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What it Takes to Bring a Medical Device to Market

Interview with Tim Blair, CEO of ICHOR

Following in his family’s footsteps, Tim Blair discovered he, too, had a passion for entrepreneurial pursuits early on. After completing his college education, Tim was eager to start his career in sales and marketing roles, slowly orienting himself towards the medtech space.

His extensive exposure to the industry granted him a deep understanding of both the business and the commercial aspects of the medical device arena. In 2009, he joined NAMSA, an animal testing lab focusing on biocompatibility. Thanks to Tim's leadership, the company expanded its vision and became one of the largest medtech players. As part of the expansion, the company acquired various global animal facilities, regulatory services, quality systems, and clinical CROs, which helped it become a more comprehensive service provider. 

During his tenure at NAMSA, Tim gained invaluable insights into the complex process of bringing a medical device to market, from regulatory challenges and compliance issues to fundraising. This experience eventually led him to co-found ICHOR Vascular, where he currently serves as the CEO.

ICHOR Vascular is developing novel approaches to thrombectomy in the peripheral vascular system. This procedure is traditionally executed with Fogarty catheters that physically remove clots via an incision. However, ICHOR Vascular aims to replace the standard of care with an endovascular technique that is less invasive and more efficient. 

ICHOR also focuses on addressing health economics, believing that the future of such procedures lies in outpatient sites of care. As of mid-2023, ICHOR is awaiting FDA clearance for their percutaneous arterial and venous peripheral solutions.

Key Learnings From Tim’s Experience

  • Building a strong team from the very start and focusing intensely on user needs are crucial for successful, capital-efficient product development.
  • One of the main roles of a CEO is to secure funding. This means you need to ensure your product is not only innovative but fundable, and the only way to do that is to perform adequate upfront due diligence and market research. 
  • Prioritize regulatory strategy from the very beginning and keep the communication flowing with FDA. A well-detailed plan dictates timelines and sets an overall operational strategy, forming the backbone of a startup's runway.
Guest
Tim Blair
CEO of ICHOR

With a rich, 30+ year career in the medtech industry, Tim has held diverse roles spanning sales, marketing, and strategy development, both in multinationals and startups. In 2009, Tim brought his strategic vision to NAMSA, shaping it into one of the world's first Medical Research Organizations (MROs). Currently, as CEO and co-founder, Tim is leading ICHOR on its quest to transform thrombectomy in the peripheral vascular system.

Anchoring Success: The Team, Partners, and User Centricity

"Team is everything. Investors love tech, they love cool things, but what they really love is the team," says Tim. Based on his experience, building a thriving early-stage venture requires three major pillars, with the core leadership group being paramount. He advises arming yourself with people that have proven experience, as this can help you minimize risks and streamline the path toward growth.

Tim also draws attention to the importance of building a diverse ecosystem that includes multiple stakeholders. Alongside engineers, the inclusion of marketing professionals and regulatory strategists in the product development process is crucial for devising a well-thought-out reimbursement strategy.

Tim’s second pillar is forming meaningful partnerships that’ll benefit all parties in the long run. For example, for a startup, there are potential risks associated with youthful engineering firms, as they may not provide the necessary long-term stability, especially in the field of medtech. Tim advises taking the time to choose the right partners to avoid disruptive shifts in the future.

Lastly, Tim highlights the importance of adopting a user-centric framework when developing new technology. He believes it's crucial to understand the perspectives of everyone involved, from techs to physicians and nurses, as they will be the ones using the device and determining its success. 

Break Fundraising Down Into Its Building Blocks

In a world where capital is essential to drive growth, the ability to attract and secure funding is one of the most crucial roles of a company leader — without it, even the most promising ideas may never reach their potential. As a CEO, you need to continuously work on securing more funding as you scale and evolve your business. Tim says: "The primary task of a CEO is fundraising. Regardless of the variety of roles you have to play, the need for raising funds is constant. It's a continuous process that requires substantial time and effort to secure commitments."

A prudent approach to securing capital is moving forward on your device development with confidence and a clear vision. Tim stresses the importance of making sure you have a market opportunity that will impress investors before you start spending your initial funds on prototypes and testing. 

On top of the quantity, the quality of the funding matters, too. Early-stage capital raises often come from high-net-worth individuals, key opinion leaders, and people from the industry. These investors not only understand the medtech space but can also provide invaluable insights and guidance as the company continues to evolve.

To keep the quality of your investor base high, Tim suggests maintaining a minimum investment amount when approaching high-net-worth individuals. This way, you can avoid the administrative burden of managing many small investors while attracting more sophisticated parties who can provide a greater amount of capital. And as a bonus, having intelligent investors on your cap table also raises the likelihood of them understanding the inherent risks and rewards associated with your startup.

Work on Your Regulatory Strategy From the Start

As an early-stage startup in the medical sector, your focus might heavily lean on the engineering aspect of the product you’re building. However, Tim advises placing equal emphasis on your regulatory and clinical strategies from the start of your entrepreneurial journey. 

To do that, Tim recommends engaging early with FDA through pre-submission meetings to outline your company’s plans, such as bench testing or device validation. This will allow you to gather valuable feedback and receive a guiding document with the required tests. Moreover, it will significantly enhance your budget, time, and risk management.

However, Tim underscores that this is just one facet of the broader effort required to bring a product to the market. His overarching advice for early-stage startups is a well-mapped, go-to-market strategy driven primarily by regulatory planning. Organize your product development, timelines, and budget allocation around the go-to-market strategy to avoid unwanted surprises.

