Medsider Radio: Learn from Proven Medtech and Healthcare Experts

What do Stryker, Biomet, Medtronic, and Boston Scientific all have in common? Yes, they all manufacture medical devices. But more specifically, all four of these medtech companies have implantable device divisions. And from 2005 – 2011, the implantable device segment has been the most consistent top performer relative to other categories including: in vitro diagnostics, medical consumables, medical equipment, and diversified life sciences. But the times are quickly changing. Why? Well, the implantable devices segment has the highest SG&A expenses in comparison to the other previously mentioned categories. In fact, it’s estimated that orthopedic medical device companies spend $35B per year on sales support. Perhaps “bloated” is the best word to describe this situation? But it’s not just the implantable devices segment that may be in a for a rude awakening. Many medtech companies spend anywhere from 200-500% more on SG&A versus comparable high tech firms. And as gross margins for medical devices continue to be squeezed, all medtech companies (regardless of the specific product segment) will need to reevaluate their SG&A spend. One tool that may help in this process is MedPassage. In this interview with Gavin Fabian, cofounder and CEO, we learn how MedPassage is trying to build a more efficient medtech market through e-commerce and collaboration technologies. Interview Highlights with Gavin Fabian - What is MedPassage and how does the platform work? - How the idea for MedPassage was born. - Can MedPassage be considered the “anti-GPO”? - How MedPassage is overcoming the “chicken and egg” problem as they build out their network. - How have hospitals, surgery centers, and other healthcare providers responded to MedPassage?  And what has the response been like from medical device companies? - What types of medical products are moved through the MedPassage platform? - What cost savings do healthcare providers experience through the network? - How MedPassage reduces price exposure issues for medical device companies. - How do medical device companies transition to the MedPassage platform? - Can medical device companies charge for service and support through MedPassage? - How is MedPassage different than services like Wright Medical Direct and Novation Aptitude? - And much more… This Is What You Can Do Next 1) You can listen to the interview with Gavin Fabian right now: Download audio file (GavinFabian_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 Gavin Fabian. Read the Interview with Gavin Fabian 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, the place where you can learn from proven and experienced med tech and medical device thought leaders. And on today’s program, we've got Gavin Fabian, who ...

Warren Buffet is often quoted as stating, “The best time to be greedy is when others are fearful.” But can this same concept apply to the medtech space? Can limited partners (the investors in a venture fund) be sold on the idea of bankrolling early stage medical device companies? In this interview with Mike Carusi, General Partner at Lightstone Ventures, we learn why his firm believes the current medtech environment represents an incredible investment opportunity. Interview Highlights with Mike Carusi - Because of the challenges involved with raising money for early-stage medtech deals, will there be a large innovation gap in 7-10 years?- Is there any sort of mandate within large strategics to keep the medtech ecosystem alive?- For those “bloated” medical device startups that have raised $100+ million, how much pressure are they under?- Why early stage medical device companies should look at biotech and pharma in order to discover creative ways to fund companies.- Will the build-to-suit (“exclusive incubator”) trend continue?- VC firms win by trying to hit home runs versus singles. But if you can be efficient with capital, can hitting singles be a viable model? In other words, can Fred Khosravi's success be duplicated?- Is there room left for the traditional model of incremental product improvements (with minimal clinical data) at higher market prices? AKA the “fast follower” approach.- Are we in a renal denervation bubble?- How does a medtech engineer, physician, or entrepreneur get the attention of Mike and his VC colleagues?- What are medical device acquirers looking for in pre-revenue startups? In other words, what markets should startups be pursuing?- Best practices for “de-risking” a potential acquisition.- How Mike’s early experience in sales helped him throughout his medical device career. This Is What You Can Do Next 1) You can listen to the interview with Mike Carusi 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 Mike Carusi. Read the Interview with Mike Carusi 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. For those of you who are new to the program, this is a show where I bring on experienced and proven med tech and medical device experts and ask as many questions as I can fit in in about 30 minutes. And on today’s program I’ve got Mike Carusi, who is a General Partner and Team Leader of Lightstone Ventures. He focuses on biopharmaceutical and medical device investments out of the firm’s Palo Alto office. Mike also joined Advanced Technology Ventures in 1998 and serves as a general partner. Some of his representative investments include Altura Medical, Ardian, which was acquired by Medtronic, EndoGastric Solutions, GI Dynamics, and several others. Mike was also featured on the 2011 Forbes Midas List of top technology investors. He is of course a recognized thought ...

Warren Buffet is often quoted as stating, “The best time to be greedy is when others are fearful.” But can this same concept apply to the medtech space? Can limited partners (the investors in a venture fund) be sold on the idea of bankrolling early stage medical device companies? In this interview with Mike Carusi, General Partner at Lightstone Ventures, we learn why his firm believes the current medtech environment represents an incredible investment opportunity. Interview Highlights with Mike Carusi - Because of the challenges involved with raising money for early-stage medtech deals, will there be a large innovation gap in 7-10 years? - Is there any sort of mandate within large strategics to keep the medtech ecosystem alive? - For those “bloated” medical device startups that have raised $100+ million, how much pressure are they under? - Why early stage medical device companies should look at biotech and pharma in order to discover creative ways to fund companies. - Will the build-to-suit (“exclusive incubator”) trend continue? - VC firms win by trying to hit home runs versus singles.  But if you can be efficient with capital, can hitting singles be a viable model?  In other words, can Fred Khosravi's success be duplicated? - Is there room left for the traditional model of incremental product improvements (with minimal clinical data) at higher market prices? AKA the “fast follower” approach. - Are we in a renal denervation bubble? - How does a medtech engineer, physician, or entrepreneur get the attention of Mike and his VC colleagues? - What are medical device acquirers looking for in pre-revenue startups?  In other words, what markets should startups be pursuing? - Best practices for “de-risking” a potential acquisition. - How Mike’s early experience in sales helped him throughout his medical device career. This Is What You Can Do Next 1) You can listen to the interview with Mike Carusi right now: Download audio file (MikeCarusi_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 Mike Carusi. Read the Interview with Mike Carusi 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. For those of you who are new to the program, this is a show where I bring on experienced and proven med tech and medical device experts and ask as many questions as I can fit in in about 30 minutes. And on today’s program I’ve got Mike Carusi, who is a General Partner and Team Leader of Lightstone Ventures. He focuses on biopharmaceutical and medical device investments out of the firm’s Palo Alto office. Mike also joined Advanced Technology Ventures in 1998 and serves as a general partner. Some of his representative investments include Altura Medical, Ardian, which was acquired by Medtronic, EndoGastric ...

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 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: 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 ...