ARTICLES BY JIM KASIC

• Key QMS Considerations For Your Medical Device Startup

  3/17/2025

  A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and provides information to help you make the right decision for your medical device company.

• How To Prevent Device Misuse Through Formative Studies

  12/9/2024

  While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

• Your 510(k) Hasn't Sailed Through. Now What?

  9/24/2024

  Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? How can a Q-Sub help? This article shares practical recommendations.

• Medical Device Assembling And Packaging: Should You Outsource?

  6/18/2024

  Medical device assembly and packaging are often afterthoughts, but they are critical decisions. Consider these crucial factors to make the right decision for your device and your company.

• 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.