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A. Pal et al.

5.11 Conclusion

The topic of human skin interface behaviour is extensively researched in both indus­try and academia due to its signicance for the functional performance of many items. People with varying age groups, genders, ethnicities, and skin types have diverse skin qualities. Furthermore, the features of the skin vary based on the part of the body and can be affected by lifestyle choices and body mass index. Even though the skin’s primary function is to act as a barrier, some substances can nevertheless be absorbed. A large portion of the underlying fundamental physical mechanisms are still unknown due to the complexity of skin interactions. Gaining more insight into skin tribology will require targeted, in-depth experimental studies.

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Chapter 6
Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
AvinashKumar , PradiptaGajjar, KavithaSharanappaGudadur, AbhishekKumar , AshishKumarGupta , AmitChoudhari , NusratChowdhury , andAshwaniKumar
Abstract Manufacturing of biomedical device involves in-depth understanding of
tribology and biology, biotribology. The word “tribology,” comes from ancient Greek. In this chapter, the focus is on challenges and future scopes of biotribology in the eld of biomedical devices. Some of the problems while designing a
A. Kumar (*) Indian Institute of Information Technology Design & Manufacturing (IIITDM), Kancheepuram, Chennai, Tamil Nadu, India
Department of Mechanical Engineering, Stanford University, Stanford, CA, USA e-mail: avikr@iiitdm.ac.in
P. Gajjar · K. S. Gudadur Indian Institute of Information Technology Design & Manufacturing (IIITDM), Kancheepuram, Chennai, Tamil Nadu, India
A. Kumar J.Mike Walker ’66 Department of Mechanical Engineering, Texas A&M University, College Station, TX, USA
Department of Mechanical Engineering, University of California, Merced, CA, USA e-mail: akumar71@tamu.edu
A. K. Gupta School of Mechanical and Aerospace Engineering, Oklahoma State University, Stillwater, OK, USA e-mail: ashish.gupta10@okstate.edu
A. Choudhari Mechanical Engineering Department, Cleveland State University, Cleveland, OH, USA e-mail: a.choudhari@vikes.csuohio.edu
N. Chowdhury University of Illinois Urbana-Champaign, Urbana, IL, USA e-mail: nusratc2@illinois.edu
A. Kumar Department of Mechanical Engineering, Technical Education Department Uttar Pradesh (under Government of Uttar Pradesh), Kanpur, Uttar Pradesh, India
A. Kumar etal. (eds.), Applications of Biotribology in Biomedical Systems,
https://doi.org/10.1007/978-3-031-58327-8_6
167© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
168
A. Kumar etal.
biomedical device involve making the device nano, large-scale production of the device, inconsistency of quality of the device, use of chips in human organs(brain), high- cost manufacturing, mechanical biocompatibility, poor bioprinting mecha­nism, cell damage rate(high), the device user’s ability, etc. Here the discussion is about how to target each one of them with highly advanced techniques like using combination of 3D and 4D printing techniques, biomedical gadgets which incorpo­rate gecko’s skin, bionic ears/eyes, biosensors, and microgels, biorobots, shark skin properties, biomimetic watery oil applications, lotus leaf surface, creepy crawly silk, and catsh skin bodily uid, they are highly advance application and still lack­ing in understanding of their organic working and strategy of manufacture. Human factors engineering (HFE), role of voltametric sensors, internet of things (IoT) in healthcare, and binder jetting-based 3D printing also have contribution to biomedi­cal device’s future. Using software like Autodock, Discovery studio, and Pyrx will help inrecognizing the material (protein or ligand) in silico. Italso helps in estimat­ingthe interaction that is taking place,such as bond types (protein-ligand interac­tion proler)and their negative delta G prediction in nature (mimicking). Hence, minimizing theuncertainty of desired results. To target these future scopes vari­ousadvanced techniqueshas been discussed in this chapter. The most commonly usedtechniques arebiocompatible lm technology, cost-effective techniques for CKD biodevice, non-invasive glucose monitoring devices technique, biosensing device techniques involving volumetric glucose sensors, optical or spectroscopy techniques for other detection purposes, cost-effective electrochemical voltametric sensors techniques, non-invasive glucose monitoring devices technique, three­dimensional (3D) printing techniques, ultraviolet light-emitting diode (UV-LED) stereolithography printer technique, four-dimensional (4D) printing techniques, fabrication(techniques) of hollow self-folding 4D vascular tubes having shape memory by direct-ink-writing (DIW) printing techniques, technique for direct­write printing (DWP) of a vascular 4D scaffold by shape memory nanocomposites (SMNCs: Iron oxide (Fe3O4)), shape memory polymers (SMPs: PLA ink), and advanced biomedical techniques involving biorobots.
Keywords Biomedical devices · Tribology · Biofabrication · Biomedical systems
· Manufacturing technologies