Download a copy of the interview transcript right here.
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Following in his family’s footsteps, Tim Blair discovered he, too, had a passion for entrepreneurial pursuits early on. After completing his college education, Tim was eager to start his career in sales and marketing roles, slowly orienting himself towards the medtech space.

His extensive exposure to the industry granted him a deep understanding of both the business and the commercial aspects of the medical device arena. In 2009, he joined NAMSA, an animal testing lab focusing on biocompatibility. Thanks to Tim's leadership, the company expanded its vision and became one of the largest medtech players. As part of the expansion, the company acquired various global animal facilities, regulatory services, quality systems, and clinical CROs, which helped it become a more comprehensive service provider. 

During his tenure at NAMSA, Tim gained invaluable insights into the complex process of bringing a medical device to market, from regulatory challenges and compliance issues to fundraising. This experience eventually led him to co-found ICHOR Vascular, where he currently serves as the CEO.

ICHOR Vascular is developing novel approaches to thrombectomy in the peripheral vascular system. This procedure is traditionally executed with Fogarty catheters that physically remove clots via an incision. However, ICHOR Vascular aims to replace the standard of care with an endovascular technique that is less invasive and more efficient. 

ICHOR also focuses on addressing health economics, believing that the future of such procedures lies in outpatient sites of care. As of mid-2023, ICHOR is awaiting FDA clearance for their percutaneous arterial and venous peripheral solutions.

Key Learnings From Tim’s Experience

  • Building a strong team from the very start and focusing intensely on user needs are crucial for successful, capital-efficient product development.
  • One of the main roles of a CEO is to secure funding. This means you need to ensure your product is not only innovative but fundable, and the only way to do that is to perform adequate upfront due diligence and market research. 
  • Prioritize regulatory strategy from the very beginning and keep the communication flowing with FDA. A well-detailed plan dictates timelines and sets an overall operational strategy, forming the backbone of a startup's runway.
Guest
Tim Blair
CEO of ICHOR

With a rich, 30+ year career in the medtech industry, Tim has held diverse roles spanning sales, marketing, and strategy development, both in multinationals and startups. In 2009, Tim brought his strategic vision to NAMSA, shaping it into one of the world's first Medical Research Organizations (MROs). Currently, as CEO and co-founder, Tim is leading ICHOR on its quest to transform thrombectomy in the peripheral vascular system.

Anchoring Success: The Team, Partners, and User Centricity

"Team is everything. Investors love tech, they love cool things, but what they really love is the team," says Tim. Based on his experience, building a thriving early-stage venture requires three major pillars, with the core leadership group being paramount. He advises arming yourself with people that have proven experience, as this can help you minimize risks and streamline the path toward growth.

Tim also draws attention to the importance of building a diverse ecosystem that includes multiple stakeholders. Alongside engineers, the inclusion of marketing professionals and regulatory strategists in the product development process is crucial for devising a well-thought-out reimbursement strategy.

Tim’s second pillar is forming meaningful partnerships that’ll benefit all parties in the long run. For example, for a startup, there are potential risks associated with youthful engineering firms, as they may not provide the necessary long-term stability, especially in the field of medtech. Tim advises taking the time to choose the right partners to avoid disruptive shifts in the future.

Lastly, Tim highlights the importance of adopting a user-centric framework when developing new technology. He believes it's crucial to understand the perspectives of everyone involved, from techs to physicians and nurses, as they will be the ones using the device and determining its success. 

Break Fundraising Down Into Its Building Blocks

In a world where capital is essential to drive growth, the ability to attract and secure funding is one of the most crucial roles of a company leader — without it, even the most promising ideas may never reach their potential. As a CEO, you need to continuously work on securing more funding as you scale and evolve your business. Tim says: "The primary task of a CEO is fundraising. Regardless of the variety of roles you have to play, the need for raising funds is constant. It's a continuous process that requires substantial time and effort to secure commitments."

A prudent approach to securing capital is moving forward on your device development with confidence and a clear vision. Tim stresses the importance of making sure you have a market opportunity that will impress investors before you start spending your initial funds on prototypes and testing. 

On top of the quantity, the quality of the funding matters, too. Early-stage capital raises often come from high-net-worth individuals, key opinion leaders, and people from the industry. These investors not only understand the medtech space but can also provide invaluable insights and guidance as the company continues to evolve.

To keep the quality of your investor base high, Tim suggests maintaining a minimum investment amount when approaching high-net-worth individuals. This way, you can avoid the administrative burden of managing many small investors while attracting more sophisticated parties who can provide a greater amount of capital. And as a bonus, having intelligent investors on your cap table also raises the likelihood of them understanding the inherent risks and rewards associated with your startup.

Work on Your Regulatory Strategy From the Start

As an early-stage startup in the medical sector, your focus might heavily lean on the engineering aspect of the product you’re building. However, Tim advises placing equal emphasis on your regulatory and clinical strategies from the start of your entrepreneurial journey. 

To do that, Tim recommends engaging early with FDA through pre-submission meetings to outline your company’s plans, such as bench testing or device validation. This will allow you to gather valuable feedback and receive a guiding document with the required tests. Moreover, it will significantly enhance your budget, time, and risk management.

However, Tim underscores that this is just one facet of the broader effort required to bring a product to the market. His overarching advice for early-stage startups is a well-mapped, go-to-market strategy driven primarily by regulatory planning. Organize your product development, timelines, and budget allocation around the go-to-market strategy to avoid unwanted surprises.

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

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