The Material of Choice for Medical Device Manufacturing
Amir Mohammed Alsharabasy
*
Department of Radiation Biology, National Center for Radiation Research and Technology, Cairo, Egypt
*
Corresponding author: Alsharabasy AM, Department of Radiation Biology, National Center for Radiation Research and Technology, Cairo, Egypt, Tel:
00447470132989; E-mail: Alamier@Ymail.com
Received date: December 19, 2017; Accepted date: January 02, 2018; Published date: January 08, 2018.
Copyright: © 2018 Alsharabasy AM. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and source are credited.
Commentary
Te medtech sales have been improved since 2015, with around 5%
annual increase in the medical devices and technology globally. Tere
are expectations for such growth, which was $370 billion in 2015 to
reach $530 billion in 2022 [1]. Diferent medical devices are designed
for the treatment of diferent organs (e.g., lung, neurons, skin, heart
and bones), drug delivery, diagnostics and in the designing of surgical
devices. However, there is still a long journey for creating the materials
which can achieve the optimal properties for [1] the repairing of each
organ, [2] providing the optimum condition for the delivery of
diferent therapeutic molecules, whether this is locally or systemically,
[3] giving the most accurate results for diagnosis as well as [4]
providing the ideal properties for using in minimally invasive
surgeries.
Tere are diferent classifcations of the bioactive materials: organic
and inorganic, amorphous and crystalline, macromolecules and
materials with simple structures, and natural and synthetic materials.
Tese include polymers, plastics materials, metals, ceramics and
glasses. Taking the latter two classes as examples; although they have
proven efciency for using as bone implants, coatings, fllers and in
dentistry [2-4], their usage in sof tissue repair has started as well, but
still in the primary stages of development [5,6].
Choosing the Right Material for Medical Device
Designing
For the designing of a medical device, each composing material
should have certain characteristics, which should be in a harmony with
the fnal properties of the medical device as well the target application.
Te manufacturing companies take into consideration the following
criteria as bases for choosing each material towards their targeted
applications [7]:
• Te frst criterion is the availability of the material in sufcient
quantities for the mass production of the device to meet the market
needs.
• Te second one is the fexibility of the material towards a targeted
design, where the material can be needed in diferent forms (e.g.,
flaments, fbers, nanoparticles, etc.). For instance, the fexibility
can be achieved using certain types of polymers, which can be
processed as fbers, nano fbers, hydrogels, etc. towards certain
application [8,9]. Te usage of bioactive ceramics or glasses can be
the best choice for others, especially in bone applications, which
require implantation of rigid structures [10-12]. Moreover,
bioactive glass-based fbers can be also designed for bone grafing
[13,14], and drug delivery [15].
• Te third criterion is the material cost. Tis includes the costs of
production, transportation, and amounts required for each device.
However, on deciding the best material from this point of view, a
general look at the true lifecycle costs is essential. For instance, the
melting-quenching technique for bioactive glass synthesis requires
higher temperatures and energy than the sol-gel method; however,
the costs of chemicals used in the latter method are to somewhat
higher [16].
• Te fourth criterion depends on the matching between the
material properties and the required specifcations of the designed
device. For instance, certain polymers with certain properties are
suitable for wound healing applications, and sof tissue repair;
while the usage of metals is efcient for bone healing. However,
through the recent improvements in the bio ceramics/glasses
design and modifcation, they have found diferent applications. In
fact, this is the most important factor which the biomaterials
researchers concentrate on. However, the other criteria should be
taken into account as well, especially for the further shifing to the
industrial production stage to guarantee the productivity of the
fnal medical devices.
• Te ffh criterion is the choosing of the trusted/certifed materials
for the medical applications. Although the stage of research for
fnding and optimizing the properties of the material is essential
for the development of medical devices industry, this criterion may
be of importance for shortening the period required for the device
approval.
• Te sixth criterion is the biocompatibility of the fnally designed
device, as well as its components. It can be considered one of the
most important factors for selecting the material, where the
formation of any harmful products following the usage of the
device will lead to its failure [17]. Moreover, according to the type
of the device and its application, the sterilization method, as well as
the storage conditions, which can guarantee its optimum
biocompatibility, can be decided [18,19]. Te biocompatibilities of
the diferent composing materials before and afer processing are
assessed under certain protocols. Although the degradation
products of some biomaterials (e.g., synthetic polymers and
metals) in the body may induce some immune reactions and
device rejection may happen in severe cases, four main options can
solve these problems. Te frst one is the combination of the
polymer with a compatible material, so the severity of such
reactions can be reduced, especially if the outcome using this
polymer is desirable [20,21]. Te second option involves the
further purifcation of the polymer before using in the device
manufacturing [22,23]. Te third option is to replace it by another
compatible polymer, or other inorganic material which can provide
similar mechanical properties and outcomes. Te last option is the
coating of the material (e.g., metal) with a biocompatible material
(e.g., bioactive ceramic/glass), so the compatibility can be
improved [24,25]. Moreover, the compatibility of the device is
tested, but this stage may take a long time for validation of the
sterilization efcacy and confrmation of compatibility.
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Journal of Clinical Research
Alsharabasy, J Clin Res 2018, 2:1
Commentary Open Access
J Clin Res, an open access journal Volume 2 • Issue 1 • 1000101