HONE YOUR COMPETITIVE EDGE - Camber Spine
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HONE YOUR
COMPETITIVE EDGE
2018 Orthopaedic Industry Annual Report
Members, download
your copy at
ORTHOWORLD.com
or join today for access.
210 Pages | 86 Exhibits | Sample Pages | Table of Contents at ORTHOWORLD.com
or, contact Fran Bursic, 440.543.2101, fran@orthoworld.com
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IN THE ZONE
“AM is set to play a major role in the manufacturing of tomorrow’s
novel orthopaedic devices based on its flexibility, economies of scale Volume 17 | Issue 3 | August 2018
for short runs and ability to produce parts of almost unlimited
complexity.” Editorial & Production
The tomorrow that additive manufacturing veteran Andy Christensen Chief Content Officer
wrote about in a 2013 BONEZONE article is here today. Orthopaedic Carolyn LaWell: carolyn@orthoworld.com
device and supplier companies have accelerated their adoption of
additive manufacturing and are experiencing the benefits and trials Senior Editor
Rob Meyer: rob@orthoworld.com
of the technology.
Editorial Assistant
This issue’s special focus is additive manufacturing, and you’ll see Julie Vetalice: julie@orthoworld.com
that many uncertainties remain. From page 35, “Device compa-
nies continue to develop new designs and push the technology in Media Production Coordinator
Karen Young: karen@orthoworld.com
ways that additive machine companies themselves hadn't expected.
Further, companies throughout the orthopaedic supply chain that BONEZONE is printed 5 times per year in March, June,
have decades of additive experience are joining the call for increased August, October and December by ORTHOWORLD.
standards and guidance. This call is partially driven to ensure that Online content is published monthly at
additive is employed and advanced in a way that won’t harm patients www.BONEZONEpub.com.
and ultimately the industry, and partially because companies seek to
substantiate their additive processes. Outstanding questions pertain
to significant topics like material standardization, process validation,
8401 Chagrin Road, Suite 18
design limitations and cleanliness recommendations.”
Chagrin Falls, Ohio 44023 USA
www.ORTHOWORLD.com
Additive manufacturing is a business-critical subject in orthopaedics.
Significant resources are dedicated to harnessing its potential. With Copyright © 2002-2018
this in mind, this issue presents a number of different perspectives by ORTHOWORLD Inc.
and considerations to bear in mind when discussing additive within All rights reserved.
your company. We provide OEM and surgeon insight, detail the rea-
sons why there is so much more to learn about additive, investigate
issues such as lead time, design and testing, and share wisdom from On the cover:
regulatory experts on additive standards and submissions. Serial titanium
3D-printed spinal
implants arising
We expect additive manufacturing to dominate industry conversa- during the powder
tion for years to come. As its adoption expands and the technology removal process.
becomes even more complex, so will the discussion. — The Editors
Photo courtesy of
FMI Instrumed,
fmi-international.com
INDUSTRY ADVISORY BOARD
A world-class board of industry advisors steers BONEZONE and OMTEC toward relevant and timely educational content
that is consistent with the needs of OEM professionals and companies.
Active Implants MicroPort Orthopedics Wright Medical Zimmer Biomet
Ryan Belaney Scott Shankle Mary McCombs-Stearnes Howard Levy
Director, Regulatory Affairs Vice President Operations Director, Quality Vice President, Global Sourcing
Operations & Engineering Instruments and Trauma
Arthrex Smith & Nephew Orthopaedics
Lance Provance Mark Hall Wright Medical Honorary Members:
Supply Chain Manager Global Commodity Leader – Jody Scrivner
Implants, Advanced Senior Manager, Matthew Poggie, Senior Vice
DePuy Synthes Surgical Devices Global Sourcing President of R&D and Chief
Sharon Starowicz Technology Officer
Director, Regulatory Policy Stryker Orthopaedics Zimmer Biomet Acuitive Technologies
Innovation, Global Orthopaedics, Kenneth Trimmer Michael Esch
Johnson & Johnson Chief Engineer - Knees Director, Product Development, Dale Tempco, Industry Consultant
Knee Creations
DePuy Synthes Tyber Medical Rich Woods, Founder
Paul Wyatt Jeff Tyber MedCon
Senior Principal Engineer President, CEO and Founder
BONEZONE • August 2018 3
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TABLE OF CONTENTS
6 Market Watch INDEX OF ADVERTISERS
Supplier News
Stryker’s David Floyd Announces Retirement, Effective in June 2019 3D Systems – pages 35, 39, 41
Apex Tools – page 7
8 Research Report Bradshaw Medical – front inside cover
Study Validates NuVasive’s Porous PEEK Cohere
FMI Instrumed – page 17
Top-Line Results from Anika’s CINGAL Trial
Final Patient Treated in Active Implants’ NUsurface Trials Huron Tool & Cutter Grinding – page 33
Marox – page 4
10 Spinal Cages Continue Trend Toward Metals, Miraclean – page 49
Expandable and Additive Designs
Three surgeons provide insight into the shift to titanium, a forecast for the next Orchid Orthopedic
five years in cage technology and thoughts on device companies' priorities. Solutions – back outside cover
Paragon Medical – page 13
14 How EU’s MDR Will Impact Your Supply Chain
Phillips Precision Medicraft – page 11
OEMs must engage partners in conversations about the information needed
from each party in order to meet regulatory requirements, timelines for Superior Polymers – page 43
CE Mark approval and make critical considerations for audits.
