Spineway USA Inc

On The Avenu with Scott A. Nelson, Reuleaux Technology, LLC

For over 30 years Scott Nelson has led product development, product management, and entrepreneurial business growth as a technology and business leader. In 2015 he founded Reuleaux Technology, LLC, which advises companies and startups on strategies and new business development in IoT markets.

Recently Mr. Nelson was the Chief Product Officer and Vice President of Product at Digi International (NASDAQ: DGII), a leading global provider of business and mission-critical Internet of Things (IoT) products and services and the Chief Technology Officer (CTO) and Executive Vice President of Corporate Development at SkyWater Technology Foundry, where he led strategy, growth, and new-offering development.

Mr. Nelson was named a Titan of Technology by the MSP Business Journal in 2015 and received an HW Sweatt award while at Honeywell. Mr. Nelson holds a Ph.D. in Applied Engineering Physics from Cornell University, a Doctorial Minor in Business Administration from Samuel Johnson School of Management at Cornell University and a B.A. degree in Physics and Mathematics from St. Olaf College.

In retrospect, what one activity have you identified in your field of expertise that didn’t work and should cease?

Specialized medical protocols and regulations for patient worn monitoring devices. Bluetooth Continua is a specific example. Another is highly regulated “clinical” sensors for parameters like pulse, heart rate, or temperature where trends and deviations are more important than accuracy for finding upcoming events. Digital Health developers should focus more on the effect they can have on patient behavior with sensors and communications vs. traditional laboratory/clinical measurement as the outcome. Real life measurement in a sustained manner is more important than diagnosis when it comes to chronic care. One 10 second blood glucose measurement diagnoses diabetes. Therapy lasts a lifetime.

And what one activity should begin immediately?
Integration and use of Patient Generated Health Data (PGHD) into both therapy and clinical systems to educate patients and help them behave better. We need to help patients be accountable — tough love — and PGHD is the key.

 

 

 

AVENU is Sitting Down with Leaders in Med Tech Healthcare.

Welcome to AVENU’s On The AVENU interview series. Join us as we sit with innovators in the Med Tech Industry, giving us – and in turn, you – access to diverse perspectives on how Med Tech is changing and what lies ahead.

On The Avenu is sponsored by Spineway USA, Inc.is a French based publicly traded company that treats severe spinal column pathologies. On The Avenu is meant to share insights and spark discussions. If you have a perspective on the future of Med Tech, feel free to share it by reaching out to Jon Luedke, CEO at jrl@spineway.com

On The Avenu Series
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Spineway USA Inc

On The Avenu with Frank Jaskulke, VP of Intelligence, The Medical Alley Association

Frank Jaskulke has the greatest job in the world as he is paid to hang out with smart people who save and improve lives every day. As the Vice President of Intelligence for the Medical Alley Association he is tasked to help Medical Alley members find partners, promote the region as the global epicenter of health innovation and care around the world, and mentor the association’s talented staff. Prior to Medical Alley Association he worked at the Minnesota House of Representatives as a
Page. He received an Undergraduate and Master’s degree in Political Science from the University of Minnesota.

In retrospect, what one activity have you identified in your field of expertise that didn’t work and should cease?
Sending Linkedin requests to people you don’t know. Expanding the network is good but ask first.

And what one activity should begin immediately?
Learning more about the business models of your stakeholders. Healthcare is changing and the business model that got us here will not get us to where we want to go. If you’re in device you should understand deeply the ways payors and providers are evolving – and not just as it relates to your product – understand at a systems level. We may find that new problems in one sector are old problems in another and we can bring solutions to bear.

 

 

 

AVENU is Sitting Down with Leaders in Med Tech Healthcare.

Welcome to AVENU’s On The AVENU interview series. Join us as we sit with innovators in the Med Tech Industry, giving us – and in turn, you – access to diverse perspectives on how Med Tech is changing and what lies ahead.

On The Avenu is sponsored by Spineway USA, Inc.is a French based publicly traded company that treats severe spinal column pathologies. On The Avenu is meant to share insights and spark discussions. If you have a perspective on the future of Med Tech, feel free to share it by reaching out to Jon Luedke, CEO at jrl@spineway.com

On The Avenu Series
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Spineway USA Inc

SPINEWAY USA Inc

Tell us about Spineway, what does the company do and what makes it unique?

