Founder and CEO, Boston Device Development
In 2014, the medical device industry will see increasing interest
in “agile development,” a process of iteration that has become
a mainstay in software development. Rather than following the
standard waterfall process, teams will rely on “sprints” (rapid iterations) to
achieve functional embodiments of medical devices.
While these sprints may lack extensive up-front analysis, this way of working promises several advantages. Working in sprints enables the early discovery of flaws. Realizing these issues sooner allows teams to change directions
without spending excessive time or money on a pre-selected pathway. Overall,
agile methods will facilitate higher quality devices in shorter periods of time.
However successful, this shift will also create new obstacles. Medical device
development requires a documentation trail that can be time intensive and prevent sprints from progressing at their optimal pace. Furthermore, verification
requirements may slow down the sprint process. Quality system methods and
documentation will need to adapt to be compatible.
Despite these challenges, we welcome the increasing implementation of
agile processes that reduce costs for medical device manufacturers, increase
product quality, and accelerate the path to market. MDT
Gerry Gunderson, CPP
VP of Engineering, Quality Tech Services
The Final Rule for FDA’s Unique Device Identification
(UDI) mandate is now released and will be in focus in
2014. Class III device manufacturers will need to comply by
September 2014, unless granted an exception (and exclud-
ing grandfathered salable inventory). The “go-live” obliga-
tions include: updating their quality system as appropriate; establishing a
unique Device Identifier (DI) for each device; changes to package labeling
for AIDC marking and standardized date formatting; and publishing
information to FDA’s GUDID database.
Similar requirements apply to the other device classes in subsequent
years. Device manufacturers and their contract manufacturing partners
will be refining their internal programs and systems as they approach
One obvious challenge is the control of data and creation of GUDID
records; a program generally referred to as Master Data Management.
The GUDID database is an integral part of the UDI program and these
data records require as much care and diligence as the pending label copy
For a subset of manufacturers, direct part marking (DPM) represents
another significant challenge. Some devices will require a physical UDI
marking as soon as September 2015. Given the complexity of this challenge, impacted manufacturers will begin DPM research in earnest in