Interview with Healthfil sales manager by 3dprintsante.com
You can find the original interview in french language here
The first all over the world. A better quality, a better service, an innovative revolution in medical field. This is Healthfil Line: the first medical line filaments worldwide, made by TreeD.
A new generation of filaments in medical use: especially developed for extrusion technique, these are the first with a skin contact certification. They allow more complex realisations than conventional machines and the result is a brace that adapts itself perfectly to your body line.
These are the words of an interview made with a french magazine, 3D Print Santé, about our company and innovative products of Healthfil line.
Who’s TreeD Filaments?
– We are a plastic extruder manufacturer company founded in 1964
– We always faced and approached industrial customers with technical application for industries and an engineering expertise
– In 2014 we decided to open a sort of spin-off and, thanks to Mr. Pizzigoni’s knowledge in polymers, we started the production of 3D Printing Filaments
– We tried (and it’s still our aim) to shift our “plastic background” in this new market
– Thanks to a good know-how we can propose ourselves as a high level and trusted partner, having acquired huge and wide knowledge about FDM 3D printers’ materials.
– We are not a big reality but this dimension makes us very fast in follow market trends and fit our customer need. Considering also a very fast processing decision time.
It’s a new branch. We have always produced technical filaments but never for medical application
About a year and a half ago, talking with some technicians (an italian orthopedic and a prosthodontist: Ing. Marco Avaro and Dott. Lelio Leoncini) who were starting to use this technology for their application, and in collaboration with a printer producer too we’ve got the idea to create filaments dedicated to this market.
The reason were double:
– coming towards to the two technician needs
– giving a plus to our filaments
As regards the two technicians needs, we studied a dedicated compound. We didn’t take a formerly existing material, but we tried to face some problems during printing as per their suggestion adjusting the formula
We created that line by following market trends, our owner’s strategy and the two technicians’ requests.
Giving a plus (certification) to our products means to make them being certified.
Do you think it is an area of future?
Yes, for us this is the future.
There are lots of advantages in using 3D (customs make products, usually made by machines, in less time then old techniques, and cheaper)
Have you ever got a particular request that made you interested in medical applications?
Yes, as I already told you one and half year ago by talking with the italian technicians Ing. Marco Avaro and Dott. Lelio Leoncini and also a printer producer. Then we chose to join this market.
What are the technical features of the filaments you offer? What are the particular constraints for such filament to be recognized as biocompatible?
To answer the question, technical skills of our filaments are:
– custom made filaments (a new formula)
– skin contact certification
Please be informed that we didn’t make any test for Biocompatibility.
Our filaments can’t be used on “open wounds” or they can’t be implanted.
I can confirm you that they respect ISO 10993-5 regulation and they passed cytotoxicity tests.
Next steps could be:
1) irritation > this certification should be done “in vivo” (and not “in vitro”).
This means you should take a piece of skin (3D skin) and make new tests
2) Sensitization > this certification should be done through tests on guinea pigs.
This means you should “use animals”
At the moment we do not make any tests in those two ways.
We would like to inform you that we didn’t have the FDA, yet.
We’re working on it.
As soon as we will have any update we will inform you.
I wanna conclude that our filaments do not have a class.
They are NOT medical devices.
You must pay attention on this. Once you print an object, you should make it certify once again.
Our materials during printing sustain some mechanical and thermal stress.
Certification of the object will establish – as medical device – the class of it.
This type of filaments has never existed before? Do you only offer threads or also the impression of finished objects?
No, this kind of filaments has never existed before.
We are the first one to produce them.
We produce only filaments.
We have some printed objects and we make some printing tests but we can’t show or use them (for privacy reasons)
Note that we do not provide a “service” and we do not sell stl file or printed objects.
For which type of medical products is Healthfil the most suitable line of filaments?
The filaments are studied for orthopedic application and for skin contact.
With our filaments you can print:
upper leg tutors
upper and lower limb prosthetics
Structural support elements
New corset lines
Lower leg guards and tutors
Sealed gaskets for prosthetics vases
Plastic joint elements
Are you working in relation with doctors, hospitals, researchers?
Yes. In order to develop products, as I told you before, we partnered with two technicians and a printer producer.
Now we are closing business partnerships with potential customers and distributors all over the world.
Exactly, could you explain the process of manufacturing an object from a doctor request to the finished product.
Someone (a young guy or girl) with a health problem (for example scoliose) goes to a doctor.
The orthopedic decides that a bust (for example) could help or solve his/her problem. He suggests 3D printing technology as the new frontier. Then he proceeds to scan the body (bust) of the guy/girl.
The orthopedic will proceed to print the file (the scansion). *
In 24/48 hours (or less, it depends) the guy/girl will have his/her custom made own bust **
* to print this bust there are some specific filaments. Ours.
** once the orthopedic made the printed bust he should (cause it’s his own responsibility) have to make this bust been certified.
Do you have other upcoming projects, new types of products or other still in medical field?
Yes. As i already told you, we would like to receive new certifications for our products, like irritation and sensitization. It is not easy and we do not make any tests in those two ways at the moment, but these are our objectives for the future and we’re working on it.
Why do we report this interview? Because we are proud of our work, our company history, our development, our products and our innovation in this market.
If we captured your interest and you would like to know something more about our Healthfil line and our products, do not hesitate to request now your complete sample pack!