“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.” David Uffer – VP of MedTech and Sr. Partner of Alira Health 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. 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 David Uffer on LinkedIn  Website (https://www.alirahealth.com/) Email: ufferdm@yahoo.com 

Avenu Podcast

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

“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”-Frank Jaskulke, Vice President of Intelligence, Medical Alley, Minneapolis, MN 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. 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: · Frank Jaskulke on LinkedIn  · Website medicalalley.org · Email: fjaskulke@medicalalley.org

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

"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 Hovda, President & Chief Executive Officer – Simplify Medical 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.   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: · David Hovda on LinkedIn  · Website: www.simplifymedical.com · Email: dhovda@simplifymedical.com

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

“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.   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: · Michael Ferguson, Ph.D. on LinkedIn · Website atricure.com 

Michael Ferguson: Medical Device Commercialization and Securing Payor Coverage.

"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.   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: · Scott A. Nelson on LinkedIn  · Website reuleauxtech.com · Email: scottnelson@reuleauxtech.com

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

"I think the more that we can put online to do self-paced learning, the better. I think the more that we can provide micro-learning environments, the better. People are wise enough and disciplined enough and have the technology now to train at their own pace. And we should be doing things that ascribe to that belief... And it should be fun and entertaining."- Bob Milani, Principal Consultant at REM Consulting Pro What goes into a great training strategy? Bob explains that a well-trained sales team can lead to very large returns for a company. He identifies the value in a micro-learning environment and reveals that people base their buying decisions on trust and believability. Sales training is a competitive advantage with the caliber of the salesperson being the most important factor that influences any prospect's decision to buy. Bob discusses the value in a direct feedback, field-based component to sales training.   Today’s Podcast Topics: · Bob informs our audience why Sales Training is critical to a Company’s Success. · What method is the best performer for training new salespeople · When a sales rep doesn’t achieve sales quota, how did you ensure they reach their next quota · How does Bob suggest an individual prepare for a presentation? · Finally, Bob’s perspective to people who are newly entering the Med Tech Industry?   Links and Resources Mentioned: · Bob Milani on LinkedIn · Email: milani_bob@yahoo.com  

Bob Milani: Why Sales Training is Critical to a Company’s Success

“A robot has an accuracy and precision that we can never achieve with navigation or manual instruments. So, we're going to continue to develop new software applications, provide surgeons more information on the patient, and that surgeon will be able to assess the patient intraoperatively. And then, with the robot, be able to execute a preparation, with an accuracy that we never could before.”- Robert Cohen VP of Global R&D, Chief Technology Officer at Stryker Joint Replacement   Summary: Robert discusses how Stryker got into the robotics business and how robots are replacing the instruments set and adding benefit to the implants already on the market. He explains that robots have accuracy and precision never provided before to deliver surgeons more information on the patient and to optimize a procedure to try and gain the best clinical outcomes possible and improve patient satisfaction. Robert gives insight into how big the robotics surgery market is right now and discusses that the future of surgical robotics will be obtaining digital information and using that information for individualized medicine.   “So that's the next evolution is how do you change the workflow of the surgical procedure and total hips and total knees. That hasn't really changed in over 50 years. Now we have a tool that's for the change. And then let's go one step further. … We can make medical implants in completely different configurations, with different tolerances different surfaces, things that could have a shape that conventional manufacturing processes could never make”- Robert Cohen VP of Global R&D, Chief Technology Officer at Stryker Joint Replacement   Today’s Podcast Topics: · What are some of the current applications of Robotic systems? · Robotic advancements that will have an impact in transforming healthcare · Future of surgical robotics integrating navigation, enhanced imaging, and data analytics · Will surgical robotics evolve to being remote telesurgery systems? · Data integration from robotic surgeries is immensely valuable in the ability to help create consistent execution of surgical procedures, how hospital systems can ensure this clinical success · What advice would you provide to people who are entering Med Tech industry?   Links and Resources Mentioned in this Podcast: · Robert C. Cohen on LinkedIn · Website: Stryker · Email: Robert.Cohen@stryker.com

