journal of the mechanical behavior of biomedical materials 143 (2023) 105930

Contents lists available at ScienceDirect

Journal of the Mechanical Behavior of Biomedical Materials

journal homepage: www.elsevier.com/locate/jmbbm

3D printed biomedical devices and their applications: A review on

state-of-the-art technologies, existing challenges, and future perspectives
Hana Beyene Mamo *, Marcin Adamiak , Anil Kunwar
Faculty of Mechanical Engineering, Silesian University of Technology, Konarskiego 18A, 44-100, Gliwice, Poland

A R T I C L E I N F O A B S T R A C T

Keywords: 3D printing, also known as Additive manufacturing (AM), has emerged as a transformative technology with
3D printing applications across various industries, including the medical sector. This review paper provides an overview of
Additive manufacturing the current status of AM technology, its challenges, and its application in the medical industry. The paper covers
Internet of medical things (IoMT)
the different types of AM technologies, such as fused deposition modeling, stereolithography, selective laser
AI-Enabled 3D printed medical devices
Safety standards
sintering, digital light processing, binder jetting, and electron beam melting, and their suitability for medical
applications. The most commonly used biomedical materials in AM, such as plastic, metal, ceramic, composite,
and bio-inks, are also viewed. The challenges of AM technology, such as material selection, accuracy, precision,
regulatory compliance, cost and quality control, and standardization, are also discussed. The review also high­
lights the various applications of AM in the medical sector, including the production of patient-specific surgical
guides, prosthetics, orthotics, and implants. Finally, the review highlights the Internet of Medical Things (IoMT)
and artificial intelligence (AI) for regulatory frameworks and safety standards for 3D-printed biomedical devices.
The review concludes that AM technology can transform the healthcare industry by enabling patients to access
more personalized and reasonably priced treatment alternatives. Despite the challenges, integrating AI and IoMT
with 3D printing technology is expected to play a vital role in the future of biomedical device applications,
leading to further advancements and improvements in patient care. More research is needed to address the
challenges and optimize its use for medical applications to utilize AM’s potential in the medical industry fully.

1. Introduction
3D printing is a revolutionary technology that allows the creation of
three-dimensional objects from digital models. Unlike traditional
manufacturing methods that remove material from a larger block or
form a shape through molding, AM builds objects layer by layer with
materials such as plastic, metal, or organic matter (Tura and Mamo,
2022), (McDonagh et al., 2022). This technology can revolutionize how
we design and produce products, offering benefits such as increased
flexibility, speed, and customization while reducing waste and costs. As
a result, it is becoming an increasingly important part of the
manufacturing landscape and can potentially transform many industries
in the future (Tang et al., 2023), (Gong et al., 2022a). Although it has
gained widespread popularity in recent years, the history of AM can be
traced back to the 1980s, when Chuck Hull developed the first 3D
printing technology (Hull, 2015). However, the concept of additive
manufacturing dates back to the 19th century, when the French inventor
and artist Joseph Nicéphore Niépce created the first photographic image
using a process similar to 3D printing (Su et al., 2018). The use of AM in
the medical sector began in the 1990s with custom surgical instruments
and implant production (Meng et al., 2022). Over the years, AM has
evolved and expanded in various industries, including aerospace
(Abderrafai et al., 2022), (Arena et al., 2023), automotive (Garmabi
et al., 2022), medical (Zhang and Guan, 2023), (Zhang et al., 2023), and
fashion (Dip et al., 2020), (Abdulhameed et al., 2019). It has allowed for
more efficient and cost-effective manufacturing processes and the pro­
duction of complex geometries that are challenging to achieve with
traditional manufacturing methods. As technology advances, the possi­
bilities for AM are endless, and it is expected to revolutionize how we
produce and design products (Chen et al., 2023), (Mahmood et al.,
2022).
The medical sector uses various 3D printing techniques and mate­
rials, depending on the intended use, and Fig. 1(a) illustrates the most
commonly used 3D printing techniques in medical device applications.
3D printing offers benefits such as precise and personalized
manufacturing, reduced waste, cost efficiency, and faster production

* Corresponding author.
E-mail address: hana.mamo@polsl.pl (H.B. Mamo).