Spineway USA, Inc. is the principal subsidiary of Spineway SA – a publicly traded spinal devices manufacturer based in Ecully, a suburb of Lyon, France. Spineway USA offers spine surgeons a product portfolio of proven spinal implants and instruments that meet both the clinical and economic challenges in providing treatment of spinal disorders. Spineway USA understands the unique balance of increasing support spine surgeons place on manufacturers to provide high quality “gold standard” medical devices while at the same time offering these services in a market setting that is financially affordable. Fine-tuning and formalizing our focus to clinical outcomes and operational excellence has transformed our structure.

How did you end up joining Spineway?

I have over 20 years of experience in the US medical device industry, holding progressive senior-level roles in sales, marketing, and commercialization at Zimmer Spine (IN), Centinel Spine (NY), Wenzel Spine (TX), and most recently Prosidyan (NJ), which the exclusive rights were acquired by DePuy Synthes (Johnson & Johnson company) in June, 2018. As a result, I was approached with the opportunity to join, and subsequently lead, Spineway USA, Inc. as President & CEO.

Why setup the US HQ in Medical Alley?

It was the familiar dilemma all leaders face everywhere: how to add value to your business without inadvertently subtracting from it though misguided influence and time wasted. Minneapolis/St. Paul (MSP) is known for its medical technology landscape. The MSP medical device industry is, in large part, led by the talent pool of individuals who are available to impact small businesses and startup companies. Most gifted and talented people that reside in the Twin Cities are well-educated and have a certain zest for being part of the startup culture. These same
individuals say “no thanks” to opportunities to join traditional corporate America, having seen the way big companies grind down dreams and preempt work-life balance. Spineway USA selected Minnesota namely for financial incentives, large talent pool, work ethic, culture and the arts, and the access to MSP International Airport.

Will the future of healthcare be most significantly defined by reigning in costs or accelerating outcomes?

I firmly believe the medical device industry will be centered on the delicate balance of providing high-quality devices in a financially affordable manner that are clinically proven. Group Purchasing Organization (GPO) systems are increasingly consolidating their approved vendors while fine-tuning and formalizing reimbursement of clinically proven technology. In the wake of this movement, full line suppliers are traditionally awarded these contracts, excluding “carve- outs” for products that are new and unique technology typically categorized as “revolutionary” or “breakthrough.” “Me-too” small company products are not considered for “carve-outs.” Financial concern and lack of clinical outcomes being the central factors, as these healthcare systems seek to limit their vendors while controlling costs.

What is the definition of value in healthcare today and what should it be?

My definition of value in healthcare is centered around service, quality, and cost. Patients, employees, and physicians all have conflicting opinions of what constitutes value and that naturally has a costly consequence on the healthcare sector. I believe that healthcare must deliver value, but it’s not clear what that means or how you prioritize the components of cost, service, and quality. Spineway USA has made the commitment to transform into a company focused on providing financially affordable technology that is clinically proven. Systematically reshaping our approach to value by offering cost, service, and quality in a financially affordable, clinically-proven technology manner.

What’s the biggest “blind spot” in healthcare today?

Patient safety and quality of care are well-recognized among the healthcare community as critical goals, even if quantifying progress is a challenge. Improving patient safety and quality of care process is not only possible but is morally and professionally imperative. Achieving this goal will require a significant re-envisioning of the process and a widespread commitment to change amongst healthcare, patients, and policy administrators.

What’s your company’s or sector’s biggest “blind spot?”

Biggest “blind spot” for Spineway USA, Inc. is staying ahead of the curve. The medical industry is built on rapid technological innovation. Companies realize the importance of staying ahead of the curve in order to stay ahead of the competition. If you’re not early, you’re late. Companies and industries are undergoing vast infrastructure changes to keep up with advances and to continuously strive to provide their customers with the most cutting-
edge approaches.

My opinion on the importance of staying ahead of the curve, predicting the next device evolution, and how to not get left behind or having a competitive development is a major driving force to being current. Spineway USA, Inc. has always played to its strength at what we do best.

However, continuing to play to your strengths, without considering what’s happening in the market around you, is dangerous for a company. I’ve warned against this type of behavior. It’s human nature is to stick with what has worked in the past, but we’ve learned from the past that this focus can become dangerous and impede the company’s innovation.

Mature companies and startup ventures alike will find success if they are flexible enough to quickly and adeptly change when facing (or foreseeing) threats or opportunities.

What is the one thing, other than time or money, you wish you had more of?
Wisdom – if you think you know the answer, you’re far from wise. Keep learning. Wisdom comes from knowing how little you actually know. Spend some time learning something new, perhaps even becoming skilled at something. You’ll surprise yourself at what you gain, often far beyond the mere knowledge you hoped to attain.

