What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

September 16, 2015 / by Kapstone Medical posted in 3d print, 3D Printing, 3d prosthetics, Additive Manufacturing, august, FDA, FDA 510(k), FDA approval, FDA clearance, first 3d printed pill, Intellectual Property, intellectual property strategy, jiminy, medical device, medical device inventors, medical devices, medtech, Monthly Round-Up, orthopediatrics, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, phototyping, physician inventors, Product Development, Regulatory, Regulatory affairs, spinal stenosis, what you missed last month

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It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading list - three articles to Inspire, Equip, and Guide you through the last month:

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

June 10, 2015 / by Kapstone Medical posted in 3D Printing, Additive Manufacturing, FDA, FDA approval, FDA clearance, innovators, intellectual property strategy, inventors, IP fit, IP services, kapstone, kapstone medical, kneeEOS, medical device, medical device inventors, medical devices, medical emergency, medtech, Model Prints, Monthly Round-Up, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, physician inventors, Product Development, prototyping, Radiography, Regulatory, Regulatory affairs, spinal fusion, titanium implant, TKA, what you missed last month

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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.

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.

Three Considerations for 3D Printing of Medical Devices in 2015

January 12, 2015 / by Kapstone Medical posted in 3D Printing, FDA, manufacturing, medical device, medical device inventors, orthopedics, physician inventors, Regulatory affairs, surgeons

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In late October, Medical Innovations Labs of Austin, TX announced their new 3D printing hub. They plan to provide a hands-on lab environment for medical device inventors and clinicians to launch a new generation of innovation.

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...

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...

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

Making the Case for Industrial Design and Human Factors

August 27, 2014 / by Ryan Lewis posted in 510(k), FDA, IP fit, manufacturing, Product Development, prototyping, Regulatory affairs

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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...

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...

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