Tecomet – back inside cover
16 Supply Chain Quality: OEM and Supplier Perspectives
Tegra Medical – page 15
At OMTEC 2018, a panel of experts discussed relationships, regulations Teleflex Medical OEM – page 47
and standards that impact supply chain quality. WebOps – page 23
Willemin-Macodel – page 9
34 Additive Manufacturing
Xact Wire EDM – page 19
34 - An Introduction from 3D Systems
36 - What We've Learned about Additive...So Far
39 - Surgeons Establish Society to Advance Additive Applications
40 - FDA Responds to Questions on 510(k)s, Reusing Powder, Testing
44 It's Time to Think Different About Management Reviews
When done correctly—with preparation and an energized approach—these
reviews can complement strategic planning and measure the effectiveness of
your QMS in relation to your business model.
46 Finding Your Way in a Post-Lean/Six-Sigma World
Using Data, People and Science
Operations science allows executives to start from well-established first
principles and build business success. Decisions are guided by practical
applications that govern all operations.
IN EACH ISSUE
3 Industry Advisory Board
5
42
Index of Advertisers
20 Featured Player Directory
42 Supplier Talks: Milling
50 Surgeon’s Suite
BONEZONE • August 2018 5
MARKET WATCH
Supplier News
Carpenter Technology is adding an Emerging Technology gain a greater understanding of their processes and over-
Center to its Athens, Alabama campus. The facility, slated come the difficulties with AM in critical applications, process
to open in approximately 12 months, will initially focus stability and part quality, according to the company.
on additive manufacturing technology development, with
future investments slated for meltless titanium powder and Tecomet bolstered its high-precision instrument manufactur-
other materials. Carpenter expects to invest $52MM in the ing with the acquisition of HD Surgical. Bristol, Pennsylva-
Emerging Technology Center, which will create approxi- nia-based HD Surgical — which employs 70 people and has
mately 60 jobs over the next five years. been serving the medical device industry for over 25 years
— supplies instruments to the orthopaedic, ENT and cardio-
HP and Siemens expanded their collaboration to enable vascular industries and possess a wide array of machining
more advanced functionality across a broader set of Siemens capabilities. This acquisition of aligns with Tecomet's recent
PLM software, to support users with design and manufacture M&A activity, as well as the activity of other orthopaedic
employing HP’s Multi Jet Fusion 3D printing technology. contract manufacturers. ORTHOWORLD estimates for 2017
placed Tecomet first among the top five contract manufactur-
Integer sold its Advanced Surgical and Orthopedics product ers serving the orthopaedic industry, ranked by revenue.
lines to MedPlast for US $600MM in cash. MedPlast subse-
quently rebranded as Viant. With the Integer ASO line acqui-
Stryker’s David Floyd
sition, Viant gains a range of metals manufacturing capabili-
ties (e.g. machining, stamping, coating and metal forming),
as well as design, development and prototyping services. Announces Retirement,
MedTorque announced a line of single-procedure torque- Effective in June 2019
limiting drivers, offering the Torque-Shield™ cycle count The company announced other leadership
system as well as a ratcheting drive mechanism as standard changes, including Timothy Scannell as COO.
features. The company also entered into a European market
D
distribution agreement with Swiss company MPS Precimed, avid Floyd, Group President of Orthopaedics at
a global provider of trauma products. The agreement gives Stryker, will retire on June 30, 2019. Until then,
Switzerland-based MPS Precimed access to MedTorque’s he will remain Group President and Advisor to
product portfolio for distribution in the European market, Kevin Lobo, Chief Executive Officer.
including MedTorque’s silicone handled components, fixed Mr. Floyd began his orthopaedic career at Zim-
drivers, ratchet drivers with TRI-GEAR™ technology and mer after graduating from college. He joined Stryker
torque-limiting drivers. in 2012 after 25 years in medical technology, including
leadership roles at Abbott Spine, AxioMed, Centerpulse
Metal Craft and Riverside Machine & Engineering (Sulzer), DePuy Orthopaedics and OrthoLogic. He also
appointed James Rindy as the company’s Business Develop- served a term as Chief Executive Officer of OrthoWorx in
ment Manager. Warsaw, Indiana and has been a board member of NN,
Inc. since 2016.
