Barbara Kanegsberg
Edward Kanegsberg
BFK Solutions LLC
Pacific Palisades,
Calif.
In addition to the typical challenges of navigating an over- whelming conference and trade show, the 2014 MD&M West conference, held in Anaheim, Calif., provided food for thought about the current and near-future direction of
medical device manufacture. As might be expected, designing,
monitoring, and maintaining appropriate controlled environments will be increasingly important. In addition, current and
proposed designs will require careful attention to critical cleaning, contamination control, and leachable residue.
Emphasis
The program provided multiple options for education, includ-
ing futuristic predictions about 3D printers in the home, the
growth of on-demand custom implantable devices, and the
growth of “gaming” in device design. There were hands-on,
interactive workshops. The emphasis on creative, innova-
tive product design, including design for manufacturability,
is heartening in that it meshes well with the need to design
products that can be successfully cleaned, both during man-
ufacture, and, in some cases for reuse.1 The trend toward life-
cycle approach2, 3 that is being adapted from pharma for use in
device manufacture was a topic in some presentations. 4, 5
Lifecycle
The goal of the three-stage lifecycle approach is to assure that
a product or process remains in control throughout the product lifetime. A consequence of this approach is an emphasis on
pre-validation during the design and continued monitoring
after product introduction. The FDA Center for Devices and
Radiological Health Strategic Priorities for 20146 includes
striking the right balance between pre-market and post-market data collection by shifting—when appropriate—some
pre-market data needs to the post-market setting in order to
reduce the time for patient access to high-quality, safe, and
effective medical devices of public health importance.
Stage 1 is design and development, with the primary aim
to fully understand the process so that it is suitable for routine commercial manufacturing. We are strong proponents of
