4 Questions to Ask Before Submitting a 510(k)

November 12, 2020 / by Kapstone Medical / 2 minute read

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical / 1 minute read

The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical device industry in the five countries participating in Medical Device Single Audit Program (MDSAP).

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FDA’s Strategic Policy Roadmap for 2018

April 25, 2018 / by Kapstone Medical / 2 minute read

FDA Commissioner aims to streamline review and beef up technical support

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What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

November 13, 2015 / by Kapstone Medical / 2 minute read

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

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What You Missed Last Month (Apr 2015 Edition)

May 2, 2015 / by Kapstone Medical / 2 minute read

It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with some of the most interesting, engaging, and inspiring news from the FDA, biomedical, and 3D printing communities. Read on for what you may have missed last month:

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What You Missed Last Month (Mar 2015 Edition)

April 17, 2015 / by Kapstone Medical / 2 minute read

Welcome to the latest round of Kapstone Medical’s “What You Missed Last Month” in the Medical Device industry. Here’s what you missed in Med Device and 3D Printing industry for the month of March:

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An Integrated vs. Piecemeal Approach to Product Development

December 4, 2014 / by Stuart Lindquist / 0 minute read

In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects of product development from the very onset, regardless of how far you plan to go. Read More...

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Roadmap to Success...Does Your Design Need a Second Opinion?

September 26, 2014 / by admin / 0 minute read

When and how to get constructive feedback throughout the development process

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A Roadmap to Success for Surgeon Inventors, Part 5 (installment 2)

September 26, 2014 / by John Kapitan / 0 minute read

The Top Ten Things to Avoid

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Making the Case for Industrial Design and Human Factors

August 27, 2014 / by Ryan Lewis / 0 minute read

An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to a procedure, a way to save time in the OR; medical technology is driven by physicians on the front lines of medical practice. How can ideas be harnessed for the benefit of patients and physicians? Read More...

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A Roadmap to Success for Surgeon Inventors, Part 4: The Cost of Developing Your Idea

August 20, 2014 / by John Kapitan / 0 minute read

This series of articles focuses on a different paradigm for bringing new ideas to market, one in which you as a surgeon inventor retain control over designs, aggressively pursue milestones on your own (such as issuance of a patent, testing of prototypes or obtaining a regulatory clearance) and build value before presenting them to industry for possible licensing or sale. Why would you consider this option? Why not just take your sketch straight to a big company? One of the best reasons to pursue development on your own is that the value of your idea can increase exponentially compared to the costs of development—if the process is managed properly. Read More...

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A Roadmap to Success for Surgeon Inventors, Part 3: Technologies for Development of Your Ideas

July 18, 2014 / by John Kapitan / 0 minute read

Traditionally, as a surgeon inventor, you may have waited for one of the large implant companies to recognize the value of your new product idea. Then the game began by negotiating timelines, team structure and ultimately, your royalty agreement. While this process has been rewarding for some, it has proven to be disappointing for others. Is there a better way? What would it look like to maintain control of your design, timeline and budgets while hitting milestones and advancing your idea? And what if you could do this while creating intellectual property along the way to build exponential value? Read More...

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A Roadmap to Success for Surgeon Inventors, Part 2: Is Your Next Product Idea Viable?

July 1, 2014 / by John Kapitan / 0 minute read

Is Your Next Product Idea Viable?

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A Roadmap to Success for Surgeon Inventors – Part 1: From Concept to Commercialization

June 1, 2014 / by John Kapitan / 4 minute read

Introduction
Thomas Edison is quoted as saying, “Anything that won't sell, I don't want to invent. Its sale is proof of utility, and utility is success.” Busy physicians often find themselves identifying a clinical need that could be satisfied with a new product or new technology. In fact, many of the best ideas are born on those difficult days when surgical cases present unique challenges.

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