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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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 (September 2015 Edition –Medical Device & 3D Printing)

October 22, 2015 / by MedTech Momentum / 2 minute read

As summer drew to a close and the leaves began to turn to vivid shades of orange, red, and yellow, Team Kapstone was busy exploring the most educational and inspirational stories in 3D printing, medical device, and orthopedics. We are proud to provide our season-changing September “What You Missed” articles that inspired, equipped, and guided us through the end of summer and the advent of autumn:

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What You Missed Last Month (June 2015 Edition- Medical Device & 3D Printing)

July 10, 2015 / by Kapstone Medical / 2 minute read

Each month, as our team digs through the array of medical device, 3D printing, and orthopedics stories on the web, a theme seems to emerge and dominate the MedTech headlines. Throughout June 2015, the most-read stories surrounded 3D printing of tissues and 3D printing’s overall potential in healthcare, now and beyond.

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What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

June 10, 2015 / by Kapstone Medical / 3 minute read

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most inspiring and thought-provoking topics of 2015.

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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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What You Missed Last Month (Jan 2015 Edition)

February 18, 2015 / by Kapstone Medical / 1 minute read

While you were busy drawing up your latest medical device invention during the month of January, here are a few interesting industry stories you may have missed:

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Four of the Top 3D Printing Stories in Orthopedics in 2014

January 1, 2015 / by Kapstone Medical / 1 minute read

The 3D printing industry is taking the orthopedics world by storm. Here at Kapstone, we’ve been watching the developments all year, and expect much more innovation and regulation news to come in 2015.

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Creating Exponential Value, Part II: What is Your Idea Worth?

November 2, 2014 / by John Kapitan / 0 minute read

While it may be enticing to look for possible suitors soon after inception of your idea, chances are that the full value of that idea has not yet been realized. Could you have garnered interest from multiple companies if you had prototyped and tested it? What would it have been worth if you had gained regulatory approval first? Read More...

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Creating Exponential Value, Part I: How Far Should You Take Your Idea?

October 23, 2014 / by Stuart Lindquist / 0 minute read

Our series of articles for the physician inventor continues with a three-part look into the business side of developing and commercializing your ideas. Part One, presented here, introduces a few common situations that you may face when choosing a course of action for your idea. These hypothetical scenarios seek to answer the all-important question, “How far should I take my idea on my own?” 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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A Roadmap to Success for Surgeon Inventors, Part 5 (installment 1 of 2)

September 15, 2014 / by John Kapitan / 0 minute read

The Top Ten Things to Avoid

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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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