While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing. Scientists at the Tel Aviv University, Israel, 3D printed the world’s first human heart using actual human tissues.1 I knew the basic definition of 3D printing but after going through this impeccable research work, I was surprised to learn that there has been such a level of technological advancements in 3D printing and biomedical research...

1. Software Tools as Medical Devices in 3D Printers
By: Govind Yatnalkar
While going through my daily tech-news, I came across an interesting piece of research
relating to 3D printing. Scientists at the Tel Aviv University, Israel, 3D printed the world’s first
human heart using actual human tissues.1 I knew the basic definition of 3D printing but after
going through this impeccable research work, I was surprised to learn that there has been such a
level of technological advancements in 3D printing and biomedical research.
3D Printing is also referred to as “additive manufacturing”, it is the process of building
3D objects using Computer-Aided Design (CAD) which is a digital image generated in a 3D
space. This image defines the structure of the object and it is fed to the printer to construct 3D
objects. Coming from a software engineering background, my major area of interest was to
unravel how does an internal software tool process images and instruct the hardware to create
such a dimensionally accurate real-world object.
The 3D printer works like a simple inkjet printer that is operated via a machine. In the
case of 3D printers, the 3D CAD model is broken down into many cross-sectional 2D models by
the internal software. Based on these 2D images, the printing starts from the very bottom layer.
It then keeps adding molten plastic or metal one layer after the other till the complete object is
fused and completed. Indeed, software plays a key role right from the 3D object design to object
monitoring (during printing) and completion.2
3D-printing is categorized based on two major design types. If a standard object is to be
3D printed, the same design could be utilized to manufacture multiple objects many times. The
second type that caught my attention is the custom-made CAD design which is used for
manufacturing patient-specific objects such as external prostheses (i.e. artificial limbs or
hands). Following my research, I thought of a software tool where these 3D-printers are
integrated with an AI/ML-based image recognition algorithm. Especially in the case of
prostheses, a complete body image of a patient could be fed to an AI model that is trained on
millions of patient-body images. This AI model records the dimensions of the person from the
newly fed image, and based on the learned dataset, it generates the required prostheses CAD
image. An additional tweak to this tool could be supplying this image to the 3D-printer directly
using Cloud or wireless networks. Such an integrated and automated software tool will
1 Colin Drury(April 2019). Scientists make ‘world’sfirst 3D printed heartusing human tissue’. Retrieved on February5th, 2021 from
https://www.independent.co.uk/news/world/middle-east/heart-3d-printed-human-tissue-tel-aviv-university-israel-
a8872631.html.
2 FDA (December 2017). Process of 3D Printing Medical Devices. Retrieved on February 5th, 2021from
https://www.fda.gov/medical-devices/3d-printing-medical-devices/process-3d-printing-medical-devices.

2. significantly increase manufacturing productivity and immensely facilitate precision while
drafting the CAD model.3
Based on the discussed software integration approach with these 3D printers, if the
software tools in these devices are considered medical devices then they must be thoroughly
verified and validated. Surely, several activities are involved in software validation and it can get
tricky to implement and execute these validation processes without any support. Such activities
include documenting the software requirements, architecture, conducting in-depth code testing
with quality inspections, and most vitally, risk-assessment of the software tool. This is where our
team from EMMA International can provide you a helping hand for validating your software and
hardware device. We can guide you step-by-step through the FDA compliance process and make
sure your medical device follows all the required FDA regulatory guidelines. Do you have a
software tool or a medical device that is utilized in additive manufacturing, and do you want it to
get FDA cleared or approved? Contact us at 248-987-4497 or info@emmainternational.com for
more information.
3
Jawad, M. S., Bezbradica, M., Crane, M., & Alijel, M. K. (2019, October). AI Cloud-Based Smart Manufacturingand 3D Printing
Techniquesfor Future In-House Production. In 2019 International Conference on Artificial Intelligence and Advanced
Manufacturing(AIAM) (pp. 747-749). IEEE.