Millstone Medical hired Mr. Khrishna Mangal as Chief Infor-
As head of Stryker Orthopaedics, he has overseen a
mation Officer. Mangal joins Millstone with over two decades
number of acquisitions since 2013 — most notably Mako
of experience in senior IT, supply chain and shared services
Surgical, and also Instratek, Small Bone Innovations and
operations positions. He most recently served as a Consul-
Stanmore Implants.
tant for Paragon Medical, managing the implementation of
Responsibility for all operating business and regions
its global ERP system and integration planning with NN, Inc.
will now fall to Timothy Scannell, who assumed the title
Nexcore Technology and Phase 2 Medical Manufacturing of President and Chief Operating Officer in August 2018.
combined to form NextPhase, which specializes in single-use Stryker is adopting a new commercial leadership
instruments and disposable devices. structure with two new Group Presidents. J. Andrew
Pierce will head MedSurg and Spencer Stiles will lead
North Grove Enterprise added OrthoMed as a resource Instruments, Neurotechnology and Spine.
provider to its lineup of hand instrumentation and design/ Mr. Scannell began his career with Stryker in 1990 and
engineering services. served in roles of increasing responsibility, most recently
leading MedSurg and Neurotechnology divisions.
Renishaw debut InfiniAM Spectral, a new additive manu- Mr. Pierce and Mr. Stiles have both been with Stryker
facturing process monitoring software. Developed for use since 2008.
on Renishaw systems, the software package helps AM users
6 BONEZONE • August 2018
RESEARCH REPORT
Study Validates NuVasive’s Porous PEEK Cohere
Cohere provides a 3-dimensional architecture to help elicit and encourage bone ingrowth.
N
uVasive announced results of the study, “Early Outcomes of Anterior Cervical Discectomy and Fusion Using Porous
PEEK Interbody Fusion Device,” demonstrating that the company’s patented porous polyetheretherketone (PEEK)
technology is a clinically viable alternative to improve osseointegration and fusion rates of interbody implants to treat
degenerative disc disease.
The study tracked 31 female and 19 male degenerative disease patients with an average age of 60 who underwent anterior
cervical discectomy and fusion with a Cohere device, with 100% of participants experiencing positive results.
Thirteen subjects had previous unsuccessful anterior cervical fusion. All those who underwent revision with Cohere achieved
fusion at six months post-op. At 12 months post-op, all 50 patients demonstrated improved motion, decreased neck pain and
average disc height increased by more than 4mm, as well as radiographic fusion.
NuVasive acquired Cohere and the technology's developer, Vertera Spine, in September 2017 with plans to apply the porous
PEEK technology to its product development pipeline.
Top-Line Results from Final Clinical Patient Treated in
Anika’s CINGAL Trial Active Implants’ NUsurface Trials
Certain outcomes consistent with If cleared by FDA, NUsurface
statistically significant results in Phase III would be the first
placebo-controlled clinical study. “artificial meniscus.”
A
ctive Implants
A
nika Therapeutics announced results
announced
from the Phase III clinical trial of
treatment of
CINGAL to support U.S. registration.
Photo courtesy of Active Implants
the final patient in
A previous placebo-controlled Phase III trial
SUN and VENUS trials
demonstrated safety and efficacy through 26
evaluating the NUsur-
weeks, while the current trial compared CIN-
face Meniscus Implant
GAL, a combination of cross-linked HA and tri-
for the treatment of
amcinolone hexacetonide (TH), with TH alone
persistent knee pain
and cross-linked HA to treat knee osteoarthritis
from injured or deterio-
(OA). The primary endpoint was a comparison
rated meniscus tissue.
of the pain reduction of CINGAL vs. TH alone
The company is pursuing
at 26 weeks. While CINGAL achieved greater
FDA De Novo 510(k) clear-
pain reduction numerically at every time point
ance for the device.
in the study, the difference at 26 weeks did not
The trials enrolled a com-
reach statistical significance.
bined 243 patients, 176 of which
Researchers observed significant improve-
received NUsurface. VENUS (Veri-
ments in pain, function and quality of life at
fication of the Effectiveness of the
levels consistent with or greater than results of
NUsurface System) commenced in
the placebo-controlled study, as well as a strong
2015 as a randomized, prospective, controlled study compar-
safety profile. Patient follow-up in a prospec-
ing NUsurface to non-surgical care, enrolling 128 patients at 10
tively designed extension phase will gather data
U.S. sites. SUN (Safety Using NUsurface) followed in 2016 as a
through 39 weeks.
single-arm study assessing the restoration of function similar to
CINGAL is a third-generation viscosupple-
a healthy meniscus, enrolling 115 patients at 13 U.S. sites.
ment, following Anika's ORTHOVISC and
If cleared by FDA, NUsurface would be the first “artificial
MONOVISC, to treat knee OA pain.
meniscus.”
Anika will continue to work with regulators
The implant has been used in Europe under CE Mark since
to gain U.S. approval of CIGNAL.
2008 and in Israel since 2011.
8 BONEZONE • August 2018
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Spinal Cages Continue Trend
Toward Metals, Expandable
and Additive Designs
Rob Meyer
ORTHOWORLD
T
he trend in newly-launched spinal cages has been a focus on expandables and additively manufactured devices, with a
shift away from traditional manufacturing with all-PEEK to those that incorporate titanium, whether in the coating
or the body.
Neither manufacturers nor surgeons have reached a consensus on whether or not spinal cages should be 100% PEEK,
coated PEEK or titanium. What can’t be disagreed on is the fact the shift away from all-PEEK cages is a direct response by
device companies, based on what they’ve been hearing from surgeons, to manufacture implants using materials or coatings
with greater strength, porosity and bone-ingrowth capabilities.
With this in mind, and in an effort to get a better understanding of what is happening in this space, we posed questions
on spine cage technology to three veteran spine surgeons.
While all three confirmed the shift to incorporate titanium, they also provided insight which we thought you would find
interesting—including a forecast for the next five years in cage technology and thoughts on device companies’ priorities.
Michael Steinmetz, M.D., is Chairman and endplate injury, but after expansion an appropriate fit
of the Department of Neurosurgery at the to the endplates.
Cleveland Clinic Neurological Institute.
He also serves as the vice president of the What are the benefits to these cages?
Congress of Neurological Surgeons, sec-
retary of the Council of State Neurological Dr. Steinmetz: Material properties have increased fusion
Societies, an executive committee member rates, at least anecdotally. Cages made of PEEK were
of the AANS/CNS Section on Disorders advantageous, as the modulus of elasticity is similar to
of the Spine and Peripheral Nerves and is involved with the bone and are minimally visualized on x-ray and CT. The
American Association of Neurological Surgeons, the North cage may have a decreased chance of subsidence due to its
American Spine Society and the Society for Neurosciences. modulus, and fusion may be more easily visualized due to
its radiolucency on imaging. But these cages are limited, as
What are your thoughts on cages that are expandable, they do not integrate with bone. Specifically, bone does not
additively manufactured or those that incorporate grow into the cage, which may be problematic.
titanium? Additively-manufactured cages made of titanium
or alloys are designed to match the porosity of normal
Dr. Steinmetz: Cage design has been a game changer in bone. The metal properties and porosity have shown
spine surgery. Surgical approaches have been somewhat increased bone attraction and ingrowth into the cage. I
stagnant, but cage design has made surgery easier and have seen an increase in successful fusion with these newer
potentially safer. Cages require an appropriate “fit” in designs. These could perhaps be considered biologic cages,
the interbody space to effectively fuse. If too loose, fusion as opposed to simple cages.
may not occur; if too large, endplates may fracture or be
“plowed” during insertion, resulting in subsidence and Are there other technology advancements that you think
construct failure. More importantly, cage placement in the device companies should be prioritizing?
posterior transforaminal route places both the traversing
and existing nerve roots at risk of damage during inser- Dr. Steinmetz: Currently, the two most significant advances
tion. This may result in the surgeon choosing too small of are robotic and metal properties, including 3D printing. I
a cage to lessen the chance of nerve injury, but increase the think most companies are currently prioritizing these two
risk of unsuccessful fusion. areas. Robotics merging with computer assisted navigation
Expandable cage design permits a smaller cage to be will likely change how we perform spine surgery five to 10
inserted in the disc space, hence easing the chance of nerve years from now.
10 BONEZONE • August 2018WORLD-CLASS MANUFACTURING
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FDA REGISTEREDMARKET SPOTLIGHT
Robert S. Bray Jr., M.D., founded DISC Sports outcomes for the patient? Are you increasing cost efficiency?
& Spine Center in 2006. Dr. Bray launched Is the implant of quality? Are you decreasing complication
DISC after tenure at Cedars-Sinai, where he rates? If you are doing all of that, you're moving the mark
had founded The Institute for Spinal Disor- forward. Implant companies have to be on board with where
ders. He has also served as the director of neu- medicine is going.
rosurgery and headed the spinal programs at
St. John’s Medical Center, Century City Hos- Stephen H. Hochschuler, M.D., is a Co-
pital and Daniel Freeman Memorial Hospital. Founder of the Texas Back Institute. He
has over 30 years of experience and spe-
What are your thoughts on expandable cages? cializes in lumbar problems. He is Presi-
dent and a founding member of the Spine
Dr. Bray: The concept of an expandable cage is a very valid Arthroplasty Society, past Chairman and
and useful one, when you consider minimally invasive proce- current Board of Director at SpineMark
dures. Currently, I don’t use expandable cages because I think and Founder of the Spine Division at the
they’ve failed. I think the device companies are sort of missing Veterans Administration.
the point in some of the design aspects. I think the technologies
will grow, but they are on a slow learning curve. What is shaping the spinal cage market right now?
