Spineway USA Inc

Episode 12 : David Uffer: How to Maintain High Growth Rates and Margins Based on Innovation Strategy

“Growth will come from many different factors: market share capture, accelerating the market whether that’s through market growth or pricing increases, as well as new products and technology introductions. But the ability to drive high growth rates in low growth markets is becoming more and more difficult. That’s where you look at consolidation and many times you’ll see acquisitions from the larger players to be able to grow inorganically.”

What innovative businesses are leading in emerging markets?
David discusses how to evaluate an emerging market and how to drive high growth rates in low growth markets. He stresses that new technology introductions must be transformational and able to be used in a value-based environment to get adoption. He explains there is a shift away from physician-directed preferences and product selection to a demonstrated approach showing many different value propositions.

“There’s no question to be successful in entering a substantial market that the US is nearly mandatory, but for those companies that already have significant presence in the US or established markets there’s high growth to be expected and projected and to be planned for in emerging markets.”



Today’s Podcast Topics:

  • David informs our audience what are some innovative businesses which are emerging as market leaders?
  • Are existing clinically proven technologies shifting to a “good enough” economical cost model?
  • Few Med Tech companies can maintain high growth rates and margins based on innovation strategy – David provides insight into what effect globally rationalized pricing necessitate cost reductions?
  • As the future of Med Tech plays out, how should emerging companies evaluate its business portfolio to decide which markets to focus?
  • Finally, David’s perspective to people who are newly entering the Med Tech Industry?

Links and Resources Mentioned in this Podcast:

 

Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.

 

About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.

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Spineway USA Inc

Episode 11 : Frank Jaskulke: How connectivity in the community can generate a superior return on investments

“Investments here will generate a superior return to investments made elsewhere. And we are trying to lean into that a bit, ya know, do more work to connect those investors to the companies and tell the story so that more investment finds its way in. For 2019 we tracked 1.2 billion dollars of capital that came in. The first time the State of Minnesota crossed the billion dollars in venture capital in any fashion since 2001 just before the .com bubble blew up”

How do you support a rapidly growing industry both in care delivery and in technology?
Frank discusses that Medical Alley was started to make sure we had a forum to raise issues that were important to us, to build peer networks, and connect companies so they could partner and support each other. Connectivity has value in social capital in addition to financial Capital. We also need excellent manufacturer and supplier infrastructure, access to first-rate healthcare, universities and research facilities, clustered med-tech startups, and access to funding. He thinks it is vital to promote the industry, work on public policy issues, and connect leaders in the industry so they can more easily collaborate.

“What we’ve observed over the last, maybe, 5-10 years is a lot of device companies have found new models for starting and developing early-stage companies. They’ve lowered the cost to start and to get early evidence which then reduces the risk that an investor takes in that company. FDA has done really fantastic work in getting to be more efficient, more predictable, and more productive. And I think companies are now starting to figure out the reimbursement environment and develop products that solve, not just for the clinical issue but for the economic issues. The result is there’s good returns to be generated in medical device again, and that’s attracting investment.”

Listen using the embedded player on this page or click to listen on your favorite podcast app icons.

Today’s Podcast Topics:

  • Frank tells our audience about the Smithsonian recognizing “Great Places for Invention in the US” Medical Alley receiving this esteemed distinction.
  • How Venture Capital firms are recognizing the innovation occurring within Medical Alley in a profitable way, thus adding increasing value?
  • How Medical Alley promotes the development of new and existing companies through innovation, thus contributing to economic growth and job creation.?
  • What are the ideal elements for forming a successful Medical Alley Association?
  • Finally, Frank’s perspective to people who are newly entering the Med Tech Industry?

Links and Resources Mentioned in this Podcast:

 

Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.

 

About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.

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Spineway USA Inc

Episode 10 : David Hovda: Total Disc Replacement Market. Clinical Investigation Studies. MDR

“There’s certainly a lot of interest in robotics within spine and orthopedics, certainly on total knee replacement. Robots have been a big advance, I think, in total joint replacement. They’re also gaining a lot of interest in spine, primarily, initially, for pedicle screw placement. I think there’s some interesting things you can do in terms of precision cutting and placement going forward. So, I think that’s a trend that’s here to stay. I also believe there’s a huge interest in moving procedures out of hospitals into ambulatory surgery center or hospital outpatient settings …I think there’s a big effort to move into the lower-cost sites of service. And then I say maybe a third aspect would be more patient-specific implants or trying to get closer to a patient-specific implant.”

David describes how big the global Total Disc Replacement Market is and shares his insights into what trends he is observing in healthcare and orthopedic innovation. David shares the monetary challenges of Clinical Investigation Studies and explains there is going to be an increased focus on getting more data, proving that your device works, and its cost-effectiveness. He explains the challenges emerging companies are having in gaining market access with GPOs and formulary pricing trends.

He examines the new MDR requirements and the struggles some companies will have due to lacking clinical evaluation information and that the once European-first strategy will cease. He suggests payers are using their ability to withhold reimbursement to compel companies to bring forward the clinical data proving the procedure is effective.

“The fact that we live in a class three world and we’ve done clinical trials and we’ve had a design control system in place, and a strong quality system that’s really where MDR is headed and that’s what we’ve been all along. …. I think that the bigger challenge is just all the puts and takes and how it’s going to be implemented. …So for companies that don’t have the clinical wherewithal or don’t have the clinical data available to meet the MDR requirements, we see some of those products ultimately going away. The other thing that was an interesting challenge, here recently, is notified bodies and with the pending Brexit. We have Brexit. What would happen if your notified body was based in the UK and Brexit occurred and now you can’t get your products, you know on the continent …but I think a lot of companies, as I said, that
really haven’t had the clinical focus, are going to be challenged because you have to have a very robust clinical evaluation report to meet the MDR requirements.”

Listen using the embedded player on this page or click to listen on your favorite podcast app icons.

Today’s Podcast Topics:

  • What is the latest in orthopedic innovation and healthcare trends?
  • What financial expense should be avoided in developing a clinical investigation study?
  • With intensifying public pressure to reduce spending, payers are increasingly using formulary tiering to help control and manage market access do you foresee this trend likely continuing?
  • New EU Medical Device Regulation’s (MDR) transition begins in May what scenarios will likely unfold?
  • What is the Future of Spine 2025?
  • What advice would you provide to people who are entering the Med Tech industry?

Links and Resources Mentioned in this Podcast:

 

Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.

 

About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.

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Spineway USA Inc

Episode 09 : Michael Ferguson: Medical Device Commercialization and Securing Payor Coverage

“what I would recommend to folks is really to understand the payer landscape … you need to do your due diligence on the front end and understand the landscape before bringing the product in. And where I’ve seen too many companies make mistakes is they focus on the FDA first. And then they wait until they get the FDA, and then they start on the payer. In my opinion, they should need to do those in tandem, in parallel. They need to think about it on the front end in what’s it going to be required.”- Michael Ferguson, Ph.D., Vice President, Global Healthcare Economics and Reimbursement, AtriCure

Michael advises early startup Med Tech companies on how to secure payor coverage or clinical adoption. We discuss that the medical device commercialization in the US has two significant challenges, FDA approval and a successful reimbursement strategy. He suggests that you need to start working on a reimbursement strategy immediately and not wait until you already have FDA approval. Reimbursement also is driven by the level of competition and that influences how payor coverage is achieved. Michael provides insight on if it is clinical or cost-effectiveness that is more important when introducing a new product. He shares that with pressure to decrease spending there’s an effort to focus on quality over volume to lower costs while not giving up access to the newest, most innovative type of therapy. Michael reflects on the impact that removing the Med Device Tax has had on his company and gives his perspective of the future of global healthcare.

“In my mind, any good health economics is driven by good clinical. So really what a good health economics study does, or cost-effectiveness study would do, is they demonetize the clinical work. That’s what you’re really attempting to do and so when I do an economic study, or cost-effectiveness study, I’m attempting to showcase clinical value but in a monetary term … so I think it’s clinical-effectiveness first, and then if you’ve got good clinical-effectiveness you put monetary value to it.”

