Tag Archives: 3d printing

FDA Released Draft Guidance on 3D Printing

Boatloads of people and a brain computer interface — #3Dprinting & #Robohand folk at #MakeHealth

The FDA recently released draft guidance for those using 3D printing (also known as “additive manufacturing”) to create or modify medical devices.

Technical Considerations for Additive Manufactured Devices
Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.
Document issued on May 10, 2016.

This is a pretty interesting happening, and particularly interesting in the context of the maker movement, #DIYability, #InventHealth, #MakerNurse, and #MakeHealth. These are all concepts or movements driving the improvement of health and healthcare through engagement with the general public. This is where a lot of patients and the general public use creativity, insight, experience, and often various technologies such as 3D printing in order to craft custom solutions to interesting health challenges.

Here, at the University of Michigan, most of the press we’ve gotten around 3D and 4D printing has related to saving babies (in multiple ways) and making surgeries safer.

So, will the FDA guidance impact on people trying to make stuff at home, at work, in the hospital? Possibly. Actually, according to the strict interpretation of the current definitions, it sounds pretty likely. (Please, note, I am not a lawyer!) Here is one section on that aspect.

“Point-of-care device manufacturing may raise additional technical considerations. The recommendations in this guidance should supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.”

So, this is talking about point-of-care, which would include pretty much all the maker communities I was mentioning above, but it’s really really vague. I’m not the only person who thinks so.

“Although the draft guidance is a start, there are still many unresolved regulatory issues that need to be addressed, especially as the technology continues to evolve and more innovative products are brought to market. One still-pressing, unanswered regulatory issue associated with 3D printing is how the FDA intends to approach non-traditional device manufacturers. As background, under the existing FDA regulatory framework, a manufacturer is defined broadly to include “any person who designs, manufactures, fabricates, assembles, or processes a finished device.” As 3D printers become increasingly accessible, a person (or entity) with a 3D printer does not need the financial capital, infrastructure, or resources historically associated with traditional manufacturing operations. While the draft guidance acknowledges point-of-care manufacturing, it does not provide much discussion on non-traditional entities, such as healthcare providers and suppliers becoming “manufacturers” of medical devices. … We also do not know how the FDA intends to resolve the legal and regulatory issues associated with point-of-care manufacturing.”
Matt Jackson, Kevin Madagan. FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown http://www.meddeviceonline.com/doc/fda-s-d-printing-draft-guidance-leaves-much-unresolved-even-more-unknown-0001

The next thing they mention, in the same paragraph, is biofabrication (which technically is less about making devices and more about 3d printing with biological “ink,” living cells, biomaterials, and such).

“In addition, this guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM. Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Therefore, all AM questions pertaining to products containing biologics, cells or tissues should be directed to the Center for Biologics Evaluation and Research (CBER).”

I’m actually relieved that they are leaving biofabrication alone for now, but it is not going to go away forever (nor should it). For people working at the intersectional spaces of 3D printing, where it combines with biologics, electronics, programmables, smart materials, and other materials with interactive potential, there is a possibility that content from this guidance may interact in unexpected ways with the other side of the work they are trying to do.

Here’s the good news.

“This draft guidance is a leap-frog guidance; leap frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leap-frog guidance represents the Agency’s initial thinking, and our recommendations may change as more information becomes available.”


“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”

So, don’t worry TOO MUCH just yet, but do please read this, consider how it might impact on work happening in your community, and consider replying to the draft guidance or filing comments. You may submit comments on the Technical Considerations for Additive Manufactured Devices Draft Guidance until August 8, 2016.

Additional reading

3D Printing of Medical Devices http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm

FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices http://www.raps.org/Regulatory-Focus/News/2016/05/09/24901/FDA-Issues-Long-Awaited-3D-Printing-Guidance-for-Medical-Devices/

The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing https://3dprint.com/133570/fda-draft-guidance-3d-printing/

FDA releases long-awaited draft guidance for 3D printed medical devices http://www.3ders.org/articles/20160510-fda-releases-long-awaited-draft-guidance-for-3d-printed-medical-devices.html

Tactile Graphics, An Introduction

Book Cover, Texture, Quackery All Bricked Up and Nowhere to Go ... Nailed Texture
Texture: Drain Cover Washington, DC: Donkeys: Black & Braille Rough
Montebello: Pottery Texture Woven Sculpture #4 Univ of Mich Binding Imprint

This week I attended a webinar on tactile graphics. Most people I know would say, “Tactile graphics? What does that mean?” So let’s start with that.