https://doi.org/10.1016/j.jmbbm.2023.105930
Received 6 April 2023; Received in revised form 21 May 2023; Accepted 21 May 2023
Available online 27 May 2023
1751-6161/© 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
H.B. Mamo et al.
Fig. 1. (a) Most commonly used 3D printing and (b) Benefit of 3D printing in biomedical device applications.
Fig. 2. (a) 3D printed anatomical model of a pathological heart (Riedle et al., 2021) and (b) 3D printed anatomical model of the shoulder (Goh et al., 2021).
times, making it an attractive medical solution (Gonzalez et al., 2022)–
(Gkika et al., 2023). Benefit of 3D printed in biomedical device appli­
cations shown in Fig. 1(b). The healthcare sector’s global monetary
expenditure is growing at an alarming rate due to factors such as an
aging population, the increasing prevalence of chronic diseases, and
technological advancements. The estimated global healthcare spending
in 2021 was $9.6 trillion, with a significant portion going toward
biomedical device design and development. The annual spending on
biomedical device design and development is estimated at $350 billion
globally (Kniesner and Sullivan, 2020). Proper and economical design,
and production of biomedical devices and equipment can positively
impact societies by leading to cost savings, improved quality of care,
better patient outcomes, and a more sustainable future for the health­
care sector (Andreoni, 2014). Affordable and accessible medical devices
can help diagnose and treat diseases early, improving patient outcomes
and reducing healthcare costs in the long run. The IoMT and AI are
monetary methods used in 3D printing devices. The IoMT and AI have
transformed how medical devices are designed, produced, and used.
With the help of IoMT, medical devices can collect and transmit
real-time data, allowing for remote monitoring of patient’s health and
early detection of potential health problems. AI algorithms can analyze
this data and provide valuable insights into patients’ conditions,
enabling more personalized treatment plans (Prabhaker and Ponnan,
2022)– (Manickam et al., 2022).
This review article provides a comprehensive overview of AM’s
status, challenges, and potential applications in the medical industry.
The ongoing advancements in the artificial intelligence (AI) field can
prove to be a promising tool for developing AI-enabled 3D printed
biomedical devices, instruments, and equipment’s. In addition to briefly
2
Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930
highlighting the future perspectives of biomedical informatics and the
Internet of Medical Things (IoMT) for 3D printed biomedical devices,
this review work will also outline the safety standards associated with
AI-guided design and development of materials and products utilized in
the healthcare sector. While challenges remain to be addressed, the
potential benefits of AM technology in the medical field warrant further
research and development.
2. Current trends of 3D printing in the biomedical sectors
3D printing is a rapidly growing technology that is transforming the
medical industry. From patient-specific implants and surgical guides to
bioprinting and pharmaceutical manufacturing, 3D printing can revo­
lutionize how medical devices and components are designed and man­
ufactured. As this technology continues to evolve, it will likely
profoundly impact patient care and outcomes. This technology has been
widely used in the medical industry for various applications. Some ex­
amples include printing prosthetic limbs, surgical guides, customized
implants, rapid prototyping medical devices and components, and food
manufacturing (Pitol-Palin et al., 2023)– (Bai et al., 2023).
Additionally, researchers are exploring using 3D printing for various
medical applications, including producing tailored drug delivery devices
(Patel et al., 2021), (Tracy et al., 2023), fabricating tissues and organs
for regenerative medicine (Dinoro et al., 2022a), manufacturing surgical
guides and implants (Sun et al., 2022), and developing models for sur­
gical planning and training (Li et al., 2022a). The technology also cre­
ates personalized medication, such as tablets with specific dosages
(Alzahrani et al., 2022). Fig. 2 shows applications of 3D printing in an
anatomical model of a pathological heart in (a) and an anatomical
H.B. Mamo et al. Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930

sintering (SLS) (Trenfield et al., 2022), digital light processing (DLP)

