Medsider Radio: Learn from Proven Medtech and Healthcare Experts

Bill Facteau joined Earlens Corporation as Chairman, President, and CEO in November of 2013. Most recently, he was the Vice Chairman of ExploraMed, a medical device incubator based on the West Coast and an Entrepreneur in Residence at New Enterprise Associates. Previously, Bill was at Johnson & Johnson from early 2010 through early 2012 as Worldwide President of their ENT Division. Facteau joined Johnson & Johnson via the $800M dollar acquisition of Acclarent where he served as President, CEO, and a member of the Board of Directors since the company’s formation in 2004. Under Bill’s leadership, the Acclarent went from concept to acquisition in 5 ½ years, raised over $100M, created jobs for approximately 400 employees, grew revenues to $100M and became profitable. Prior to joining Acclarent, Bill was the General Manager of the Endovascular Division at Abbott Vascular where he served as a member of the executive team and created the entry strategy for Abbott to participate in the peripheral vascular space. He joined Abbott Laboratories via the $683 million acquisition of Perclose, a vessel closure company, where he was Sales Director. From July 1993 to April 1998, Bill worked in a number of sales and sales management positions at United States Surgical Corporation, or otherwise known as US Surgical. Interview Highlights with Bill Facteau - How Bill and his team celebrated after Acclarent was acquired by Johnson & Johnson. - Bill’s current role at Earlens, the technology they’ve developed, and how they intend to commercialize it. - What brought Bill into the medical device space with U.S. Surgical back in the early 1990's. - How Bill’s medtech sales experience has impacted the rest of his career. - What medtech entrepreneurs can learn from Bill’s experience helping to build Acclarent from the ground floor. - Why Bill didn’t want to stay in venture capital after spending time at ExploraMed and NEA after J&J's acquisition of Acclarent. - Mindshare and comfort zones: Bill’s advice on how to experience personal growth as a leader in medtech. - People, product, opportunity: what they mean to Bill as a medtech executive. - Bill's thoughts on the regulatory and reimbursement environments and why he loves the direct-to-patient approach they are taking at Earlens. - Bill’s favorite business book, the CEO he admires most, and what he would tell his 25-year old self. This Is What You Can Do Next 1) Listen to the interview with Bill Facteau right now: 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. The post The Importance of Medical Device Sales Experience, the Rocket Ship that was Acclarent, and How to Achieve Personal Growth as a Medtech Leader: Interview with Bill Facteau, President and CEO of Earlens appeared first on Medsider.

Dr. John Simpson. Even if you’re a medical device newbie, you’ve probably heard of him. He’s credited with inventing and commercializing the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA). This single idea created the field of interventional cardiology as we know it today. Over the course of his renowned medtech career, Dr. Simpson has founded and successfully exited companies like ACS and DVI (both acquired by Eli Lily), CVIS (acquired by Boston Scientific), Perclose (sold to Abbott), Lumend (acquired by Cordis), Fox Hollow (acquired by ev3 which now part of Medtronic). It’s borderline exhausting just thinking about all of these companies, let alone starting them! Plain and simple, Dr. Simpson is a legend in the space and he isn’t done yet. He currently serves as the Executive Chairman of Avinger, where he and his team are developing a portfolio of unique cardiovascular products aimed at solving the challenging space of peripheral artery disease. In this interview with Dr. Simpson, we learn about the key lessons he’s learned throughout his historic medtech career and why he’s still fired up about medical device innovation after all these years. Interview Highlights with Dr. John Simpson - How Dr. Simpson's infamous encounter with Jack Nicklaus (yes, that Jack Nicklaus) led to his firing as a bank teller, which forced him down a new career path.- What initially attracted Dr. Simpson to the field of cardiology and how treating vascular disease has been a consistent theme throughout all of the companies he’s started.- The reasons why Dr. Simpson decided to pursue Andreas Gruentzig's balloon catheter technologies and how it led to his own inventions.- As a medtech entrepreneur, why knowing your strengths and limitations is key to making a difference in the lives of others.- Discover Dr. Simpson's approach to building a team, and how surrounding himself with people that have a broad group of skill sets has enabled his success throughout the years.- The key challenges Dr. Simpson has faced with his new company, Avinger, and the important lessons he’s learned.- Simpson reveals his approach to raising capital in the medtech industry, and how persevering through challenges has been crucial for Avinger's success.- The advice Dr. Simpson would give to his 30-year-old self, and how endurance through criticism is what ultimately leads to revolution within the medical field. This Is What You Can Do Next 1) Listen to the interview with Dr. John Simpson right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Dr. John Simpson Dr. John Simpson received his PhD in Immunology from the University of Texas and his MD from Duke University. He completed his fellowship in interventional cardiology at Stanford University. Dr. Simpson is a member of the American College of Physicians and a fellow of the American College of Cardiology. He has published extensively on a wide variety of subjects and lectured throughout the world. Dr. Simpson has started several companies dedicated to providing patients with the most cutting-edge therapies in a variety of different areas. He invented and commercialized the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA). This single idea created the field of interventional cardiology as we know it today. He currently serves as Executive Chairman of Avinger. The post Why Curiosity and Persistence are Crucial Characteristics for Medtech Entrepreneurs: Interview with the Legendary Dr. John Simpson, Executive Chairman of Avinger appeared first on Medsider.