In a way, we’ve always had tactile graphics, in the broad sense of pieces designed for visual impact which carry tactile interest or information. Leatherworking often has designs punched into the leather; quipu knotwork carried mathematical data; old books had logos embossed into the covers; pottery might have painted ornaments layered onto the surface which can be felt and distinguished; sculptural shapes might be designed with textures that add layers of insight to the underlying meaning of the work; fabrics can have textures woven into them.

And of course, there’s always Braille, in which embossed or raised dots carry very specific kinds of meaning — words and numbers. In the center of the opening montage is an image of a sculpture of a donkey covered with Braille letters and words. This was a political statue in Washington DC. I don’t know what it says, but I imagine someone with blindness caressing the glossy blackness and curved shapes of the statue, reading the words of the Declaration of Independence, or the statements of the Bill of Rights. Such a powerful metaphor for the idea of tactile graphics. But in another sense, this explanation is a kind of digression, for in the actual world of artists creating art to be touched, the phrase they use is not “tactile graphics” but “tactile art” or “sensational art,” meaning art for senses beyond simply vision and art explicitly designed to be touched. If you are interested in this aspect of tactile artistry and graphics, you might want to be aware of the work of Ann Cunningham, who is a leader in this space.

Ann not only creates artwork that carries dual meaning through combined visual and tactile designs, but is also engaged in how this can carry over to shaping information and making “sensational books.” If you have ever tried to read a plain text (ASCII) version of a heavily illustrated book, in which the images have been redacted since they are not text, you may have some insight into the challenges of reading books while blind. You can read the text, but whenever you reach a place where an image is referenced, you read whatever description was given in the text, but that is usually minimal and refers to the image itself for further insight, and the image is not there. As a sighted person, I often go the the Internet Archive and download both the ASCII version of the book (for speed and portability) and a PDF version (which includes the graphics). I’ll read the ASCII text, and when I become sufficiently frustrated, I will open the PDF online version to see what image they are talking about.

Here is an example of what I mean, a work about Vincent Van Gogh. In the first screenshot, if you are sighted, you will see the title page and opening etching, entitled “Le Semeur.” The image shows a young man in peasant garb, grasping a large bag with his left hand, and making a gesture with his open palmed right hand. Even if you don’t read French, you may be able to guess at the meaning of “Le Semeur,” which is “The Sower.” In the second screenshot, if you are sighted, you will see the same area of the book in the raw text format. Where the image should be, there is nothing but a string of cryptic meaningless computer code, followed by the words, “LE SEMEUR.” There is no indication that you are even missing an image, no clue given as to what content it is that you are missing. Later on in the book, there will be a table listing images in the text, and that may give you a clue, but until you get to that point, you are pretty much lost.

Screenshots illustrating how images "translate" to text in OCR.
Screenshots illustrating how images "translate" to text in OCR.
Van Gogh, par Théodore Duret. Full: https://archive.org/details/vangoghvincent00dureuoft Text only:

So, very broadly then, tactile graphics are graphics which carry meaning through elements that can be touched. More narrowly, the phrase “tactile graphics” has become meaningful as an explicit technique in the creation of accessible information for persons with visual impairment. This is actually closely related to the work being done by Ann Cunningham, since the technologies used function in a similar way, often creating a kind of bas-relief version of an image so that it can be perceived and interpreted by persons who are blind. It is also work that is closely related, conceptually, to Braille, in that it explicitly tries to convert information into a format that can be deciphered by persons with blindness, in this case, visual information.

This can be done with making lines on paper that will puff up so people can feel them. This can be done with special paper, special printers, or special pens. This works fine when the images are linear, but less effective when they are more complex. It can also be done through the techniques mentioned earlier, embossing, embedding, interweaving, etcetera. There are kits, special hardware, a whole variety of technologies being developed around ways to make tactile graphics. All of those approaches tend to be very time-consuming. New technologies being used to create accessible tactile graphics include 3D printing, in which image characteristics are converted to a three-dimensional form and literally converted into a kind of flattened sculptural form of the image. There are some concerns that all the hype around 3D printing will lead to people focusing on that as the ONLY kind of tactile graphic option, which is far from the case, or that people will mistake the conversion of images to 3d format for actually making the images accessible, which may or may not be the case. A particularly eloquent description of this dilemma was posted to Facebook by a teacher of young children with special needs, Yue-Ting Siu.