(Chaudhary et al., 2022), (Montgomery et al., 2022), selective laser
beam melting (Kong et al., 2018), (Ginestra et al., 2020), electron beam
melting (Surmeneva et al., 2021), (Ishfaq et al., 2022), binder jetting
(Chen et al., 2022), and directed energy deposition (Salmi, 2021).
SLA is one of the most commonly used 3D printers in the medical
sector, well suited for creating objects with high resolution and fine
details, which makes it ideal for producing dental and orthopedic im­
plants. While the medical industry has used 3D printing for over two
decades, using SLA in medicine is relatively new; however, the medical
industry began exploring SLA technology’s potential applications (Xu
et al., 2021), (Rodríguez-Pombo et al., 2023). FDM is also one of the
medical industry’s most widely used 3D printing techniques, mainly due
to its low cost and easy accessibility. In FDM, a plastic filament is heated
and extruded layer by layer to create the final 3D-printed object (Tura
et al., 2022). One of the earliest uses of FDM in the medical industry was
Fig. 3. 3D printer guide to producing a customized pill or tablet in pharma­ for creating anatomical models of patient-specific organs and tissues.
ceutical formulation development. This technology allowed doctors to plan surgeries and procedures better,
as they could better understand the patient’s specific anatomy (Can­
o-Vicent et al., 2021), (Grivet-brancot et al., 2022). SLS is a
Table 1
powder-based 3D printing technique that employs a laser to selectively
Various 3D printing techniques used in biomedical device applications.
fuse powdered materials to create the final thing (Yang et al., 2023),
3D printing techniques Biomedical application References (Guo et al., 2023). SLS is often used to produce complex geometries and
Fused Deposition Dental implants, hearing (Park et al., 2020), ( high-strength components for orthopedics, prosthetics, dosage forms,
Modeling (FDM) aids, pharmaceutical Lüchtenborg et al., 2021), and pharmaceutical applications (Kulinowski et al., 2022), (Thakkar
applications, and surgical (Buj-Corral et al., 2021), (
et al., 2021). DLP is a similar technique to SLA but uses a digital light
instruments or tools. Melocchi et al., 2021)
Stereolithography Implantable devices, (Triacca et al., 2022), ( projector to cure the resin instead of a laser (Kumar et al., 2020). DLP is
(SLA) surgical planning, Kim et al., 2022), ( widely used for tissue engineering (Gong et al., 2022b), (Wang et al.,
prosthetics, orthodontics Grzeszczak et al., 2021), ( 2022b) and surgical applications (Keßler et al., 2022) due to its high
and dental, and drug Dostalova et al., 2022) accuracy and speed.
delivery.
Selective Laser Orthopedics, tissue (Păcurar et al., 2021)– (
Binder jetting is a 3D printing technique that uses a liquid binding
Sintering (SLS) engineering, and surgical Dinoro et al., 2022b) agent to bind layers of powder together to create the final object
instruments or tools (Rahman et al., 2023). Binder jetting is well suited for creating large,
Digital Light Tissue engineering, surgical (Wang et al., 2022b), ( complex things and is often used to produce medical implants. The use of
Processing (DLP) planning, medical imaging Keßler et al., 2022), (
binder jetting in the medical industry is a relatively recent development
Zuzak et al. et al., 2009), (
Hornbeck and Wu, 1999) (Basit and Gaisford, 2018). EBM is a high-precision AM technique using
Binder Jetting Surgical instruments or (Meglioli et al., 2020), ( an electron beam to melt and fuse metal powders (Mosallanejad et al.,
tools, drugs implants Wang et al., 2022c), (Lee 2022) EBM is a high-precision and versatile manufacturing process with
prosthetics, and medical et al., 2022), (Ono et al., various applications in the medical industry and has often been used to
models. 2000).
Electron Beam Cranial implants, dental (Hauser et al., 2021), (
create patient-specific metal implants, such as cranial implants (Palm­
Melting (EBM) implants, hip and knee Barbin et al., 2020), ( quist et al., 2023), hip and knee replacements (Hauser et al., 2021),
replacements, and surgical Ataee et al., 2018), ( dental implants (Barbin et al., 2020), and surgical tools (Bordin et al.,
instruments or tools. Moiduddin et al., 2021) 2016). Table 1 summarizes the various techniques of 3D printing used in
applications for biomedical devices. Fig. 4 shows that (a) Scaffolds
printed by utilizing SLA(b)3D prototypes of honeycomb neck orthosis
shoulder (3D printed) in (b). application of 3D printer guide to pro­
printed by FDM, (c) 3D printed of heart with blood vessels prototypes by
ducing a customized pill or tablet in pharmaceutical formulation
SLS technique, (d) 3D Prosthesis part printed by DLP technique, (e) 3D
development shown in Fig. 3.
printed Scoliosis backbone by Binder Jetting method, and (f) 3D-printed
Overall, 3D printing in the medical industry is expected to grow as
cranial implants using titanium alloys (Ti6Al4V) to treat patients.
technology improves and becomes more widely adopted by healthcare
providers. Additionally, additive manufacturing is playing an increas­
ingly important role in the medical industry and has the potential to 4. Challenges of 3D printing technology in medical sectors
improve patient outcomes significantly. Although there are still chal­
lenges to overcome, the potential benefits of AM in the medical industry 3D printing technology offers significant benefits over traditional
make it a technology worth watching. The industry continues to evolve, manufacturing methods but poses several challenges that must be
offering new solutions for medical professionals and improving patient addressed for its widespread adoption in the medical sector. One of the
outcomes (Kourra et al., 2018), (Culmone et al., 2019). critical challenges of AM technology in the medical sector is material
selection. The materials used in AM must be biocompatible, sterilizable,
3. Major categories of 3D printing in the biomedical industry and safe for human use. In addition, the material’s properties must
match the intended application, such as strength, flexibility, and wear
The medical sector utilizes a variety of 3D printing techniques, and resistance. Therefore, it is essential to identify and develop new
the most commonly implemented categories of 3D printing in the biocompatible, sterilizable materials that can withstand the harsh
biomedical industries the most commonly implemented categories of 3D environment of the human body (Ghidini, 2018).
printing in the biomedical industries including stereolithography (SLA) Accuracy and precision are also essential factors in 3D printing for
(Basile et al., 2022), (Chen et al., 2021), fused deposition modeling medical applications. The medical industry demands high accuracy and
(FDM) (Grivet-Brancot et al., 2022), (Wang et al., 2022a), selective laser precision for AM parts, and the technology has made significant strides
in achieving these requirements. However, there are still challenges in

