Arena provides these medical device manufacturers a collaborative environment for centralizing,
controlling and analyzing complex and constantly changing product information, including the design
history file (DHF), device master record (DMR), bills of materials (BOMs), part specifications and
change orders. The software helps reduce design errors while increasing the speed of information
exchange across the enterprise and with its outsourcing partners. In addition, Arena makes it much
easier for small and mid-size medical device manufacturers to comply with the ever-changing standards
and regulations that govern the development and delivery of products in their industry.
The companies using Arena to gain greater control over their design and manufacturing processes are
bringing to market new technologies that will significantly benefit healthcare across the nation and
throughout the world. Among them are:
AcuTemp Thermal Systems, which is responsible for the design and manufacture of reliable products
for the storage and transport of temperature-sensitive goods that enhance or save human life.
- Nanostim, Inc., a company that creates miniaturized, leadless cardiac pacemakers.
VasoNova, which is developing a new peripherally inserted central catheter to facilitate easier,
more accurate catheter placement.
ProGenTech Limited, a life science and molecular diagnostics company committed to delivering
next-generation instrumentation for nucleic acid and protein purification and molecular diagnostic testing.
Because Arena is a web-native, on-demand (SaaS) application, these small and mid-size manufacturers
have been easily able to take advantage of its benefits in the areas of availability, cost savings,
security, ease of implementation and ease of use. With no servers or IT staff required, companies are
able to get up and running with little to no investment or overhead.
Perhaps the most significant advantage of the SaaS model is the Arena Validation Maintenance Service
(VMS). Arena is able to provide customers with results of its internal software validation for use as
their own evidence of system compliance, saving customers the time and expense associated with completing
these efforts themselves. This type of service is not available with traditional client/server software and
can often take internal teams hundreds of hours every time a new software version is released.
“Our newest medical device customers are terrific examples of innovative companies with great foresight.
They are staying squarely focused on getting their products to market instead of on trying to work with,
and ultimately around, inefficient and error-prone spreadsheet software that many small and mid-size companies
use at the start and quickly find to be one of their greatest roadblocks,” said Marc Escobosa, vice president
of product design at Arena Solutions. “When it comes to the success of their companies, these managers have
recognized the critical role played by their operations professionals, quality and regulatory leaders and key
team members like document control managers, and have made sure to provide them with software that can enhance
the way they do their jobs.”
To learn more about Arena Solutions: