How to Listen to What the Market is Saying

Interview with CurvaFix CEO Steve Dimmer

Steve Dimmer is a seasoned professional in the medical device industry with over 30 years of experience and a background in engineering. Throughout his career, he has participated in various startups in several different therapeutic arenas, from radiation oncology to the treatments of chronic obstructive lung disease and orthopedic trauma.

In 2000, Steve moved from Southern California to Seattle to become the founding vice president of Calypso Medical, a company focused on targeting systems for radiation oncology. In 2008, he created his own startup, Nuvaira, together with Dr. Martin Mayse, an interventional pulmonologist, formerly from Washington University in St. Louis. Despite the subsequent global financial crisis, they managed to raise funds, and Steve ran Nuvaira for about five years through its Series B financing. He then worked as an entrepreneur-in-residence for a division of Johnson & Johnson, gaining invaluable insight into the world's largest medical device company.

While serving as an advisor for Johnson & Johnson, Steve also played a role in evaluating a new technology for a local venture capitalist, which brought him to Vancouver, Canada, where he met Dr. Robert Meek, the founder of the orthopedic trauma department at Vancouver General Hospital. Together they founded CurvaFix to address the need for better treatment options for pelvic fractures, which affect a significant portion of the population.

Traditional methods of fixing pelvic fractures using straight screws and bone plates can be limiting due to the curved nature of the bone, often leading to unpredictable outcomes or lengthy and costly surgeries. CurvaFix offers a minimally invasive device that holds the bones together with minimal motion, reducing pain and promoting mobility. The CurvaFix IM Implant is designed to follow the natural curve of the pelvis, providing a more secure fixation and reducing complications.

CurvaFix targets two main patient groups: high-impact trauma patients and patients with fragility fractures of the pelvis (FFP). Fragility fractures are a growing concern for the aging population with 150,000 estimated FFP injuries in 2023 in the U.S. alone. Due primarily to limitations of existing implants, only 10% of FFP patients receive surgery today. Often, conservative FFP treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. The innovative approach pioneered by the company has the potential to improve the quality of life for thousands of patients who suffer from pelvic fractures every year.

The company received its first FDA clearance and then conducted [SD1] a small clinical study, demonstrating the readiness of the product before commercializing. Today, after its first million dollars in sales, over 200 treated patients, and 280 implants already in use, the CurvaFix technology has proved that it simplifies surgery, solves challenging surgical problems for high-impact patients, enables immediate pain relief and early mobility for FFP patients compared to existing methods. CurvaFix recently received its second FDA clearance for a smaller implant and is now transitioning from its pilot launch phase and is well-positioned to continue expanding its market presence.

In this Medsider episode, Steve discusses his journey as an entrepreneur and the development of the innovative CurvaFix device and offers valuable advice for medtech startups looking to make their mark in the industry.

Key Learnings From Steve's Experiences

  • Stay focused on your mission, but don't put on blinders – be open to exploring new opportunities and pivoting when necessary.
  • Don't be afraid to ask questions and listen to feedback from potential investors. Use this feedback to improve your pitch and strengthen your narrative.
  • Develop a tailored regulatory strategy for your specific therapeutic area and assemble a team of domain experts to help you successfully navigate the often-complex regulatory landscape.
Guest
Steve Dimmer
CEO of CurvaFix

Steve Dimmer holds a Bachelor of Science in Electrical Engineering from San Diego State University and a Master’s in Business Administration from the University of Washington. He has over 30 years of experience building medtech companies, including multiple start-ups and stints at several large multinationals. Currently, Steve is the CEO of CurvaFix, a medical device company focused on developing innovative solutions for orthopedic procedures.

Ensure You Have a Market Fit and Keep an Open Mind

Before diving into the development of a medical device or health technology platform, Steve suggests that founders and CEOs should ensure they’re addressing a significant problem recognized by their target audience.

They should validate the problem with potential customers, ask questions, and confirm they’re headed in the right direction. Market fit is a buzzword, but it’s also necessary for a successful journey. In Steve’s words: “It’s important to evaluate the market and find a product that fits into it. Then you need to present your product in clear terms because there’s a lot of noise out there, especially in the medtech industry. So, you gotta make sure your product stands out…”.

It’s crucial to make sure that the problem you’re solving has a large enough market to justify the investment and effort you will put into it. Tackling these issues early on can save you time and resources down the line and help your start-up stand out in a crowded market. In short, Steve’s strategy is to go for the Achilles heel early on before investing too much time and resources in a product.

Steve encourages medtech entrepreneurs to maintain focus while developing their products, but at the same time, keep an open mind. While it's essential to validate the problem with customers and the market early on, it's also crucial not to overlook bigger and better opportunities. “Is that really the problem you should be solving, or do you have a bigger opportunity that you didn't know about because your blinders were on?” Steve asks.

