• Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

    You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.

  • 9 Key Investor Milestones Every Med Device Developer Should Know

    Since few medical device startup companies can bootstrap complete product development, they typically look to investor funding. As daunting and overwhelming as the funding process can be, there are definite guidelines and stages of investor de-risking that can make the design and development process much more on target and successful.

  • How To Untangle Your Medtech Regulatory, Engineering & Business Decisions

    Making decisions in medical device development is tough. From initial concept to market introduction, countless factors influence almost every decision. It’s easy to confuse and intermingle engineering, regulatory, and business decisions. Knowing which type of decision you’re making can make all the difference in how effectively you can bring your device to market.

  • 5 Tips To Make Your Medical Device Start-Up More Investable

    Say “start-up” in the medical device community and the conversation can move quickly to funding. Who will invest? How much? How long will it take? Here are five tips to help a medical device start-up be more interesting, more attractive, more investable – and less risky – to potential funders.

  • How To Eliminate The Gate In Medtech Product Development's Phase-Gate Approach

    We all know the phase-gate approach to medical device development is cumbersome and slow – the exact opposite of what’s needed for products essential to critical treatment or prevention of disease or chronic conditions. The good news is that there are ways to make dramatic improvements to the efficiency of the product development process while maintaining project phase controls. 


Jim Kasic

Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patients. His career includes experience with companies ranging from large multinational corporations to start-ups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science in physics and a Master of Science in chemical/biological engineering from the University of Colorado and a Master of Business Administration from the University of Phoenix. He can be reached at