6.1 Introduction

In biomedical systems with intriguing designs, biomechanics, biomaterials, bioin­strumentation, and framework scienceplay important role in developing a building block and integration of various parts of system. These biomedical system design
6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
169
have a widespread usethat varies from designing and creating prosthetics and arti­cial organs to creating biomaterials for the delivery of medications. Scientic models are used to improve healthcare systems, and machine learning is used to advance microscopy and restorative imaging. Medical devices include any tool, equipment, apparatus, implant, or invitro reagent that isn’t a medication used for human or animal diagnostic or therapeutic purposes, according to the Food and Drug Administration (FDA) of the United States (US). On the other hand, any tool, apparatus, machine, appliance, or other item that the manufacturer has invented to be used for biomedical purposes and whose main function is not accomplished by means of metabolic, immunological, or pharmacological means is classied as a medical device by the World Health Organization (WHO) [1]. In the US, the FDA is in charge of regulating the security and effectiveness of medical equipment. Medical device regulation, both before and after they are put on sale in the US, is primarily the responsibility of the FDA’s Centre for Devices and Radiological Health (CDRH). In terms of regulatory regulation, Class I, II, and III are the higher classications of medical equipment. The device categorization regulations set forth the legal requirements for a wide range of devices. Class II devices must have pre­market notice, Class III devices must have premarket approval (PMA), while the majority of Class I devices are exempt from FDA notication. Humanitarian Use Devices (HUDs) are marketed for a certain demographic under a totally separate approach known as Humanitarian Device Exemptions (HDEs). CDRH evaluates the majority of medical devices in compliance with premarket notication [2]. In bio­medical system any device, appliance, machine, implant, invitro reagent or calibra­tor, software, material, or other similar or related article that the manufacturer intends to be used, either alone or in combination.one or more of the specic pur­poses of disease prevention, diagnosis, treatment, monitoring, or harm reduction.It also helps to achieve investigation, replacement, alteration, or support of the anat­omy or a physiological process; life support or control; or sterilization of medical equipment; or providing data for medical or diagnostic purposes through invitro examination of human specimens [1]. Figure6.1 explains the classication in ow­chart. Figure6.1 simplies the imagination of sub-classication of all the medical devices according to FDA.

6.1.1 Class 1

Technologies classied as class I apparatuses don’t raise the risk of absurd patient injury or disease. Class I devices (lowest risk) are subject to general controls, which are generally accepted guidelines for labeling, manufacturing, post-market surveil­lance, and reporting. Devices are classied as class I when there is a reasonable certainty that general controls alone will be sufcient to guarantee safety and ef­cacy [3]. 95% of medical devices are exempt from regulation under the FDA’s
170
Fig. 6.1 US FDA medical device classication
A. Kumar etal.
classication standards found in 21 CFR (Code of Federal Regulations), which apply to about 47% of devices [1]. As an illustration, consider surgical sponges, reusable scalpels, masks for surgery, bandages, wraps, oxygen masks, tongue depressors, exam gowns, hospital beds, and electric toothbrushes [1, 4, 5].