3D printing and Misappropriation for Tactile Graphics https://www.facebook.com/notes/yue-ting-siu/3d-printing-and-misappropriation-for-tactile-graphics/333500170166311

This was in response to a long conversation around this topic, one for which the entire conversation is well worth digging into.

That’s a very brief introduction into the concept of tactile graphics. I’ll include a few more links at the end if you want to explore more. The webinar from the Diagram Center was very interesting. The webinar, presented by Richard Ladner of the University of Washington, included a solid background in how tactile graphics for accessibility are being created now, some of the technologies, challenges, and solutions. Some of the problems are the time needed to create the tactile graphics, the low resolution of the information, the loss of complexity in the information content, and that certain types of information don’t translate well into current tactile graphic modalities. Then Dr. Ladner described the special problems associated with complex mathematical images and equations, especially those in advance mathematics, physics, and engineering texts. Without access to those images and that content, persons with blindness can be, in essence, excluded from those professions no matter what their actual talents might be. His team has been working on some new approaches to the idea of tactile graphics, creating images that can be read with a smartphone. Wow. Now, this is still fairly early in the development life cycle, but the potential for this new approach is phenomenal.

The Storify (below) includes my notes and links from livetweeting the webinar. The webinar itself, Tactile Graphics with a Voice, will soon be posted on the DIAGRAM site.

Storify: Tactile Graphics With a Voice: https://storify.com/pfanderson/tactile-graphics-with-a-voice


Tactile Graphics: http://www.tactilegraphics.org/
– Producing Tactile Graphics: http://www.tactilegraphics.org/computerassistedtactiles.html

3D Tactile Graphics: http://3dtactilegraphics.com/

American Foundation for the Blind:
– Basic Principles for Preparing Tactile Graphics http://www.afb.org/info/programs-and-services/professional-development/teachers/tactile-graphics/1235
– Braille Writing Tools and Tools for Tactile Graphics http://www.afb.org/info/living-with-vision-loss/using-technology/reading-and-writing/braille-writing-tools-and-tools-for-tactile-graphics/1235
– Deciding Whether to Create a Tactile Graphic http://www.afb.org/info/programs-and-services/professional-development/solutions-forum/electronic-files-and-research-work-group/deciding-whether-to-create-a-tactile-graphic/12345
– Resources for Preparing Quality Tactile Graphics http://www.afb.org/info/resources-for-preparing-quality-tactile-graphics/5
– Tactile Graphics Course: http://www.afb.org/info/programs-and-services/professional-development/solutions-forum/interested-in-becoming-a-braille-transcriber/tactile-graphics-3016/12345
– Types and Producers of Tactile Graphics http://www.afb.org/info/programs-and-services/professional-development/solutions-forum/training-and-other-needs-work-group/types-and-producers-of-tactile-graphics/12345

American Printing House for the Blind:
– Tactile Graphics Image Library: http://www.aph.org/tgil/
– Tactile Graphics & Manipulatives Available from APH (Missouri School for the Blind: Outreach Services) http://msb.dese.mo.gov/outreach-services/documents/Tactile-Graphics-Products.pdf


The DIAGRAM Center: http://diagramcenter.org/
– The Accessible Image Sample Book: http://diagramcenter.org/standards-and-practices/accessible-image-sample-book.html
– Poet Image Description Tool: http://diagramcenter.org/development/poet.html
– Research Reports from DIAGRAM: http://diagramcenter.org/research.html
– Tools from DIAGRAM: http://diagramcenter.org/development.html
– Webinars: http://diagramcenter.org/webinars.html

At the Movies: 3D Printing

If you haven’t already heard of 3D printing, then we need to fix that right away. If you have heard of 3D printing, this post will probably be fun for you, and will hopefully still include some new information. I have talked about 3D printing here before, and still am hoping that in the renovation of the library where I reside there will included be a small makerspace complete with 3D printer. We wouldn’t be the first medical library to do so! At least one other medical library is currently in the position of deciding which model to purchase.

