Medical Design Technology® April/May 2015 / 17
6 Mantras for Medical
By Bart Reitter, Director,
QAD Life Sciences
If the physician’s maxim is Primum non nocere – first,
do no harm – then a
similar phrase can be
applied to medical device manufactur-
ers: produce safe, high-quality products
with a reasonable return on investment.
Lengthier and less succinct perhaps,
but no less critical.
The challenge for medical device
companies has always been to create safe
and effective products that provide therapeutic benefit to patients in need. It has
become an even greater challenge with
the advent of the global economy where
products are not only sold in multiple
countries, but manufactured there as well.
1. Global Compliance Challenges
With regulatory standards imposed by
different countries, it can be a burden
for organizations to remain compliant.
Medical device manufacturers who
want to ensure that they effectively
meet current good manufacturing
practices (cGMP) as defined by the U.S.
Food and Drug Administration (FDA)
and other governmental agencies can
benefit from technology solutions built
around their needs.
2. Manual vs. Automated Processes
Tracking inventory movements, machine
settings, and suppliers via spreadsheets is
a time-intensive burden and frequently
results in human error and increased cost.
A more efficient way for medical device
manufacturers to approach 21st century
production standards is by leveraging
a cloud-based, integrated enterprise
resource planning (ERP) system with
quality management (QM) as a central
function — not as a bolted-on afterthought.
With an effective cloud-based ERP
solution and integrated quality functions
in place, manufacturers can preserve capital, comply with global regulations, and
focus on innovation.
3. The Cost Versus Risk Conundrum
Medical device manufacturers are
constantly balancing cost versus risk.
They must determine how much cost
is required to mitigate risk. Companies
who spend little on quality face considerable risk. Meanwhile, manufacturers
reach a point where increased spend on
compliance yields a diminishing return.
This will vary for each company and
product, and is based upon factors such
as potential liability, risk tolerance, and
process improvements. Determining
the optimum point where cost and risk
intersect is a critical factor when strategically planning production.
4. Integrating Quality Processes
The FDA requires medical device
manufacturers to have a quality system
in place. While managing the organizational procedures, processes, and
resources of a medical device company
can be achieved through manual means,
an enterprise quality management
software (EQMS) solution can more efficiently integrate quality processes into
core business functions. The results are
production processes with fewer errors,
greater efficiency, and lower costs.
When medical device manufacturers
place quality at the core of their business
processes, they shift the cost versus risk
curve to reduce incremental costs for the
same level of risks. It’s through integrating
ERP and EQMS functionality that quality
is embedded into the production process.
5. It’s All in the Cloud
Leveraging cloud technology allows life
sciences manufacturers to achieve the
results described previously and to more
rapidly deploy a comprehensive ERP and
EQMS system that helps organizations focus on innovation, meet their compliance
needs, and preserve capital.
Historically, some manufacturers have
been reluctant to embrace cloud technology, citing a perceived lack of control
or security concerns when compared to
legacy, on-premise systems. However,
real-world experience with cloud deployments has proven predictable security and
reliability. They deliver the same globally
accessible, full-strength ERP and EQMS
capabilities as on-premise solutions, while
reducing the challenge of supporting an
6. The FDA’s Analysis
Recently, the FDA completed an analysis
that showed that medical device companies that managed risk by driving quality
across the organization tended to be more
productive, with fewer complaints and
investigations per lot.
The message in the FDA’s analysis is
clear: quality is no longer a burden associated with higher cost; it is a competitive
advantage. Integrated cloud ERP and
EQMS solutions not only result in a more
efficient, regulatory-compliant manufacturing process, they also help life science
companies fulfill the promise of the
manufacturers’ mantra to produce a safe,
high-quality product with a reasonable return on investment. Thanks to integrated
cloud ERP and EQMS solutions, it has
never been easier to achieve.
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