In general, what are device companies missing with Dr. Hochschuler: In my world, the patient is always in the cen-
their cage technologies? ter, but part of that is safety, efficacy, etc. Most good surgeons
have no problem putting in any cage. The new cage technology
Dr. Bray: The biggest thing with any implant, including inter- has its benefits: faster healing, covering more surface area and
vertebral, is first, do they work? Not how cute the technology ease of implant. Especially now, as everyone is focusing on
is. In the long run, does it work for the patient? One, the surface minimally invasive procedures.
of the implant has to bind with the bone. Two, the area of the
fusion that ultimately happens for the patient or the amount of Are you using cages that are expandable, additively
surface it fuses has to exceed the surface of the implant. In the manufactured or those that incorporate titanium?
design, a number of products have failed in implementation as
the device companies have failed to apply these principles. My Dr. Hochschuler: I have used them, but I stopped operating
experience, and that of many others, is that PEEK routinely gets one year ago, after 40 years of surgery. That said, we have
a poor binding to the surface of the bone and often causes an over 20 spine surgeons at the Texas Back Institute and they
inflammatory reaction around the implant. use them.
When it comes to expandables, the only one that can expand
What will the spine industry be saying about cages mediolaterally and height-wise, that I know of, is made by
five years from now? Integrity Implants. They have a cage that’s unreal.
Dr. Bray: Versions of implants will exist that have better surface What will the next five years bring in spinal cage technology?
areas and better binding. I see a reduction in PEEK, if not being
replaced altogether. I see devices getting simpler and certainly Dr. Hochschuler: Device companies need to focus [their prod-
not more expensive. Making implants more complex and more ucts] on simpler, faster minimally invasive procedures that can
expensive doesn’t really answer what’s going on in medicine. be done in ASCs. With 3D printing, you’re going to get more
I’m sensitive about something that costs $1,000 or $2,000 more in terms of individualized medicine. You’ll probably be able
because it has a cute little ratchet in it. to match exactly what you want to do, per level, per patient
The basics of bone binding to whatever the surface may be, and I envision every hospital will have its own 3D printer.
whether it’s coated or just titanium, I think that’s very impor- The manufacture, distribution and utilization are all going to
tant. Design is going to remain very important and the basis change. Titanium has been fine and new titanium is even bet-
of forming fusion and the weight-bearing characteristics of the ter. I think memory alloy could be important.
implant will remain important principles. How about a minimally invasive approach where you build
a cage inside the disc space? That’s a futuristic thought. How
What else do you see happening in spinal cages? will you do that? Right now, I don’t know. But can you do that?
Absolutely. It’s a matter of exploring the technology, what it
Dr. Bray: I applaud people for looking at new designs and new would cost, etc. What I love about spine is that it’s always
possibilities. For routine degenerative spine, I think technology changing. It’s interesting to watch how the approaches change.
has to keep changing and evolving. There are some good con-
cepts, but I don’t think they’re there. Companies have to return
to the basics and ask themselves why they’re doing this—and Rob Meyer is Senior Editor at ORTHOWORLD.
not just for marketing purposes. Are you getting positive He can be reached at rob@orthoworld.com.
12 BONEZONE • August 2018Design & Development • Surgical Instruments • Implantable Components • Cases & Trays
INDUSTRY UPDATE
How EU’s MDR Will Impact Your
Company's Supply Chain
C
linical data requirements against unauthorized access necessary to run the software as
tend to dominate conversa- intended.
tions about the forthcoming
EU Medical Device Regulation. To Specifically, how might the regulations impact the device
understand the impact the regula- company and contract manufacturer/supplier relationship?
tion will have on your company And when might they feel the impact?
as a whole, you must grasp how
it affects your supply chain and Wolf: It’s reasonable to expect that the type and extent of
engage your partners in discussions control exercised by manufacturers over suppliers and out-
about the information you need sourced processes will trend toward more scrutiny rather
from them—and they need from than less. As noted above, manufacturers in many cases will
you—to meet regulatory requirements, your timeline for CE require more data in order to demonstrate compliance with
Mark Approval and critical considerations for audits. the GSPR. This may develop into a longer-term communica-
To put MDR supply chain changes into perspective, we tion requirement with some manufacturers, rather than just
asked Mike Wolf, Director of Solutions Delivery at Maetrics, a one-off request.
