How to Prevent Your Device From Getting Knocked Off

Interview with PN Medical CEO Mark Carbone

The entrepreneurial journey of Mark Carbone started when he was young. Through the years, the CEO of PN Medical has admittedly made many mistakes along the way. However, he believes what’s most important is that you not only learn from your failures, but you it’s crucial to get up, dust your feet off, and keep going.

Mark comes from an entrepreneurial family. His ventures evolved from cutting grass for neighbors, painting houses, to buying and selling cars. After receiving his MBA, he started XE Corporation with just $5,000, a software company that helps businesses streamline their processes.

Fast forward to 2015, Mark took the reins at PN Medical as CEO and oversees the development of new medical devices and software. In addition to operationally running the company, he sees himself as its visionary, chief recruiter, and deal maker.

PN Medical was founded by respiratory therapist Peggy Nicholson in 1980 and Mark has helped the company become the top developer of respiratory muscle (RMT) training devices. PN Medical offers various iterations of its RMT device called The Breather, which helps cardiopulmonary patients, vocal artists, and professional athletes improve their respiratory health and performance without pharmacological intervention.

The company plans to continue the development of its software app, which includes on-demand breath and respiratory coaching. PN Medical is also planning to launch new products in 2023.

In this episode of the Medsider, Mark shares his perspectives and experiences on finding the ideal people to get things done, best practices for protecting your IP, and how to ensure the commercial success of your products.

Guest
Mark Carbone
CEO of PN Medical

Mark is the CEO of PN Medical, makers of medical devices that help improve pulmonary performance of patients, vocal artists, and professional athletes. Mark used his technology background and entrepreneurial experience to turn PN Medical into a frontrunner in the pulmonary space.

Key Learnings From Mark’s Experience

  • Finding champions is crucial. People who can truly move the needle for your business. Look for individuals who not only have domain expertise, but are driven to leave a legacy.
  • Protect your products at all costs. You need to partner with the right IP counsel, allocate enough legal budget, and secure as many trademarks and patents as possible.
  • Identify distributors that not only can execute, but are trustworthy as well. Ensure they have an actual salesforce on the ground that can deliver real results for your brand.

Find Champions Who Can Get Things Done

When Mark became the CEO of PN Medical, the founder requested that the company continue to put patients and clinicians first. With that as his compass, Mark pushed the brand into its next phase using his technology background, which started with the development of PN’s own hardware and software.

Mark shared the challenges getting the company to where it is now and what formula worked for him in leading PN Medical into the future.

“HR is my biggest issue. It's the biggest investment. The most important thing you can do as a CEO, I think, is to form the best team. It's pretty much half of my job to find great people who are just really good at what they do,” Mark says.

Building the team at PN Medical involved tapping into his trusted circle of family and friends. Mark also revealed that he specifically looked for professionals on gig economy platforms such as Upwork, where he found his chief scientist and nearly half of PN’s current team.

Along the way, Mark also learned that deep research is crucial if you want to drive awareness and experience any type of commercial success. Using PN Medical’s solid reputation and semi-limited budget, Mark aimed to find a balance between publishing clinical evidence and promoting the brand. That meant persuading potential champions willing to devote their time to building their legacy of helping move healthcare forward.

“I always found a really excited champion, somebody who had a little budget in their department. They're into new stuff and they want to move up the ladder at their organization and they'll do anything to get a study published,” Mark says. 

However, he reminded fellow medical device entrepreneurs and leaders to know when to walk away and move on when partnerships or collaborations are stuck.

Like most medtech companies, Mark needed help navigating the various regulatory complexities, including commercializing through Amazon. Mark advises finding regulatory and legal professionals with proven domain expertise and demonstrated track records. 

“You really have to find someone who knows somebody. Not so much for approvals, but for coaching, so that when you do go through the approval process, you don't get crushed with endless denials. The more you do your homework upfront and don't try to make too many claims, it should push you through faster,” he says.

Mark also put the spotlight on the significance of striving to improve one’s self as a business leader. When asked about things that keep him up at night, he had this reflective thought, “It's me. It's me as a leader. I need to work on being a better leader every day. I was great as a startup leader, but it’s different now.”

He said you might be good when the company is small, but as the business grows, you need to find ways to become a better leader. Mark is an avid reader and relies on leadership coaches to help him figure out what works and what doesn’t.

Make a Concerted Effort Early On to Protect Your IP and Build Relationships with the Right Investors

Aside from finding the right champions, Mark believes medical device and health technology CEOs should focus on ways to protect your brand and its products. This involves working with the right IP attorneys, allocating the right legal budget, and making sure you pursue the proper trademarks and patents.

