adding a porous surface layer to implants
to ensure better osteointegration while
improving how a patient’s bone grows
into it. Traditional methods included a
secondary step of spraying on this porous surface, while additive methods allow this complex design to be made with
the rest of the part. This eliminates the
risk of delamination between the coating
and the solid portion of the implant.
While it’s still an area the medical
field is exploring, AM allows for the
development of patient-tailored parts
through 3D data obtained from MRI, CT
or CAD9. Since AM-produced parts, like
spinal implants (Figure 3), can be made
as a single unit part (instead of having
multiple components), the structural
integrity of the part is much greater than
those produced using traditional methods.
A complex implant produced using AM
isn’t isolated to the R&D lab either. There
are several cases of additive implants with
longer-term clinical history. For example,
more than 100,000 3D printed hip cups
have been implanted in patients, with 10
years of clinical history10.
How 3D Printing Stacks Up to Tradi-
tional Machining
In medical parts production, choosing a
manufacturing method always depends
on the application and ability to redesign
a product. Generally, you’re not able
to design a device or instrument for a
traditional subtractive method, and then
decide to additively produce it one-to-one, especially not from a cost-effective
standpoint. In most cases, a redesign for
true functionality is beneficial to utilize
the potential of AM. At the most basic
level, AM is cost-effective in design when
it’s used to accomplish three things:
1. Create a complex design not feasible
using traditional methods
2. Address a unique or custom patient need
Spinal implants are one example that
demonstrates the ability to use AM
methods to innovate faster with less cap-
ital investment by optimizing production
to one whole part. Within a spinal prod-
uct family, there are a variety of surgical
approaches which require multiple im-
plant designs, all needing their own tradi-
tional machining set up for production.
With AM, one machine can produce
many different designs, eliminating the
need for multi-tooling and decreasing the
large capital investment needed to set up
production. This type of application en-
ables smaller companies to gain entrance
and compete in the market.
AM has great potential to signifi-
cantly reduce costs, especially when it
comes to part consolidation. In the case
of medical instrumentation, AM has
proved to drastically reduce the number
of parts, potentially shortening produc-
tion time—even eliminating distribution
barriers by having parts made onsite.
When it comes to comparing additive
versus traditional subtractive methods
of manufacturing, it always depends on
what you’re making, what you’re trying
to achieve and the flexibility of the sup-
ply chain model.
An Additive Future
Medical device makers were some of
the earliest adopters of AM back when
the technology was first available in the
1980s for prototyping purposes. Since
then, applications have gone far beyond
prototyping, with some device makers
making several thousand printed devices
a month, bringing AM into “
production-level” territory. If orthopedic device
manufacturers are not looking at AM,
they are behind.
The industry has already seen regu-
latory activity pick up in regard to AM,
with more than 100 FDA cleared addi-
tively manufactured devices currently on
the market. AM processes are subject to
the same level of accuracy and material
contamination risks of any manufactur-
ing approach, which means companies
have to invest time and money into
R&D before AM parts are ready for the
market, just as they would with conven-
tional manufacturing techniques. The
good news is that R&D efforts occurring
over the past few decades are supporting
the technology and allowing it to gain
traction in an increasing number of appli-
cations. In response, the FDA has put
significant focus on providing a regula-
tory pathway in an attempt to keep up
with the rapid pace of adoption.
Those that are first to market with a
new technology are often the most successful, whatever the industry or field. The
medical industry is not only well ahead of
the game when it comes to AM adoption
and application, it is positioned to rapidly
increase its investment in the near future.
References:
1 Deloitte: 3D opportunity in medical
technology
2 Avicenne Medical: The worldwide
orthopedic Contract Manufacturing
market report 2016-2021 and Top
100 Supplier profiles
3 MMI: Medical Additive Manufactur-
ing/3D Printing Annual Report 2018
Smith & Nephew Visionaire
• 4 Based on internal Smith & Nephew sales data from 2017
• 7 United Hospital Efficiency Program with VISIONAIRE Cutting
Guides. St. Paul, MN.
• 8 Based on published Smith &
Nephew manufacturing protocols
5 Mayo Clinic: First nationwide prevalence study of hip and knee arthroplasty shows 7. 2 million Americans
living with implants
6 Bodycad
9 3D Printing Industry: FDA Clears
“First Ever” 3d Printed Spine Implant
To Treat Of Multiple Injuries
10 3D Printing Industry: Lima Corporate’s Ebm 3d Printed Hip Plant
‘Could Last A Lifetime’ MDT
Figure 3. 3D printed spinal implants can
be made as a single unit part instead of
having multiple components, increasing
structural integrity over parts produced
using traditional methods.
