Medical Design Briefs - September 2022 - 32

life cycle, all the way through to decommissioning.
This means that
even if the product is already distributed,
it must be continuously
monitored. This includes a reporting
system, a problem resolution
process, and regular updates. It
should be borne in mind that medical
devices are designed for a significantly
longer operating life
than, for example, household electronics
or software for private use.
The European
General
A secure product requires effective security measures
and a clear set of requirements. (Credit: Pixabay/VIN JD)
have little experience with cybersecurity,
and there are no clear guidelines, for example
on how to implement " security by
design " for medical devices. In addition,
there are only a few industry-specific
standards, such as the technical report
IEC TR 60601-4-5 ( " Medical electrical
equipment - Part 4-5: Guidance and interpretation
- Safety-related technical security
specifications " ).
n Risk Management from Design
to Decommissioning
To identify all risks and threats, cybersecurity
should be a key consideration at every
stage of development. Because many
security vulnerabilities only become apparent
after a product is on the market, risk
management must encompass the entire
Data
Protection Regulation (GDPR) already
defines high requirements
for data security. Regulations EU
2017/46 (In-vitro Diagnostic Device
Regulation, IVDR) and EU
2017/745 (Medical Device Regulation,
MDR) set cybersecurity requirements
and demand, among other things, IT security
measures in accordance with the " generally
accepted state of the art. " Depending
on the product class of a medical
device, based on the classification by the
MDR, extensive safety and performance
requirements are the result for European
market access.
Useful guidance exists for some subareas.
The MDCG 2019-16 guide, for example,
specifies the requirements for security
risk management throughout the entire
product life cycle. In its " Postmarket Management
of Cybersecurity in Medical Devices "
guide, the U.S. Food and Drug Administration
(FDA) highlights the cybersecurity
aspects of products already placed on the
market. This is also helpful for manufacturers
outside the U.S. market.
n Continuous Monitoring
and Testing
A comprehensive risk management
and a security life cycle form the basis
for a secure medical device. In addition,
ongoing controls such as vulnerability
scans, penetration tests, and fuzzing are
necessary to ensure safe functioning -
even during the operational phase.
With the implementation of existing
standards and specifications, manufacturers
and developers ensure that their
medical product corresponds to the
technical state of the art. Proof of cybersecurity
of the medical device must be
provided to the regulatory authorities
or notified bodies as part of the certification
process.
References
1. 2021 Global Threat Intelligence Report, https://
hello.global.ntt/en-us/insights/2021-globalthreat-intelligence-report
2.
The Internet of Things: A Movement, Not a Market,
https://cdn.ihs.com/www/pdf/IoT_ebook.pdf
3. " Driving the digital transformation of Germany's
healthcare system for the good of patients, "
( " Digitale- Versorgungs-Gesetz " , DVG) https://
www.bundesgesundheitsministerium.de/digital-healthcare-act.html
This
article was written by Dr. Abtin Jamshidi
Rad, Global Director Functional
Safety, Software and Digitization, TÜV
SÜD Product Service GmbH, Munich,
Germany. Contact abtin.jamshidirad@
tuvsud.com or +49 (0)89/50084-388.
Medical Packaging: Automation of Thermoforming
Processes
Automation facilitates
higher, more predictable
throughput.
GN Thermoforming Equipment
Chester, NS, Canada
The medical packaging market has
quickly embraced the use of automation
for the thermoforming process.
Automation has enabled adherence to
stringent quality requirements and has
addressed the need for high levels of
repeatability. Automation has also facilitated
higher and more predictable
throughput.
32
n What Is Different About Medical
Packaging?
Thermoformed medical packaging is
designed to protect a wide variety of items
ranging from implantable medical devices
to surgical instruments, to disposable catheters
and syringes. The selection of materials
and the forming and sealing processes
are crucial to ensuring that the integrity of
the sterile barrier system is maintained
during shipping and handling until the
product is opened by the user.
Medical items are often delicate. Therefore,
the packaging must protect the
products from damage during shipping
and handling, securely holding each item
www.medicaldesignbriefs.com
in place and separating multiple items
packaged together from damaging each
other. For sharp objects, such as needles,
screws, and drills, the packaging must be
designed to protect the safety of the people
handling and opening the package.
n Considerations
Material Selection. Ensuring an effective
and durable sterile barrier starts with
material selection. Polyethylene terephthalate
glycol-modified (PETG) and
high-impact polystyrene (HIPS) are often
selected for medical packaging applications.
PETG is created by adding a glycol
modifier to PET, making it slightly
Medical Design Briefs, September 2022
https://hello.global.ntt/en-us/insights/2021-global-threat-intelligence-report https://cdn.ihs.com/www/pdf/IoT_ebook.pdf https://www.bundesgesundheitsministerium.de/digital-healthcare-act.html http://www.medicaldesignbriefs.com
Medical Design Briefs - September 2022

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