to outline points of discussion for you and your suppliers. Manufacturers may propose changes in their Supplier
Quality Agreements (or similar contractual arrangements)
How will MDR impact the orthopaedic device to account for the need for more technical data and more
supply chain? transparency throughout the supply chain that is inherent
in MDR. Suppliers may start to feel the impact as 2018 pro-
Wolf: MDR identifies distributors, importers and EU autho- gresses, and certainly in 2019 as most manufacturers’ MDR
rized representatives as Economic Operators, each with projects unfold with greater energy and urgency, since the
specific responsibilities regarding verification of compliance, 2020 compliance deadline approaches rapidly.
cooperation in complaint handling and field safety corrective Also, MDR continues the requirement for Notified Bodies
actions, and cooperating with manufacturers and Compe- (NBs) to conduct unannounced audits of manufacturers, and
tent Authorities in device traceability. Manufacturers should to include critical suppliers in those audits. As MDR effec-
review agreements with distributors, importers and autho- tively applies greater scrutiny of the performance of NBs, it’s
rized representatives to ensure that the interactions with these possible that the inclusion of critical suppliers in these audits
Economic Operators are clearly defined and agreed upon. will become more frequent and more challenging.
As manufacturers begin the task of achieving the CE Mark
for their devices against the MDR, they need to have more The constraints of NBs are well understood and already felt
data as evidence in support of compliance to the General amongst device companies and suppliers. What advice do
Safety and Performance Requirements (GSPR). Suppliers you have for companies experiencing overwhelmed NBs?
can expect to receive requests from their manufacturer part-
ners for additional data as the manufacturer must ensure Wolf: If you haven’t already done so, contact your NB imme-
that each applicable requirement in the General Safety and diately. Learn about their intentions relative to designation as
Performance Requirements (GSPR) is addressed in a compre- NB for MDR, and the status of their application for designa-
hensive way. tion. It’s also prudent to confirm your interpretation of the
For example, suppliers of certain types of materials or classification of your device(s) under the new classification
components that contain CMRs (carcinogenic, mutagenic or rules. Lay out at least a tentative schedule for a conformance
toxic to reproduction) may need to cooperate with manufac- assessment for each product family. Work cooperatively with
turers to collect data, perform additional testing if required to your NB to spread the assessments out over time, if possible,
demonstrate compliance with the 0.1% by weight limit, and to accommodate the NB’s scheduling challenges.
if necessary, discuss with the manufacturer the possibilities Ask for any guidance the NB is willing to give in terms of
for a material change or a rationale for continued use of the data requirements for compliance to specific requirements in
material. the GSPR. Discuss the approach to clinical data that is most
As another different example, suppliers of software or appropriate for your device families, so that these data can be
components of electrical devices employing software may gathered, organized, analyzed and presented in a way that
need to cooperate with manufacturers to demonstrate evi- allows the NB to judge it to be adequate and does not extend
dence of adequate IT security measures, including protection the process of data collection and re-assessment.
14 BONEZONE • August 2018Going back to the device company/supplier relationship, what conversations about MDR should they engage in today? Wolf: Manufacturers should communicate with their sup- plier partners the fact that they are organizing their efforts that will culminate in achieving a CE certificate for the devices in which the suppliers play a part. Have prelimi- nary conversations about the specific requirements in the GSPR and the Technical Information requirements in which the suppliers play a role, and what new or additional data or information may eventually be requested. To the extent that it is not confidential, device manufac- turers should consider sharing with supplier partners their schedule for MDR implementation, including key mile- stones and any presumptions of the need for supporting actions or information from suppliers. It might be appropriate and necessary to have conversa- tions about possible revisions to quality agreements or pur- chasing agreements and the implications of those revisions. What additional advice would you like to provide? Wolf: Be proactive. Suppliers and contract manufacturers would be well advised to study the GSPR and the Techni- cal Documentation requirements, in order to better under- stand the compliance challenge faced by the manufactur- ers and the role that suppliers might play. Suppliers may have subject matter experts within their organizations who could play a key role in generating useful data or rationales in cooperation with the manufacturer. Don’t hide. Device manufacturers will need help from suppliers in achieving full compliance with the MDR in an efficient way. Being a trusted supplier partner during this challenging period will allow the bonds created by shared effort to lead to shared reward and a stronger long-term business relationship. There are also many consultancies now that offer the support that manufacturers and suppli- ers need in the MDR transition period, either to help plug a skills gap or just simply to make it happen for your orga- nization within the deadline. Mike Wolf, Director of Solutions Delivery at Maetrics, has more than 25 years of experience in management and consultation roles. Mr. Wolf has helped organizations design, implement and improve Quality Management Systems and processes and achieve and maintain regulatory compliance, including market clearance for new devices and related international licenses or product registrations. He recently served as Regulatory Subject Matter Expert within a large-scale improvement project at a global orthopaedic device company, leading the legacy review and remediation of Labelling, Regulatory Assessment and Premarket Product Launch processes and records. Maetrics LLC | maetrics.com | mwolf@maetrics.com BONEZONE • August 2018 15
SUPPLY CHAIN MANAGEMENT
Orthopaedic Supply Chain Quality:
OEM and Supplier Perspectives
Rob Meyer
ORTHOWORLD
S
upply chain quality impacts every device company With that comes an understanding of what we need to do
and supplier partner, involving personnel across when working with us on new product introductions or
departments. OEMs and their suppliers play roles in on some of the transfer processes. The suppliers that really
engaging individuals within their own companies to ensure stand out are the ones who recognize [the need] for positive,
that product quality, integrity and patient safety remain areas professional, painful persistence. We really appreciate the
of focus throughout the entire manufacturing process. suppliers who can partner with us on a better way to do
At OMTEC® 2018, a panel comprising two OEM and two business; a two-way communication.