6.1.2 Class 2

Medium-risk devices belong to a single class, unlike the medical device regulation of the European Union, that are subdivided into Class IIa (medium-risk devices) and Class IIb (medium-to-higher-risk devices) [6]. Examples of common items used in medical procedures include surgical masks, wheelchairs, catheters, surgical drapes, blood pressure cuffs, blood transfusion kits, magnetic resonance imaging (MRI) machines, contact lenses, pregnancy test kits, electrocardiogram (ECG) monitors, diagnostic endoscopes, and colonoscopes [1, 4, 7].
6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
Table 6.1 Classication of biomedical devices
Classication Examples
Class 1 Hospital beds, exam gowns, reusable surgical scalpels, surgical bed and masks,
tongue depressors, bandages, crutches, electric toothbrushes wraps, oxygen masks, scissors
Class 2 (A and B)
Class 3 Wearable automated external debrillators, silicone implants, bone and
Contact lenses, hypodermic needles, blood pressure cuffs; pregnancy test kits; ECG monitors, diagnostic endoscopes, blood bags, colonoscopes, and syringes; surgical drapes; catheters; surgical masks; X-ray and MRI machines; blood transfusion kits; and so on
implants, implanted prostheses, implanted pacemakers, implanted heart valves, and high-frequency ventilators
171