Mark reveals that one of the biggest steps in protecting your business is choosing the right investors. It can mean success or eventual death. Not only do you need to find investment partners that understand the medical space, but it’s equally important to work with investors aligned with your brand's values.

“The investor really [should] be equally yoked. You have to have similar beliefs. And if there is an exit strategy, it can't be like a two-year window; it has to be longer. They have to give you some room,” Mark says. “You shouldn’t take money just because they're giving it.”

Mark holds a firm belief that it is imperative for businesses to have a plan when your medical device, for example, finally has a good share of the market. He recalled a story when the company had to hire lawyers after realizing their products were at the crosshairs of competitors and counterfeiters. 

“You need to have a legal budget once once you have a good market share. There has to be a set line item every month,” Mark says.

Once you make significant inroads and start taking share, you’ll get the attention of competitors and regulatory bodies, too.

Based on this experience, Mark reminds business leaders to have corresponding plans as their forecasted growth becomes reality to avoid potential disasters. Today, PN Medical works with a top legal firm that helps them go after counterfeiters and other bad actors across the globe.

Aside from having enough legal budget to protect your business from intellectual property infringements, Mark said one of the wisest moves medtech companies can do is get as many trademarks and patents as possible. This is crucial if you want to protect all the things that you have worked hard for.

Work with Powerhouse Distributors that Will Keep the Cash Register Ringing

As a startup, finding a trustworthy distributor that can truly drive results can be a major reason why you succeed or fail. 

But how do you find a good distributor to partner with? Here’s Mark’s advice: “First, I need to know that they have a real sales force, that they really do have salespeople on the ground.”

He also warns of exclusive relationships with distributors, something he did not have to deal with when he started at PN Medical. If that’s your only option, Mark recommends having the right hooks in place – product volume, timeframe, or sales revenue – so you remain in control.

Distributors can get you very far, but the wrong partners might abuse your relationship and undercut you by commercializing products through non-approved channels or selling at lower prices.

Mark reinforced the idea that the road to success in the medical device and health technology industry is difficult.

“It's harder than you think. You're going to want to give up a lot. And it's going to affect your family, it's going to affect your marriage, it's going to affect your kids, it's going to affect your health. You’ll want to give up, but just keep pressing through.”

Download a copy of the interview transcript right here.
Share:
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The entrepreneurial journey of Mark Carbone started when he was young. Through the years, the CEO of PN Medical has admittedly made many mistakes along the way. However, he believes what’s most important is that you not only learn from your failures, but you it’s crucial to get up, dust your feet off, and keep going.

Mark comes from an entrepreneurial family. His ventures evolved from cutting grass for neighbors, painting houses, to buying and selling cars. After receiving his MBA, he started XE Corporation with just $5,000, a software company that helps businesses streamline their processes.

Fast forward to 2015, Mark took the reins at PN Medical as CEO and oversees the development of new medical devices and software. In addition to operationally running the company, he sees himself as its visionary, chief recruiter, and deal maker.

PN Medical was founded by respiratory therapist Peggy Nicholson in 1980 and Mark has helped the company become the top developer of respiratory muscle (RMT) training devices. PN Medical offers various iterations of its RMT device called The Breather, which helps cardiopulmonary patients, vocal artists, and professional athletes improve their respiratory health and performance without pharmacological intervention.

The company plans to continue the development of its software app, which includes on-demand breath and respiratory coaching. PN Medical is also planning to launch new products in 2023.

In this episode of the Medsider, Mark shares his perspectives and experiences on finding the ideal people to get things done, best practices for protecting your IP, and how to ensure the commercial success of your products.

Guest
Mark Carbone
CEO of PN Medical

Mark is the CEO of PN Medical, makers of medical devices that help improve pulmonary performance of patients, vocal artists, and professional athletes. Mark used his technology background and entrepreneurial experience to turn PN Medical into a frontrunner in the pulmonary space.

Key Learnings From Mark’s Experience

  • Finding champions is crucial. People who can truly move the needle for your business. Look for individuals who not only have domain expertise, but are driven to leave a legacy.
  • Protect your products at all costs. You need to partner with the right IP counsel, allocate enough legal budget, and secure as many trademarks and patents as possible.
  • Identify distributors that not only can execute, but are trustworthy as well. Ensure they have an actual salesforce on the ground that can deliver real results for your brand.

Find Champions Who Can Get Things Done

When Mark became the CEO of PN Medical, the founder requested that the company continue to put patients and clinicians first. With that as his compass, Mark pushed the brand into its next phase using his technology background, which started with the development of PN’s own hardware and software.

