before ever building a physical prototype. Human body computational modeling and simulation is another advanced software
application that allows medical device companies to explore a
variety of different designs in less time, at a fraction of the cost,
compared to traditional approaches.
“Predictive human body simulation has broad applications
across the healthcare environment, from assessing human body
reaction to implanted medical devices, long-term reaction to
pharmacological drugs, interaction between drugs and implants
(passive and active), and outcome effects to surgical procedures,”
The Internet of Things, combined with increased computer
abilities, will push Industry 4.0 to the forefront. Driven by data
analytics, automation, and cloud-based computing, Industry 4.0
will take real-time analysis and behavioral predictions in manufacturing to new levels—for example, identifying and correcting
potential problems before they get worse and shut down a process.
“Industry 4.0 is a goal for manufacturers to aspire toward and
is particularly relevant to North American and European manufacturers, who want to stay at the forefront of global manufacturing competitiveness and quality,” said Randunz.
Software will be at the forefront of all these advancements.
The demand for mobile, wearable, wireless, connected, and
Io T for medical devices has already resulted in a surge of medical
smart systems and software. But this surge brings some caution-
ary advice from Willett.
“Not all companies creating these products are aware of the
stringent requirements needed for quality and compliance, nor
understand the full gamut of testing and validation needed associated with their product’s patient risk,” she stated.
Therefore good design, streamlined clinical execution and
data, regulatory oversight, and overall quality management are
needed more than ever across a device company’s enterprise.
“This has not always been the case over the years, where automated software to help in these operational areas has been
disparate, duplicative, and not visible,” added Willett. “As the
industry turns to expand its business model with service-based
solutions, the data which documents the success of healthcare
delivery—and the software that collects it—will be as important
as the product device itself.” v
Mark Crawford is a full-time freelance business and marketing/com-munications writer based in Madison, Wis. His clients range from
startups to global manufacturing leaders. He also writes a variety of
feature articles for regional and national publications and is the author
of five books. Contact him at firstname.lastname@example.org.
Using Technology to Turn Operational
Excellence Vision into Reality
Wednesday, April 19th | 2:00 PM EST
JOIN US FOR OUR NEXT WEBINAR
When one hears the phrase “Operational Excellence” they think process improvement or increasing ef;ciency in the process. But most companies struggle to turn their Operational Excellence (OPEX) vision into reality. What happens AFTER you design your OPEX program?
How do you improve effectiveness and ef;ciency while maintaining compliance and reducing risk?
In this session we look to answer those questions by demonstrating how your re;ned process can translate
into an electronic system that can help turn vision into reality.
To register, visit www.mpo-mag.com/contents/list_webinars/
PRESEN TED B Y
Principal, Quality and Compliance Services
Product Strategist for Life Sciences
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