supplier experts discussed how relationships and regulations
impact supply chain quality. We learned much from the Bill Ditty, Vice President, Quality
discussion and thought you would, too. Assurance, Compliance and Legal,
Orchid Orthopedic Solutions:
David Finch, Founder and Principal, Certainly, the best customers are
Insight Collaboration Partners: leading with quality first. But it’s not
a given. I don’t think it would surprise
What are some of the traits that define anyone to know that we still have
the highest-quality customers vs. the customers who are driving price first. When I’m reviewing
difficult customers? agreements, though it is rare, we still get customers who say,
“We just want the good data. Don’t give us the other stuff.”
That creates problems down the line.
Greg Coberly, Global Quality
Director, Autocam Medical: Scott Shankle, Vice President of
Operations, MicroPort Orthopedics:
Some of our best customers are the ones
who really understand manufactur- We like to think about the Kano model,
ing. We have some that are very good with satisfiers and delighters. Quality
at procurement or quality systems, but and compliance come first. What we
they don’t necessarily understand what measure every day and talk to suppliers
we do. What differentiates between best and not best is their about includes quality, cost, delivery
understanding of our process, so that we have a better rela- and lead time—these are all satisfiers. You’ve got to perform
tionship in terms of understanding how we launch a product, in those to survive and remain an active supplier for any of the
how we control our processes and how we change control. OEMs. What are the delighters? To me, it’s one simple word:
Some of our more difficult customers seem to be inconsistent trust, which encompasses the people making real partnerships
with the systems they have in place, sometimes even within and the people we know we can rely on to consistently perform
their own organizations, in approach. This makes it difficult in those satisfier metrics. Also, who are the people who will be
for us to know what we have to do to achieve acceptance of there for us when things don’t go right? Because we know that
products or changes. they always don’t. Who’s going to be able to respond and act
like an extension of our organization, or a shareholder? We get
Howard Levy, Vice President, Global one chance with new customers, existing customers and with
Sourcing, Instruments & Trauma each patient. Without having suppliers around you that you
Supply Chains, Zimmer Biomet: can trust, you are going to drop the ball.
With the supply base, you can never take Finch: The quality and functional responsibility of
quality and compliance for granted. all devices and instruments really lies with the OEM.
You can’t just say quality is a given. But in recent years, that responsibility seems to have
There’s an intimacy and relationship broadened to include supply partners, distributors and
level that is critical to [create a] positive relationship. even distributed products OEMs don’t make, they sell.
16 BONEZONE • August 2018SUPPLY CHAIN MANAGEMENT
One example of this is the recently-enacted EU MDR. As to last forever, because they’re going to be very difficult
in the case of many regulations, MDR provides outcome to change after your initial offering of, or licensing of, the
requirements and some general guidelines. But details are product. The bar for return on investment of what changes
kind of short, as far as exactly what you are supposed to you make is going up, because making those changes is
do, what the expectations are and how you are supposed going to be that much more difficult.
to achieve them. This often causes an overreaction among
the regulatory group because they want to make sure you Coberly: It’s certainly all going to flow down to [the
comply, which can set up conflicts between a company’s contract manufacturers]. From our standpoint, we are
regulatory, operations and supply chain management seeing more questions from our customers, asking for more
departments. It may seem like you have a number of years information, like contact materials lists and different kinds
before you have to concern yourself with this, but you of information. MDR won’t change a lot for us, but it will be
really don’t have that much time to get prepared for it. about providing more information to our OEM customers
When it comes to EU MDR, what do you see as some of who have to use that information to market their devices
the challenges you anticipate having, from a supply chain in the EU.
perspective, for sourced or distributed products?
