Medtech companies are used to running
into regulatory obstacles during their innovation processes. According to MDDI,
these companies are divided into three type of business: large scale medical
device innovators and manufacturers; new device innovators (ranging from the
surgeon with a good idea to the existing medical device company with a product
line of a few products); software technology innovators. It’s true that they
all share common challenges, but their primary ones are different according to
their role in this complex industry.
Source: MDDI
When talking with each
segment; here are the three biggest challenges they all share:
1. Cost and complexity
to improve and enhance innovation: large scale medical device innovators have a
great overview of the marketplace and the regulatory system, but identifying
the best R&D opportunities is not always easy. Big data analytics are
expensive and complex to implement. “The more incremental the deployment of any
new technology can be made, the more likely you are to achieve final success.”
2. Time and volume of
follow-up and tracking data from FDA: it’s very time-consuming to go through
FDA notices, recalls and regulatory changes. “Technology now allows you to both
take optimal advantage of the level of effort required and increase the quality
of the results for you by automating the access to the data.”
3. “Getting blindsided
by regulatory issues is probably the most common complaint from software
innovators”. Having access to FDA guidance, regulations and industry best
practices can help these innovators avoid this type of problem.
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