3
H.B. Mamo et al. Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930

Fig. 4. Illustration of (a) 3D scaffold printed by SLA (Elomaa et al., 2011), (b) the neck orthosis printed by FDM (Rizzi et al., 2022), (c) 3D printed of heart with blood
vessels prototypes by SLS (Tejo-Otero et al., 2020), (d) 3D Prosthesis part printed by DLP (Hollander et al., 2006), (e) 3D printed Scoliosis backbone by Binder Jetting
method (Salmi, 2016), and (f) Cranial implant printed part by EBM (Moiduddin et al., 2017).

ensuring consistent quality, especially in large-scale production. The

tolerances for the medical parts must be very tight, and any deviation
from the desired specifications can result in significant consequences for
the patient. Achieving the required level of accuracy and precision can

Fig. 5. Challenges of 3D printing in biomedical sectors.

Fig. 6. Workflow of IoMT in medical sectors.

Table 2
Common biomedical materials in 3D printing.
Biomedical Material Properties 3D printing Processes Biomedical Device Reference
Applications

Plastics (e.g. PLA, PCL, PETG)
Metals (e.g. titanium, stainless
steel, cobalt-chromium)
Ceramics (e.g. hydroxyapatite,
zirconia)
Composites (e.g. graphene,
carbon fiber)
Biomaterials (e.g. collagen,
alginate, chitosan)
Biocompatible, flexible, and easily
customizable
High strength, corrosion resistance,
and biocompatibility
Biocompatible, osteoconductive, and
mechanically strong
Lightweight, high strength, and
electrical conductivity
Biocompatible, biodegradable, and
capable of supporting cell growth
Fused Deposition Modeling (FDM)
Direct Metal Laser Sintering (DMLS),
Electron Beam Melting (EBM)
Stereolithography (SLA), Binder
Jetting (BJ)
Selective Laser Sintering (SLS), Fused
Filament Fabrication (FFF)
Inkjet Printing, Extrusion Printing
Tissue engineering, drug
delivery, implants
Implants, prosthetics,
dental restoration
Bone tissue engineering,
dental implants
Tissue engineering,
implants, drug delivery
Tissue engineering, drug
delivery, wound healing
(Kakanuru and Pochiraju,
2020), (Haryńska et al.,
2020)
(Tang et al., 2020)– (
Buj-Corral et al., 2020)
(Jiang et al., 2023), (Li et al.,
2022b)
(Alam et al., 2022), (Song
et al., 2020)
(Xie et al., 2023), (Sultan
et al., 2022)