6.1.3 Class 3

Several general and particular controls are applied to the most dangerous equipment in order to ensure their efcacy and safety. Ten percent of the medical gadgets under FDA regulation fall into this group. Body orice, surgically invasive, and implanted entities make up the bulk of these device groups, all of which are intrusive. Class III devices need to go through premarket approval (PMA) and other required processes before they may get a license. Examples include silicone implants, implanted pace­makers, wearable automated external debrillators, implanted prostheses, bone and hip implants, and high-frequency ventilators [1, 8]. A summary of each class’s examples may be found in Table6.1.
6.2 Types ofBiomedical Devices
It is a broad-spectrum eld that includes regenerative medicine and biomaterials; systems and engineered biology; neuro sensory and rehab designing; and sensors, nano/microsystems, and instrumentation. Courses cover embryonic development principle and tissue building, numerical modeling in cell and molecular biology, natural and restorative imaging, omic innovations, biomechanics and rehabilitation designing, physiological control systems, and computational biology. These sys­tems can be divided further, biomedical systems for arthropathy, biomedical sys­tems for dermatology, buccal cavity, human and animal organ system, and therapeutics (cancer and immunotherapy). Tables 6.2 and 6.3 have information about different types of biomedical devices, while Fig.6.2 explains the types of biomedical systems (Fig.6.3).
172
A. Kumar etal.
Pain, swelling, and
redness can all result
from surgical methods.
Bruising at the surgical
site is also a possibility
implants are composed
of plastic, ceramic,
metal, or other materials,
others are made of skin,
bone, or other bodily
tissues
Human organs While the majority of
Automatically applies
medication by heating
tiny needles that are
soaked into the skin
The interval between
tissue and blood glucose
levels
Tears, saliva, sweat,
mucus in the
airways, or the
subcutaneous tissue’s
Skin piercing
To create a voltametric
interstitial uid
Biouids include
O
2
glucose sensor that is
bearable, Cu
nano-clusters were used
as the touchy fabric and
drop cast on the nest
part of the working
anode
interstitial uid,
saliva, tears, and
perspiration
Biomedical
Table 6.2 Types of medical devices with their mode of action, location they are used in, requirements for the devices and tribology involved with them [915]
If a medical device is inserted
entirely or partially into the human
body after surgery or other
restorative procedures and is
expected to stay there indenitely,
then it is considered implantable
(ETT), urine catheters
(UC), central venous
catheters (CVC), breast,
craniofacial, and dental,
cochlear implants,
metal-on-metal bone and
hip implants, etc.
system Type of device used Mode of action Location of device Requirements Tribology
Invasive device Endotracheal tubes
A non-invasive gadget is any
symptomatic device or gadget that
does not incorporate the opening of
the skin into the body
An SVM classication
algorithm and a pulse
radar sensor comprise the
Vascular Wall motion
Non-invasive
device
Make strides the consolation level
of patients, particularly those
inuenced with diabetes and in
some cases incessant wounds.
(VWM) monitoring
system
Biosensors, biochemical
markers, non-invasive
electronic skin patch,
skin chip
Biosensing
device
Evaluate genuine-time interstitial
liquid glucose levels; in any case,
they don’t do this without
depending on skin piercing, rely on
optical or spectroscopy strategies
6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
nanoparticles
4
O
Biomimicking
implants with
characteristics akin to
those of real bone
Metal 3D-printing
strategy empowers the
fabricating of
biomimicking to embed
gadgets with comparative
properties compared to
Application of
craniofacial embeds
tailored to each
patient for the
replication of the
cranium and
normal bone,
3D-printing advances too
incorporate coordinate-
type in strategies such as
inkjet printing with
skeleton, facial
titanium bone, hip
and mandibular
prostheses, and a
platform for tissue
distinctive bio- materials
engineering,
implants, external
prostheses, and
3
Form memory-4D,
Fe
that allowed for
nanoparticles, an
4
O
3
Fe
UV-LED
stereolithography printer
automation
remotely controlled
and structure-
magnetically directed
behavior were on
display for biomedical
devices
173
Fabric is put consecutively in a
layer-by-layer design to construct
The osteofab craniofacial
patient-specic stability
Biomedical
system Type of device used Mode of action Location of device Requirements Tribology
3D-printed
bio-medical
the utilitarian 3D objects, strategy
gives adaptability in terms of
customized patient-specic
gadgets, plan opportunity, and
complex inner structures
device, the DENTCA
three-dimensionally
printed polymer dentures,
the TirboLOX-L titanium
lumbar cages for spinal
stabilization, and the
trachea-bronchial splint
(TBS)
device
development
4D printing is the ability to
transform 3D things instantly off
the print bed from one shape to
another. Therapeutic devices can
benet from a range of thermo-
mechanical qualities that can be
engineered into shape memory
thermosets
1
Tracheal stents, vascular
regeneration and stents,
4D printing of stent
vascular graft devices,
and magnetic eld-
triggered 4D stents are
examples of materials
with a mol. wt of
10,000gol
4D printing of
biomedical
devices
174
A. Kumar etal.
[1520]
Skull and face skeleton reconstruction,
tissue engineering, scaffolding
Targeted areas for device
implementation Application References
Joints (mimicking cartilage-
bone to bone joints), elbows,
hips, spine
[1]
perspiration and automatically delivers
Skin epidermis, middle layer Detection of too much glucose in
[1, 20]
medication by heating tiny needles that
are absorbed into the skin
biosensor to identify chronic uropathy,
and the possibility of continuously and
accurately measuring biochemical
indicators in biouids such as sweat, tears,
Dental cavities, saliva Salivary conductivity is employed as a
saliva, and interstitial uid has been
produced
[2, 2124]
Such as retinal prostheses that are
implanted in the human eye, has been
created to access ow failure in
arteriovenous stulas (AVF), identifying
chronic kidney disease (CKD), spine
stabilization made by captiva spine,
vascular regeneration, 4D-printed
constructions, because these materials’
tubular structure may be readily achieved
by 4D rolling or stretching, self-expanding
biocompatible polymer stents
Trachea, ureter, veins,
arteries, vascular walls,
heart, spine, stula, kidney
manufactured by 4D printing for
minimally invasive heart valve
replacement
Direct write techniques including inkjet
printing with various biomaterials,
metal 3D printing, titanium hip and
mandibular prosthesis, 3D printing
technologies
An electronic skin patch, osteofab
craniofacial patient-specic stability
device
Biomedical system Device and system
Biomedical systems for
Table 6.3 Types of biomedical systems, the devices included in them with their system
arthropathy
Biomedical systems for
dermatology
Biosensors. Chronic uropathy,
DENTCA three-dimensionally printed
polymer dentures
Biomedical systems for
buccal cavity
Silicon chip covers that are bioinert or
biocompatible, urine catheters (UC),
central venous catheters (CVC), and
endotracheal tubes (ETT). A support
vector machine (SVM) classication
Biomedical systems for
human and animal organ
system
algorithm and a pulse radar sensor
make up this non-invasive vascular wall
motion (VWM) monitoring device.
Affordable biosensor, magnetic
eld-triggered 4D stent, TirboLOX-L
titanium lumbar cages, 4D-printed
vascular stents, and 4D-printed heart
valves