Robert Cohen – The Future of Robotics and Stryker R&D

“The secret of evaluating opportunities is have the right evaluation in mind, number one, number two a technology that overcomes the average management team, and number three an ability to recognize that you make wrong decisions all the time and a willingness to modify those wrong decisions to be good decisions.”- Anthony G. Viscogliosi, Co-Founder, Viscogliosi Brothers, LLC Are entrepreneurs born or made? Anthony uses his knowledge from his experience as a Chief Executive, Entrepreneur, and Business Strategist to discuss what makes a great entrepreneur, the essential qualities of a great leader, and how to evaluate new opportunities. He shares his insight on how to tell if someone has the right DNA and how to turn a "No" into a "Yes, with conditions." He also expresses the importance of the ability to adjust a decision when it’s wrong. “the essential qualities of a leader … number one do what you love. Number two become you, evolve into all you can be. Number three be a risk-taker. Number four have grit, persevere when no one else will, that’s grit, and finally, number five turn every no that you get into a yes with conditions.” Todays Topics List: You’ve started several successful companies. Did you always know you wanted to be an entrepreneur? What do you think: are entrepreneurs born or made? What are the essential qualities of a great leader? How can you tell if someone has the right DNA? When evaluating new opportunities what factors are deal-breakers to you? Finally, Mr. Viscogliosi’s perspective to people who are newly entering the Med Tech Industry? Links and Resources Mentioned List: Anthony G. Viscogliosi on LinkedIn Website  Email: aviscogliosi@vbllc.com 

Anthony Viscogliosi- Entrepreneurship. Identifying value creators. Evaluating opportunities.

 “We are moving at light speeds with respect to smart technologies, incorporating that, and that’s everything from smart software in feedback and telemetrics systems but, also moving towards artificial intelligence, augmented reality. All of this is starting to come to fruition within the device industry, having these smart implants, being able to use your iPhone to track its performance or if there are problems.” -Lisa Ferrara, PhD On Today's Episode:   Lisa discusses the challenges with the FDA approval process for new Smart Technologies. She explains that each Smart Technology will be very unique and customized, so we have to work as a team to asses, evaluate, and test these new technologies. She stresses that you must put together the appropriate evaluation strategy, identify the risks, and make a plan to mitigate these risks. Lisa also shares insight into healthcare’s move to non-invasive and minimally invasive treatments.    “What I’m seeing is the FDA wants to work with us, as a team because it is going to take a very large team effort to really solve certain issues and concerns. For instance, how do we test these, how do we evaluate the particular smart technology?” -Lisa Ferrara, PhD  Today’s Podcast Topics  Lisa informs our audience on the key technologies she believes will have a profound impact in Med Tech  Dr. Ferrara explains what biomechanical research should an early stage Medical device address prior to FDA submission  How has the FDA Med Device approval process changed during her career?  What financial “headwinds” should be avoided in research?  What is the Future of Healthcare?  Finally, Lisa’s perspective to people who are newly entering the Med Tech Industry?      Links and Resources Mentioned in this Podcast:  Lisa Ferrara, PhD on LinkedIn  Website: OrthoKinetic Technologies   Email: lisa@orthokintech.com   

Lisa Ferrara: Smart Technologies - the future of MedTech

“Do your research, understand the principles, the anatomic principles, the materials. Understand the history of that material with the FDA. Understand the regulatory pathway. Ask!”- Glen Stiegman. Will a pre-submission meeting with the FDA speed up or delay your 510(k) approval process? Can companies redefine how some devices are regulated? Glen shares his perspective of the FDA regulatory process from his experiences of working in the FDA versus working in the industry. He identifies trends and observations of how technology has evolved and provides advice to companies entering the med-tech industry. “A huge component of the future in innovation in medical technology is the diagnosis. Human-like diagnosis. A lot of the data gathering appliances. Whether it’s a watch, whether it’s a patch, whether it’s a belt. They are coming out with all sorts of biometric wearables that are gathering data for the patient, for the physician.”   Today’s Podcast Topics  What are some recent trends/observation regarding regulatory affairs and clinical strategies observed by Mr. Stiegman?  Should an early start-up (Med Tech) consider a pre-submission meeting?  When should a Med Tech start-up begin communicating its regulatory strategy with the FDA?  Smartwatch technologies offering human-like diagnosis … will they pursue FDA De Novo pathway?   Mr. Steigman provides prospective on the once Europe first strategy for Med Tech with new MDR 2020.  Finally, Mr. Steigman’s perspective to people who are newly entering the Med Tech Industry.  Links and Resources Mentioned in this Podcast  Glenn Steigman on LinkedIn Website www.MCRA.com Email: gstiegman@mcra.com  