Dr. John Simpson.  Even if you’re a medical device newbie, you’ve probably heard of him.  He’s credited with inventing and commercializing the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA).  This single idea created the field of interventional cardiology as we know it today. Over the course of his renowned medtech career, Dr. Simpson has founded and successfully exited companies like ACS and DVI (both acquired by Eli Lily), CVIS (acquired by Boston Scientific), Perclose (sold to Abbott), Lumend (acquired by Cordis), Fox Hollow (acquired by ev3 which now part of Medtronic).  It’s borderline exhausting just thinking about all of these companies, let alone starting them! Plain and simple, Dr. Simpson is a legend in the space and he isn’t done yet.  He currently serves as the Executive Chairman of Avinger, where he and his team are developing a portfolio of unique cardiovascular products aimed at solving the challenging space of peripheral artery disease. In this interview with Dr. Simpson, we learn about the key lessons he’s learned throughout his historic medtech career and why he’s still fired up about medical device innovation after all these years. Interview Highlights with Dr. John Simpson - How Dr. Simpson's infamous encounter with Jack Nicklaus (yes, that Jack Nicklaus) led to his firing as a bank teller, which forced him down a new career path. - What initially attracted Dr. Simpson to the field of cardiology and how treating vascular disease has been a consistent theme throughout all of the companies he’s started. - The reasons why Dr. Simpson decided to pursue Andreas Gruentzig's balloon catheter technologies and how it led to his own inventions. - As a medtech entrepreneur, why knowing your strengths and limitations is key to making a difference in the lives of others. - Discover Dr. Simpson's approach to building a team, and how surrounding himself with people that have a broad group of skill sets has enabled his success throughout the years. - The key challenges Dr. Simpson has faced with his new company, Avinger, and the important lessons he’s learned. - Simpson reveals his approach to raising capital in the medtech industry, and how persevering through challenges has been crucial for Avinger's success. - The advice Dr. Simpson would give to his 30-year-old self, and how endurance through criticism is what ultimately leads to revolution within the medical field. This Is What You Can Do Next 1) Listen to the interview with Dr. John Simpson right now: 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Dr. John Simpson Dr. John Simpson received his PhD in Immunology from the University of Texas and his MD from Duke University.  He completed his fellowship in interventional cardiology at Stanford University.  Dr. Simpson is a member of the American College of Physicians and a fellow of the American College of Cardiology. He has published extensively on a wide variety of subjects and lectured throughout the world. Dr. Simpson has started several companies dedicated to providing patients with the most cutting-edge therapies in a variety of different areas. He invented and commercialized the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA).  This single idea created the field of interventional cardiology as we know it today.  He currently serves as Executive Chairman of Avinger. The post Why Curiosity and Persistence are Crucial Characteristics for Medtech Entrepreneurs: Interview with the Legendary Dr. John Simpson, Executive Chairman of Avinger appeared first on Medsider.

