We recently participated in an incredibly infor- mative and thought- provoking workshop
about additive manufacturing (AM),
frequently referred to as 3D printing.1 The program was planned as
an interactive discussion; many of
the participants and attendees had
friendly, productive chats with FDA
personnel. Really! The workshop was
sponsored by the Center for Devices and Radiological Health
(CDRH), which is the section of FDA that has jurisdiction for
regulation of medical devices. The stated purpose of the workshop was to provide technical input to FDA personnel about
technical assessments related to AM, and to foster a transparent process for future AM medical device submissions. While
the program was focused on medical device manufacture, there
was a strong representation from aerospace. This should not be
surprising since many of the issues inherent in 3D printing are
common to the manufacture of all high value products. Some
of these issues relate to critical cleaning, contamination control, surface quality, materials characterization, and materials
It was impressive to observe the range of additive manufacturing that already occurs. Broadly speaking, participants
described objects made of metal, of polymers, and even of cells.
By using cells in what amounts to an ink jet printer, tissue and
even artificial organs made of more than one cell are possible.
In terms of metals and polymers, 3D printing of implantable
devices shows great promise in terms of customization and
response to acute trauma. Of course, implanted devices require
particular attention to detail in terms of design, risk assessment,
process design, and ongoing monitoring. Also, in the hospital,
CT or MRI imaging followed by 3D printing can also be used to
obtain models of organs, including damage or defects. Surgeons
may find it helpful to simultaneously touch and visually inspect
a model of the organ prior to surgery.
Interaction and reaction
In addition to prepared PowerPoint presentations, an unusually
high proportion of the program was devoted to questions, answers,
comments, and concerns. The program was webcast; comments
were taken from those in the room and online. Video documenta-
tion and conference materials are available online. 2 Many partici-
pants discussed the desirability of
AM and the need to encourage
development of the technique.
As might be expected with such
audience participation, there were
differences of opinion and spirited
exchanges. One example of differing opinions relates to the batch
to batch consistency of polymers.
Some participants felt that con-
sistency has been achieved; others
found it to be a problem. The concept of “consistency” is somewhat
like the concept of “how clean is clean.” The concepts of consistent
and clean are inherently related to performance requirements. It
is well known that successes are published; however, people tend
to soft-pedal failure, or report failures anecdotally. Therefore, one
approach may be to encourage publication of failures, of situations
where inconsistency is found, and of defining such inconsistencies
in the context of the application. It may be that we need to define
additional requirements. A related approach to resolve the issue
may be to establish additional standards or test methods to demon-
strate such consistency. We do not have all of the answers, but the
workshop was certainly a step in the right direction.
How does one decide how clean is clean enough? How do you
demonstrate cleanliness? What extraction techniques ought to be
used? In some of our verbal comments during the workshop, we
explained that the issues raised by the prospect of 3D printing are
not new. Instead, they are brought into a fresh focus by the prospect of devices and components that can be essentially all surface—devices that may have a very high complexity of configuration, and products that may be comprised of blends of metals and
polymers that historically were not available before. We proposed
the concept of mindfulness. Not the mindfulness associated with
meditation or yoga but rather the mindfulness associated with a
healthy respect for the number of variables involved. This is closer
to the way that that many in the life-sciences approach their work.
Some factors include considering the likely risks, balancing cleaning with the potential for surface damage, providing the rationale
for decisions made, and demonstrating ongoing process control.
One example of where we are all likely to have to come to
a rational, mindful approach is in minimizing the level of particulates on the surface. Let us suppose you are manufacturing a
complex, convoluted part produced by 3D printing using metal
…the issues raised by the prospect of 3D printing are not new.
Instead, they are brought into
a fresh focus by the prospect of
devices and components that
can be essentially all surface.
BFK Solutions LLC
FDA Additive Manufacturing
Exploring the future of 3D printing.