In Steve’s case, he saw the opportunity in fragility fractures when he was working as a consultant for a local VC on high-impact trauma applications, which does make a difference in people’s lives but is not a huge market. When Steve moved his focus to fragility fractures, he knew that he was not only solving a fundamental problem, but a problem that serves a large market.

Mastering the Art of Fundraising

When it comes to raising capital, Steve advises entrepreneurs to take a strategic approach by setting clear milestones to track progress and considering alternative funding options if initial capital is hard to secure. Understanding the financial expectations of investors and tailoring your pitch to appeal to their desire to make a profit is also key.

According to Steve, entrepreneurs should view their pitch to potential investors as a train that needs to be loud and clear when it arrives. The goal is to make investors think they’ll lose out on a big opportunity unless they invest.

If you get rejected, which is not that uncommon, it’s important to ask VCs for feedback and identify areas that need improvement. By actively listening and addressing these issues, entrepreneurs can increase their chances of securing investment in the future. Steve suggests putting together a deck, getting feedback from a group of people who aren’t afraid to offer critiques, and asking them to identify the things that aren’t clear enough or don’t make sense.

Entrepreneurs should also ask themselves whether they’d be curious to know more about the proposal if they were in the investors' shoes. “I think the best entrepreneurs are really self-critical and critical of what they're doing. I think you need to be good at it. If you're just drinking your own Kool-Aid, you may end up finding out later that you weren't right,” explains Steve.

Again, even if you get rejected, the ultimate goal is to receive an invitation to come back and present an improved proposal down the road.

Crafting a Tailored Regulatory Strategy

When navigating the regulatory landscape, it’s crucial for medical device startups to develop a well-informed and flexible strategy. Consider whether to engage in pre-submissions (Q-subs) or go straight to the actual submission, taking into account the nature of your device and the available guidance. Remember that regulatory strategy is not one-size-fits-all and should be tailored to the specific needs of your medical device and company.

Another crucial thing to consider is to assemble a team of domain experts, including regulatory specialists and medical advisory board members, to provide advice and validation for your approach. Keep in mind that the FDA's primary concern is patient safety, so be prepared to educate them on your technology and its benefits.

In terms of building a strong team, Steve stresses the importance of starting with a well-rounded Board of Directors. He suggests selecting members with complementary skills and experience, including venture capitalists (VCs) who can provide strategic insights and attract investors. In addition, he recommends reaching out to physicians to join the advisory board, as they can help establish credibility. When building out your advisory team, Steve emphasizes that you shouldn’t be afraid to say no to certain individuals. If you run the process with the right diligence, the best partners for your company will surface.

Download a copy of the interview transcript right here.
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Steve Dimmer is a seasoned professional in the medical device industry with over 30 years of experience and a background in engineering. Throughout his career, he has participated in various startups in several different therapeutic arenas, from radiation oncology to the treatments of chronic obstructive lung disease and orthopedic trauma.

In 2000, Steve moved from Southern California to Seattle to become the founding vice president of Calypso Medical, a company focused on targeting systems for radiation oncology. In 2008, he created his own startup, Nuvaira, together with Dr. Martin Mayse, an interventional pulmonologist, formerly from Washington University in St. Louis. Despite the subsequent global financial crisis, they managed to raise funds, and Steve ran Nuvaira for about five years through its Series B financing. He then worked as an entrepreneur-in-residence for a division of Johnson & Johnson, gaining invaluable insight into the world's largest medical device company.

While serving as an advisor for Johnson & Johnson, Steve also played a role in evaluating a new technology for a local venture capitalist, which brought him to Vancouver, Canada, where he met Dr. Robert Meek, the founder of the orthopedic trauma department at Vancouver General Hospital. Together they founded CurvaFix to address the need for better treatment options for pelvic fractures, which affect a significant portion of the population.

Traditional methods of fixing pelvic fractures using straight screws and bone plates can be limiting due to the curved nature of the bone, often leading to unpredictable outcomes or lengthy and costly surgeries. CurvaFix offers a minimally invasive device that holds the bones together with minimal motion, reducing pain and promoting mobility. The CurvaFix IM Implant is designed to follow the natural curve of the pelvis, providing a more secure fixation and reducing complications.

CurvaFix targets two main patient groups: high-impact trauma patients and patients with fragility fractures of the pelvis (FFP). Fragility fractures are a growing concern for the aging population with 150,000 estimated FFP injuries in 2023 in the U.S. alone. Due primarily to limitations of existing implants, only 10% of FFP patients receive surgery today. Often, conservative FFP treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. The innovative approach pioneered by the company has the potential to improve the quality of life for thousands of patients who suffer from pelvic fractures every year.

The company received its first FDA clearance and then conducted [SD1] a small clinical study, demonstrating the readiness of the product before commercializing. Today, after its first million dollars in sales, over 200 treated patients, and 280 implants already in use, the CurvaFix technology has proved that it simplifies surgery, solves challenging surgical problems for high-impact patients, enables immediate pain relief and early mobility for FFP patients compared to existing methods. CurvaFix recently received its second FDA clearance for a smaller implant and is now transitioning from its pilot launch phase and is well-positioned to continue expanding its market presence.

In this Medsider episode, Steve discusses his journey as an entrepreneur and the development of the innovative CurvaFix device and offers valuable advice for medtech startups looking to make their mark in the industry.

Key Learnings From Steve's Experiences

  • Stay focused on your mission, but don't put on blinders – be open to exploring new opportunities and pivoting when necessary.
  • Don't be afraid to ask questions and listen to feedback from potential investors. Use this feedback to improve your pitch and strengthen your narrative.
  • Develop a tailored regulatory strategy for your specific therapeutic area and assemble a team of domain experts to help you successfully navigate the often-complex regulatory landscape.
Guest
Steve Dimmer
CEO of CurvaFix

Steve Dimmer holds a Bachelor of Science in Electrical Engineering from San Diego State University and a Master’s in Business Administration from the University of Washington. He has over 30 years of experience building medtech companies, including multiple start-ups and stints at several large multinationals. Currently, Steve is the CEO of CurvaFix, a medical device company focused on developing innovative solutions for orthopedic procedures.

Ensure You Have a Market Fit and Keep an Open Mind

Before diving into the development of a medical device or health technology platform, Steve suggests that founders and CEOs should ensure they’re addressing a significant problem recognized by their target audience.

They should validate the problem with potential customers, ask questions, and confirm they’re headed in the right direction. Market fit is a buzzword, but it’s also necessary for a successful journey. In Steve’s words: “It’s important to evaluate the market and find a product that fits into it. Then you need to present your product in clear terms because there’s a lot of noise out there, especially in the medtech industry. So, you gotta make sure your product stands out…”.

It’s crucial to make sure that the problem you’re solving has a large enough market to justify the investment and effort you will put into it. Tackling these issues early on can save you time and resources down the line and help your start-up stand out in a crowded market. In short, Steve’s strategy is to go for the Achilles heel early on before investing too much time and resources in a product.

Steve encourages medtech entrepreneurs to maintain focus while developing their products, but at the same time, keep an open mind. While it's essential to validate the problem with customers and the market early on, it's also crucial not to overlook bigger and better opportunities. “Is that really the problem you should be solving, or do you have a bigger opportunity that you didn't know about because your blinders were on?” Steve asks.

In Steve’s case, he saw the opportunity in fragility fractures when he was working as a consultant for a local VC on high-impact trauma applications, which does make a difference in people’s lives but is not a huge market. When Steve moved his focus to fragility fractures, he knew that he was not only solving a fundamental problem, but a problem that serves a large market.

Mastering the Art of Fundraising

When it comes to raising capital, Steve advises entrepreneurs to take a strategic approach by setting clear milestones to track progress and considering alternative funding options if initial capital is hard to secure. Understanding the financial expectations of investors and tailoring your pitch to appeal to their desire to make a profit is also key.

According to Steve, entrepreneurs should view their pitch to potential investors as a train that needs to be loud and clear when it arrives. The goal is to make investors think they’ll lose out on a big opportunity unless they invest.

If you get rejected, which is not that uncommon, it’s important to ask VCs for feedback and identify areas that need improvement. By actively listening and addressing these issues, entrepreneurs can increase their chances of securing investment in the future. Steve suggests putting together a deck, getting feedback from a group of people who aren’t afraid to offer critiques, and asking them to identify the things that aren’t clear enough or don’t make sense.

Entrepreneurs should also ask themselves whether they’d be curious to know more about the proposal if they were in the investors' shoes. “I think the best entrepreneurs are really self-critical and critical of what they're doing. I think you need to be good at it. If you're just drinking your own Kool-Aid, you may end up finding out later that you weren't right,” explains Steve.

Again, even if you get rejected, the ultimate goal is to receive an invitation to come back and present an improved proposal down the road.

Crafting a Tailored Regulatory Strategy

When navigating the regulatory landscape, it’s crucial for medical device startups to develop a well-informed and flexible strategy. Consider whether to engage in pre-submissions (Q-subs) or go straight to the actual submission, taking into account the nature of your device and the available guidance. Remember that regulatory strategy is not one-size-fits-all and should be tailored to the specific needs of your medical device and company.

Another crucial thing to consider is to assemble a team of domain experts, including regulatory specialists and medical advisory board members, to provide advice and validation for your approach. Keep in mind that the FDA's primary concern is patient safety, so be prepared to educate them on your technology and its benefits.

In terms of building a strong team, Steve stresses the importance of starting with a well-rounded Board of Directors. He suggests selecting members with complementary skills and experience, including venture capitalists (VCs) who can provide strategic insights and attract investors. In addition, he recommends reaching out to physicians to join the advisory board, as they can help establish credibility. When building out your advisory team, Steve emphasizes that you shouldn’t be afraid to say no to certain individuals. If you run the process with the right diligence, the best partners for your company will surface.

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

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