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Industry        Surgeon

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Surgeon Entrepreneurs Tackle Different Commercialization Challenges

Posted in Surgeon as Entrepreneur | Jan 2017 | Comments (0)

Tags: FDAapproval processsurgeon entrepreneurscommercializationarthroscopy/soft tissue


The path from device idea to operating room use is not straight, especially for surgeons who are commercialization rookies. In looking back on our recent surgeon entrepreneur
interviews, we noticed that their greatest challenges popped up during different stages of the commercialization process. If you’re considering development of a new product, or even if you’re several steps in, you can benefit from understanding the hurdles that others faced in getting their product to market. 

  


 
PRODUCT CLEARANCE



Thomas “Toney” Russell, M.D.
 
Company: Innovision
Product: N-force, an augmented fracture fixation system comprising fenestrated screws, washers and calcium phosphate materials

Question: What were your biggest challenges in working with FDA? How did you overcome those?

Answer: We did a risk mitigation analysis, which took us about two years to develop with FDA. Of all the risks, there were a few things that FDA was concerned about. The first was implant strength. They challenged, ‘You have to design implants that deliver these biomaterials to be equivalent in ASTM [American Society for Testing and Materials] testing to the predicate devices on the market.’ We started working on different ways to equal out the stresses, and then developed a process to manufacture that reproducibly.

Then, we had to prove that the [calcium phosphate] material would flow in the screws. We worked with a group at ETEX (a bioresorbable bone substitute materials manufacturer acquired by Zimmer in 2014) and developed protocols. We had to show that it was a low-pressure injection; all of the previous techniques involved high pressure to get materials in. With low-pressure, we minimized the chance of embolism. We designed that characteristic in the screws through fluid dynamic analysis and thermodynamics. We had to re-engineer the material itself, so we changed the implant design and the material to make it optimized for the flow.

FDA said, ‘You’re injecting materials that harden around the implant; they could turn into bone, how are you going to get the metal out?’ So we designed a self-extraction feature in the hydraulic grooves that cut a path through the biomaterial once it hardens. If you have to take it out for some reason, you can do so without destroying the calcium phosphate around the bone.

FDA thought that this was impossible since from a mechanical standpoint, once you insert holes or perforations in a cylindrical structure, it weakens the device. Also, bone substitute materials are non-Newtonian fluids that resist flow and movement down a closed cylinder, but we were able to engineer it. Once we received regulatory clearance, we performed a small release to several centers and collected experience with approximately 200 screw insertions. We learned more about the bone substitute materials and conducted more cadaver research, leading to another generation of bone substitute material and mixing system to increase surgical efficiency, as well as a better sheath injection system for version 2.0 of the N-Force. We then went back to FDA and repeated the protocol testing to receive our next 510(k) clearance.

Most of the stuff that FDA asks you about is legitimate; it’s just so time-consuming and expensive that most people run out of resources and money before they can complete the work. This has been a high-risk project.
 


 
CLINICAL EVIDENCE



Brian Thornes
, left orthopaedic residency to purse medical device entrepreneurialism
Company: X-Bolt Orthopaedics, Founder and CEO
Product: X-Bolt, an expanding device for the treatment of hip fractures

Question: What is the greatest challenge you faced with the commercialization of the X-Bolt, and how did you overcome it?

Answer: Getting clinical evidence, because surgeons will not change their habits unless they have overwhelming clinical evidence to assume that [a new device] is better. In 2012, we started a clinical trial in the U.K. called WHiTE One, which stands for The Warwick Hip Trauma Evaluation. It was a 100-patient randomized control trial, which compared the X-Bolt against a standard sliding hip screw. It was reported in The Bone & Joint Journal that there were 0% reoperations for the X-Bolt, and 6% for the screw group. We have proven that we have a safe and effective device.

To get physical superiority, we have embarked upon a 1,000-patient hip fracture trial, investing €1 million (~$1.2 million) into that trial. It’s going to be in ten centers in the U.K. and we’ll report results in 2018. What we’re looking for is the re-operation rate. Classically, there’s about a 5% or 6% re-operation rate with hip fracture fixation. The problem is, there’s a huge socioeconomic burden to have elderly patients re-admitted and their hip fixation redone or converted to a total hip replacement. Per case, that probably adds an extra $80,000 to the hospital or the system. For the patient, it’s terrible because they become more dependent and may get infections and pressure sores, and it’s not good for an elderly patient to be debilitated for that length of time. The average age of hip fracture patients is 84, so they usually come in with a lot of other intercurrent illnesses. Every day they’re in the hospital incumbent, they run the risk of getting other complications—it’s like a spiral of doom when they’re not mobilizing.

[Clinical trials are] a process where we need to have a lot of talks and engage with the right people. You have to make sure that you go to the right centers and that everybody’s interests are aligned. Some people want to have a clinical trial looking at a certain research question, and we might have a different opinion of what the research question is going to be. Navigating that has been a bit of a challenge. Again, it’s something that’s been part of our company strategy. We’re quite established in the U.K. at the moment. We outsource our manufacturing and also use sales agents to help sell.



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