Biz Stone, the co-founder of Twitter, has famously stated, “Timing, perseverance, and 10 years of trying will eventually make you look like an overnight success.” In the world of medtech startups, this is almost always the case. And it’s certainly true with UroLift, a device that came to life in the fall of 2004. In this interview with Ted Lamson, co-founder of NeoTract and primary inventor of UroLift, we learn how they achieved U.S. and European approvals, obtained a category 1 CPT code in near-record time, and their approach to convincing CMS and commercial payers to cover their device. Interview Highlights with Ted Lamson - Ted’s experience at ExploraMed and how the idea for UroLift came to fruition.- The process Ted follows when pursuing ideas for disruptive medical devices.- Why Ted and his team at NeoTract decided to pursue a CE Mark and what they learned through that process.- Lessons learned after raising 4 different rounds of financing for NeoTract.- Against the advice of consultants, why Ted and his team decided to pursue positive guidance from NICE.- How NeoTract was able to obtain a category 1 CPT code for UroLift less than 6 months after receiving FDA clearance.- The approach Ted and his team are taking to convince CMS and commercial payers to cover UroLift.- Ted’s favorite business book, the business leaders he admires the most, and the one piece of advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Ted Lamson right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Ted Lamson Co-founder of NeoTract, Ted Lamson is a primary inventor of UroLift and served as President and CEO for the first 4 years of the company. He currently oversees clinical affairs, procedure development, reimbursement and medical affairs. Ted has over 25 years experience in the medical device industry in multiple fields and holds over 50 patents, many of which represent current commercial medical products. Ted has played a leadership role in successful ventures, such as Vice President R&D for TransVascular (sold to Medtronic), co-inventor for Acclarent (sold to J&J), and is a Strategic Advisor to the ExploraMed incubator, which has launched several medical device companies, including NeoTract, Inc. In addition to his deep start-up experience Ted has served as Vice President in the Vascular division of Medtronic and Section Manager within the prior-owned Schneider division of Pfizer. Ted holds a PhD and MS in Biomedical Engineering from Penn State University as well as a BS in Chemical Engineering from Rensselaer Polytechnic Institute. The post 4 Rounds of Financing, CE Mark, FDA Clearance, and a Category 1 CPT Code – How NeoTract has Grinded its Way to Success Over the Past Decade appeared first on Medsider.

Biz Stone, the co-founder of Twitter, has famously stated, “Timing, perseverance, and 10 years of trying will eventually make you look like an overnight success.”   In the world of medtech startups, this is almost always the case.  And it’s certainly true with UroLift, a device that came to life in the fall of 2004. In this interview with Ted Lamson, co-founder of NeoTract and primary inventor of UroLift, we learn how they achieved U.S. and European approvals, obtained a category 1 CPT code in near-record time, and their approach to convincing CMS and commercial payers to cover their device. Interview Highlights with Ted Lamson - Ted’s experience at ExploraMed and how the idea for UroLift came to fruition. - The process Ted follows when pursuing ideas for disruptive medical devices. - Why Ted and his team at NeoTract decided to pursue a CE Mark and what they learned through that process. - Lessons learned after raising 4 different rounds of financing for NeoTract. - Against the advice of consultants, why Ted and his team decided to pursue positive guidance from NICE. - How NeoTract was able to obtain a category 1 CPT code for UroLift less than 6 months after receiving FDA clearance. - The approach Ted and his team are taking to convince CMS and commercial payers to cover UroLift. - Ted’s favorite business book, the business leaders he admires the most, and the one piece of advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Ted Lamson right now: Download audio file (Medsider_Interview_Ted_Lamson_NeoTract_UroLift.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Ted Lamson Co-founder of NeoTract, Ted Lamson is a primary inventor of UroLift and served as President and CEO for the first 4 years of the company. He currently oversees clinical affairs, procedure development, reimbursement and medical affairs. Ted has over 25 years experience in the medical device industry in multiple fields and holds over 50 patents, many of which represent current commercial medical products. Ted has played a leadership role in successful ventures, such as Vice President R&D for TransVascular (sold to Medtronic), co-inventor for Acclarent (sold to J&J), and is a Strategic Advisor to the ExploraMed incubator, which has launched several medical device companies, including NeoTract, Inc. In addition to his deep start-up experience Ted has served as Vice President in the Vascular division of Medtronic and Section Manager within the prior-owned Schneider division of Pfizer. Ted holds a PhD and MS in Biomedical Engineering from Penn State University as well as a BS in Chemical Engineering from Rensselaer Polytechnic Institute. The post 4 Rounds of Financing, CE Mark, FDA Clearance, and a Category 1 CPT Code – How NeoTract has Grinded its Way to Success Over the Past Decade appeared first on Medsider.

