http://www.bbc.com/news/health-32496547

The DMLS process can be used to manufacture medical devices and has been gaining popularity of late. There are a couple of companies located in Ohio and Michigan that I have worked with.

In dental i have used SLM over 10 years.

Yes, at LIM Innovations on San Francisco we incorporate 3D printing along with other manufacturing techniques to produce our adjustable prosthetic "Infinite" socket.

Consensus Orthopedics in Sacramento uses 3D printing in surgery to custom print a part of their knee or hip replacement assembly.I don't know all the details.

JoAnne Moody I just learned Stryker is making Additive Titanium knee replacements.

Chris Melton 3D printing has been a part of pre-clinical prototype testing we've run on our product lines. Since your conference is on med dev trends in the Bay Area, it might interest you to know that I moved my med device operations away from Silicon Valley and into Denver about a year ago because of the exponential growth of the health IT, med dev, and biotech infrastructure in the Denver metro, Boulder, and Northern Colorado areas, as well as the overwhelming support in the startup community here. There are many companies around me here that have done the same. I have been pleasantly surprised by the number of 3D printing companies that do great work here but I have also found that due to the tight tolerances of our products, 3D isn't quite ready for prime time for us but there's promise for its future in our FDA approved devices.

We are designing x-ray equipment, and have rapid prototyped radiation shielding components using GMASS high-density 3D printer material and a Makerbot printer. http://www.gmass.turnermedtech.com/ Our plan is to go into production using this material, as our production volumes will be low enough that we don't want to tool up for injection molding.

Robert Christensen Starting in about 1991 I formed a company, Medical Modelling, inc. To manufacture medical devices for my sister company, TMJ Implants, inc. We would produce SLA anatomical models at firsthand then would produce the implants to replace a defective or missing part. Later we skipped the SLA model phase and just went to the,production of the implants.

Dear JoAnne, we know European companies that are far ahead in Additive Manufacturing in medical products and applications. For plastics one can use Materialise
http://www.materialise.com/products-and-services/products-and-services-for-medical-professionals-0
and for metal parts LayerWise http://www.layerwise.com/medical/
Regards, Paul - TSG

The latest issue of Harvard Business Review has a good article on additive mfg and points out that hearing aid production is converting to additive. You may like to look at the article as reference material for your conference.

Salvatore Emma, Jr. We print wax patterns used in conventional investment casting of knee components. It's much more cost effective than DMLS and yields a component which is patient specific. We use the same system for small batches of identical components. Www.micronmedical.com

Hi JoAnne,
Yes, there are a few approved medical devices that have been 3D printed. Some of them I can recollect are:
1. Stryker's Triathlon series of knee implants: https://www.stryker.com/en-us/products/Orthopaedics/KneeReplacement/Primary/TriathlonTritanium/index.htm
2. Oxford Performance Plastics' Facial & Cranial implants that are custom made to reconstruct a patient's anatomy: http://www.cnet.com/news/3d-printed-face-implant-gets-fda-approval/
3. Invisalign's transparent custom made dental braces: http://www.invisalign.com/
4. Phonak, a leading hearing aid manufacturer uses 3D printing to produce almost 98% of its shells: http://envisiontec.com/applications/hearing-aid/

Salvatore Emma, Jr. We make the Conformis femurs. ;-) - in the interest of full disclosure this is public information.

in addition to the products that Sukhdev Balaji listed earlier, Biomet has 510(k) cleared (and commercialized) devices in the hip, knee and extremity segments that are manufactured using 3D printing techniques.

Michelle Bonn Joanne,

A variety of companies are using "3D printing"- Additive Manufacturing- to make medical implants.

Companies like conformis- www.conformis.com (total knee replacement kits) and renovis surgical - www.renovis-surgical.com (porous hip joints and spinal implants) are some of the early adopters and innovators in this space.

These companies are using the highest end materials (titanium powders) and electron beam manufacturing (type of 3D print). These materials and processes are biocompatible and validated for tight tolerance manufacturing output.

This space is ripe for innovation. The above mentioned companies have successfully navigated the FDA process, with cleared products. Keep in mind: this production process is far more complicated that standard, subtractive manufacturing. The typical learning curve for companies implementing process controls for this manufacturing is most likely a 2+ years. The FDA regulatory and compliance work be a sticking point, thus leading to a longer product launch times.

John Sanchez Has anyone ever used this company for 3D printing?

http://i.materialise.com/

Their material selection is impressive, and you can get instant quotes. I haven't worked with them yet, but I'm curious to hear if anyone has.

We are printing dental models and surgical guides for dental implant placement.

Christopher Ostrovski Our company Stemmed Implant Technology Inc. ( www.stemmedimplant.com ) is using additive manufacturing to "print" the SIT dental implant in Titanium. We have successfully run the first pre commercialization run of the dental implant using the EOS 280 printer - we are very satisfied with the product and its competiveness.

Christopher Scorzelli, MD Yes, there is a orthopedics spine company that has.

JoAnne Moody Have you heard about 3D printing of composites from startup company Arevo Labs? They are presenting this technology for the first time at the SME SV Medical Trends event, May, 2015. Check out http://smesv.org/conference

Christopher Ostrovski There is the question of how the regulatory bodies will accept additive manufacturing - a recent article stated the following ( this is but an excerpt from http://www.mddionline.com/article/fdas-view-3-d-printing-medical-devices ):

FDA doesn’t see the need to pile on new regulations to address 3-d printing.

“The current perspective is that it’s not something we’re unprepared for with the current paradigm we have for regulation,” Pollack said.

However, a pair of guidances on the topic of 3-D printing are in the works. For one that will cover the agency’s thinking on who the manufacturer is and where manufacture occurs when 3-D printing is used, Pollack provided no estimated time of arrival, saying only, “It’s complicated.” But guidance on what questions manufacturers of 3-D printed medical devices can expect from FDA will come out this year, he said.

So far, issues that tend to come up with 3-D printed devices include the following:
•How do you clean it?
•How do you remove the processing agents form the final product?
•How do you ensure biocompatibility?

But, as Pollack said, “they’re not showstoppers, just questions.”

And if you’re unwilling to take the agency at its word, consider the experience of Stryker, which has received 510(k) clearance for two orthopedic implants made using 3-D printing. Naomi Murray, the company’s senior manager of additive manufacturing, told an MD&M West audience that although the company faced questions from FDA with regard to its additive manufacturing processing and testing, it “wasn’t overwhelming.”

Paul Marshall, CPPL, PMP We sell 3D manufactured products and have done so for the last 6-8 years. They are custom printed components to match the anatomy of a specific customer. This is the future for orthopedic implants.

Robert Christensen Yes in the early 1990s when I founded Medical Modelling alongside of TMJ Implants I used it.

Christopher Ostrovski the distinction between metal additive manufacturing and plastic ( polymer ) 3D additive manufacturing should be made

I used a massive and not very cost effective 3D printer to make inhaler prototypes. Nowadays the cost of machine and material are more reasonable and their precision is much better than a decade ago. 3D printing may prove to be a great tool for clinical studies.

Yes. We at Micatu have built and are marketing a production tissue microarrayer see website -- www.micaarray.com that is almost 95% built on 3D production printed parts. We initially built this via a machining process for the NCI/NIH and found that the advent of production level 3D printers, we could save over 90% of our production costs using the 3D printer. Quite a success story.