Mark shared the challenges getting the company to where it is now and what formula worked for him in leading PN Medical into the future.

“HR is my biggest issue. It's the biggest investment. The most important thing you can do as a CEO, I think, is to form the best team. It's pretty much half of my job to find great people who are just really good at what they do,” Mark says.

Building the team at PN Medical involved tapping into his trusted circle of family and friends. Mark also revealed that he specifically looked for professionals on gig economy platforms such as Upwork, where he found his chief scientist and nearly half of PN’s current team.

Along the way, Mark also learned that deep research is crucial if you want to drive awareness and experience any type of commercial success. Using PN Medical’s solid reputation and semi-limited budget, Mark aimed to find a balance between publishing clinical evidence and promoting the brand. That meant persuading potential champions willing to devote their time to building their legacy of helping move healthcare forward.

“I always found a really excited champion, somebody who had a little budget in their department. They're into new stuff and they want to move up the ladder at their organization and they'll do anything to get a study published,” Mark says. 

However, he reminded fellow medical device entrepreneurs and leaders to know when to walk away and move on when partnerships or collaborations are stuck.

Like most medtech companies, Mark needed help navigating the various regulatory complexities, including commercializing through Amazon. Mark advises finding regulatory and legal professionals with proven domain expertise and demonstrated track records. 

“You really have to find someone who knows somebody. Not so much for approvals, but for coaching, so that when you do go through the approval process, you don't get crushed with endless denials. The more you do your homework upfront and don't try to make too many claims, it should push you through faster,” he says.

Mark also put the spotlight on the significance of striving to improve one’s self as a business leader. When asked about things that keep him up at night, he had this reflective thought, “It's me. It's me as a leader. I need to work on being a better leader every day. I was great as a startup leader, but it’s different now.”

He said you might be good when the company is small, but as the business grows, you need to find ways to become a better leader. Mark is an avid reader and relies on leadership coaches to help him figure out what works and what doesn’t.

Make a Concerted Effort Early On to Protect Your IP and Build Relationships with the Right Investors

Aside from finding the right champions, Mark believes medical device and health technology CEOs should focus on ways to protect your brand and its products. This involves working with the right IP attorneys, allocating the right legal budget, and making sure you pursue the proper trademarks and patents.

Mark reveals that one of the biggest steps in protecting your business is choosing the right investors. It can mean success or eventual death. Not only do you need to find investment partners that understand the medical space, but it’s equally important to work with investors aligned with your brand's values.

“The investor really [should] be equally yoked. You have to have similar beliefs. And if there is an exit strategy, it can't be like a two-year window; it has to be longer. They have to give you some room,” Mark says. “You shouldn’t take money just because they're giving it.”

Mark holds a firm belief that it is imperative for businesses to have a plan when your medical device, for example, finally has a good share of the market. He recalled a story when the company had to hire lawyers after realizing their products were at the crosshairs of competitors and counterfeiters. 

“You need to have a legal budget once once you have a good market share. There has to be a set line item every month,” Mark says.

Once you make significant inroads and start taking share, you’ll get the attention of competitors and regulatory bodies, too.

Based on this experience, Mark reminds business leaders to have corresponding plans as their forecasted growth becomes reality to avoid potential disasters. Today, PN Medical works with a top legal firm that helps them go after counterfeiters and other bad actors across the globe.

Aside from having enough legal budget to protect your business from intellectual property infringements, Mark said one of the wisest moves medtech companies can do is get as many trademarks and patents as possible. This is crucial if you want to protect all the things that you have worked hard for.

Work with Powerhouse Distributors that Will Keep the Cash Register Ringing

As a startup, finding a trustworthy distributor that can truly drive results can be a major reason why you succeed or fail. 

But how do you find a good distributor to partner with? Here’s Mark’s advice: “First, I need to know that they have a real sales force, that they really do have salespeople on the ground.”

He also warns of exclusive relationships with distributors, something he did not have to deal with when he started at PN Medical. If that’s your only option, Mark recommends having the right hooks in place – product volume, timeframe, or sales revenue – so you remain in control.

Distributors can get you very far, but the wrong partners might abuse your relationship and undercut you by commercializing products through non-approved channels or selling at lower prices.

Mark reinforced the idea that the road to success in the medical device and health technology industry is difficult.

“It's harder than you think. You're going to want to give up a lot. And it's going to affect your family, it's going to affect your marriage, it's going to affect your kids, it's going to affect your health. You’ll want to give up, but just keep pressing through.”

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
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