Engaging with patients in a genuine and transparent way is tough. Really tough. It’s challenging for all healthcare stakeholders – payers, providers, and industry. From a medtech perspective, we often times get stuck in a certain mindset when trying to engage with patients. Whether it’s a continuous glucose monitor for diabetic patients or a new hip implant for orthopedic patients, we gravitate towards communicating the features and benefits of our particular product. For example, this might sounds familiar – “Joe Patient, you should consider our knee implant because it has a greater arc than Competitor X.” But is this really the right approach? If our end-goal is for a patient to take action, is this the best way to engage with them? To answer this question, I invited Neal Sofian to the program. He’s currently the VP of Engagement & Innovation at Vivacity, a subsidiary of Premera Blue Cross. Neal is recognized internationally for his work in population health management and behavioral change. Interview Highlights with Neal Sofian - What does patient personalization really mean? And why messaging around life and context is so important.- Why do so many life science companies fail to effectively personalize their messages to patients?- What technologies can actually support effective patient engagement?- Examples of companies that have been successful at patient personalization. - How to overcome some of the legal challenges associated with patient engagement. - The top 2 things that medtech or biotech companies should do right now to improve their patient engagement initiatives. - Neal’s favorite non-fiction business book, the business leaders he admires the most, and the one piece of advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Neal Sofian right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Neal Sofian Neal Sofian is recognized internationally for over 35 years of innovation in population and corporate health management as well as organizational change. He is responsible for commercializing the first telephonic coaching programs including Free & Clear and many of the early social networking platforms including the Cancer Society’s ‘Cancer Survivors Network’. Neal is currently the VP of Engagement & Innovation at Vivacity, a subsidiary of Premera Blue Cross. He develops new strategies to actively engage the 2 million members of Premera in their health and wellbeing. He is also a clay artist and has done standup comedy. Neal holds a master’s degree in public health from the University Of Missouri School Of Medicine. The post Patient Engagement for Medtech Companies is Hard – Here’s Some Advice on How to Do it Right appeared first on Medsider.

Engaging with patients in a genuine and transparent way is tough.  Really tough.  It’s challenging for all healthcare stakeholders – payers, providers, and industry. From a medtech perspective, we often times get stuck in a certain mindset when trying to engage with patients. Whether it’s a continuous glucose monitor for diabetic patients or a new hip implant for orthopedic patients, we gravitate towards communicating the features and benefits of our particular product.  For example, this might sounds familiar – “Joe Patient, you should consider our knee implant because it has a greater arc than Competitor X.” But is this really the right approach?  If our end-goal is for a patient to take action, is this the best way to engage with them?  To answer this question, I invited Neal Sofian to the program.  He’s currently the VP of Engagement & Innovation at Vivacity, a subsidiary of Premera Blue Cross.  Neal is recognized internationally for his work in population health management and behavioral change. Interview Highlights with Neal Sofian - What does patient personalization really mean?  And why messaging around life and context is so important. - Why do so many life science companies fail to effectively personalize their messages to patients? - What technologies can actually support effective patient engagement? - Examples of companies that have been successful at patient personalization. - How to overcome some of the legal challenges associated with patient engagement. - The top 2 things that medtech or biotech companies should do right now to improve their patient engagement initiatives. - Neal’s favorite non-fiction business book, the business leaders he admires the most, and the one piece of advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Neal Sofian right now: Download audio file (How_Medtech_Companies_Should_Approach_Patient_Engagement_-_Medsider_Interview_with_Neal_Sofian.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Neal Sofian Neal Sofian is recognized internationally for over 35 years of innovation in population and corporate health management as well as organizational change.  He is responsible for commercializing the first telephonic coaching programs including Free & Clear and many of the early social networking platforms including the Cancer Society’s ‘Cancer Survivors Network’.  Neal is currently the VP of Engagement & Innovation at Vivacity, a subsidiary of Premera Blue Cross.  He develops new strategies to actively engage the 2 million members of Premera in their health and wellbeing.  He is also a clay artist and has done standup comedy.  Neal holds a master’s degree in public health from the University Of Missouri School Of Medicine. The post Patient Engagement for Medtech Companies is Hard – Here’s Some Advice on How to Do it Right appeared first on Medsider.

