center for multiple OEMs. The organization brings an OEM standard of quality to the ISO market and supports healthcare organizations around the globe.

The company’s capstone is their Center of Excellence for Design and Manufacturing. The FDA-registered facility is a contract manufacturer of ultrasound probes and ultrasound related devices for several very prominent OEMs. The facility’s cGMP’s (Current Good Manufacturing Practices), engineering expertise, and acoustic testing lab assist to develop, verify and validate repair processes and materials for the Tulsa Ultrasound Repair Center of Excellence.

Q&A With Ted Lucidi, Director of Commercial Operations

WHAT IS THE MISSION AND VISION OF YOUR COMPANY?

Simply put, our goal is to assist healthcare organizations in realizing significant savings and improving upon the quality of patient care by restoring and extending the lifecycle of imaging devices. Our teams accomplish this by developing innovative solutions to meet our clients’ needs and strive to produce products and services of the highest quality and safety, while fulfilling all requirements - from customers, regulatory bodies, and industry standards.

WHAT MAKES YOUR COMPANY UNIQUE OR ESSENTIAL IN TODAY’S MARKET?

Innovatus Imaging is unique in that we are a true specialty organization. We may only provide 3 very specialized

services, yet we do them with extreme precision. In a time where more and more Independent Service Organizations (ISOs) are merging and being acquired by other ISOs to become one-stop-shops, Innovatus remains committed to providing the most comprehensive solutions on the products that we support. While many in our industry are currently focused upon providing replacement/exchange options, our efforts remain on repair/restoration. Our FDA registration and heritage make us uniquely qualified to restore your ultrasound probes and MRI coils back to OEM form, fit, function, safety and efficacy.

WHAT MILESTONES OR ACHIEVEMENTS HAS YOUR COMPANY REACHED?

What stands out is that some of the most prominent and well-respected OEMs have chosen to place their trust in our organization. OEMs choose to partner with us as we deliver consistent, high-quality solutions that meet the strict regulatory standards to which they are held accountable. That says a lot.

HOW HAS INNOVATUS GROWN AND ADAPTED TO REMAIN A LEADING PROVIDER IN SUCH A COMPETITIVE INDUSTRY?

We make investments. Investments in people, investments in engineering, and investments in tools and technology. Rather than be all things to all people, we ask: What are the most popular models, right now? Which of those are failing; AND, which are causing the most distress for our clients. Our teams determine how and why the devices are failing and determine what solutions can be developed to address the most-frequently encountered failures. We are always innovating and engineering new solutions. In the past year, we released full-repair capabilities on over 50 MRI coil models including the Philips dStream and GE Air coils. On the probe side, we recently released micro-technology repair solutions to our clients. This technology will make obsolete conventional probe repair processes, with regard to the cable harness, and Innovatus Imaging is first to market.

WHAT

IS

MOST IMPORTANT TO YOU ABOUT THE WAY YOU DO BUSINESS?

For our teams, it’s all about honesty, integrity, transparency, and, ultimately, trust. Whether via email, phone, or live chat, our teams will inform on exactly what we can AND CANNOT do. If someone asks if we can repair model XYZ, and we cannot, they are informed, up-front. Inquirers will not encounter, “send it in and we’ll let you know.”

WHAT IS THE COMPANY CULTURE LIKE?

At Innovatus, our teams are driven to provide outstanding value to our clients in everything we do. We take pride in knowing that what we do is important, and that we are relied upon by countless healthcare professionals around the world. The source of our excellence is anchored in our honesty and integrity. We truly believe career satisfaction is realized through hard work, solving problems head-on with our teammates, and using new solutions to make ourselves, and the company, better for the future. By working together in this way, we build excellent business and technical judgement, a command of the facts, and the confidence to have a strong bias toward action. Our average tenure for employees exceeds 10 years, and some have over 20, indicating a strong sense of belonging, dedication and sense of mission.

CAN YOU SHARE SOME COMPANY SUCCESS STORIES WITH OUR READERS – A TIME THAT YOU “SAVED THE DAY” FOR A CUSTOMER?

Early last year, we released Next-Day MRI Coil Repair. Not every coil is a candidate, but if so, the repair time can be significantly accelerated. A few months ago, a local hospital experienced a failure on a newer-model, high-priority, specialized MRI coil. The HTM tech informed our team of their critical need, he hand-delivered the coil to our facility in the morning, and it was completed mid-day. The coil was placed back into service same day for a few thousand dollars versus the $75,000 replacement cost. Not only is that a success story, but it’s also a win-win-win scenario.

WHAT’S YOUR UNIQUE SELLING PROPOSITION?

A simple Internet search reveals that there are 50+ ISOs promoting probe repair or selling replacement probes; AND everyone uses the word “quality.” I like to ask potential clients, “How do you manage your risk?” How do you know that your chosen provider has the proper processes in-place, that qualified components are being used, and that their materials have undergone the appropriate testing? Non-conforming probes and coils will still function – but how do you know they meet the OEM intent? At Innovatus, the term compliance is very important. Our goal is to return every device to its original form, fit, function, and intended design, and do so at a fair, cost-effective price.

HOW DOES INNOVATUS MANAGE RISK?

As an OEM of ultrasound probes, acoustic arrays, and associated products, and with a legacy in MRI coil

manufacturing, our engineers possess a full understanding of the devices that we service. We approach service and repair with a manufacturing mindset.

Our approach to repair is consistent with that found in new product development manufacturing. Many of the processes and practices utilized in our manufacturing division are transferred to our repair divisions. For example, Innovatus will not perform repairs that have not undergone rigorous verification and validation processes which are required in new product development.

The engineers in our repair divisions utilize many of the same tools used in new product development. These include custom test fixtures, MRI scanner emulators, acoustic power measurement, pulse-echo testing, radiation force-balance testing, transducer face temperature testing, wiring light boxes, and cable and strain relief stress testing.

Release of new repair offerings include formal documentation of items such a schematic and wiring diagrams, bills of materials, component qualifications, material qualifications, biocompatibility testing (ISO 10993), as well as shipping package testing. All processes, test results, and documentation are captured within our ISO 13485:2016 certified quality management system.

Having a deep understanding of the technology we support and having all of the tools that are necessary to ensure that all of our products are fully qualified, gives a clinical engineer a high level of assurance that when that product is returned to the healthcare professional, that it is clinically safe and effective.

WHAT DOES PARTNERING WITH INNOVATUS MEAN FOR ME, MY BUDGET, MY CUSTOMERS, AND MY PATIENTS?

Clients who choose Innovatus, as a service partner for ultrasound probes and MRI coils have confidence in knowing that 1) The safety and performance of their devices has been entrusted to those with first-hand experience in manufacturing such devices, 2) The organization has a commitment to quality consistent with new device manufacturing and embraces practices to improve outcomes and lower costs, and 3) Is accountable to multiple OEMs, dozens of ISO partners and asset management organizations, hundreds of healthcare organizations, but, ultimately, each and every patient on which our repaired devices are used. •

AN ISO WITH OEM QUALITY

As an FDA-registered medical device Original Equipment Manufacturer (OEM), Innovatus Imaging has the specialized in-house expertise, talent, and quality management system to uniquely qualify them to be your Independent Service Organization (ISO) for ultrasound probe repair.

SAFETEE PROGRAM OVERVIEW

Learn how Innovatus Imaging’s SafeTEE program can help you reduce TEE probe failure rates, failure severity, and, ultimately, TEE probe support costs. CLICK BELOW TO WATCH NOW!