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Spineway USA Inc

Spine ASCs: Approach With Caution -Part 1

As the saying goes, “With great power comes great responsibility.” And with spine surgery on the menu of an increasing number of ambulatory surgery centers (ASCs), the chance for physicians to participate in this new wave is tempting.

But prudence is advised, says Reginald Davis, M.D., a neurosurgeon with The BioSpine Institute in Tampa, Florida, who has some experience with spine ASCs.

“It is undeniable that physicians have experienced a substantial downward drift in their ability to influence patient care,” says Dr. Davis, a former assistant professor of neurosurgery at Johns Hopkins in Baltimore. “While the nucleus of medicine used to be comprised of the physician and the patient, other parties have now moved in, and the voice of the physician has been crowded out.”

Which is one reason why surgeons might find a spine ASC alluring.

“There is a mounting interest in taking spine to the ASC,” states Dr. Davis, “and because this trend will likely continue, we must approach it in a measured, thoughtful manner.”

“The advantage of spine surgery in an ASC is that the patient benefits from a system that is very unique and highly focused on their problem. The experience is deeply personalized for individual patients, the outcomes can be superior, the recovery time is less, and many procedures cost less than in a hospital.”

But the major drawback is one that should give any surgeon pause.

Dr. Davis: “In the event that things go awry, you do not have the backup of hospital resources at your disposal. Unusual circumstances can occur…a certain instrument is needed or there is a complication. Things are particularly serious if the patient experiences a cardiac event or requires a transfer.”

Lesson #1:

And that is why, according to Dr. Davis, the key to success in a spine ASC is patient selection. “You want the healthiest patients with a specific pathology and no comorbidities. You are essentially cherry picking with your eye on the bullseye…and the further you stray from bullseye the closer you are to catastrophe.”

“Comorbidities such as cardiac, pulmonary, or renal issues can lead to anesthesia problems. Intraoperative cardiology issues in particular will result in the immediate cessation of surgery and transfer to a hospital. If you have an otherwise healthy patient who is a smoker with elevated blood pressure you are on a slippery slope. A higher body mass index (BMI) is notorious for creating anesthesia problems, and the more difficult the surgery the longer it takes and the more likely you are to have complications.”

“Let’s say at the preop weigh-in a patient’s BMI is 40.8, but on the day of surgery it has risen to 42. It may not represent a major issue—and things may go well—or not. It is important to deconstruct what goes into patient selection. Examine the medical comorbidities by sorting through every major system, which is an overwhelming algorithm. For the most part it is always best not to make your selection on a case-by-case basis. It is better to anticipate every variable and have a hard stop for each one. And forget about exceptions…the ones that didn’t go well were always the exceptions.”

Medicine…walking a tightrope.

“In any medical arena there is a pull and push between providing the highest level of care and delivering the most economical care. This warring can turn internal, in essence, and put the physician is a difficult situation. It may be tempting to cut corners and focus more on cost, but then the quality of care may be compromised. It is a balancing act that is replayed over and over in a surgeon’s day-to-day life.”

“Attempting to complete a procedure hastily or doing anything that would jeopardize the best outcomes can turn into a cascade of negative events. For example, if you are doing a lumbar fusion and you want good decompression then you must be on target with the alignment, stabilization, and fusion. But good decompression takes time. You have to prepare the bed, and use good bone or Infuse. If the thought, ‘I will use the cheapest demineralized bone matrix I have, ’ then think again.’

“Doctors are trained in traditional settings such as universities where you do whatever it takes—for as long as it takes—to reach the zenith of patient care. Frankly, that is how doctors are programmed. For the longest time we were the patient’s best advocates and compromising on quality was unheard of. Now that the difference comes out of the surgeon’s pocket, he or she is routinely placed in comprising positions as far as conflicts of interest. Performing spine surgeries in an ASC requires an ethical surgeon with strong integrity.”

“It’s easy to give lip service to being patient-centric, but if your hospital says, ‘You will use this screw, or you will not be allowed to operate here’ then the patient will pay out of pocket…and so will you.”

No standing still…

“We are all either headed toward evolution or extinction, meaning that our past successes are almost irrelevant. The failure to evolve or to have perspicacious situational awareness is detrimental to physician as the patient, industry, and hospital landscapes are always on the move.”

“There is no formal training for a surgeon who commences work at a spine ASC…it’s basically on-the-job training. Until we have a journal and/or meeting where the business, medical, and legislative aspects of spine ASCs can be addressed, then this remains an area where interested parties should make their decision after thorough vetting and careful consideration.”

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