Medical Design Briefs - December 2021 - 91

■ IoT Bluetooth Module
A radio law-certified Bluetooth® module from Renesas
Electronics Corp., Tokyo, Japan, combines an MCU, an antenna,
and peripheral circuits in a small package. The RX23W Module
includes full Bluetooth 5.0 low energy support for system control
and wireless communication on IoT endpoint devices. The module is equipped with an antenna,
oscillator and custom-matched circuit. The new module is certified under Radio Law for
multiple countries, including Japan and the United States and is Bluetooth SIG certified, which
eliminates the need for additional RF design work, tuning, or specialized RF knowledge. The
very small 6.1 × 9.5 mm, 83-pin LGA package makes it possible to design more compact devices
with fewer external components. This improves the development efficiency of IoT endpoint
devices such as healthcare equipment.
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■ PEEK Biomaterial
Evonik, Darmstadt, Germany, is partnering with Swiss plastics
specialist Samaplast to develop an osteoconductive PEEK bio -
material for injection molding. As part of the collaboration, both
partners are demonstrating and documenting the processing
properties of the high-performance polymer VESTAKEEP® Fusion using the first prototypes of
spinal implants. The functional BCP (biphasic calcium phosphate) additives are available on the
surface of injection-molded components, which is ensured by the specially configured
microparticles and their homogeneous distribution. The material was developed with a goal to
process in different manufacturing technologies and is initially offered as granules and semi-finished
products. It can be milled, compression molded, extruded, and injection molded.
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■ Circular Polycarbonate
SABIC, Houston, TX, has launched a certified circular polycarbonate
(PC) resin and blends made from the up cycling of postconsumer
mixed plastic - a first in the industry. According to an
internal SABIC LCA study, the certified circular polycarbonate offers a potential carbon footprint
reduction up to 23 percent in comparison to its incumbent. Part of the company's TRUCIRCLE™
portfolio, the material is produced through the advanced recycling of postconsumer mixed plastic
that could otherwise be destined for incineration or landfill. Through a process called pyrolysis,
difficult-to-recycle used plastic is broken down into a liquid called pyrolysis oil and then used as a
feedstock to create certified circular building blocks for high-performance plastics.
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■ Thermoplastic Gears
Intech Power-Core, Closter, NJ, offers thermoplastic gears suitable
for medical equipment such as mammography units and robotic
surgery devices. The Power-Core™ gears, which combine a proprietary
polymer gear material with a metal core, have a unique balance
of properties that make them well-suited to medical equipment
applications. In addition to absorbing shock and vibration, compared to metals, the
gears reduce noise by up to 6 db. Because the gears are available with a stainless steel, nonmagnetic
core, they are suitable for magnetic resonance imaging (MRI) machines. They provide
precise control over the gear's mesh engagement and backlash, maintaining high image
quality over time. They also eliminate fuzzy imaging due to motion chatter.
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■ Autoclave-Resistant Adhesive
Dymax, Torrington, CT, has released a line of adhesives for
medical device assembly applications. Designed to be autoclave
resistant for more than 100 cycles, MD® 1040-M offers extremely
low water absorption (0.5 percent), making it ideal for surgical
tools and devices that are subjected to numerous instances of sterilization, including autoclave
or STERRAD (plasma). The material also works well as an encapsulant, protecting
critical sensors and electronic components, where moisture ingression may be of concern.
The material cures quickly upon exposure to broad-spectrum UV light and successfully
bonds to a variety of substrates.
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Medical Design Briefs, December 2021
Cov
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ToC
■ Guide to Biological Equivalence
To address manufacturer uncertainty
around the acceptability of their biological
equivalence strategies under the EU Medical
Device Regulation (EU MDR), RQM+,
Monroeville, PA, has
produced a new guide
providing insight into
notified body expectations
for biological
equivalence, as well as
a reference tool of
potential methodologies.
This guide provides
an overview of
the EU MDR requirements for biological
safety evaluation and outlines practical
approaches for establishing biological equivalence.
It also presents a detailed table of
potential methodologies to demonstrate
equivalence. For each of the common material
differences between a product and its
equivalent device, the guide explains the
likelihood of acceptance by notified bodies
and suggests actions manufacturers can take
to increase this likelihood.
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SILICONE FOR
MEDICAL
APPLICATIONS
Master Bond MasterSil
151Med is an optically
clear, flexible potting
and encapsulation compound. It exhibits superior
electrical insulation properties and very low shrinkage
upon cure. MasterSil 151Med is resistant to vibration
and shock and has a service operating temperature
range of -65°F to +400°F. It meets USP Class VI
requirements for medical applications. http://www.
masterbond.com/tds/mastersil-151med
Master Bond
Free Info at http://info.hotims.com/79420-832
MEDTECH LEADERS
www.medicaldesignbriefs.com
2020
Technology Leaders
From the Publishers of
Free annual publication from
Medical Design Briefs features
informative articles and profiles
of leading companies
in nine areas of technology:
Electrical Connectors/Wires/
Cables, Testing, Tubing/
Extrusion, Materials/Coat ings/
Adhesives, Motors & Motion
Control/Robotics, Ortho ped -
ics/Implants/Prosthetics,
Electronics, Contract Manu -
facturing/Outsourcing, Gas/Fluid Handling/Pumps
www.medicaldesignbriefs.com/
techleaders20
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Medical Design Briefs - December 2021

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