What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.

2. Orthopedic Coatings:
Predictions for 2025
A Surgeon’s Perspective
Gordon D. Donald, M.D.
NJ Ortho Group, LLC
Molecular Surface Technologies, LLC
June 13, 2019

3. Pin Tract Infections and Bioglass Coated Pins
Univ of Vermont, 1979-80
Poor materials
Poor manufacturing (by today’s standards)
Mismatched materials

4. Orthopaedic Surgeons’ Motivations
• Professional Success/Clinical
Effectiveness
• Good patient outcomes
• Do no harm
• Compensation
• Procedural reimbursement
decreasing across the board
• Change
• Creatures of habit
• Cost

5. Clinical Effectiveness
• Process works and is
clinically significant
• Process is easy requiring
no extra work
• Process is transparent to
normal workflow

6. Compensation
• Orthopedic surgery is a
“piecemeal” business
• There are a finite number of
surgical cases
• Must improve surgeons
efficiency and/or allow for more
procedures or decreased
operative time
• Improve surgeon’s quality of life

7. Change
• Orthopedic surgeons hate change
• Device changes need to be transparent
or imperceptible to the surgeon
• Must feel the same and give same
proprioceptive feedback
• No change in normal
workflow or technique
• No extra work
• No extra time

8. Cost
• The new bane of an orthopedic surgeon’s survival
• Multiple stakeholders
• Surgeon
• Does it take more of my or my staff’s time and effort
• Hospital
• Is this a pass-through cost or does it effect my bottom line
• Insurance Company
• Generally considers only immediate cost with
little investment in future outcome
• Patient
• Does this cost more recovery time, out of work time,
or can I avoid another operation

9. 5 Year Spinal Surgeon Wish List
• Improved clinical outcomes
• Many variables but most dependent on boney healing and decreased complications
• MIS
• Less invasive and faster healing/return to function
• Less space/volume for bone grafting materials
• Improved navigation
• High cost with no separate reimbursement
• Robotics
• High cost with no separate reimbursement
• Biologics/tissue engineering
• Need much more research

10. Orthopedic Clinical Needs for Coatings
• Antimicrobial
• Decrease device related
deep infections
• Bone
• Improve bone healing directly
to material surface
• Others (lubricity, surface
protection, drug delivery)

11. Device Related Deep Infections
• Almost all implant infections are related to
the inoculation of bacteria on to the device
surface at the time of surgical implantation
• There is only a small percentage of deep
infections that are truly secondary (occur
from late bacterial seeding), mostly with
immunocompromised patients
• Deep implant infections are
a surface phenomena

12. Device Surface
• For most current biomaterials used, the
material surface is immunodeficient and acts
almost as an immunocompromised host
• Whereas 1000s of bacteria are required to
initiate a non-implant infection, only a few
bacteria may result in an implant related
infection
• For prevention of infections, the primary, and
probably only needed antimicrobial effect is
that the device surface be
• most clinically effective
• least systemically toxic (best regulatory strategy)

13. Antibacterial coating of implants: are we missing something?
C. L. Romanò, H. Tsuchiya, I. Morelli, A. G. Battaglia, L. Drago
Published Online: 28 May 2019 https://doi.org/10.1302/2046-
3758.85.BJR-2018-0316
• Romano et. al (2019)calculated
that the total direct costs savings
of decreasing infection rate of
TJA implants, with up charge of
€600 per implant, would save
€440 million per year in Europe.
This would be roughly a savings
of $1.75 billion in the US
marketplace.

14. Characteristics of an Ideal Antimicrobial Surface
• Broad-spectrum antimicrobial effect
• Rapid antimicrobial effect
• Stable
• No change to mechanical characteristics of device
• Easy, scalable manufacturing
• Relatively low-cost
• May be applied to multiple materials
• Clear regulatory pathway

15. Bone: “the more bone the better”
• Bone healing
• Bone stabilization
• Bone fusion
• Spinal implants
• Interbody
• Posterior instrumentation
• Joint reconstruction

16. Treatments to Enhance Bone
• Passive
• Coatings or surface modifications that allow
for biologic activity resulting in local bone
growth
• Provides for a geometrically friendly surface
and osteointegration
• May allow surface protein adsorption to
promote osteogenic process
• Active
• Promotes osteogenic process without the
need of separate signaling protein
adsorption
• Osteoblastic response occurs directly with
material surface

17. Passive Bone Enhancement Surfaces
• Specific biomaterials
• Ti is hydrophilic and considered “bone friendly”
• Normal PEEK is very hydrophobic and bone
unfriendly
• Surface texturing/3-D
• Osteoconductive/osteointegration
• Fibrous layer between bone and material remains
• CaP surfaces
• Osteoconductive and requires protein
deposition/adsorption
• Nano texturing
• Requires protein absorption to
initiate cellular response
• Osteoconductive and probably osteoinductive

18. Active Bone Enhancement Surface
• Molecular surface modification with
bioactive signaling peptides, proteins, etc.
• Direct attachment of osteoblast to surface
• No need for passive protein adsorption and
therefore not dependent on host response
• Results in not only surface attachment of
bone cells but also acceleration and
amplification of local bone healing process

