4 Questions to Ask Before Submitting a 510(k)

March 5, 2015 / by Kapstone Medical posted in 510(k), FDA, FDA approval, innovators, kapstone medical, medical devices, physician inventors, product development advice, realize your idea, Regulatory, Regulatory affairs, surgeons

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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.

An Integrated vs. Piecemeal Approach to Product Development

December 4, 2014 / by Stuart Lindquist posted in 510(k), FDA, inventors, medical device, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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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...

Manufacturing at Home: Advancements in 3D Printing

November 20, 2014 / by John Kapitan posted in 3D Printing, inventors, manufacturing, medical device, orthopedics, physician inventors, prototyping, R&D, R&D projects, realize your idea, surgeons

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No matter where you turn, you are bound to run into a news headline expounding on the wonders of 3D printing. From medical devices to guns and even to food, it seems that possibilities are endless and our appetites are growing for the technology. Read More...

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

November 2, 2014 / by John Kapitan posted in innovators, inventors, medical device, orthopedics, physician inventors, Product Development, realize your idea, surgeons

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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...

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

October 23, 2014 / by Stuart Lindquist posted in innovators, intellectual property strategy, inventors, IP fit, IP services, medical device, monetize your idea, orthopedics, physician inventors, Product Development, protect your idea, realize your idea, Regulatory affairs, surgeons

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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...

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

September 26, 2014 / by admin posted in 510(k), FDA, innovators, inventors, medical device, orthopedics, physician inventors, Product Development, protect your idea, prototyping, realize your idea, surgeons

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When and how to get constructive feedback throughout the development process

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

September 26, 2014 / by John Kapitan posted in 510(k), FDA, innovators, intellectual property strategy, inventors, IP fit, medical device, orthopedics, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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The Top Ten Things to Avoid

A Roadmap to Success for Surgeon Inventors, Part 5 (installment 1 of 2)

September 15, 2014 / by John Kapitan posted in FDA 510(k), innovators, intellectual property strategy, inventors, IP fit, medical device, orthopedics, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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The Top Ten Things to Avoid

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

August 20, 2014 / by John Kapitan posted in 510(k), FDA, feasibility studies, innovators, intellectual property strategy, inventors, IP fit, manufacturing, medical device, orthopedics, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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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...

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

July 18, 2014 / by John Kapitan posted in 510(k), FDA, innovators, intellectual property strategy, inventors, IP fit, medical device, orthopedics, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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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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