To help promote collaborative
innovation, the sterility assurance
community needs to leverage its
scientific foundation to constantly
question the status quo, thereby
opening doors to innovation. Here
are three steps the sterility assurance community can take to help
make collaborative innovation a
1. Avoid duplication and bring
technical findings to light: One
area that prevents collaborative
innovation is the hesitation by
many companies to allow Sterility Assurance professionals to
publish technical findings, which
stems from a history of wanting
to protect intellectual property.
However, some of these technical findings may include data
regarding publicly available
At the most recent Kilmer Conference, Matt Arduino, senior advisor at the Centers for Disease Control and Prevention, spoke about infection controls and the importance of having sterile products.
technologies and are not always
protectable intellectual property.
This hesitation to publish means
that we’re often forced to duplicate efforts and repeat studies
multiple times to provide objective evidence to support change.
Repeating studies prevents the
community from continuing to
build upon the technical compe-
tency, and is one of the reasons
for a delay in technical advance-
ments. In addition, the need to
repeat studies adds delays in
bringing new products to the
market to benefit patients.
2. Challenge the status quo: Another area that prevents collaborative innovation is the hesitation
to challenge the status quo.
The FDA and many regulators
around the world are open to
working with the sterility assurance community to improve our
processes. Even so, we have not
seen significant advancements
in our technical area in the last
20 years or more. The sterility assurance community and
regulators need to work together to improve how we deliver
sterile products using alternative
needs to leverage its
scientific foundation to
constantly question the