Medsider: Learn from MedTech and HealthTech Experts

How will healthcare reform affect care delivery and reimbursement? And what will the impact be for medical device companies? These are probably the 2 biggest questions that medtech companies need to answer in order to succeed in the future. Unfortunately, there aren’t solid answers at this point. But there are some people that can help! In this interview with Brian Contos, Executive Director for the Advisory Board Company, we learn how medical device companies can respond to the changing healthcare dynamics. Interview Highlights with Brian Contos - Brian explains the following trends: From 2005-2011, lower extremity angioplasty procedures increased by 67%, venous ablations increased by 400%, and venous angioplasty 62%. Yet coronary intervention procedures decreased by 20%.- How will the increased scrutiny regarding the appropriateness of certain procedures impact healthcare providers and medical device companies?- The number of hospitals offering catheter-based revascularization has increased by 30% over last 10 years. What are the results of these trends?- How will reduced reimbursement affect the recent influx of POL’s (physician-owned labs)?- From 2008-2013, inpatient reimbursement of peripheral arterial revascularization increased by 15%. However, physician fee schedules for endovascular specialists have decreased substantially over the last 5 years. Will this continue?.- Value-based purchasing (VBP) programs, readmissions reduction incentives, value-based payment modifiers for physicians, bundled payments for care improvement initiatives, and commercial ACOs. What do all of these healthcare delivery changes mean for medtech companies?- Percutaneous transcatheter heart valves and renal denvervation. Is there too much hype around these two spaces? Brian provides us with his expert opinion.- What is the one major initiative that medical device companies need to really grasp as we head into the new era of healthcare?- And much more!This Is What You Can Do Next 1) You can listen to the interview with Brian Contos 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. 3) Read the following transcripts from my interview with Brian Contos. Read the Interview with Brian Contos I hate to have these interviews interrupted. So before we dig in, listen to these quick messages: First, to get free email updates when another Medsider episode goes live, simply go to Medsider.com/free. We don't send emails often. But when we do, they're full of valuable content. No spam…ever. Just go to Medsider.com/free to sign up. Second, Medsider is on iTunes. Just go to Medsider.com/iTunes and you can subscribe to the podcast for free. That way, all the new episodes will automatically download to your iTunes account. It's super easy. Also, if you like the podcast, don't forget to rate it. That really helps us out. Okay, for you ambitious doers…here's your program… Scott Nelson: Hello, hello everyone. It’s Scott Nelson, and welcome to another edition of Medsider. This is the program where you can learn from proven and experienced med tech and medical device thought leaders and experts, and on today’s program we have Brian Contos, who’s the Executive Director for the Advisory Board Company, a global technology research and consulting firm partnering with 150,000 leaders in 3700 organizations across healthcare and higher education. So without further ado, welcome, Brian. Appreciate your coming on the program. Brian Contos: Great. Well, thank you, and thank you for inviting me to the discussion today. Scott Nelson: Absolutely. 00:00:39 So let's first start out with a little bit more about you as well as the role you play within the ...

How will healthcare reform affect care delivery and reimbursement? And what will the impact be for medical device companies? These are probably the 2 biggest questions that medtech companies need to answer in order to succeed in the future. Unfortunately, there aren’t solid answers at this point. But there are some people that can help! In this interview with Brian Contos, Executive Director for the Advisory Board Company, we learn how medical device companies can respond to the changing healthcare dynamics. Interview Highlights with Brian Contos - Brian explains the following trends: From 2005-2011, lower extremity angioplasty procedures increased by 67%, venous ablations increased by 400%, and venous angioplasty 62%. Yet coronary intervention procedures decreased by 20%. - How will the increased scrutiny regarding the appropriateness of certain procedures impact healthcare providers and medical device companies? - The number of hospitals offering catheter-based revascularization has increased by 30% over last 10 years.  What are the results of these trends? - How will reduced reimbursement affect the recent influx of POL’s (physician-owned labs)? - From 2008-2013, inpatient reimbursement of peripheral arterial revascularization increased by 15%.  However, physician fee schedules for endovascular specialists have decreased substantially over the last 5 years.  Will this continue?. - Value-based purchasing (VBP) programs, readmissions reduction incentives, value-based payment modifiers for physicians, bundled payments for care improvement initiatives, and commercial ACOs.  What do all of these healthcare delivery changes mean for medtech companies? - Percutaneous transcatheter heart valves and renal denvervation.  Is there too much hype around these two spaces?  Brian provides us with his expert opinion. - What is the one major initiative that medical device companies need to really grasp as we head into the new era of healthcare? - And much more! This Is What You Can Do Next 1) You can listen to the interview with Brian Contos right now: Download audio file (BrianContos_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Brian Contos. Read the Interview with Brian Contos I hate to have these interviews interrupted.  So before we dig in, listen to these quick messages: First, to get free email updates when another Medsider episode goes live, simply go to Medsider.com/free.  We don't send emails often.  But when we do, they're full of valuable content.  No spam…ever.  Just go to Medsider.com/free to sign up. Second, Medsider is on iTunes.  Just go to Medsider.com/iTunes and you can subscribe to the podcast for free.  That way, all the new episodes will automatically download to your iTunes account.  It's super easy.  Also, if you like the podcast, don't forget to rate it.  That really helps us out. Okay, for you ambitious doers…here's your program… Scott Nelson:    Hello, hello everyone.  It’s Scott Nelson, and welcome to another edition of Medsider. This is the program where you can learn from proven and experienced med tech and medical device thought leaders and experts, and on today’s program we have Brian Contos, who’s the Executive Director for the Advisory Board Company, a global technology research and consulting firm partnering with 150,000 leaders in 3700 organizations across healthcare and higher education. So without further ado, welcome, Brian. Appreciate your coming on the program. Brian Contos:  Great. Well, thank you, and thank you for ...