CMS has an objective to shift 50% of all reimbursement services from fee-for-service to alternative, value-based methods by 2018. And bundled payment models, according to Dr. Dan Mazanec, will be the principal driver of this transformative initiative. But the topic of value-based healthcare can be pretty confusing , right? Comprehensive Care for Joint Replacement. Medicare Access and CHIP Reauthorization Act. MIPS vs. APM. The list goes on and on. How do you begin to understand it all? And if you’re a leader within your medtech or biotech organization, how should you begin to prepare your company for the future? To help answer some of these questions, I invited the aforementioned Dr. Dan Mazanec to join Medsider Radio. He’s currently the Chief Medical Officer for Dorsata. Prior to joining Dorsata, Dr. Mazanec was the Associate Director of the Center for Spine Health at the Cleveland Clinic. Board certified in internal medicine and rheumatology, Dan led the development and implementation of the Spine CarePath across the entire Cleveland Clinic Health System. Interview Highlights with Dr. Dan Mazanec - How did the original concept of bundled payment models start? And what was the original intent?- 2 early examples of bundles payments from the 80’s and 90’s.- An overview of the Comprehensive Care for Joint Replacement (CCJR) program and the potential ramifications for medical device companies.- The shifting financial risk in healthcare and why care coordination will be so important.- What the Medicare Access and CHIP Reauthorization Act (MACRA) means for healthcare, and more specifically, the 2 paths to reimbursement for physicians (MIPS vs. APMs).- How the concepts of Meaningful Use and Advancing Care Information will change and their impact on solo or small physician practices. - Specific to bundled payments and reimbursement, the top 2-3 things that medtech companies need to consider right now.- Dan’s favorite non-fiction business book, the business leader he finds most inspiring, and the one piece of advice he’d tell his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Dr. Dan Mazanec right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Dr. Dan Mazanec Dr. Dan Mazanec is the Chief Medical Officer for Dorsata. Prior to joining Dorsata, he was the Associate Director of the Center for Spine Health at the Cleveland Clinic. Board certified in internal medicine and rheumatology, he has been a leader in the development of the emerging specialty of Spine Medicine. A frequent lecturer at international and national meetings, he has authored more than 70 book chapters and papers and is an active member of the North American Spine Society with a particular focus on the development of evidence-based clinical guidelines. Dan led the development of the Cleveland Clinic Spine CarePath, which merges evidence-informed clinical management of spine disorders with patient-entered clinical outcome data. The post Demystifying Value-Based Healthcare – A Physician Expert Explains All (with Real-World Examples) appeared first on Medsider.

CMS has an objective to shift 50% of all reimbursement services from fee-for-service to alternative, value-based methods by 2018.  And bundled payment models, according to Dr. Dan Mazanec, will be the principal driver of this transformative initiative. But the topic of value-based healthcare can be pretty confusing , right?  Comprehensive Care for Joint Replacement.  Medicare Access and CHIP Reauthorization Act.  MIPS vs. APM.  The list goes on and on.  How do you begin to understand it all?  And if you’re a leader within your medtech or biotech organization, how should you begin to prepare your company for the future? To help answer some of these questions, I invited the aforementioned Dr. Dan Mazanec to join Medsider Radio.  He’s currently the Chief Medical Officer for Dorsata.  Prior to joining Dorsata, Dr. Mazanec was the Associate Director of the Center for Spine Health at the Cleveland Clinic.  Board certified in internal medicine and rheumatology, Dan led the development and implementation of the Spine CarePath across the entire Cleveland Clinic Health System. Interview Highlights with Dr. Dan Mazanec - How did the original concept of bundled payment models start?  And what was the original intent? - 2 early examples of bundles payments from the 80’s and 90’s. - An overview of the Comprehensive Care for Joint Replacement (CCJR) program and the potential ramifications for medical device companies. - The shifting financial risk in healthcare and why care coordination will be so important. - What the Medicare Access and CHIP Reauthorization Act (MACRA) means for healthcare, and more specifically, the 2 paths to reimbursement for physicians (MIPS vs. APMs). - How the concepts of Meaningful Use and Advancing Care Information will change and their impact on solo or small physician practices. - Specific to bundled payments and reimbursement, the top 2-3 things that medtech companies need to consider right now. - Dan’s favorite non-fiction business book, the business leader he finds most inspiring, and the one piece of advice he’d tell his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Dr. Dan Mazanec right now: Download audio file (Demystifying_Value-Based_Healthcare_with_Dr._Dan_Mazanec.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Dr. Dan Mazanec Dr. Dan Mazanec is the Chief Medical Officer for Dorsata.  Prior to joining Dorsata, he was the Associate Director of the Center for Spine Health at the Cleveland Clinic. Board certified in internal medicine and rheumatology, he has been a leader in the development of the emerging specialty of Spine Medicine. A frequent lecturer at international and national meetings, he has authored more than 70 book chapters and papers and is an active member of the North American Spine Society with a particular focus on the development of evidence-based clinical guidelines. Dan led the development of the Cleveland Clinic Spine CarePath, which merges evidence-informed clinical management of spine disorders with patient-entered clinical outcome data. The post Demystifying Value-Based Healthcare – A Physician Expert Explains All (with Real-World Examples) appeared first on Medsider.