4
H.B. Mamo et al.
Fig. 7. IoMT and 3D printing interaction.
Fig. 8. Barriers to implementing IoMT in Healthcare (Javaid et al., 2022b).
be challenging and requires careful consideration of the printing pro­
cess, materials, design, and adherence to strict quality control standards
(Giganto et al., 2020)– (Rückschloß et al., 2019).
Regulatory compliance is another significant challenge that must be
addressed in 3D printing for medical applications. Medical devices
produced using 3D printing must meet strict regulatory standards to
ensure their safety and effectiveness. These standards may vary
depending on the country or region where the device is being used. Any
design or production process changes must be carefully evaluated and
documented to ensure that the final product meets all regulatory re­
quirements. To address these challenges, manufacturers must imple­
ment robust quality control processes and procedures, including
material testing, post-processing validation, orientation optimization,
and regulatory compliance testing. They must also work closely with
regulatory bodies to establish appropriate standards and guidelines for
AM technology in the medical sector. Quality control procedures must
be developed and implemented to ensure that the 3D-printed parts meet
the desired specifications and are safe for use in humans (Kotsis et al.,
2022)– (Wong et al., 2019).
Costs are another significant challenge for medical applications that
5
Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930
must be addressed in 3D printing. While 3D printing can potentially
reduce the cost of producing medical devices, there are still significant
costs associated with the technology. These costs, including the equip­
ment, materials, and time required to produce the device and software,
can be prohibitive for many medical facilities. In addition, the post-
processing and finishing of the 3D-printed parts can also add to the
overall cost (Culmone et al., 2019), (Wazeer et al., 2022), (Deh­
ghan-Manshadi et al., 2020).
Lastly, standardization challenges must be addressed to ensure the
safe and efficient use of 3D printing technology in the medical sector.
Standardization in materials, design, printing processes, testing and
validation, post-processing, and quality control can help overcome the
challenges and accelerate the adoption of 3D printing in the medical
sector. Compliance with these standards requires close collaboration
between 3D printing experts, medical professionals, and regulatory au­
thorities to ensure that the device meets all the requirements (Goda
et al., 2022). Fig. 5 illustrates the most common of 3D printing chal­
lenges in biomedical device applications.
Overall, while additive manufacturing technology offers many ben­
efits for medical applications, these challenges must be addressed for
widespread adoption in the industry. To address these challenges, re­
searchers and manufacturers are developing new materials, optimizing
printing parameters, and improving the design and post-processing
techniques to ensure the accuracy and precision of additive
manufacturing in the medical sector. Ongoing research and develop­
ment, along with collaboration between industry, government, and
academia, can help overcome these challenges and accelerate the
adoption of AM technology in the medical sector (Patpatiya et al.,
2022)– (Rouf et al., 2022).
5. Biomedical materials in additive manufacturing
AM uses a wide range of materials depending on the specific appli­
cation and the type of 3D printer used. To enhance human health and
quality of life, biomaterials are employed to design the functional repair
of various tissues. There are natural and artificial biomate0rials (Petretta
et al., 2021), (Bose et al., 2018). One of the most common materials in
3D printing is plastic, specifically thermoplastics like ABS (acrylonitrile
butadiene styrene) and PLA (polylactic acid). These materials are rela­
tively easy to print and are used to create many objects, from simple toys
to complex engineering prototypes (Kakanuru and Pochiraju, 2020),
(Haryńska et al., 2020). Another common material used in 3D printing is
metal. Common metals in additive manufacturing include ferrous and
non-ferrous alloys, stainless steel, aluminum, titanium,
cobalt-chromium alloys, gold, and platinum. These metals are
commonly used in medical devices such as joint replacements, dental
implants, and pacemakers (Tang et al., 2020)– (Buj-Corral et al., 2020).
Ceramic materials are also used in 3D printing, although this appli­
cation is relatively new. Ceramic 3D printing is most commonly used to
produce dental implants (Jiang et al., 2023), (Li et al., 2022b). Com­
posite materials combine two or more materials, typically a matrix and a
reinforcing material. Composite 3D printing creates objects with specific
mechanical properties, such as high strength or stiffness. Carbon
fiber-reinforced plastics and glass fiber-reinforced plastics are
commonly used in composite 3D printing (Alam et al., 2022), (Song
et al., 2020). Bio inks are a class of materials used in bioprinting, a type
of 3D printing used to produce living tissue and organs. Bio inks are
typically made from a combination of biological materials, such as cells
and extracellular matrix components, and synthetic materials, like
hydrogels. These materials are used in medical 3D printing (Xie et al.,