Picture this. You're a medical device sales rep covering a procedure in one part of your territory. But unexpectedly, you get a call from a physician needing case support on the other side of your geography. What do you do? There's no way you can cover the case, right? The drive-time won't allow you to get the hospital in time. Perhaps your only option is to provide phone support? Enter Nurep, a unique mobile platform that allows medical device reps to support physicians in a virtual fashion. Think Skype on steroids. And then apply that thought to the medtech space. In this interview with Paul Schultz, Cofounder of Nurep, we learn more about their novel platform and how it can foster increased efficiency within the medical device sales channel. Interview Highlights with Paul Schultz - Where did the idea for Nurep come from?- The unique way in which Paul and Adam met their first advisor, Dr. Edward Bender.- The challenges within the medtech space that Paul and Adam saw when formulating their MVP (minimum viable product).- Why did Nurep decide to develop for iOS vs. Android?- 4 key features of the Nurep platform: Product Feeds, Call Pulse, Live Video, and Analytics.- How have medical device companies responded to Nurep? What has been the response within the healthcare provider community?- Features of Nurep that we’re likely to see in the future.- Paul’s thoughts on their experience in Blueprint Health.- Why did Paul leave behind a solid gig at Cambell Alliance to embark on an entrepreneurial adventure?- And much more!This Is What You Can Do Next 1) You can listen to the interview with Paul Schultz 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. 3) Read the following transcripts from my interview with Paul Schultz. Read the Interview with Paul Schultz Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate. Job leads. Opportunities to network. Access to specialized groups. Sound interesting? Then you should check out the Medical Devices Group on LinkedIn. It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Not only that, but it’s the single largest medical group on all of LinkedIn. Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands. Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes. Just go to https://medsider.com/itunes and you can subscribe to the podcast for free. That way, all the new episodes will automatically download to your iTunes account. It's super easy. Also, if you like the podcast, don't forget to rate it. That really helps us out. Again, that’s https://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson: Hello, hello everyone. Welcome to another edition of Medsider. This is your host, Scott Nelson, and on the program today we’ve got Paul Schultz, who is the cofounder of Nurep, which is a mobile platform for medical device companies that allows on-demand virtual device support to physicians in the operating room. So welcome to the call, Paul. Really appreciate you coming on. Paul Schultz: Thanks, Scott. It’s a pleasure to be on. Scott Nelson: 00:00:29 Okay, so let's first start with what is Nurep, what is this platform that I just mentioned, and then I’d like to dive into how the idea for this platform was born. Paul Schultz: Sure. So Nurep is a mobile health technology platform and what it does is bring the live remote medical device rep into the operating room to a physician’s ...

Picture this. You're a medical device sales rep covering a procedure in one part of your territory. But unexpectedly, you get a call from a physician needing case support on the other side of your geography. What do you do? There's no way you can cover the case, right? The drive-time won't allow you to get the hospital in time. Perhaps your only option is to provide phone support? Enter Nurep, a unique mobile platform that allows medical device reps to support physicians in a virtual fashion. Think Skype on steroids. And then apply that thought to the medtech space. In this interview with Paul Schultz, Cofounder of Nurep, we learn more about their novel platform and how it can foster increased efficiency within the medical device sales channel. Interview Highlights with Paul Schultz - Where did the idea for Nurep come from? - The unique way in which Paul and Adam met their first advisor, Dr. Edward Bender. - The challenges within the medtech space that Paul and Adam saw when formulating their MVP (minimum viable product). - Why did Nurep decide to develop for iOS vs. Android? - 4 key features of the Nurep platform: Product Feeds, Call Pulse, Live Video, and Analytics. - How have medical device companies responded to Nurep? What has been the response within the healthcare provider community? - Features of Nurep that we’re likely to see in the future. - Paul’s thoughts on their experience in Blueprint Health. - Why did Paul leave behind a solid gig at Cambell Alliance to embark on an entrepreneurial adventure? - And much more! This Is What You Can Do Next 1) You can listen to the interview with Paul Schultz right now: Download audio file (PaulSchultz_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Paul Schultz. Read the Interview with Paul Schultz Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate.   Job leads.  Opportunities to network.  Access to specialized groups.  Sound interesting?  Then you should check out the Medical Devices Group on LinkedIn.  It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.  Not only that, but it’s the single largest medical group on all of LinkedIn.  Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands.  Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes.  Just go to http://medsider.com/itunes and you can subscribe to the podcast for free.  That way, all the new episodes will automatically download to your iTunes account.  It's super easy.  Also, if you like the podcast, don't forget to rate it.  That really helps us out.  Again, that’s http://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson:    Hello, hello everyone.  Welcome to another edition of Medsider. This is your host, Scott Nelson, and on the program today we’ve got Paul Schultz, who is the cofounder of Nurep, which is a mobile platform for medical device companies that allows on-demand virtual device support to physicians in the operating room. So welcome to the call, Paul. Really appreciate you coming on. Paul Schultz:   Thanks, Scott. It’s a pleasure to be on. Scott Nelson:    00:00:29 Okay, so let's first start with what is Nurep, what is this platform that I just mentioned, and then I’d like to dive into how the idea for this ...

