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A Great Match in the 3D Printed Medical Device World

Medicine Hat College and Tangent Design Engineering partner to build innovative medical devices

By Walter Garrison 

This article is the first in a series on 3D printing and medical devices. Medicine Hat College

A surgeon is about to perform a complex hip replacement procedure, fully confident in their ability to do so because of the true-to-life 3D printed practice models and surgical guides that they have used in preparation. The patient ends up with a custom hip replacement and very few if any post-surgical problems. This is not the distant future but is part of the impact of additive manufacturing on the medical field today. And Canadian companies and post-secondary institutions are significant players in this leading edge application of additive manufacturing (AM) technology.

Tangent Design Engineering Ltd. located in Calgary and Medicine Hat College in Medicine Hat, Alberta have developed a successful relationship in the design and rapid prototyping of parts for a number of medical purposes. Tangent is a mechanical and electrical engineering firm that specializes in the design and prototyping of products for clients in numerous industry sectors. With expertise in medical, industrial, and consumer devices, coupled with an ISO 9001 and ISO 13485 registered quality system, Tangent provides a unique service in bringing design expertise and engineering rigour to turn-key product development projects.

Medicine Hat College has an additive manufacturing centre that has been in operation for two years. The centrepiece of this facility is a Stratasys Fortus 400mc 3D printer, supplied and supported by additive manufacturing specialists Cimetrix Solutions Inc. This professional grade production based system is capable of printing in a broad selection of high performance engineering grade thermoplastics. MHC also has various scanning technologies used in the dimensioning and reverse engineering of objects for a number of applications. The centre has performed rapid prototyping work for clients in several industry sectors including manufacturing, engineering, health sciences, unmanned aerial vehicles, agriculture, ceramics, and entertainment. The AM centre at MHC received financial support from Western Economic Diversification CanadaAlberta Innovates Technology Futures, local industry, and significant investment from the college itself.

The MHC AM centre website clearly and concisely describes the process for industry engagement. On this website there is a short video detailing the workflow in the 3D printing process, FAQs, and downloadable cost estimate forms. A client can send a .stl file to Steve Penzes, the Fabrication Technician at the centre, which is analyzed and processed. Typically within 24 hours the client has received a cost estimate for their print job. The technician will talk with the client to determine if 3DP is appropriate for what they are wanting to achieve. There is also considerable discussion regarding the technical requirements for the prototype with the client before printing it to ensure that it will be appropriate for the purpose for which it has been designed.

Once the client approves the estimate, the object is then printed and shipped. The client obtains a prototype far faster than with traditional manufacturing methods. Since MHC has a world-class printer with state-of-the-art materials, the quality of the prototypes is unmatched by other current thermoplastic rapid prototyping technologies. It is not just the technology that accelerates the product development process for industry. It is equally important that the technology is applied in an appropriate manner so that clients can realize their prototype in a form that quickly and effectively takes the product iteration process to the next level.

Tangent and MHC came together on a recommendation from our Industrial Technology Advisor Cal Koskowich of the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP). Walter Garrison, the Manager of Innovation and Scholarship at Medicine Hat College, had been in contact with Mr. Koskowich regarding the commissioning of the printer which led to the introduction of John Person, Vice-President at Tangent, to Mr. Garrison.

From the initial print jobs MHC did for Tangent, the relationship between the two organizations has grown. The continual interaction between MHC and Tangent made each organization more effective in the use of rapid prototyping technology for product development. The suitability of the designs for 3D printing has improved greatly over the course of the organizations’ interactions over the last two years.

In this process there is usually a back-and-forth conversation between MHC and the engineers at Tangent to determine what the critical product parameters are so that the device can be printed successfully.

While MHC has printed prototypes for Tangent for a number of industrial uses, medical devices are becoming much more significant for both organizations in the application of AM. MHC recently prototyped an orthopaedic device based on Tangent’s design. Tangent’s client for this device was then able to license the use of this device in the European marketplace. The synergy between Tangent and the college enabled this process to occur relatively quickly and is a concrete example of how a Canadian company and a post-secondary institution are actively utilizing AM technology in the innovation sector with a global reach.

One of the major factors in the impactfulness of additive manufacturing for medical device prototyping is the wide variety of materials available. In the first project, for example, MHC recommended Tangent print in Ultem material for the application which required the device be sterilized by high temperature steam for clinical use. The material survived the process and held tolerances perfectly, even after repeated sterilization. From this initial success, Tangent has been working with MHC on a new project to develop a novel implant guide which can be used in surgery. The device has been patented, tested on lab specimens, and is now poised for clinical trials on human patients. Again using Ultem material, the device can be sterilized through approved procedures, and validated in a clinical setting. This clinical validation is the key step towards approval as a medical device, so having reliable AM tools and process available greatly accelerates the process.

The use of AM in product development and in understanding the capabilities of this technology for medical devices has accelerated as Tangent and MHC continue to work together. Tangent is very quickly able to realize their designs and the functionality of the printed product. They have been able to expand their suite of services as prototypes of their designs can be rapidly fabricated and given to their clients. The 3D printed products are of high-quality which allows for more effective testing of parts. The close relationship with MHC and continued work with the college’s facility has assisted in evolving Tangent’s design process for rapid prototyping.

MHC’s AM facility has matured rapidly, in no small part due to its interaction with Tangent, as well as support from WD, AITF, NRC, and Cimetrix. The college gained critical knowledge as to the requirements of industry and the AM centre has developed a reputation for responding at the speed of business for its external clients. MHC’s facility is making a significant contribution to the larger innovation community.

What’s next? Tangent and MHC have expanded their relationship to include more project-focused initiatives. Both organizations see the value in having a longer-term perspective on the R&D aspect of their engagements while responding to their clients’ needs with unparalleled speed. The use of AM for medical device development is at a nascent stage. Both Tangent and MHC are poised to make significant contributions in this sector and, as a team, develop Canadian innovations on the world stage.