Listen using the embedded player on this page or click to listen on your favorite podcast app icons.

Today’s Podcast Topics:

  • Michael offers his advice on developing a successful Med Device reimbursement strategy.
  • With intensifying public pressure to reduce spending, payers are increasingly using formulary tiering to help control and manage market access, Michael provides his perspective if this trend will likely continue?
  • Is the main objective of health economics – clinical or cost-effectiveness?
  • What is the Future of Global Healthcare?
  • Finally, what if any impact will the removal of the medical device tax have on the Med Tech Industry?

Links and Resources Mentioned in this Podcast:

 

Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.

 

About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.

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Spineway USA Inc

Episode 08 : Scott Nelson: Internet of Things (IoT) and how it is affecting the Med Tech industry.

“anytime you’re dealing with IoT, you know, the first thing one has to realize is you’re working at a systems level, at a very high systems level. And the key to good systems engineering and systems design is don’t build what you should buy… Basically, you have to build, only that which really differentiates you in the marketplace, and that really solves the problem that you’re trying to solve. And then the follow on to that is the biggest miss in IoT right now, particularly industrial IoT, is the developers forget about one extremely important thing, and that’s deployment.”-Scott A. Nelson, Reuleaux Technology, LLC

What is the Internet of Things?
Scott explains it is the digitization of the physical world and connecting that to the internet where you can apply unlimited computing resources to convert that data into useful information. He discusses the evolution and future of IoT. He identifies the smartphone to have the most profound impact on the current health tech industry. Scott discusses the financial mistakes startup companies make when creating a new IoT product. He also stresses that security is not something you buy, it’s something you get through your development. It must be core to everything you do. Scott thinks AI systems will continue to learn if the system is built right, if more data keeps coming into the system, and as long as it’s parameterized broadly.

“for me, the biggest kind of issue with AI, particularly in healthcare right now, is what is the definition of true AI? A lot of what’s called AI, in my opinion, is actually machine learning because it’s deterministic. It’s the deployment of algorithms with known outcomes based on unknown inputs… You know, the outcome is determined and then the system remembers it so that it can do it faster the next time … A true AI system is nondeterministic. You give the system a general direction and a general desired outcome, but you don’t know exactly how it’s going to get there … I think there’s a lot of opportunity when one starts looking at behavior modification and one starts … learning from data and allowing, you know, agents to do experiments on big data, intrinsic experiments, where I have a parameterize data set from, that’s statistically relevant and I can effectively run clinical trials without touching patients a second time because I have enough data. You can cut loose AI bots on that situation because if you fail there’s still kind of a human in the loop at some point to not impact lives with that failure. You’ll, basically, be a checks and balances.”

Listen using the embedded player on this page or click to listen on your favorite podcast app icons.

Today’s Podcast Topics:

  • Scott provides his perspective on how Internet of Things (IoT) has advanced today vs 5 years ago, and what is the future of IoT in 2025?
  • What one key technology Scott believes will have the most profound IoT impact in the Med Tech industry?
  • What financial “headwinds” that should be avoided in developing an IoT platform?
  • What advice Scott would offer to the Med Tech industry to protect against various strains of malware?
  • Will Artificial Intelligence continue to “learn” about the learning process?
  • Finally, Scott’s perspective to people who are newly entering the Med Tech Industry?

Links and Resources Mentioned in this Podcast:

 

Did you enjoy this episode? Click here to Leave a Review. Each review helps us grow the Avenu Community and bring more guests to you! Thank you.

 

About the Host:

Jon has more than 25 years of experience in the medical device industry with progressive senior level experience with both public and private medical device companies.  Prior to Spineway USA, Inc., he was EVP of Prosidyan, Inc., focused on synthetic bone graft materials for optimal healing, exclusive rights were acquired by DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies in June, 2018.  Jon has successful commercialization and revenue generation with Zimmer Spine, Centinel Spine and Wenzel Spine.  Jon received a BS from Ball State University and is an active Board Member (Advisory) at ZygoFix, Ltd.

Connect with me directly on LinkedIn or subscribe to “Avenu Podcast” via our Website News Letter.

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