The lean startup movement has become increasingly popular within the tech community after the release of Eric Ries’ book in 2011. Although I personally believe the lean startup methodology is brilliant, some aspects are difficult to apply to the medtech space. For example, it costs significantly less money to iterate on a software idea in comparison to a medical device prototype. However, medical device models could be a potential solution to this challenge. They are not nearly as expensive as you would think. And it’s much more efficient to make changes to a model vs. an actual prototype. In this interview with Allison Rae, Principal at Pulse Research and Development, we learn how to best utilize models throughout the entire medical device lifecycle from concept to commercialization. Here's What You Will Learn - How medical device models can help “juice” the R&D development cycle.- The benefits of using medical device models for physician training and education.- Are medical device models more cost-effective than apps?- How medical device models make for a more compelling learning experience.- The “play-doh” effect: Using medical device models to create strong brands and memories.- Can medical device models be a key differentiator in the sales process?- What does it cost to produce a medical device model?- Why rapid prototyping and avoiding surprises are incredibly important concepts to master.- And much more!This Is What You Can Do Next 1) You can listen to the interview with Allison Rae 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. 3) Read the following transcripts from my interview with Allison Rae. Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate. Job leads. Opportunities to network. Access to specialized groups. Sound interesting? Then you should check out the Medical Devices Group on LinkedIn. It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Not only that, but it’s the single largest medical group on all of LinkedIn. Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands. Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes. Just go to https://medsider.com/itunes and you can subscribe to the podcast for free. That way, all the new episodes will automatically download to your iTunes account. It's super easy. Also, if you like the podcast, don't forget to rate it. That really helps us out. Again, that’s https://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson: Hello, hello, everyone. It’s Scott Nelson and welcome to another edition of Medsider, the program where you can learn from proven and experienced medical device and med tech thought leaders. And on today’s call we’ve got Allison Rae, who is the Principal/Chief Creative Officer at Pulse Research and Development. Allison is an industrial designer by trade. And what is Pulse R&D? Pulse R&D is a team of highly specialized individuals who are experts in the development and manufacturing of medical devices. They have a specific expertise in product pipeline development, IP-driven design solutions, custom soft tissue anatomical model development—that's a really long phrase there—voice of customer research, ergonomic design, product manufacturing engineering, and custom 3D marketing models. That’s a lot. We’re definitely not going to talk about all of that, but the ...

The lean startup movement has become increasingly popular within the tech community after the release of Eric Ries’ book in 2011. Although I personally believe the lean startup methodology is brilliant, some aspects are difficult to apply to the medtech space. For example, it costs significantly less money to iterate on a software idea in comparison to a medical device prototype. However, medical device models could be a potential solution to this challenge. They are not nearly as expensive as you would think. And it’s much more efficient to make changes to a model vs. an actual prototype. In this interview with Allison Rae, Principal at Pulse Research and Development, we learn how to best utilize models throughout the entire medical device lifecycle from concept to commercialization. Here's What You Will Learn - How medical device models can help “juice” the R&D development cycle. - The benefits of using medical device models for physician training and education. - Are medical device models more cost-effective than apps? - How medical device models make for a more compelling learning experience. - The “play-doh” effect: Using medical device models to create strong brands and memories. - Can medical device models be a key differentiator in the sales process? - What does it cost to produce a medical device model? - Why rapid prototyping and avoiding surprises are incredibly important concepts to master. - And much more! This Is What You Can Do Next 1) You can listen to the interview with Allison Rae right now: Download audio file (AllisonRae_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Allison Rae. Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate.   Job leads.  Opportunities to network.  Access to specialized groups.  Sound interesting?  Then you should check out the Medical Devices Group on LinkedIn.  It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.  Not only that, but it’s the single largest medical group on all of LinkedIn.  Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands.  Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes.  Just go to http://medsider.com/itunes and you can subscribe to the podcast for free.  That way, all the new episodes will automatically download to your iTunes account.  It's super easy.  Also, if you like the podcast, don't forget to rate it.  That really helps us out.  Again, that’s http://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson:    Hello, hello, everyone.  It’s Scott Nelson and welcome to another edition of Medsider, the program where you can learn from proven and experienced medical device and med tech thought leaders. And on today’s call we’ve got Allison Rae, who is the Principal/Chief Creative Officer at Pulse Research and Development. Allison is an industrial designer by trade. And what is Pulse R&D? Pulse R&D is a team of highly specialized individuals who are experts in the development and manufacturing of medical devices. They have a specific expertise in product pipeline development, IP-driven design solutions, custom soft tissue anatomical model development—that's a really long phrase there—voice of customer research, ...

The 2.3% medical device tax is burdensome. Regulatory timelines are long (and expensive). Reimbursement is not only decreasing, but also incredibly hard to obtain. Venture capitalists are losing interest in early stage medical device deals. Is it all downhill for medtech? There is no doubt the current healthcare environment is challenging. But certainly not impossible! Case in point: Intersect ENT. This startup medtech company is well-funded as evidenced by their recent series C round of financing. They were able to get regulatory approval for a “device + drug” combination product. And perhaps most impressive, they are actually expanding their sales force! In this interview with Lisa Earnhardt, President and CEO of Intersect ENT, we learn how this medical device startup company is succeeding despite the strong headwinds within the medtech space. Here's What You Will Learn - Can ENT companies steal the drug-eluting stent playbook from the cardiology space?- How is Intersect’s Propel device different than traditional balloon sinuplasty?- Was the regulatory pathway for the Propel device more difficult because of the “device + drug” combination?- Are otolaryngology (ENT) doctors early adopters? How do they compare to cardiologists andvascular surgeons?- What has been the biggest challenge to increased adoption of the Propel device?- Did Intersect ENT consider launching their medical devices with an indirect sales force?- What are the exit strategies for Intersect ENT? Could the company actually go public?- How important are large strategic medtech companies in terms of providing capital for start-up medical device companies?- Lisa’s opinion of the top-line 2.3% medical device excise tax.- How will medtech companies need to change considering the strong headwinds of longer regulatory timelines, lower reimbursement figures, and changing healthcare delivery models?- Lisa’s advice for ambitious medtech professionals.- And much more!This Is What You Can Do Next 1) You can listen to the interview with Lisa Earnhardt 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. 3) Read the following transcripts from my interview with Lisa Earnhardt. Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate. Job leads. Opportunities to network. Access to specialized groups. Sound interesting? Then you should check out the Medical Devices Group on LinkedIn. It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Not only that, but it’s the single largest medical group on all of LinkedIn. Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands. Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes. Just go to https://medsider.com/itunes and you can subscribe to the podcast for free. That way, all the new episodes will automatically download to your iTunes account. It's super easy. Also, if you like the podcast, don't forget to rate it. That really helps us out. Again, that’s https://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson: Hello, hello, everyone. Welcome to another edition of Medsider. This is your host, Scott Nelson, and for those of you who are new to the program, listening this is a show where I bring on experienced and proven med tech thought leaders in order to learn about a wide variety of topics, all pertaining to the medical device space. And on today’s program we Lisa Earnhardt, who is the ...

The 2.3% medical device tax is burdensome. Regulatory timelines are long (and expensive). Reimbursement is not only decreasing, but also incredibly hard to obtain. Venture capitalists are losing interest in early stage medical device deals. Is it all downhill for medtech? There is no doubt the current healthcare environment is challenging. But certainly not impossible! Case in point: Intersect ENT. This startup medtech company is well-funded as evidenced by their recent series C round of financing. They were able to get regulatory approval for a “device + drug” combination product. And perhaps most impressive, they are actually expanding their sales force! In this interview with Lisa Earnhardt, President and CEO of Intersect ENT, we learn how this medical device startup company is succeeding despite the strong headwinds within the medtech space. Here's What You Will Learn - Can ENT companies steal the drug-eluting stent playbook from the cardiology space? - How is Intersect’s Propel device different than traditional balloon sinuplasty? - Was the regulatory pathway for the Propel device more difficult because of the “device + drug” combination? - Are otolaryngology (ENT) doctors early adopters? How do they compare to cardiologists and vascular surgeons? - What has been the biggest challenge to increased adoption of the Propel device? - Did Intersect ENT consider launching their medical devices with an indirect sales force? - What are the exit strategies for Intersect ENT? Could the company actually go public? - How important are large strategic medtech companies in terms of providing capital for start-up medical device companies? - Lisa’s opinion of the top-line 2.3% medical device excise tax. - How will medtech companies need to change considering the strong headwinds of longer regulatory timelines, lower reimbursement figures, and changing healthcare delivery models? - Lisa’s advice for ambitious medtech professionals. - And much more! This Is What You Can Do Next 1) You can listen to the interview with Lisa Earnhardt right now: Download audio file (LisaEarnhardt_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Lisa Earnhardt. Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate.   Job leads.  Opportunities to network.  Access to specialized groups.  Sound interesting?  Then you should check out the Medical Devices Group on LinkedIn.  It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.  Not only that, but it’s the single largest medical group on all of LinkedIn.  Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands.  Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes.  Just go to http://medsider.com/itunes and you can subscribe to the podcast for free.  That way, all the new episodes will automatically download to your iTunes account.  It's super easy.  Also, if you like the podcast, don't forget to rate it.  That really helps us out.  Again, that’s http://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson:    Hello, hello, everyone. Welcome to another edition of Medsider. This is your host, Scott Nelson, and for those of you who are new to the program, listening this is a show where I bring on experienced and proven med tech ...

Did you know the FDA recently issued a multi-million dollar contract to a private company that will be charged with monitoring social media? Yes, multi-million. Needless to say, that’s a significant amount of money. Although many would argue the FDA has not been very clear regarding its guidance towards social media, you can’t deny that the FDA is beginning to take social media more serious than it ever has. In this interview with Dr. Mukesh Kumar, Senior Director of Regulatory Affairs for Amarex Clinical Research, we’ll discuss common issues, misconceptions, and possible solutions in regards to using social media to market and sell FDA-regulated medical devices. Here's What You Will Learn - Why one particular company received a warning letter from the FDA for clicking the Facebook “Like” button.- Trends and recent discussions regarding the FDA's overview and enforcement of social media as it pertains to marketing medical devices.- Risks and benefits: FDA guidance documents regarding the distribution of information via social media.- Best practices for managing social media within the medical device space.- If a patient submits a question regarding a medical device via Twitter, how is it possible to present balanced information given the 140-character limit?- If unidentified patients post comments regarding adverse events on a website not controlled by the medical device company, is that company required to report the event to FDA or attempt to contact the patient?- And much more!This Is What You Can Do Next 1) You can listen to the interview with Dr. Mukesh Kumar 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. 3) Read the following transcripts from my interview with Dr. Mukesh Kumar. Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate. Job leads. Opportunities to network. Access to specialized groups. Sound interesting? Then you should check out the Medical Devices Group on LinkedIn. It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Not only that, but it’s the single largest medical group on all of LinkedIn. Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands. Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes. Just go to https://medsider.com/itunes and you can subscribe to the podcast for free. That way, all the new episodes will automatically download to your iTunes account. It's super easy. Also, if you like the podcast, don't forget to rate it. That really helps us out. Again, that’s https://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson: Hello, hello everyone, welcome to another edition of Medsider. Of course, this is your host Scott Nelson, and for those of you who are new to the program, Medsider is the place where I interview medical device and med tech thought leaders on a wide variety of subjects. And in this particular episode, we’re going to cover all things social media as it pertains to FDA-regulated medical devices. And the guest on the program today is Dr. Mukesh Kumar, who is the Senior Director of Regulatory Affairs and Quality Assurance for Amarex Clinical Research. Dr. Kumar, his key expertise is in global, regulatory and business processes for medical and diagnostic products. He's a well-known expert in global drug approval processes as well and has been involved in clinical trials in more than 60 countries. And lastly, Dr. Kumar is a PhD in Biochemistry ...

Did you know the FDA recently issued a multi-million dollar contract to a private company that will be charged with monitoring social media? Yes, multi-million. Needless to say, that’s a significant amount of money. Although many would argue the FDA has not been very clear regarding its guidance towards social media, you can’t deny that the FDA is beginning to take social media more serious than it ever has. In this interview with Dr. Mukesh Kumar, Senior Director of Regulatory Affairs for Amarex Clinical Research, we’ll discuss common issues, misconceptions, and possible solutions in regards to using social media to market and sell FDA-regulated medical devices. Here's What You Will Learn - Why one particular company received a warning letter from the FDA for clicking the Facebook “Like” button. - Trends and recent discussions regarding the FDA's overview and enforcement of social media as it pertains to marketing medical devices. - Risks and benefits: FDA guidance documents regarding the distribution of information via social media. - Best practices for managing social media within the medical device space. - If a patient submits a question regarding a medical device via Twitter, how is it possible to present balanced information given the 140-character limit? - If unidentified patients post comments regarding adverse events on a website not controlled by the medical device company, is that company required to report the event to FDA or attempt to contact the patient? - And much more! This Is What You Can Do Next 1) You can listen to the interview with Dr. Mukesh Kumar right now: Download audio file (MukeshKumar_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Dr. Mukesh Kumar.  Read the Interview Before we dig in, you need to listen to these 2 brief messages. Meaningful discussion and debate.   Job leads.  Opportunities to network.  Access to specialized groups.  Sound interesting?  Then you should check out the Medical Devices Group on LinkedIn.  It’s the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.  Not only that, but it’s the single largest medical group on all of LinkedIn.  Medical device professionals worldwide are invited to join the Medical Devices Group to help build their personal and corporate brands.  Check it out: http://medicaldevicesgroup.net As a reminder, Medsider is on iTunes.  Just go to http://medsider.com/itunes and you can subscribe to the podcast for free.  That way, all the new episodes will automatically download to your iTunes account.  It's super easy.  Also, if you like the podcast, don't forget to rate it.  That really helps us out.  Again, that’s http://medsider.com/itunes. Okay, for you ambitious medical device and medtech doers, here’s your program… Scott Nelson:    Hello, hello everyone, welcome to another edition of Medsider. Of course, this is your host Scott Nelson, and for those of you who are new to the program, Medsider is the place where I interview medical device and med tech thought leaders on a wide variety of subjects. And in this particular episode, we’re going to cover all things social media as it pertains to FDA-regulated medical devices. And the guest on the program today is Dr. Mukesh Kumar, who is the Senior Director of Regulatory Affairs and Quality Assurance for Amarex Clinical Research. Dr. Kumar, his key expertise is in global, regulatory and business processes for medical and diagnostic products. He's a ...

As the world of healthcare continues to change and evolve, hospitals and healthcare providers are facing a major dilemma. There will continue to be an increasing number of patients that need healthcare. But, the reimbursement for healthcare services will continue to decline. In other words, there will be more customers checking out, but less money coming through the cash register. Therefore, healthcare providers will be looking for solutions that are both substantial and sustainable. Message to medical device professionals: do your products and solutions pass this “S and S” test? In this interview, Lars Thording and Randel Richner further explain the challenges that healthcare providers are facing and what type of solutions they are looking for. Lars is the VP of Marketing for Intralign while Randel is the VP of Advanced Analytics. Here's What You Will Learn - What are the biggest challenges that healthcare providers are facing right now?- Cost vs. quality: What’s more important? Can you avoid the trade-off?- How does Intralign help healthcare providers control costs and improve the delivery of care?- How and why are providers missing the mark in regards to the “intra-operative space”?- The impact of advanced analytics and “intelligent care design” on the delivery of care and cost containment.- Advice from Lars and Randel on how medtech companies can best partner with providers in the new era of healthcare.- And much more!This Is What You Can Do Next 1) You can listen to the interview with Lars and Randel 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. 3) Read the following transcripts from my interview with Lars and Randel. Also, feel free to download the transcripts by clicking here. Read the Interview Scott Nelson: Hello, hello everyone. Welcome to another edition of Medsider. This is your host, Scott Nelson, and Medsider, for those of you listening for the first time, is the program where you can learn from proven med tech and medical device experts. And on today’s program we’ve got two guests, the first one being Lars Thording, who’s the VP of Marketing and Public Affairs for Intralign, and then our second guest is Randel Richner, who’s a repeat performer, I guess, for lack of a better description, and Randel is the Executive VP of Advanced Analytics for Intralign, and that's a recent change on Randel’s behalf, and we’ll certainly discuss that point. So, without further ado, welcome to the call, Lars and Randel. Lars Thording: Thank you. Randel Richner: Thank you. Scott Nelson: Alright, let's start off. I’m going to give you both the opportunity to briefly introduce yourselves as well as, Lars, you can give us a brief introduction to Intralign, and then Randel, maybe you can speak to Neocure and then the recent integration of Intralign and Neocure. Randel Richner: Sure. Sounds good. Go ahead, Lars. Lars Thording: Yup. Yeah. So Scott, Intralign was formed very recently on December 31st of last year, so we’re a really young company. Our company has come together as various healthcare entrepreneurs across the healthcare spectrum that are all of us very engaged in trying to make conditions better for [00:01:25] healthcare, you know, and for hospitals particularly. So what you’ll find on the team at Intralign are folks that, including myself, if I can be so indiscreet, have been making a mark in the healthcare industry very recently through the work we’ve done with Stryker Sustainability Solutions, formerly Ascent, the first reprocessing company in the United States that ended up having a major impact in the industry and still does. Saying goodbye ...

As the world of healthcare continues to change and evolve, hospitals and healthcare providers are facing a major dilemma. There will continue to be an increasing number of patients that need healthcare. But, the reimbursement for healthcare services will continue to decline. In other words, there will be more customers checking out, but less money coming through the cash register. Therefore, healthcare providers will be looking for solutions that are both substantial and sustainable. Message to medical device professionals: do your products and solutions pass this “S and S” test? In this interview, Lars Thording and Randel Richner further explain the challenges that healthcare providers are facing and what type of solutions they are looking for. Lars is the VP of Marketing for Intralign while Randel is the VP of Advanced Analytics. Here's What You Will Learn - What are the biggest challenges that healthcare providers are facing right now? - Cost vs. quality: What’s more important? Can you avoid the trade-off? - How does Intralign help healthcare providers control costs and improve the delivery of care? - How and why are providers missing the mark in regards to the “intra-operative space”? - The impact of advanced analytics and “intelligent care design” on the delivery of care and cost containment. - Advice from Lars and Randel on how medtech companies can best partner with providers in the new era of healthcare. - And much more! This Is What You Can Do Next 1) You can listen to the interview with Lars and Randel right now: Download audio file (Intralign_MedsiderInterviews_2013.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. 3) Read the following transcripts from my interview with Lars and Randel.  Also, feel free to download the transcripts by clicking here. Read the Interview Scott Nelson:    Hello, hello everyone.  Welcome to another edition of Medsider. This is your host, Scott Nelson, and Medsider, for those of you listening for the first time, is the program where you can learn from proven med tech and medical device experts. And on today’s program we’ve got two guests, the first one being Lars Thording, who’s the VP of Marketing and Public Affairs for Intralign, and then our second guest is Randel Richner, who’s a repeat performer, I guess, for lack of a better description, and Randel is the Executive VP of Advanced Analytics for Intralign, and that's a recent change on Randel’s behalf, and we’ll certainly discuss that point. So, without further ado, welcome to the call, Lars and Randel. Lars Thording: Thank you. Randel Richner:       Thank you. Scott Nelson:    Alright, let's start off. I’m going to give you both the opportunity to briefly introduce yourselves as well as, Lars, you can give us a brief introduction to Intralign, and then Randel, maybe you can speak to Neocure and then the recent integration of Intralign and Neocure. Randel Richner:       Sure. Sounds good. Go ahead, Lars. Lars Thording: Yup. Yeah. So Scott, Intralign was formed very recently on December 31st of last year, so we’re a really young company. Our company has come together as various healthcare entrepreneurs across the healthcare spectrum that are all of us very engaged in trying to make conditions better for [00:01:25] healthcare, you know, and for hospitals particularly. So what you’ll find on the team at Intralign are folks that, including myself, if I can be so indiscreet, have been making a mark in the healthcare industry very recently through the work we’ve done with Stryker ...

Opinions abound when it comes to the 2.3% medical device tax. Most of them negative. But often times, many of these opinions are NOT backed by facts and data. For example, most medtech professionals would agree that even though more Americans will be insured through the Affordable Care Act (ACA), this will not equate to a windfall for medical device companies. Solid opinion, right? But where’s the data to back this up? Enter Matt Dolan, Senior Research Analyst at ROTH Capital Partners. In a recent report, Matt lays out the following facts: The average age of a patient that receives a heart valve, cardiac stent, and knee implant is 70, 62, and 64, respectively. However, if you compare these ages to the group of uninsured that will become insured under ACA, a stark contrast exists. Eighty percent of uninsured patients are under 45 years old and 88% are under 55, well below the average device user. Only 2% of the uninsured are over 65 years old. In this interview, Matt Dolan provides us with interesting facts as to why the premise of the medical device tax may not be justified. Here's What You Will Learn - Impact of the medical device industry on the healthcare system and overall economy. - But aren’t expensive, innovative medical devices responsible for higher healthcare costs? - Why is the medtech industry already suffering? - Will medical device companies receive a windfall because more patients will be insured through the Affordable Care Act? - Real-world example of Massachusetts: Did medical device companies benefit from Romneycare? - Why smaller medtech companies will be impacted the most by the device tax. - The negative impact on medical device R&D and the potential consequences for patients. - Other potential ramifications of the device tax: job losses, decrease in hiring, and a greater emphasis on overseas expansion. - And much more! This Is What You Can Do Next 1) You can listen to the interview with Matt Dolan right now: Download audio file (MattDolan_MedsiderInterviews_2012.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. 3) Read the following transcripts from my interview with Matt Dolan.  Also, feel free to download the transcripts by clicking here. Read the Interview with Matt Dolan Scott Nelson:    Hello, hello everyone.  It’s Scott Nelson, and welcome to another edition of Medsider, the program where you can learn from experience and proven medical device/med tech experts on your own terms without going to school. And on today’s call we have Matt Dolan, who is a senior research analyst for Roth Capital Partners. Matt’s been involved in covering the medical device industry for about 10 years. He's been with Roth Capital for about six years. His investment news has been cited in Barron’s, Investor’s Business Daily, Wall Street Transcript, Forbes, and Business Week in addition to a few others. So without further ado, welcome to the call Matt. Really appreciate you coming on the program. Matt Dolan:      Thanks, Scott. Scott Nelson:    Alright. So, on today’s call we’re going to cover the medical device tax. In particular, we’re going to focus on a really, really good report, which I’ll link to in the show notes, that Matt helped put together covering the medical device tax and its potential implications. So the three main kind of umbrella subjects that we’re going to talk about is, first and foremost, the impact of the med tech industry on the economy as well as the healthcare system overall, and then we’ll probably spend a little bit more time even talking about the other two points. Is the 2.3% medical device tax ...

As more and more hospitals acquire physician practices, do you know who the new decision makers are? Hint: It’s not the people wearing scrubs. Instead, it’s the people wearing dress shirts and ties. Don’t misunderstand me. I firmly believe physicians still have a say as to which medical devices they use. But without a doubt, ‘physician preference’ no longer rules. Enter the new dictator: PRICE! Because of external forces like the 2.3% medical device tax and changing buying patterns at the hospital level, medical device companies need to iterate on their sales models. To help navigate these rough waters, enter Tim Gleeson and Joe Andrew, co-founders of Novasyte. In this interview with Tim and Joe, we learn how medical device companies can utilize novel methodologies in order to win in today’s challenging economic environment. Here's What You Will Learn - In the midst of successful medical device careers, why did Tim and Joe decide to start Novasyte? - Tim’s ‘Jerry McGuire’ moment that triggered the creation of Novasyte. - Challenges that product conversions represent for medical device companies. - Should medical device sales reps perform non-selling activities? - The need for medical device companies to iterate on their sales models. - Remote video and phone support: Can it work? - Can service be a differentiating feature when trying to cross the pricing gap? - Novasyte’s unique offerings for medical device companies. - Lasting advice from Tim and Joe for ambitious medical device doers. - And much more! This Is What You Can Do Next 1) You can listen to the interview with Tim and Joe right now: Download audio file (Novasyte_MedsiderInterviews_2012.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. 3) Read the following transcripts from my interview with Tim and Joe.  Also, feel free to download the transcripts by clicking here. Read the Interview with Tim and Joe Scott Nelson:    Hello, hello everyone.  It’s Scott Nelson, and welcome to another edition of Medsider, the place where you can learn from med tech and medical device experts on your own terms without going to school, and on today’s show we have Tim Gleeson, who’s the CEO of Novasyte. Thanks, Tim, for coming on. Really appreciate it. Tim Gleeson:    Yeah, thanks for having me. Scott Nelson:    Alright, Tim. First, can you give us a little bit of background about you, and then tell us a little bit more about Novasyte? Tim Gleeson:    Yeah, sure. So my background is a pretty typical sales management background. I was with a business sales environment in New York City for a couple of years, and then moved into med device sales with a large company. I’m not sure if we can say the name of the companies out loud? Scott Nelson:    Yeah, that's fine. That's fine. Tim Gleeson:    Fantastic, yes. I was with Covidien for many years in the sales ranks, and then was promoted out to the West Coast here in Southern California in sales management. And as we went through some pretty big GPO swings and some pretty big IDN plays, bringing on multiple products at once, we were constantly tasked with trying to figure out how to [00:01:14] educate and manage conversions. So we spent a lot of time on sales and sales management educating end users on how to use our products. And even though they were low-tech in some instances and moderately technical in others, we would spend upwards of 40% of our year educating. And so, you know, we looked at—and we being my business partner Joe Andrew and I, and Joe’s going to join the call here a ...

Will the Sunshine Act force medical device companies to lay off even more employees? Perhaps at a rate of 2-4 per year? Let’s do some simple math: It’s estimated that compliance with the Sunshine Act will cost medical device companies about $200,000 per year. If the average annual salary of an employee within a medical device company is $65,000, that’s roughly 3 employees. Ouch. I think the overwhelming majority of the American public would like to see more transparency between physicians and medical device companies. But are the outrageous compliance costs of the Sunshine Act worth 2-4 jobs per company per year? Better yet, once the data from the legislation is made public, will ‘Joe Patient’ even be able to interpret it? To help answer some of these questions, enter David Hoffmeister, partner at Wilson Sonsini Goodrich & Rosati. In this interview, David provides us with actionable rules regarding physician and HCP consulting arrangements in addition to helping us understand the overall impact of the Sunshine Act on medical device companies. Here's What You Will Learn - Origin, scope, and purpose of the Sunshine Act and the problems this legislation hopes to solve. - Will patients be able to decipher the public data resulting from the Sunshine Act? And will they even care? - Resource constraints that will be forced upon medical device companies because of the Sunshine Act. - How will medtech startups be affected by the legislation? - Consequences within medical device companies if adequate policies are NOT put in place. Hint: David thinks it’s like driving a car without car insurance. - Policies and procedures that medical device companies need to have in place in order to comply with the Sunshine Act. We also cover the 2 exceptions. - Are their any loopholes in the Sunshine Act that medical device companies can exploit? - Importance of consistent ‘needs assessments’ pertaining to HCP consultants. - David’ lasting advice to medtech companies in regards to the Sunshine Act. - And much more! This Is What You Can Do Next 1) You can listen to the interview with David Hoffmeister right now: Download audio file (DavidHoffmeister_MedsiderInterviews_2012.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. 3) Read the following transcripts from my interview with David Hoffmeister.  Also, feel free to download the transcripts by clicking here. Read the Interview with David Hoffmeister Scott Nelson:             Hello, hello everyone.  It’s Scott Nelson and welcome to another edition of Medsider, the place where you can learn from med tech and medical device experts on your own terms without having to go to school, and on today’s call we have David Hoffmeister who is a partner at Wilson Sonsini Goodrich & Rosati, where he plays a major leadership role in the firm’s drug and device regulatory and healthcare law practice within the life sciences sort of division of the firm.  David was named as one of the 25 leading biotech attorneys in California in 2011 by the Daily Journal and is recognized as one of the leading food and drug regulatory lawyers in the country.  So without further ado, welcome to the call, David.  Really appreciate you coming on. David Hoffmeister:   Thanks, Scott. You bet. Scott Nelson:             Okay, so most of our conversation is going to be around the best practices and the critical guidelines for physician payments, more specifically the Sunshine Act, so if you don’t mind, for those listening in the audience, can you provide us ...