Let’s talk about 3D Printing or maybe you use the scientific vocabulary “Additive Manufacturing”. I prefer 3D Printing as it’s easier to understand for everyone. (For those that are asking there are no difference between additive manufacturing and 3D printing)
Future of 3D printing in the medical device industry
My question to you is, “Do you consider 3D printing as a well-known method to produce Medical Devices?”
My answer would be, “yes, more and more”. Before, this was more a garage manufacturing process or used only for prototyping until it starts to become a real mass producing process.
I should say that the price of technology decreased drastically, which was a great accelerator for manufacturers. With that, they can start considering this process as a potential replacement for our old CNC (Computer Numerical Control).
Objective
My objective today is to help you understand the status of 3D printing of medical devices products on the scope of the new Medical Device Regulation EU MDR 2017/745.
I personally started in 2017 to work on a 3D printing medical manufacturing projects and it’s really amazing what we can do with it. I really liked this new challenge to learn a new manufacturing process and all the regulation that goes around.
My advice. Read this article only if you want to learn something amazing that you can even use to argue with some colleagues in the context of “Is my 3D printed product a Custom-made device?”
But let’s start first to define 3D Printing to be all on the same page.
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INDEX
- What is 3D Printing manufacturing process?
- What is "Bioprinting" (bio-AM)?
- What are the different techniques of 3D printing?
- Is my 3D-printed product considered custom-made?
- What kind of devices are 3D printed?
- Raw material for 3D-Printers
- What about Nanomaterial?
- 3D Printing validation
- What is the situation outside of Europe?
- Have you ever used 3D Printers?
What is 3D Printing manufacturing process?
I will try to use an easy concept for you to understand what is 3D printing.
Let’s start with this. I am sure you are used to printing documents with a printer. I imagine that you understand that this format is 2D Printing. It’s printed in 2 dimensions (Length and Width).
If now I want to move to 3D Printing, I should add the Height to have the third dimension.
Easy no? Here is my 3D Printer definition.
So, similar to when you want to print a document, you’ll have to create a file and send it to the printer. But instead of printing on multiple pages, your print will be done on the same page. What will happen is that the material that will be printed will increase of 1 layer.
Why do we call it Additive Manufacturing?
We call it Additive Manufacturing, because we are adding layers. This addition of material is not the same as for conventional manufacturing. On traditional manufacturing, we are using a raw material as a block and we remove some material to create the form we want. Here we start from some material that we melt to create a from. So from zero to our product.
Types of material
One of my first questions, when I was curious about 3D printing, is “Can you 3D print metal?” I saw so often videos of products 3D printed with plastic that I was sure that this technology was still not available. And I was eye open when I learned that metal was a possibility, and polymer, and even bioprinting. So, I am sure we are only at the beginning.
Learn more on 3D Printing: Link
Let’s review more about bioprinting in the next chapter.
What is "Bioprinting" (bio-AM)?
Bio-printing is the use of a computer-guided pipette to display living cells in layers on top of one and another. We call it 3D Bio-Printer.
Do you know how they call those cells? They call it bio-ink (Logic)
In the end, you create an artificial living tissue.
I remember now. It reminds me of an episode of Grey’s Anatomy where Meredith printed a tube to be implanted on a patient. And this saved his life. (I know it’s only fiction. It was a good one.)
What are the different techniques of 3D printing?
There are many techniques used for 3D printing in the medical device industry.
Here are some examples
- DLMS (Direct Laser Metal Sintering) – Metal DLMS Printer
- FDM (Fused Deposit Model) – Plastic
- CLIP (Continuous Liquid Interface Production) – Carbon 3D Printer
Instead of giving you only some names that you will maybe not remember, I propose you to look at some videos of the process from A to Z.
This is not specifically for a Medical Device product but it’s exactly the same that the team I work with is doing to 3D Print Medical Device parts. This will also help you to see what does a 3D printer look like.
Enjoy the 3D Printer Video Youtube!
Direct Laser Metal Sintering (DLMS) Video - 3D Metal Printer
Continuous Liquid Interface Production (CLIP) Video
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Best 3D Printing Books
To help you on your journey to adopt 3D printing, I selected 2 books to review. It will tell you “What can you 3D Print”
Enjoy and let me know if these helped you by providing a comment.
Additive Manufacturing of Metals
If you want to learn more about Metal 3D printing technology I have the Book for you. This book is a reference in term of Additive Manufacturing of metals. Read the reviews.
You can also have a look at some extracts to see if this is really helpful for you. The table of content is also included.
The Author is John O. Milewski
In the 1990’s he was part of a high energy entrepreneurial team pioneering the rapid prototyping and near-net shaping of metals, now known as 3D printing or additive manufacturing (AM). His new book Additive Manufacturing of Metals, is a resource for newcomers to the field, providing a road map to where the technology stands today and where it is headed tomorrow.