2023), (Sultan et al., 2022). Table 2 summarizes the commonly used
biomedical materials used in 3D printing for biomedical device appli­
cations. The material to choose will vary depending on the purpose, the
qualities needed for the final product, and the type of 3D printer being
utilized. New materials and uses are developing as technology pro­
gresses, enhancing the potential of 3D printing.
H.B. Mamo et al.
Fig. 9. Application of AI and machine learning used for optimization (a) problem of lever, (b)process of printing lever in 3D printing, (c) analysis of data using AI,
and (d) optimization using AI (Shin et al., 2022).
6. Mechanochemical behavior of 3D printed biomedical
materials
The mechanochemical behavior of 3D-printed biomedical materials
plays an important role when developing novel materials for biomedical
applications. These materials are exposed to mechanical stresses in their
intended applications, such as implants, tissue engineering scaffolds, or
drug delivery systems. In response to mechanical stress, these materials
may undergo chemical reactions or structural changes that impact their
mechanical properties, degradative behavior, surface qualities, and
cellular interactions. Researchers can develop materials with higher
mechanical strength, regulated degradation rates, optimal surface
qualities, and better compatibility with the surrounding biological
environment by studying and managing the behavior of mechano­
chemical systems (Dunford et al., 2018)– (Li et al., 2020).
The mechanical testing and biocompatibility of 3D-printed biomed­
ical materials and devices give essential information about their per­
formance. Biocompatibility testing involves assessing cytotoxicity, in
vitro cell culture studies, and in vivo animal studies to assess the ma­
terial’s interaction with living cells and tissues. Tensile, compression,
flexural, fatigue, and wear tests are among the mechanical tests used to
evaluate a material’s strength, elasticity, durability, and resistance to
pressure and wear. These tests aid in confirming the safety, compati­
bility with biological systems, and mechanical qualities required for the
3D-printed materials and gadgets’ intended applications. This enables
researchers and manufacturers to refine the materials and optimize their
performance (Gharibi and Abdolmaleki, 2018).
3D printing settings have greatly influenced biomedical equipment’s
mechanical and chemical performance. The selection of materials is
crucial since they all have varied mechanical and chemical qualities. The
material selection affects the device’s entire performance, which also
impacts the device’s strength, flexibility, biocompatibility, and resis­
tance to the deterioration (Fallah et al., 2022), (Liu et al., 2022).
Furthermore, the printing parameters, including printing speed, layer
thickness, printing temperature, and infill density, significantly impact
the mechanical characteristics, viscosity, and flow of the material, as
well as the interlayer bonding and flow of the device. To achieve solid
6
Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930
adhesion between layers without sacrificing the material’s chemical
stability, optimal 3D printing and chemical qualities are required (Fallah
et al., 2022), (Machry et al., 2022). While surface finishing procedures
increase biocompatibility and chemical interaction resistance, heat
treatment strengthens materials. Biomedical devices may be made with
enhanced mechanical strength, biocompatibility, chemical stability, and
overall performance by carefully examining and improving these 3D
printing factors (Manickam et al., 2023), (Hu et al., 2022).
7. IoMT and AI-guided design for 3D printing of medical
equipment
7.1. IoMT
The Internet of Medical Things (IoMT) is a system of connected
medical devices, software applications, and health systems that
communicate and exchange data with each other via the internet
(Dwivedi et al., 2022) (Pradhan et al., 2021). IoMT uses various sensors,
devices, and wearables to collect real-time health data from patients,
which is then transmitted to healthcare providers and other stakeholders
as Shown in Fig. 6. IoMT devices and sensors are used to collect various
types of health data such as blood pressure, heart rate, glucose levels,
and more. These devices can be implanted, wearable, or portable and are
connected to the internet, allowing them to transmit data in real time.
The collected data is then transmitted securely to a centralized system,
such as a cloud-based platform or a hospital’s electronic health records
system, where it can be stored and analysed. The collected health data is
analysed using machine learning algorithms and other data analysis
tools to identify trends, anomalies, and patterns (Javaid et al., 2022a),
(Vishnu et al., 2020). This analysis can help healthcare providers make
more informed decisions and improve patient outcomes. The analysed
data can be used to provide feedback and interventions to patients, such
as alerts for medication reminders or lifestyle changes. Healthcare
providers can also use the data to monitor patient progress and adjust
treatment plans accordingly. IoMT devices and systems must be secure
to protect patient privacy and prevent data breaches. This includes
secure data transmission, encryption of data, and adherence to data
H.B. Mamo et al. Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930

