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Surgeon Seeks to Market 3D Printed Implants on Demand

Posted in Surgeon as Entrepreneur | Aug 2015 | Comments (0)

Tags: medical device developmentorthopaedic technologyFDAmedical device innovationentrepreneurorthopaedic surgeonsurgeon entrepreneurstechnologydesign & developmentsoftware3D printing


Richard Hurley, M.D., an orthopaedic surgeon at Dartmouth General Hospital in Nova Scotia, Canada, started Conceptualiz Inc. in 2012 with the goal of manufacturing 3D surgical planning software. The company’s mission has since shifted to creating software that allows surgeons to actually design and 3D print their own implants.

The company is currently focused on raising funds and jumping through regulatory hoops.

ORTHOPRENEUR caught up with Hurley to learn more about Conceptualiz’s founding, plans for overcoming its present challenges and the company’s vision for 3D printed implants.

ORTHOPRENEUR
: Tell us about Conceptualiz and its founding. 

Hurley: Three years ago, we started developing the product that we have today. It started out as an attempt to make 3D planning, which is currently limited to desktop computers in hospitals, more mobile, accessible and interactive. My business partners, who are computer scientists at the University of Toronto, were in a similar human/computer interaction space, so they agreed to co-develop the idea. We developed an iPad application that allows surgeons to plan surgeries in 3D. We tried to market that concept, but didn’t find a huge uptake, and even though people were excited about it, they didn’t see great potential in the surgical planning tool. Then we had this idea—what if we could actually design and 3D-print implants from this platform. What we’re marketing now is a software platform that allows surgeons to design and 3D print their own implants—a very disruptive idea.

We still need regulatory clearance, which is our next big milestone. We’re trying to raise $1 million to allow us to obtain FDA approval, or partner with either an orthopaedic manufacturer or a 3D printing company. The future vision—that surgeons could print their own implants—is quite a big step. From a regulatory standpoint, we think the way to go about it is to break it up into a few smaller steps. The first is to be able to export the design models to a manufacturer for validation and manufacture that way, and develop that process through FDA. Once we have accomplished that, we can look at the 3D printing. 

ORTHOPRENEUR: Have you discussed your idea with FDA?

Hurley: We’ve approached FDA about what type of approval is required. The software itself is a Class II device, which requires a 510(k), but no premarket data. 

Regarding the future vision of 3D printing, the entire manufacturing process will need Class III approval.

We plan to have the software at least available within six to 12 months once we get the funding to do so. 

ORTHOPRENEUR: What feedback have you received from surgeons?

Hurley: Surgeons love it. They think it’s the next big thing. They love anything to do with iPads and tablets. The best feedback we’ve had relates to simplicity of the user interface and how this is a completely revolutionary idea that could have a significant impact on the way implants are manufactured. To be specific, our main customer is not the surgeon; our main customer and value proposition is to the medical device industry. They’re the ones we’re really trying to sell this to. The surgeon is the end user, but the value proposition speaks to the medical device industry. 

Screen Shot_2015-06-03_at_9.16.17_AM_edit

What we are saying is, there’s an evolution toward patient specific implants. As they are presently manufactured, they cannot be introduced to the mass market, because they require six weeks to design and manufacture, so the path to market is slow and costly. Another issue is that the engineers are doing all the design work and surgeons aren’t really involved. The solution we bring with our platform is that—because it’s all automated by the software and performed by the surgeon—time to market and cost is reduced significantly. Our method reduces this time to two weeks and reduces the cost by half. This platform will allow patient specific implants to enter the mass market and become equivalent in cost to off-the-shelf implants. What’s more interesting is, because the surgeons’ unique clinical perspectives are being taken into account with design and planning, these implants are actually safer and of a higher quality. Using our platform, surgeons would “co-design” implants with company engineers. We think that by letting surgeons be more involved in the process, we’re going to reduce design errors that companies have seen in the past.

ORTHOPRENEUR: How long do you think it will take for this idea to become mainstream?

Hurley: Our first step is to allow orthopaedic implant companies using our platform to manufacture patient specific implants in a more cost effective, faster way with higher quality. We think we can do that within three to five years. 3D printing may be a similar time frame, depending on whom we partner with. As an early stage startup company, we want to pick the perfect industry partner. We’ll be partnering with an entity that we think is the most strategic, and that’s likely going to be a 3D metal printing company. In three to five years, we hope to have early adopters. It will take a few more years until we see this become mainstream; maybe another five years after that. A lot of changes in orthopaedics take about ten years. However, if you look at the patient specific guide market, which has only been around for three to five years, it’s already penetrated almost ten percent of the implant market.

Hannah Corcoran is Editorial & Media Assistant at ORTHOWORLD. Share your ideas with her by This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Photo credit: Richard Hurley

Conceptualiz Inc.
www.conceptualiz.com
 

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