3D Printers – A Beginner’s guide
For those that are more beginners, I suggest starting with this book on more traditional 3D Printing.
You can already see some extract of the book to evaluate if this meets your need. So don’t hesitate to click on the Learn more button to visit the site.
The author is Oliver Bothmann
3D printing is a new craft technique that seems like science fiction. Objects appear to be created out of nothing – as if by magic. This book shows you the practice of 3D printing at home. It gives the reader an overview of the basics of this technique and the materials and the knowledge you need for a successful start in the use of 3D printing. The hardware and software you need is described, and tips and tricks for the practical application of 3D printing are given. If you aspire to use 3D printing for your hobby or for spare parts, this book is a guide for your first steps into a new future.
Is my 3D-printed product considered custom-made? (Difference between MDD and MDR)
I like this question because even if the regulation is clear, there is still some debate that can happen.
I will review with you the situation of the Medical Device Directive (93/42/EC) and then what is happening with the new Medical Device Regulation (EU MDR 2017/745). You will see that this is completely different.
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MDD 93/42/EC
With MDD 93/42/EC (old regulation that will be replaced by MDR 2017/745 as of May 26th, 2020), a 3D Printed product was considered “custom made”.
There was then no need to have a Quality Management System in place (QMS).
See below the definition of a custom-made device (MDD 93/42/EC)
‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
And here the definition of mass-produced devices
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom made devices;
Instead, the manufacturer had to follow the Custom-made requirements on the directive (Annex VIII – Statement concerning devices for special purposes) asking for
- Name and address of the manufacturer
- Data allowing identification of the device in question
- A statement that the device is intended for exclusive use by a particular patient, together with the name of the patient
- The name of the medical practitioner or other authorized people who made out the prescription and, where applicable, the name of the clinic concerned,
- The specific characteristics of the product as intended by the prescription
- A statement that the device in question conforms to the essential requirements set out in Annex I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds
MDR 2017/745
For the Medical Device Regulation 2017/745, this is a different story.
Looking at the new definitions, we can see that a clarification is made on mass-produced products that are adapted to a patient. This change all concept of custom-made.
Judge by yourself
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
I know you are saying to yourself that you don’t see a major difference. I was telling myself the same when I read it first. The wording seems not the same but the meaning of custom-made device is similar.
The obvious changes are in the definition of Mass-produced medical devices. Here it is below
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
Analyze of that definition
You can see now that as soon as you use a mass-produced device (implant, instrument…) and adapt it to a patient, this is not considered anymore as a custom-made device.
Example: I am a medical device manufacturer. On my portfolio of products, I have a knee implant. There is a specific reference for that product.
A surgeon calls me and asks to have this implant modified on a specific feature to adapt to a patient with a specific condition.
It means I will create my normal mass-produced knee implant which I will customize for that patient. “Increase this dimension or decrease this one”.
Then this is not custom-made following the new regulation.
Custom-made would mean then that you create a product from zero with the prescription of the doctor. As this product will be produced only once and never again, then it can have the mention custom-made on it.
The consequence, for companies that were only doing custom-made devices, it will be difficult.
If they didn’t have it, they will need to build a QMS. And also for each product to create a Technical File (Clinical Evaluation, Post-market surveillance, complaint handling…).
What kind of devices are 3D printed?
“What can you 3D Print?” Let’s take some examples from the Medical Device Industry.
Depuy Synthes (a Johnson & Johnson company) has released a product called TRUMATCHⓇ. Looking at the description of this products, it’s fitting the new mass-produced definition in Europe.
There is also some application with 3D-printing that can save lives. Here is the case of a patient that needed to reconstruct his cranial skull. Look at the pictures at the bottom, before and after. This is impressing.
These Additive Manufacturing examples are not the only ones. If you want me to add other ones, don’t hesitate to put that on the comment section.
3D printed medical devices will increase year after year. As different countries are releasing their regulations, it helps the industry to be on the right tracks to obtain the authorization to sell products.
What material does a 3D Printer use? (Medical Devices)
Products made of 3D-printing can use any type of raw material. What is important? It is to qualify it in terms of biocompatibility and toxicity.
Materials like titanium, steel, plastic, compounds are well known. But if you are building a new production line for 3D-Printing, be careful to choose a medical grade to feed your printers.
Here is a website called all3dp listing raw material that can be used depending on the usage. On the Search box, put medical and you’ll have a list of 3D Printing materials for medical manufacturing.
See result below
What about Nanomaterial?
One of the big change coming from the MDR 2017/745, is the inclusion of the definition of Nanomaterial. And moreover, a specific rule on Annex VIII was created to define the class of a product following the nanomaterial that it contains.
