ARTICLES BY JIM KASIC

• Mass Consolidation Sweeps Through Medtech Industry: What Startups Can Do About It

  6/29/2026

  Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be part of this rebirth must develop strategies for taking advantage of the new ecosystem.

• 8 Tips To Make A Med Device Startup More Investable In 2026

  3/19/2026

  U.S. medical device companies seeking funding this year will find that innovative tech and a stand-out prototype aren’t enough. These 8 tips can help startups become significantly more investable.

• AI Enters The 510(k) Submission World: What Device Developers Need To Know

  12/15/2025

  The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.

• Considerations For Rapid Prototyping In Medical Device Development

  9/15/2025

  Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

• What To Expect When You Move Into Production For The First Time

  6/17/2025

  In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.

• 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.