What is commonly called 3D printing was probably something you first heard about in the guise of a Star Trek replicator. Actually, it has been a real emerging technology about as long as Star Trek has been around, and was called “additive processing” (or so I’ve learned by watching the TED Talk video of Lisa Harouni and her “Primer on 3D printing”).

Lisa Harouni: A primer on 3D printing: http://www.youtube.com/watch?v=OhYvDS7q_V8

The earliest patents on this came out of efforts to print circuit boards, and were instrumental in the rapid decline of the cost of computers. There are now patents for how to print with biological materials instead of simply plastic and metal. Enormous advances. There is a fair amount of talk that this may be the year that 3D printing hits mainstream. Let’s just say that if the President of the United States is talking about it in his State of the Union address, that just might be a very realistic possibility.

President Obama on 3D Printing http://www.youtube.com/watch?v=01gJYQEyBWc

3D printing is becoming so ubiquitous that one of the grad students currently working in our library showed me the delightful 3D printed Valentine she received from husband, a box-puzzle that turns into a heart. There are so many amazing, wonderful, and scary things being made right now with 3d printing. Bicycles. Cars. Houses. Guns. Ammo. Jaws. Cartilage. Kidneys. Spaceships. Yes, really. Well, little ones, at least for the spaceship, anyway. We cannot imagine what will be created with 3D printing in the future.

Bicycles. Cars. Houses. Guns. Ammo. Jaws. Cartilage. Kidneys. Spaceships.

Microscale 3D printing of a spaceship: https://www.youtube.com/watch?v=wThtfAtB5U8

3d Printing – 3d Cloning A Bicycle – YouTube: https://www.youtube.com/watch?v=oChnml1Twy0

Rational automotive design for the human race: https://www.youtube.com/watch?v=yhJCTMkn9Yo
Urbee 2 is the 3D printed Car of the Future: http://mashable.com/2013/03/01/urbee-3d-printed-car/
ExtremeTech: The First 3D Printed Car is as Strong as Steel and Half the Weight: http://www.extremetech.com/extreme/149557-the-first-3d-printed-plastic-car-is-as-strong-as-steel-and-half-the-weight

Fully-customized modular solar house is 3D printed prefab. https://www.youtube.com/watch?v=3R1CBFBxuew

3D Printing Gun Revolution: https://www.youtube.com/watch?v=b8qtJuOFbs4

Breaking Gamechanger: Printable Gun Magazines: https://www.youtube.com/watch?v=XKAaO26FAvA

Printing a Full new 3D Jawbone for Belgian Patient – Worlds First (Europe Innovation): https://www.youtube.com/watch?v=UsEtyhy81nA

3D printer and living “ink” create cartilage: https://www.youtube.com/watch?v=-RgI_bcETkM

Anthony Atala: Printing a human kidney: http://www.youtube.com/watch?v=9RMx31GnNXY

What’s next? What’s here?

Can we print a human body? https://www.youtube.com/watch?v=uJrTrIMbk9A

Well, and it isn’t like this doesn’t already happen on campus. In many places, most notably the 3D Lab and the Fab Lab. And has for many years. That last video right above is from UM. Here are some more. And look at the dates. Several of these are from within the past few weeks, but others go back years. We do this.

3D Printing: An Additive Solution: https://www.youtube.com/watch?v=y5ef7stKMe0

expoSItion: 3D printing in the developing world: https://www.youtube.com/watch?v=ThH6x09vZVE

And you know the Cube? As in the sculpture of the cube on Regent’s Plaza, in front of the Fleming Building, the one that spins around? Want one?

Endover Sculpture Puzzle: https://www.youtube.com/watch?v=fM5E__LAK4E

And the newest answer to what 3D printer is in the University Libraries? Right now they are praising the Dimension Elite. I’ve seen several different 3D printers there over the years, from MakerBots on up. I still want something accessible beyond the 3D lab, in a regular campus library, on the main campus, and preferably on the Medical Campus.

Want more videos about 3D printing?

Rapid Prototyping (playlist from UMich): https://www.youtube.com/playlist?list=PL222722191CF566C5

Bad Brad’s Bad Channel: 3d Printing Videos: http://www.youtube.com/playlist?list=PL7B951A6FDF7D81B9