Here is the definition of a nanomaterial:
‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;
Additionally to provide more clarification on some of the terms, here are some other definitions.
‘particle’, for the purposes of the definition of nanomaterial, means a minute piece of matter with defined physical boundaries;
‘agglomerate’, for the purposes of the definition of nanomaterial, means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
aggregate’, for the purposes of the definition of nanomaterial, means a particle comprising of strongly bound or fused particles;
These definitions are important as this is not only applicable to 3D-printing. You need to consider that for anything you produce. If it contains nanomaterial then you upgrade the risk level.
Classification rule
You can see that on the classification as a specific rule was created for that. It’s rule 19 of Annex VIII from MDR 2017/745.
Check its content below.
7.6. Rule 19
All devices incorporating or consisting of nanomaterial are classified as:
Class III if they present a high or medium potential for internal exposure;
Class IIb if they present a low potential for internal exposure; and
Class IIa if they present a negligible potential for internal exposure.
On the video, I presented you on the Direct Laser Metal Sintering (DLMS) you see that we use a powder that is melted by a laser to aggregate. You see also that people wear protective equipment to avoid absorption of those particles.
Imagine now that these particles are nanomaterial with a size between 1 – 100 nm, they can infiltrate our organism. This can be a high risk if they accumulate in a critical part of your body. This is why the regulation takes a particulate focus of products with this material.
If the nanomaterial is in direct contact with the body, then your product (even if without nanomaterial is considered as class I), will be classified Class III. So this is a high jump.
With this information, you need to understand that the benefit of the nanomaterial should be a reality as you will have more struggle on the regulatory side.
3D Printing validation
With the new ISO 13485:2016, validation is now something important.
The standard is not focusing only on Process validation but also Software validation. And to be more precise, not only software that is linked to product manufacturing but also a validation of the software that is related to the Quality Management System or to anything related to production from beginning to the end.
Computer System Validation (CSV)
For software, a Computer System Validation (CSV) should be considered. And even a procedure on how you should do that and the forms that you have to use to provide evidence of it must be created on your Quality System.
Process Validation
For process validation, the normal approach IQ, OQ, and PQ is well known and can be used (see IMDRF document on Process Validation Guidance – January 2004).
Invisible is invisible
My only concern is what we don’t see. Let me explain.
Usually, we receive a bar of metal and we use a CNC equipment to remove material until you obtain the right dimensions.
For 3D printing, you build everything from a powder. So what is inside cannot be inspected. So the question that is remaining is, “Did the laser power really melted the metal on all the layer? Is this reliable and reproducible?”
Validation activity should now see the process in a different way than a CNC process. The parameters are different and the risks are also different.
What is done is to include a test coupon on your load. This is a piece that is 3D-Printed with your other product but it will be used to check the porosity, geometry, microstructure of your material.
With this information, you can minimize the risk. And talking about that, your master document will be your Risk Assessment File. Look at ISO 14971 to understand better how you should build this part of your process development.
ISO 13485:2016
Medical Device - Quality Management Systems - Requirements for regulatory purposes
Best QMS
Medical Device companies should build a Quality Management System. The best choice is to use a System that proved to work and the ISO 13485 is well known.
Get your Copy
BSI is selling ISO 13485:2016 copies so get yours
What is the situation outside of Europe?
Outside Europe, some other countries are also regulating 3D-Printing. In 2 more countries, there are specific regulations on Additive Manufacturing. It’s USA and China.
USA FDA
The FDA issues a guidance for Additive Manufacturing (AM). There is excellent information that you can use also for those that are selling specifically in Europe. You will receive information related to the technical aspects.
China CFDA
To motivate innovation, CFDA issued a guidance on Additive Manufacturing. But for now, this is only in Chinese. If you want more detail here is an article explaining the context.
Download this Mind Map
I created for you a Mind Map with all the links from this article. Have a look and tell me if you like it. This is using the HTML5 technology which makes it interactive for you. Let me know if I should add something missing inside.
Have you ever used 3D Printers?
I hope you learned a lot on Medical Device Additive Manufacturing. This technology will change the shape of medical devices as this opens the possibility to create a design that was impossible with conventional manufacturing.
Metal, Plastic, Composite… Some options are still under development. The 3D technology for Medical Devices will be under focus.
The only risk is to use it to manufacture what is already done with traditional manufacturing. I hope the Engineers and Designers will think out of the box and enhance their creativity.
Now it’s your turn to give me your opinion by providing a Comment.
I am really interested to know if you have already used this technology and what are for your Pros and Cons?
Do you think this is something that will be the future of Medical Device Manufacturing or just a gadget that will not stay long?
Impatient to see your answers.
QUESTION
Thanks
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Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
