What it Takes to Bring a Medical Device to Market

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.