3d printing medical products€¦ · •introduction –“why 3d printing? ... •processes are...
TRANSCRIPT
How 3D Printing Material Plays A Critical Role In Safety Of Your Medical Device
What To Expect From Your AM Materials Supplier….
© DSM 2019Confidential
• Introduction – “Why 3D printing?”
• Definitions – do we speak the same language?
• Regulatory – do we all know what is happening?
• The critical role of your material supplier – “how can we help you?”
• Start your project – so what should I do now?
• Validation of the workflow – where do I start?
• Q&A – frequently asked questions
CONTENT
INTRODUCTION
Why 3D printing or Additive Manufacturing?
© DSM 2019Confidential
Mass customizationPerformanceIncrease bone ingrowth,
enabled by open structures
and organic shapes
Digitalization enables mass
production for unique designs and
personalized solutions
Time savingReduction transportation time,
elimination of production steps,
reduction in development cycle
Drivers for 3D printing in Healthcare
Growth 3D printing facilities in hospitals
3200%Outcome based cost
reduction
$1TnSpecialist believe in growth medical 3DP
97%
“We need to adapt to the changing environment.”
*SME medical report 2018
**The Trillion dollar Price – MCKinsey Company 2013
© DSM 2019Confidential
Let’s Manufacture Tomorrow: AM Can Revolutionize Manufacturing
Page 6
© DSM 2019Confidential
DSM Material Development
Network of partners
Experience
Developing new
chemistry
building blocks
Application & Market
understandingProduct
development
Partnership
programs
BEFORE YOU START…
Do we speak the same language?
What to discuss with the material supplier?
• Biocompatibility
“Ability of a material to perform with an appropriate
host response in a specific application.”
• Biological safety
“Freedom from unacceptable biological risk.”
• Harm
“Physical injury, especially that which is deliberately
inflicted”
• Risk
“Combination of the probability of occurrence &
severity of the harm”
• Risk-based approach
“From ‘black box’ to understanding the material.”
Definitions
• International Organization for Standardization
(ISO)
“Organization that develops minimum standard
elements e.g. ISO 10993-5 for cytotoxicity”
• Quality system
“Organization specific implementation of quality
concepts, standards, methods, and tools used to
achieve quality related goals.” e.g. ISO 13485 for
quality systems in medical devices.
Definitions
• Product classification
“Categories of potential severity of harm to
patient or user (e.g. life supporting, invasiveness
& duration) determining the processes to assess
device performance. This can differ per country
Definitions
REGULATORY“Do we all know what is happening?”
• Higher software regulations
– Software needs to be validated (in
combination with material &
equipment)
• Focus on risk management
– Understand chemistry & risk mitigation,
reduction of animal testing.
• Traceability
– Traceability should be improved this
requires material batches traceability
CHANGES
The Critical Role of Your Material Supplier
© DSM 2019Confidential
Selecting your material
Select material based on product
requirements
Evaluate certificates & processes of material (e.g.
sterilization can changes chemistry)
Contact DSM for support Hazard &
Harm analysis and to reference Material
Master File if needed
Agree on quality requirements in
supply agreement
“Materials should be compatible with body tissues,
cells and fluids considering the intended purpose.”
© DSM 2019Confidential
The process example of Somos® BioClear
Machine preparation & cleaning
Contamination prevention: Cleaning procedures: vat, recoater, lens
Build failure prevention: Machine maintenance, laser, moving parts
Printing
Mechanical properties: Software for build preparation (support, slicing, laser
settings)
Build accuracy: Machine settings (waiting time)
Cleaning
Removal of uncured residue: volume of part & cleaning bath
No cross contamination: refreshing of cleaning media
Transparency: Duration
UV-postcure
Complete conversion: UV curing length, curing duration
Controlled process: On time replacement of lights
Is the complete surface exposed: Part geometry (need to reach complete
surface)
Temperature: Increased temperature can speed up conversion process
Cleaning 2
Removal of unwanted substances: Cleaning solution, volume, temperature,
duration
No cross contamination: refreshing of cleaning media
Sterilization
Chemical modification due to interaction in the process: changing mechanical
properties, color, and toxicity of surface
Part geometry: are all area’s of your part cleaned?
Temperature: High temperature >Tgmakes part deformable, internal
unwanted substances can come to the surface
Moisture: parts can take up water, it takes some time to come back to original
state
Validate your complete process.
Many process variables can impact your product safety!
Start your project“So what should I do now?”
© DSM 2019Confidential
Keep in mind
• The Healthcare AM regulatory landscape is in transition
• Processes are complex, with a lot of variables so make sure you find an
experienced supplier.
• Selecting the right material is critical for a safe end product.
• DSM’s regulatory team and scientists :
– Monitor developments
– Developing materials & processes documented in material Master Files to enable or
enhance clinical applications
– Are available to support during your medical device development & submissions
20
Questions & Answers“ What about ….?”
Do you have an FDA approved material?
FDA does not approve or clear materials
for general medical use!
© DSM 2019Confidential
What we do:
- Developing a processing
guideline as reference
- Create a Master File with all
relevant quality data during
our material development
process
- Support customers on Hazard
& Harm analysis
What we not do:
- Develop a process that works
on all products
- Validate your end product
So can you explain what you do in my product?
© DSM 2019Confidential
Healthcare
Anatomical
models
Surgical guides Tooling for
injection molding
Material & key
benefits
Somos® BioClear
→ Clear & dual
color in OR
Somos® EvoLVe 128
→ bone models,
fitting models
Somos® BioClear
→ <24hr body
contact clear, easy
to clean,
sterilizable,
passed ISO 10993-
5, ISO 10993-10,
USPVI
Somos® PerFORM
→ printing of
inserts & molds for
injection molding,
durable & high
performing
material
Examples
28
© DSM 2019Confidential
Application Vacuum forming
molds (direct
Aligners)
Dental Drill guides &
Models
Mouthguards
Material & key
benefits
Somos® Precise for
fast build speed,
high temp
resistance, stable
accurate production
Somos® BioClear →
<24hr body contact
clear, easy to clean,
sterilizable, passed ISO
10993-5, ISO 10993-10,
USPVI
Arnitel® ID2045
Flexible TPC, >50
Ecobased, high
chemical resistance,
Fast printing, good
layer adhesion, ISO
10993-5&-10 & USP IV
tested
Example
Dental
© DSM 2019Confidential
Page 30
HOW CAN WE COLLABORATE?
BRIGHT SCIENCE. BRIGHTER LIVING.