ARTICLES BY JIM KASIC

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

  12/14/2023

  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

  1/25/2023

  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

  1/3/2022

  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

  11/8/2021

  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

  5/19/2021

  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.