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Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI

PatrickSweeneyPatrick Sweeney, M.D., a presenter in the Surgeon Pod at OMTEC 2018, is an orthopaedic spinal surgeon in practice since 1994 with a special interest in minimally invasive surgery. He is Founder and Medical Director of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Mokena, Illinois that addresses a range of orthopaedic and spinal conditions. As an inventor/entrepreneur, he holds 30+ U.S. and European patents and is also the founder of Flow-FX, a start-up focused on devices and methods for delivering medicine to bone. Most recently he co-founded ConnectSx, an eHealth company that addresses inventory management, UDI compliance, just-in-time training/knowledge delivery, and electronic transaction capabilities delivering new efficiency and discipline to the medical device distribution system.

You have been involved in so many aspects of orthopaedics, I scarcely know where to begin! Pioneer in inventory management—advocate for orthobiologics—developer of unique fracture care systems—device company founder—multinational patent holder—spine surgeon specializing in MIS—founder of an ASC…the list goes on and on. Maybe you should start. What is exciting you about orthopaedics, right now?

Dr. Sweeney: All of these roles are really just a continuation of my role as an orthopaedic surgeon. I’ve been so blessed to learn from and work with talented people that it feels like a team effort. I do feel that the task of a physician will continue to expand into these areas because we are some of the closest to the patient and their needs and can act on them. Applying common sense and our insights to healthcare problems is an exciting part of the work.

It’s clear that orthopedic knowledge and surgical skills have grown in many separate silos over the years and there will be significant advantages to integrating these areas, both for the patient and the profession. The possibilities created by this will be extensive.

Also, the amazing progress in biologic development couple with the increasingly important problems of osteoporotic fractures, antibiotic resistant infections, and the associated economic costs lead us toward precision delivery of medication through implants as an answer to many of these issues. Some of these solutions will be as useful in the developing world as in the developed. For example, chronic osteomyelitis imposes a huge economic burden on patients in the developing world, to whom we may be able to offer a cheap, technologically simple treatment. Chronic diabetic foot osteomyelitis as well as vertebral osteomyelitis are destructive, expensive world-wide diseases that result in much pain, suffering, and death and may be treatable with intraosseous antibiotics in a common sense approach. These are hugely exciting challenges you can’t walk away from.

Finally, the device distribution system as well as procedure knowledge delivery is ripe for modernization. The economic gains from this will lower the overall cost of healthcare.

What should engineers bear in mind when designing orthopaedic and spinal systems to support minimally invasive surgery? Does any particular aspect stand out in your mind as, “This is good, but this would make it far better”? Can you see the next wave of innovation in MIS, and describe it for us?

Dr. Sweeney: First and foremost, in these days of value analysis, it must demonstrably improve the likelihood of surgical success; otherwise it’s just a fad. A truly valuable surgical design will be designed in a common-sense way that can make its usage in surgery intuitive and straight forward for the support staff and the surgeon. Although designed efficiently, it must be robust enough to perform the task 100% of the time. Early design consideration should be given to making reusable devices verifiably cleaned.

My experience with MIS surgery has been mostly focused on image guided, microscopic tissue sparing surgery which reduced the iatrogenic morbidity of the procedure. This is now becoming mainstream but there’s apparently a huge forecasted demand in the near future for these procedures while there may be significant shortages of surgeons. While 3D printing has provided many opportunities, it’s likely that robotic technology and artificial intelligence will augment surgeons in ways that improve efficiency and reduce manpower requirements. Pretty exciting! Another efficiency add will be the increased success of procedures through biologic delivery. If the success of a fusion goes up 10% while the infection rate goes down 10% a huge savings in surgeon hours and resources will be achieved. Both the maturation of stem cell technology and new biologics can improve our surgical success rate markedly which will use our manpower resources more efficiently.

The Flow-FX website notes that “Flow-FX is changing orthopedic surgery, and we’re only getting started.” I understand that you’re interested in antibiotic delivery, for instance. What’s next for the technology?

Dr. Sweeney: Flow-FX 510(k) cleared devices are intended for the delivery of certain bone void fillers and fracture fixation. There has been some off-label use of our Flow-Screw with intraosseous antibiotic infusion in chronic osteomyelitis of the diabetic foot. We are impressed with the results. Our hypothesis is that circumventing the compromised arterial system is a straightforward method to achieve therapeutic or supratherapeutic medication levels that will improve the success rate. Currently, we are trying to understand the regulatory pathway for us to proceed with some clinical studies that will quantify the effect of this method. Once we understand the pathways, we’d like to study vertebral osteomyelitis and chronic post traumatic osteomyelitis in the same way.

Unique Device Identification is a pain point for orthopaedic device manufacturers. How does the UDI component of ConnectSx’s platform help your customers?

Dr. Sweeney: UDI is an ongoing challenge for much of the medical device industry, and has been met with varying degrees of success. We believe the current level of compliance is only the beginning and that the UDI infrastructure will have to be extended throughout the value chain to providers, patients, and payers to optimize its value to the global healthcare ecosystem.

As a platform focused on the management of knowledge and information across the surgical value chain, ConnectSx can provide customers a spring board for leveraging UDI to generate value to their business and their stakeholders. With the right infrastructure, UDI can be more than a mechanism for device traceability; it can be a critical data point with which to better understand processes and events throughout the device lifecycle. This is an inevitability for healthcare and we are helping our customers to do it now.

Our overall goal with ConnectSx is to manage and deliver knowledge—developed through access to information such as UDI—in such a way as to maximize the value being delivered throughout the pipeline, from the manufacturer through to the payor.



Julie Vetalice is ORTHOWORLD’s Editorial Assistant. She can be reached by 
email.

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