For as long as I can remember, at every company meeting I've ever been to, the topic of off-label promotion is always covered. Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you thrown in jail. C.R. Bard, Boston Scientific, Covidien, Medtronic. Everyone considers this to be extremely important. And rightfully so. BUT, doctors use medical devices off-label all the time. If you go to any societal conference, physicians present off-label uses for medical devices on a regular basis. In fact, talk to any KOL, and they think it's almost humorous that medical device companies take off-label promotion so seriously. Because I've spent the majority of my medical device career in a sales or marketing capacity, I've always found this to be an interesting dynamic. Our physician customers discuss and use our products off-label all the time. But we can't say anything? If a doctor asks a question about an off-label use, mum is the word. “Sorry Dr. Smith. I can't answer that question. No information. Nada. Zilch.” However, the times are certainly changing. In a recent landmark criminal case against Vascular Solutions, the actual instructions to the jury included this statement, “It is not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” Wow! That's the first time something like that has ever been uttered by the government! In this interview with Mark Duval, President of DuVal & Associates, P.A., we learn about other recent First Amendment cases and what the outcomes mean for medtech companies moving forward. Interview Highlights with Mark DuVal - The 3 key takeaways from the recent criminal case against Vascular Solutions and why everyone in medtech should pay attention.- Why the government's focus on speech vs. conduct is so important.- The government's recognition that off-label promotion is legal as long as it's “wholly truthful and not misleading”.- New implications regarding the FDA's interpretation of general vs. specific use.- Other recent cases the government has lost and why there's a significant amount of inertia for positive change.- Mark's advice for medtech leaders in light of the government's losses in so many First Amendment cases.- Mark's favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Mark DuVal right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Mark DuVal Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters. The post Is Off-Label Promotion Now Legal? What the Recent Criminal Case Against Vascular Solutions Means for Medtech appeared first on Medsider.

For as long as I can remember, at every company meeting I've ever been to, the topic of off-label promotion is always covered.  Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you thrown in jail.  C.R. Bard, Boston Scientific, Covidien, Medtronic.  Everyone considers this to be extremely important.  And rightfully so. BUT, doctors use medical devices off-label all the time.  If you go to any societal conference, physicians present off-label uses for medical devices on a regular basis.  In fact, talk to any KOL, and they think it's almost humorous that medical device companies take off-label promotion so seriously. Because I've spent the majority of my medical device career in a sales or marketing capacity, I've always found this to be an interesting dynamic.  Our physician customers discuss and use our products off-label all the time.  But we can't say anything?  If a doctor asks a question about an off-label use, mum is the word.  “Sorry Dr. Smith.  I can't answer that question.  No information.  Nada.  Zilch.” However, the times are certainly changing.  In a recent landmark criminal case against Vascular Solutions, the actual instructions to the jury included this statement, “It is not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”  Wow!  That's the first time something like that has ever been uttered by the government! In this interview with Mark Duval, President of DuVal & Associates, P.A., we learn about other recent First Amendment cases and what the outcomes mean for medtech companies moving forward. Interview Highlights with Mark DuVal - The 3 key takeaways from the recent criminal case against Vascular Solutions and why everyone in medtech should pay attention. - Why the government's focus on speech vs. conduct is so important. - The government's recognition that off-label promotion is legal as long as it's “wholly truthful and not misleading”. - New implications regarding the FDA's interpretation of general vs. specific use. - Other recent cases the government has lost and why there's a significant amount of inertia for positive change. - Mark's advice for medtech leaders in light of the government's losses in so many First Amendment cases. - Mark's favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Mark DuVal right now: Download audio file (Medsider_Interview_with_Mark_DuVal.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Mark DuVal Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters. The post Is Off-Label ...