Glen Stiegman: Understanding the FDA regulatory pathway

“Telemedicine is hot and it’s probably the easiest, fastest, cheapest way to extend medical care and get appropriate care”, Stephen Hochschuler, MD Dr. Hockschuler analyzes the current healthcare market and identifies that the road ahead comprises of Telemedicine, Artificial Intelligence, Intellectual Property, Data, Regenerative Medicine and Robotics. He notes that physicians need to regain their power by staying independent and entrepreneurial. We discuss the key to lowering healthcare expenses and how to give the best care for the patient. Today’s Podcast Topics: · Dr. Hockschuler’s perspective on the latest in Orthopedic Innovation and Healthcare Trends. · How a medical device manufacturer can grow with the Industry. · Is the “The Road Ahead” Intelligent Orthopedics – combination of techniques and high-end technology? · What is Dr. Hockschuler’s evaluation process when presented with emerging technology for the 1st time? · Finally, Dr. Hockschuler’s  perspective to people who are newly entering the Med Tech Industry.   Links and Resources Mentioned in this Podcast: · Stephen Hockschuler, MD on LinkedIn · Website: texasback.com · Email: lwilson@texasback.com  

Stephen Hochschuler, MD: Telemedicine, AI, IP, Data, Regenerative Medicine, and Robotics. What's the road ahead?

“The three things that I think are the critical issues that will affect healthcare globally are affordability, access, & trust.”-Robin R Young In this episode we explore the various levels of Medical Device Protection and discuss the Global Issues effecting the Healthcare Industry. Robin R. Young is a leading expert in Orthopedics, Medical Data Analysis and the use of Biomaterials in Surgery. Mr. Young is founder and President of RRY Publications, LLC., which publishes “Orthopedics This Week”, one of the most widely read sources of Orthopedic News in the world with more than 200,000 monthly readers.  Robin has 25 years’ experience as a medical technology analyst with such firms as Piper Jaffray, Stephens, Inc., and HealthPoint Capital.  He is the author of six books on Biomaterials, thousand of research reports and hosted the annual New York Stem Cell Summit.  Robin has been quoted in numerous national and international publications, has been a keynote speaker at dozens of global medical conferences including the Vatican Stem Cell Conference.  Mr. Young earned his B.A. in Legal Administration from the University of Minnesota and Master’s in Business Administration from the University of St. Thomas (MN).    You can find the link to Robin’s profile in the Podcast notes below, Robin kindly extended a free 90-subscription to “Orthopedics This Week” which can also be located in the Links and Resources References from today’s podcast. Links and Resources Mentioned in this Podcast: Robin Young on LinkedIn  Website Orthopedics This Week  Website PearlDiver  90-day FREE Subscription – “Orthopedics This Week”  Email: robin@ryortho.com 

Robin R. Young: Critical Global Issues Affecting the Healthcare Industry

Get to know our host of Avenu Podcast, Jon Luedke. With this podcast Jon wants to add value to the med-tech industry by providing networking, learning opportunities, insights, takeaways, and inspiration to our viewers. Avenu Podcast provides thought-provoking conversations with innovators, leaders, and pioneers in this market. He stresses the importance of a mentor to provide guidance, direction, history, knowledge, and experience. Why Avenu Podcast?: "We wanted to take the forefront and become a relevant content leader and provide that creativity to our constituents, you know, providing podcast information via that format gives another opportunity for Spineway, myself, and our guests to add value to the med tech industry”- Jon Luedke Today’s Podcast Topics: Introduction to Avenu Podcast host Jon Luedke and his Medtech background Why start Avenu Podcast? What the audience can expect to gain from listening to Avenu Podcast? Finally, Jon’s perspective to people who are newly entering the Medtech Industry? Links and Resources Mentioned in this Podcast: Jon Luedke on LinkedIn Website Podcast Link  Email: jrl@spineway.com WEBSITE: Show Notes

Intro: Jon Luedke Host of Avenu Podcast. A student and fan of the med tech industry for over two decades.

Wondering what Avenu Podcast is all about? Whether you’re an industry professional or simply have interest in MedTech, Avenu podcast will maximum your time and provide new industry insight.  Hosted by , Jon Luedke – A student and fan of the med tech industry for over two decades.  Currently President & CEO of Spineway USA, Inc., a French based publicly traded company that treats severe spinal column pathologies. https://spinewayusa.com/podcasts/

Intro- Host Jon Luedke

Avenu Podcast feature 30-minute thought-provoking conversations with innovators, leaders, and pioneers in the med tech industry providing insight into unique topics through their expertise and experiences. Whether you’re an industry professional or simply have interest in MedTech, Avenu podcast will maximum your time and provide new industry insight. Hosted by , Jon Luedke - A student and fan of the med tech industry for over two decades. Currently President & CEO of Spineway USA, Inc., a French based publicly traded company that treats severe spinal column pathologies.

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Avenu Podcast

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