Table 3 parts or even complete devices, reducing the need for shipping and
Regulatory frameworks for AI- and machine learning-enabled 3D-Printed transportation. 3D printing can produce customized prosthetics to fit
biomedical devices. individual patients’ specific needs and anatomy. IoMT sensors can be
Region Regulatory Body Regulatory Framework Reference integrated into these prosthetics, allowing for real-time monitoring of
United Food and Drug Center for Devices and (Van Norman,
their function and providing insights into patient mobility and health. In
States Administration Radiological Health 2018), ( addition, 3D printing can speed up the prototyping process for medical
(FDA) (CDRH) regulates 3D- Khairuzzaman devices, allowing for quicker design iterations and improvements. IoMT
printed medical et al., 2018) can be used to collect patient feedback on these prototypes, enabling
devices through
further refinements and improvements (Al-Turjman et al., 2020), (Kar­
premarket submission
requirements, such as agiannis et al., 2022).
the 510(k) clearance or
premarket approval 7.2. Barriers to adopting IoMT in healthcare sectors
(PMA) pathway. AI-
and machine learning-
enabled devices must The adoption of IoMT in healthcare services faces several barriers
comply with the FDA’s that hinder its widespread implementation. Security and privacy con­
software as medical cerns are significant challenges as IoMT devices generate and transmit
device (SaMD) sensitive patient data, requiring robust security measures to prevent
regulations.
European European The EMA regulates (Way et al., 2016),
unauthorized access and breaches. As healthcare systems consist of
Union Medicines Agency medical devices under (Cerreta et al., various platforms and devices, interoperability and standardization
(EMA) the Medical Device 2016) provide additional data integration and interchange difficulties. Due to
Regulation (MDR) and the enormous volumes of real-time data that IoT devices produce, data
In-vitro Diagnostic
management and analytics are challenging. Robust infrastructure and
Medical Device
Regulation (IVDR). AI- analytics skills are needed for efficient processing and actionable in­
and machine learning- sights. Due to the highly regulated nature of the healthcare sector,
enabled devices would regulatory and compliance concerns occur, mandating adherence to
need to be assessed data privacy rules and negotiating complicated legal frameworks
under these regulations
(Hajiheydari et al., 2021)– (Fatima et al., 2021). Cost considerations can
and receive a CE mark
for approval. limit the adoption of IoMT in healthcare, especially for smaller organi­
China National Medical The NMPA regulates (Zhou et al., zations with limited budgets. Demonstrating the return on investment
Products medical devices under 2019), (Song and cost-effectiveness of IoT implementations is necessary to gain sup­
Administration the Medical Device et al., 2022)
port and funding. Resistance to change and workflow integration may
(NMPA) Supervision and
Administration arise from healthcare professionals accustomed to traditional practices.
Regulations (MDSAR). Adequate training and change management strategies are needed to
AI- and machine ensure smooth adoption and acceptance (Pritika and Azam, 2023).
learning-enabled Ethical and societal issues concerning patient privacy, permission, and
devices would need to
data utilization must be addressed. It is critical to have open data
comply with these
regulations and receive collection and utilization procedures and regulations that emphasize
market authorization patient autonomy and trust. Fig. 8 shows the barriers and challenges of
from the NMPA. IoMT in implementation in healthcare. Healthcare providers, technol­
ogy creators, regulators, and lawmakers must work together to over­
come these obstacles. For the Internet of Things to be successfully
privacy regulations (Subash et al., 2020).
adopted in healthcare services, it is crucial to handle security issues,
The Internet of Medical Things (IoMT) and 3D printing can com­
promote interoperability, invest in infrastructure and analytical capa­
plement each other in various ways. Fig. 7 demonstrates how IoMT and
bilities, adhere to legislation, and address ethical issues (Javaid et al.,
3D printing interact. 3D printing technology allows the production of
2022b), (Bhushan et al., 2023).
highly customized medical devices that are tailored to individual pa­
tients’ needs. IoMT sensors can be incorporated into these devices to
monitor the patient’s health, allowing for real-time data collection and 7.3. AI-guided optimization during 3D printing of medical equipment
analysis. IoMT can remotely monitor, diagnose, and even repair medical
devices. 3D printing can allow for small manufacturing of replacement AI-guided optimization during the 3D printing of medical equipment
can significantly improve the quality and efficiency of the printing

