Amplifying the Value of 3D Printed Medical Devices (by Peter Basiliere @ Monadnock Insights blog)
Implants and prostheses are the most valuable 3D printed items. While other items may generate more revenue, 3D printed medical devices are life-altering and life-saving.
A Start-up Worth Watching
Amplify Additive, a seven-month old start-up operating three new Arcam EBM Q10plus printers, is already driving the market for titanium medical devices and instrumentation. Amplify specializes in the design, engineering, and additive manufacturing of metal 3D printed orthopedic implants.
I visited the company, located north of Boston MA, to meet with founder and CEO Brian McLaughlin and learn more about their capabilities, and came away very impressed.
Not in the medical device field? Take a few minutes to read on anyway. If you can 3D print metal implants, with their stringent quality and performance requirements, you can produce anything.
Amplify describes itself as an “additive manufacturing supply chain company for orthopaedic implants.” McLaughlin is the driving force behind the company, has more than ten years in the medical device field, having worked in varying operations and sales roles with Orchid Design, DiSanto Technologies, Arcam AB and at a start-up orthopedic OEM that used 3D printing to produce foot and ankle products, among others.
source: Amplify Additive
As they developed their business plan McLaughlin’s team not only had confidence in the market opportunity but so did prospective customers, eight of which signed Letters of Interest. As a reference, the Wohlers Report 2019 indicates the size of the medical/dental market as being 11.5% or approximately $1.230 billion of the total $9.795 billion market for AM products and services in 2018. Wohlers’ estimate includes all medical- and dental-related parts, including models.
Successful Start
Amplify closed its oversubscribed funding round in July 2018 and, with additional funding resources, acquired the three Q10plus printers. The printers have a base list price of more than 586,000 Euros ($650,000) each. Working with GE Additive, the start-up secured ample titanium powder for its operation. The three devices mean Amplify has significant production capacity and redundancy.
Within a month of receiving and installing the first of its Q10plus printers, Amplify had produced custom titanium medical instruments and shipped them to their client. The client’s customer, an international surgeon, had the instruments sterilized and successfully used them in surgery.
How Amplify 3D Prints
Amplify is located in Scarborough Maine, just minutes from a major interstate highway and the Portland international jetport. Their facility is within a two hour drive of Boston, with its leading edge hospitals and medical research labs as well as non-stop flights to major cities worldwide.
The facility, which had previously been a warehouse, was stripped to the girders and then built out to Amplify’s specifications. The result is an orderly, modern space with not only the cleanliness required to produce medical devices but also room to grow. Amplify can add another Q10plus in the existing titanium 3D printing space. Then, as the company branches into other materials such as cobalt chrome another space can be outfitted to hold six additional 3D printers for a total of ten machines.
Amplify is so focused on 3D printing high quality medical devices that it has a partner machine shop located five miles away perform any finishing work their customers may need. While in the long term some finishing may come in-house, McLaughlin did not want to either spread the company’s resources too thin or be forced to hire specialized personnel who, while expert machinists, would not know how to operate its 3D printers. Indeed, one of the reasons customers choose Amplify for their metal 3D printing needs is the fact they cannot find quality, experienced machine operators for their own machines. For its part, Amplify’s first hire had been employed by GE Additive and was responsible for training other companies on the Arcam EBM technology.
It is this focus on high quality medical devices, coupled with the team’s experience and expertise in metal 3D printing, that Mclaughlin believes sets his start-up apart. His experience, which includes selling medical devices to hospitals and surgeons, translates into a comfort level that prospective clients are looking for: a supplier that fully understands not only the nuances of designing and producing medical devices but also what the surgical team goes through from planning to operating.
source: Amplify Additive
Amplify uses Solidworks, Magics, Within and nTopology software to clean up (and sometimes design) customers’ parts in order to make them printable. Indeed, the team’s years of experience with the software packages means that they will step in to modify customers’ medical device files prior to production when necessary. All of this occurs in an environment that enabled Amplify to receive ISO 13485:2016 process certification within seven months of closing their funding. The certifications indicate Amplify has the processes necessary to consistently produce high quality first and repeat orders.
Buy or Partner?
For years I have told clients that they do not require an in-house 3D printer to take advantage of 3D printing’s benefits and opportunities. This advice is especially true for clients who need metal finished goods: prototype in plastic with an in-house device and partner with a supplier such as Amplify to produce the parts in metal.
This approach enables you to understand the technologies, learn how to design for additive manufacturing, validate potential suppliers and gain experience with 3D printing, all while minimizing your risks and investments. Buy the 3D printer after you have the volume, the ROI and can justify the investment. Whether you are in the medical device field, aerospace, consumer goods, military or another industry, 3D print service bureaus like Amplify Additive can meet your prototyping, product development and production requirements.