19. 2025: Where Are We Going to Be?
• Evolutionary tweaks and changes to the implant
systems will continue to dramatically decrease from the
past
• Advances will be all about better materials and better
biology
• We like the mechanical properties and function of
current implant materials but not very biologically
effective
• Coatings over the past 20 years have been marginally
effective and successful
• May perceive a need for new biomaterials that provide
optimal mechanical and biologic function, but unlikely
over next five years in current regulatory environment
• Optimize current material surfaces to provide necessary
function without need for additional coatings or layers

20. Molecular Surface Technologies
• Molecular modification of material surface with stable and
robust covalently bound functional molecules
• Provide potent antimicrobial properties
• Provide active bone enhancement
• Applicable to multiple materials- metals, polymers, tissue
• Defined regulatory path
• Proprietary processes for exceptionally cost-effective
scalable manufacturing

21. ORTHOPEDIC
IMPLANT COATINGS
WHERE HAVE WE BEEN AND
WHERE ARE WE GOING?
Christopher Scifert, Ph. D
Director of Engineering
Orchid Design
(A Division of Orchid Orthopedic Solutions)

22. OVERVIEW
• Clinical issues with orthopedic implants
• Current coating technologies in the market
• Market trends
• Coatings 2025

23. CLINICAL ISSUES WITH ORTHOPEDIC IMPLANTS
• Infection
– Biofilm
– Bacterial adhesion
• Loosening
– Aseptic loosening
– Osteolysis
– Stress shielding
• Wear
– Particulate debris migration
– UHMWPE particles – small particles,
number of particles
• Corrosion/Ion Release
– Galvanic
– Fretting
– Surface Oxidation
– Metal Allergy

24. CURRENT COATING TECHNOLOGIES IN THE MARKET
• Fixation - Bone Ingrowth/Ongrowth
– Sintered coatings (beads/wire)
– Plasma Spray Titanium (TPS)
– Calcium phosphate
– Hydroxyapatite
• Wear Reduction/Anti-Allergy/Anti-corrosion
– PVD/CVD coatings
• Titanium Nitride (also Titanium Niobium Nitride)
• Chromium Nitride
• Zirconium Nitride
• Diamond Like Carbon (DLC)
– Surface modifications
• Oxinium™ Oxidized Zirconium
• Nitrogen Ion Implantation
• Anti-microbial
– Gentamicin Poly(d, l-lactide)
– Silver coating (MUTARS and Agluna)
– Povidone-Iodine based coatings

25. MARKET TRENDS
• Component Trends
– Cost sensitive
– Evidence based
– CoCr materials are not price stable
– Lower stiffness components for stress shielding
– 3D printing
• Coating Trends / Needs
– Low cost
– Damage resistant
– Wear resistant coating (enhance tribological properties of the system)
– Bioinert
– Low propensity to form biofilms

26. COATINGS 2025
• Ceramic Coatings
– Allow lower modulus components as articulating surfaces
• Titanium Alloy
– Increase wettability (reduce surface tension)
– Less sensitivity to brittle failure
– Easier regulatory path than monolithic ceramic
• Plasma Spray Ceramic Coatings
– Used in aerospace and other industries
– Durable
– FDA indicates coatings like this will not change device classification
– Early indicators are that wear performance is significantly improved
vs. uncoated CoCr
– Thicker than CVD/PVD (50-200 micron vs 5-10 micron)
• Variety of materials
– Aluminum Oxide/Titanium Oxide
– Chrome Oxide
– Zirconium Oxide

27. CONCLUSION
• Low cost durable coatings
– Wear reduction
– Metal allergy control
• Articulating surface applications
– Ceramic coatings
• Plasma spray
• CVD/PVD

28. Thinner. Faster. Stronger.
Ulf Brogren, President, Promimic Inc
OMTEC 2019

29. 2
Optimized for Osseointegration
The HAnano Surface is a 20 nanometer thin layer of hydroxyapatite (HA) which through
size, shape and structure mimics human bone. The super-hydrophilic surface attracts
bone cells, accelerates healing and increases anchoring strength. Proven clinically on
dental implants to improve implant fixation and faster osseointegration.
1 µm

30. 3
New Size Regime
Traditional coating
40-80 µm
80 µm
0.02 µm

31. 4
Wet Chemistry Coating Method
Online video: http://www.promimic.com/index.php/products/coatingprocess

32. 5
Introducing Hydrophilicity

33. 6
Creator of Faster Osseointegration

34. 7
Titanium Implants in Diabetic Model
 Systemic diseases, such as diabetes mellitus (DM),
may negatively influence osseointegration
 Diabetes is considered a risky condition for dental implants
– delayed wound healing
– prevalence of microvascular disease
– impaired response to infection
 The purpose of the study was evaluate the biologic response
in diabetic and non-diabetic rats
 Acid etched titanium implants were used with
7 and 30 days of healing

35. 8
Results
Microtomographic analysis showed that the implant surface coated with the HAnano Surface presented the
best values in all of the evaluated parameters both in 7 and 30 days after implant insertion, and especially
in the diabetic rats
Scombatti de souza (2016), Microtomographic evaluation of a new nanometric hydroxyapatite covered implant surface.
In vivo study in diabetic rats
Acid etched titanium implants
HAnano Surface coated acid etched titanium implants
Improved Integration for Risk Patients

36. 9
HAnano Surface in Short
 Unique surface modification for all
implant materials and shapes
 Creates a super hydrophilic interface for osseointegration
 Verified in +20 in vivo studies and +100.000
patients for dental implants
 Regulatory pathway through 510(k)
 Cost effective business model and fast track to
market through Danco partnership