Table 4
Safety standards for AI- and machine learning-enabled 3D-Printed biomedical devices.
Standard Organization Description Reference

ISO 13485 International Organization for Quality management system (QMS) standard for medical devices, which includes requirements (Nowak and Szewczyk,
Standardization (ISO) for risk management, design and development, and validation and verification processes. 2018)
ISO 14971 ISO Standard for the application of risk management to medical devices, which includes guidance Hegde (2011)
on risk analysis, risk evaluation, and risk control.
IEC 62304 International Electrotechnical Standard for the development of software for medical devices, which includes requirements for (Muñoz et al., 2018)– (
Commission (IEC) software development planning, software requirements analysis, software design, software Kim et al., 2019)
testing, and software maintenance.
IEC 60601-1 IEC Safety standard for medical electrical equipment, which includes requirements for protection De Lima et al. (2016)
against electrical hazards, mechanical hazards, and other hazards.
ASTM F3161-16 ASTM International Standard guide for specifying 3D-printing material for medical applications, which includes Carbone et al. (2020)
guidance on material selection, material testing, and material properties.
FDA Software FDA Guidance on software validation for medical devices, which includes recommendations for Abdeen et al. (2007)
Validation verification and validation testing, documentation, and change control.

7
H.B. Mamo et al.
process. By utilizing machine learning algorithms and real-time moni­
toring of printing parameters, the AI system can identify potential issues
and suggest adjustments to optimize the printing process (Ong et al.,
2022), (Elbadawi et al., 2021). This includes selecting the best printing
materials, adjusting the printer’s temperature and speed, and identi­
fying design areas requiring additional support structures. AI can also
predict potential defects and errors in the printing process, which can be
addressed before the final product is produced. Overall, AI-guided
optimization can improve the accuracy, speed, and consistency of 3D
printing in the medical field, leading to more reliable and high-quality
medical equipment (Zhu et al., 2021), (Athanasopoulou et al., 2022).
Fig. 9 illustrates the usage of artificial intelligence and machine learning
for optimization of lever problem.
7.4. Regulatory frameworks and safety standards
The regulatory frameworks and safety standards for AI- and machine
learning-enabled 3D-printed biomedical devices are still evolving, with
various organizations and governing bodies taking steps to ensure their
safety and efficacy. The US Food and Drug Administration (FDA) has
issued guidance documents for the use of 3D printing in medical device
manufacturing, focusing on ensuring the devices’ safety and effective­
ness (Pandey et al., 2020), (Buchmeier, 2020). The International Orga­
nization for Standardization (ISO) has also developed standards for
designing, manufacturing, and testing medical devices, including those
produced using 3D printing technology (Eraliev et al., 2022). In addi­
tion, organizations such as the American Society of Testing and Mate­
rials (ASTM) have developed standards for additive manufacturing in
healthcare (Ahmed et al., 2021). As AI and machine learning algorithms
are increasingly being integrated into 3D-printed biomedical devices,
there is a growing need for regulations and safety standards to ensure
their safety and effectiveness. Table 3 and Table 4 highlight commonly
used regulatory frameworks and safety standards for AI- and machine
learning-enabled 3 d-printed biomedical devices.
8. Future directions
Future research will focus on improving AM technology to boost its
accuracy and efficiency, expand its applications in the medical field, and
ensure the security and quality of printed items. One of the primary
research goals in AM for the medical industry will be to develop inno­
vative printing materials and techniques that are biocompatible, bio­
resorbable, and capable of replicating the properties of human tissues
and organs. As a result, it will be possible to produce medical implants
and devices that are more functional and complicated, which will help
patients heal faster and with a lower risk of infection or rejection. Re­
searchers will also concentrate on creating new additive manufacturing
(AM) techniques that can print several materials or cells at once,
allowing for the creation of more complex tissues and organs for
transplantation.
Another area of AM research for the medical industry is improving
print quality and safety. This entails the development of new hardware
and software additive manufacturing (AM) solutions, such as sensors
and monitoring systems that can detect and correct printing errors and
ensure the accuracy and uniformity of printed goods. Researchers will
also focus on setting up new rules and regulations for AM in the medical
industry to ensure that printed objects meet the essential safety and
quality criteria and are compatible with the present medical systems and
practices.
The future of IoMT (the Internet of Medical Things) and AI in
healthcare seems promising, particularly for medical equipment. Med­
ical devices with AI capabilities can examine patient data to find trends
and offer individualized therapy alternatives. IoMT equipment may
gather and communicate patient data in real time to healthcare practi­
tioners, such as wearable sensors and remote monitoring systems, which
increases the precision of diagnoses and treatment regimens. We
8
Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930
anticipate seeing more AI and IoMT technology integration in medical
devices in the upcoming years, improving patient outcomes and making
the healthcare system more effective. In general, future research in 3D
printing or AM for the medical sector will concentrate on creating new
materials and methods, enhancing the quality and security of printed
items, and extending the sector’s usage of AM. These developments will
make it possible to create medical equipment and implants that are more
individually tailored and efficient, enhance the results of surgical pro­
cedures, and lower healthcare expenses for patients and healthcare
providers.
9. Conclusions
In conclusion, 3D printing technology has emerged as a powerful tool
in the medical industry, enabling the production of complex medical
devices and implants customized to meet individual patient’s specific
needs while being cost-effective. The technology offers several advan­
tages, such as reduced lead times, improved patient outcomes, and cost
savings. However, some challenges still need to be addressed, such as
standardization, regulatory compliance, quality control, material limi­
tations, and high costs. The application of additive manufacturing in the
medical industry is widespread, with applications ranging from dental
implants and orthopedic devices to prosthetics and hearing aids. The
technology has also been used to develop personalized drugs and create
anatomical models for surgical planning. AI and the Internet of Medical
Things (IoMT) are also increasingly important in the medical industry.
AI algorithms can be used to analyze medical data and identify patterns
that can aid in diagnosing and treating diseases. The IoMT can help
medical professionals monitor patients remotely, improving patient
outcomes and reducing healthcare costs. Despite the challenges, inte­
grating AI and IoMT with additive manufacturing technology is ex­
pected to play a vital role in the future of medical manufacturing,
leading to further advancements and improvements in patient care.
Continued research and development will be necessary to ensure these
technologies can be applied effectively and safely in the healthcare
industry.
CRediT authorship contribution statement
Hana Beyene Mamo: Visualization, Methodology, Investigation,
Formal analysis, Data curation, Conceptualization, Writing - original
draft. Marcin Adamiak: Supervision, Methodology, Validation, Writing
- review & editing. Anil Kunwar: Visualization, Supervision, Data
curation, Funding acquisition, Methodology, Writing - review & editing.
Declaration of competing interest
The authors declare that they have no known competing financial
interests or personal relationships that could have appeared to influence
the work reported in this paper.
Data availability
The data for this article mostly consists of bibliographic references,
which are included in the References section. Some of the figures in this
work are created by the authors of this work. Fig. 1, Fig. 3, Fig. 5, Fig. 6
and Fig. 7 are created by the authors of this article. The data associated
with Fig. 1, Fig. 3, Fig. 5, Fig. 6 and Fig. 7, are made available at
https://github.com/anilkunwar/biomedical_devices2023.
Acknowledgment
This work was supported by the National Science Centre, Poland
(UMO-2021/42/E/ST5/00339). Open-access funding was provided by
the Silesian University of Technology.
H.B. Mamo et al. Journal of the Mechanical Behavior of Biomedical Materials 143 (2023) 105930

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