Jack Dorsey received quite a bit of attention when he was recently announced as CEO of Twitter. Why? Because that made him CEO of 2 of the most rapidly-growing tech. companies in Silicon Valley at the same – Twitter and Square. Well, medtech’s version of Jack Dorsey might be Duke Rohlen. Duke led FoxHollow Technologies through an IPO and then later solid it to ev3 for close to $800M. He also founded CV Ingenuity and sold it to Covidien for approximately $300M. Now, similar to Jack Dorsey, Duke is leading 2 early stage companies at the same time – Spirox and Advanced Cardiac Therapeutics. In this interview with Duke Rohlen, CEO of both Spirox and Advanced Cardiac Therapeutics, we learn about the strategies and tactics he employed that led to the successful exits of FoxHollow Technologies and CV Ingenuity for a combined total of over $1 billion. Interview Highlights with Duke Rohlen - Why Duke and the CV Ingenuity team felt bittersweet after selling to Covidien for $300M.- Why the CV Ingenuity team pursued a US-only strategy.- Why CV Ingenuity managed their clinical trials internally vs. working with an outside CRO.- Duke’s previous relationships with the leadership at ev3 (now Medtronic) and why they were critical to closing the CV Ingenuity deal with Covidien.- How Duke secured a unique $300M collaboration with Merck while serving as President of Fox Hollow Technologies.- The major lessons Duke has learned raising money for 4 different medical device companies.- How Duke is able to successfully lead two early stage medtech companies at the same time.- Duke’s favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Duke Rohlen right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Duke Rohlen Duke Rohlen serves as Chairman and CEO of Spirox, Inc. and Chairman and CEO of Advanced Cardiac Therapeutics. Prior to these roles, Duke served as founder and CEO of CV Ingenuity where he raised $30.0 million of venture capital prior to selling the company to Covidien (now Medtronic) in 2013 for ~$300.0 million. Prior to CV Ingenuity, Duke served in a variety of roles at FoxHollow Technologies prior to being named President. Duke helped drive annual sales to ~$200.0 million, helped the company through an IPO, conceived of and structured a $300.0 million collaboration with Merck Pharmaceuticals, and ultimately led the sale of the company to EV3 (now Medtronic) for $780.0 million in 2008. Prior to working at FoxHollow, Duke held senior management positions at two other medical technology companies and served as an entrepreneur-in-residence at the private equity firm, Alta Partners. The post After Selling 2 Cardiovascular Companies for Over $1 Billion, Duke Rohlen is Now Hoping to do the Same with Spirox and Advanced Cardiac Therapeutics appeared first on Medsider.

Jack Dorsey received quite a bit of attention when he was recently announced as CEO of Twitter.  Why?  Because that made him CEO of 2 of the most rapidly-growing tech. companies in Silicon Valley at the same – Twitter and Square. Well, medtech’s version of Jack Dorsey might be Duke Rohlen.  Duke led FoxHollow Technologies through an IPO and then later solid it to ev3 for close to $800M.  He also founded CV Ingenuity and sold it to Covidien for approximately $300M.  Now, similar to Jack Dorsey, Duke is leading 2 early stage companies at the same time – Spirox and Advanced Cardiac Therapeutics. In this interview with Duke Rohlen, CEO of both Spirox and Advanced Cardiac Therapeutics, we learn about the strategies and tactics he employed that led to the successful exits of FoxHollow Technologies and CV Ingenuity for a combined total of over $1 billion. Interview Highlights with Duke Rohlen - Why Duke and the CV Ingenuity team felt bittersweet after selling to Covidien for $300M. - Why the CV Ingenuity team pursued a US-only strategy. - Why CV Ingenuity managed their clinical trials internally vs. working with an outside CRO. - Duke’s previous relationships with the leadership at ev3 (now Medtronic) and why they were critical to closing the CV Ingenuity deal with Covidien. - How Duke secured a unique $300M collaboration with Merck while serving as President of Fox Hollow Technologies. - The major lessons Duke has learned raising money for 4 different medical device companies. - How Duke is able to successfully lead two early stage medtech companies at the same time. - Duke’s favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self. This Is What You Can Do Next 1) Listen to the interview with Duke Rohlen right now: Download audio file (Medsider_Interview_with_Duke_Rohlen_of_Spirox_and_Advanced_Catheter_Therapeutics.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Duke Rohlen Duke Rohlen serves as Chairman and CEO of Spirox, Inc. and Chairman and CEO of Advanced Cardiac Therapeutics.  Prior to these roles, Duke served as founder and CEO of CV Ingenuity where he raised $30.0 million of venture capital prior to selling the company to Covidien (now Medtronic) in 2013 for ~$300.0 million. Prior to CV Ingenuity, Duke served in a variety of roles at FoxHollow Technologies prior to being named President. Duke helped drive annual sales to ~$200.0 million, helped the company through an IPO, conceived of and structured a $300.0 million collaboration with Merck Pharmaceuticals, and ultimately led the sale of the company to EV3 (now Medtronic) for $780.0 million in 2008. Prior to working at FoxHollow, Duke held senior management positions at two other medical technology companies and served as an entrepreneur-in-residence at the private equity firm, Alta Partners. The post After Selling 2 Cardiovascular Companies for Over $1 Billion, Duke Rohlen is Now Hoping to do the Same with Spirox and Advanced Cardiac Therapeutics appeared first on Medsider.

I'll be candid. This is an interview I've wanted to do for quite some time. During my time at Covidien, I considered myself fortunate to be involved with the acquisition of Sapheon, a startup company that manufactured a disruptive therapy for venous reflux. The more I learned about Sapheon through the diligence process (as well as the post-acquisition activities), the more enamored I became with their story. Great idea. Huge market. Really solid execution by people like Don Crawford, Dr. Rod Raabe, Gary McCord, and Monte Madsen. To this day, I still think it's one of the more unheralded examples of success within medtech. In this interview with Don Crawford, current President of Analytics 4 Life and former CEO of Sapheon, we learn how they went from an idea on the back of a napkin to a $240 million exit through unconventional financing, disciplined compliance, and much more. Interview Highlights with Don Crawford - How Don and his team at Sapheon celebrated after officially closing the deal with Covidien.- How the Sapheon team went from an initial idea on the back of a napkin to an eventual multi-million dollar exit.- Don’s methodology for evaluating startup medical device ideas.- The unique story of how Sapheon was funded almost completely by private, angel investors.- How Sapheon’s disciplined compliance led to regulatory efficiencies.- The offshore clinical trial work that allowed Sapheon to expedite their regulatory approvals.- The lessons Don learned at Sapheon and how they’re translating to his new company, Analytics 4 Life.- The CEO that Don follows, as well as the advice that he would give his 30-year old self. This Is What You Can Do Next 1) Listen to the interview with Don Crawford right now: 2) You can also download the mp3 file of the interview by clicking here Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes. And if you get a chance, leave us an honest rating and review. About Don Crawford Don Crawford is the President and CEO of Analytics 4 Life (A4L), a medical information technology company that uses advanced signal processing techniques for the purposes of assessing and diagnosing disease. Prior to his role with A4L, Don was president and CEO of Sapheon, which was acquired by Covidien in 2014. Before Sapheon, Don held various leadership positions with Guidant, Medtronic, DVI, Ventritex, and WebMD. He received a Bachelor of Chemical Engineering degree from Georgia Tech and a MBA degree from Emory University. The post From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon appeared first on Medsider.

I'll be candid. This is an interview I've wanted to do for quite some time. During my time at Covidien, I considered myself fortunate to be involved with the acquisition of Sapheon, a startup company that manufactured a disruptive therapy for venous reflux. The more I learned about Sapheon through the diligence process (as well as the post-acquisition activities), the more enamored I became with their story. Great idea. Huge market. Really solid execution by people like Don Crawford, Dr. Rod Raabe, Gary McCord, and Monte Madsen. To this day, I still think it's one of the more unheralded examples of success within medtech. In this interview with Don Crawford, current President of Analytics 4 Life and former CEO of Sapheon, we learn how they went from an idea on the back of a napkin to a $240 million exit through unconventional financing, disciplined compliance, and much more. Interview Highlights with Don Crawford - How Don and his team at Sapheon celebrated after officially closing the deal with Covidien. - How the Sapheon team went from an initial idea on the back of a napkin to an eventual multi-million dollar exit. - Don’s methodology for evaluating startup medical device ideas. - The unique story of how Sapheon was funded almost completely by private, angel investors. - How Sapheon’s disciplined compliance led to regulatory efficiencies. - The offshore clinical trial work that allowed Sapheon to expedite their regulatory approvals. - The lessons Don learned at Sapheon and how they’re translating to his new company, Analytics 4 Life. - The CEO that Don follows, as well as the advice that he would give his 30-year old self. This Is What You Can Do Next 1) Listen to the interview with Don Crawford right now: Download audio file (Medsider_Interview_with_Don_Crawford_-_CEO_of_Analytics_4_Life.mp3) 2) You can also download the mp3 file of the interview by clicking here. Don't forget – you can listen to this interview and all of the other Medsider interviews via iTunes.  And if you get a chance, leave us an honest rating and review. About Don Crawford Don Crawford is the President and CEO of Analytics 4 Life (A4L), a medical information technology company that uses advanced signal processing techniques for the purposes of assessing and diagnosing disease. Prior to his role with A4L, Don was president and CEO of Sapheon, which was acquired by Covidien in 2014. Before Sapheon, Don held various leadership positions with Guidant, Medtronic, DVI, Ventritex, and WebMD. He received a Bachelor of Chemical Engineering degree from Georgia Tech and a MBA degree from Emory University. The post From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon appeared first on Medsider.