Ditty: UDI is basically going to carry over to the EU. That’s
Shankle: As the operations part of the organization, we one thing that we’re following. At Orchid, we’ve already
look at MDR as a little bit vague still. The way I like to acquired the capital based on U.S. requirements. From the
put it, and the regulatory people might see this as a gross contract manufacturing standpoint, the shot across the bow
oversimplification, but it looks like not a lot of new stuff, has come our way the last month or two, with data requests
just a whole lot more of the old stuff. By “stuff” I refer to trying to identify what products are CE Marked, etc.
the requirements we all already do with validation and
documentation, but the level of which we do all of that is Levy: It’s a little fuzzy. We don’t see a big difference yet
going to increase. It also seems clear to me that it’s going to from the EU and MDR requirements. MDR could force some
further incentivize OEMs when they’re working with their product or supplier rationalization. We have an incredibly
suppliers to do it right the first time—set up your processes complex number of parts and SKUs. So, if there is a sanity
and agreements as robustly as you can, like they’re going check, both with the third-party entities and internally,
Titanium 3D printed implants
U N D E R 1 ROOF
T, A L L
D PRODUC
E R T O FINISHE
FROM POWD
+31 85 760 88 72
info-instrumed@fmi.nl
www.fmi.nl
BONEZONE • August 2018 17SUPPLY CHAIN MANAGEMENT
where we have to get rid of some of these low-volume, similar items across our facilities for things like efficiencies.
straggler suppliers or SKUs that may have, let’s say suspect, We are trying to have commodity discussions and indirectly
quality systems that MDR could bring out, I would welcome improving quality as a result.
that. In this industry, it doesn’t seem like we ever completely
retire an SKU; we’re still selling it years and years later. If Finch: Many companies put in continuous improvement
MDR drives [these changes], it could actually be a positive. efforts to address quality and cost. Some of these changes
require Supplier Change Notifications. In many cases,
Finch: What are your company’s success and challenges to especially for purchased products, that approval may
standardize supplier quality approval requirements? How require the support of multiple departments across both the
do you see a program such as MedAccred (a supply chain OEM and supplier, which have competing priorities. What
oversight program managed by the medical device industry recommendations would you make to get companies to work
to prevent product defects) enhancing, or at least supple- together more, both on the feasibility and implementation
menting, the compliance and supplier approval process? phases of these continuous improvement efforts?
Coberly: In this industry, it seems like no matter what we Levy: I think you need to go to fewer suppliers. You’re not
have, whether it’s ISO 13485 or Medical Devices Single Audit going to be able to rationalize it, unless you get a lot of help
Program certification, we still see audits every year. The from EU MDR, or a company saying we don’t need these
ability of someone like MedAccred to have an effect on the particular SKUs or products. You see this evolution to larger
industry is whether or not the OEMs embrace it. We have to suppliers; your supplier quality group needs to change how
be very data-driven; having outside companies come in and they do their business and act as project managers of these
look at the way you’re validating your processes by looking large suppliers, as opposed to doing the individual assessment.
at data is necessarily just the compliance side of it. If we can It’s a different strategic level of supplier quality that’s needed
get past where we have very inconsistent requirements from so we can allow the supply base to be more successful and
customer to customer in what we have to do to validate and bring forward better practices, better processes, protect risk
qualify processes, we could focus on improvement and how management, etc. It’s a different world than it was 10 or 20
we can better partner to make more traction. years ago. The industry needs to move toward more agility. If
someone is moving a machine five feet, why does it take two
Levy: If there was a consistent way we could do validations years to get that reviewed, vs. a change of raw materials that
across the industry and everyone agrees to it, that would be R&D needs to test out? That intelligent differentiation is key.
a great enabler to focus on quality organizations, who should
be working on new product introductions or issues that are Coberly: If we have a small change, like moving a machine,
specific to that OEM to give them a competitive advantage. how can I quickly get an approval without a six-month prior
There needs to be a pivot as we look at quality going forward. notice, which is what most of the supplier quality agreements
There has to be a more organized, sustainable way for this coming in these days say? We can’t operate that way. So, if we
industry to really figure out how to do efficient compliance want to be fast, agile and responsive, we have to have a better,
and some level of meaningful standardization. streamlined method to get changes approved. It’s a big thing
for us to work on as partners. Right now, we’re being driven
Shankle: Everyone should be trying to get more out of their every day to reduce cost…actually, reducing cost while at the
quality audits than compliance. If someone like MedAccred same time improving patient outcomes. It can be done, but it’s
can come in and look at more standardized processes, not an easy lift. One of the biggest hurdles is FDA. Part of the
whether it’s sterilization, packaging, ISO or even ASTM problem is that we’ve got so much regulatory oversight on
standards for implant cleaning, those are things where they this issue that we get tangled up and can’t get out of our own
look at validations and process controls. I do think it would way to make progress. We recently had an FDA audit with an
be hard for an independent organization look at the technical auditor who didn’t know what a CNC machine was.
aspects of what’s going on with our products. I think it’s a
stretch to say it could replace your supplier quality program, Shankle: It’s easy to talk about the regulatory requirements
but could it augment it so that instead of doing a four-day and how burdensome change control can be. I think we also
supplier audit, it shortens that time for us? need to keep some perspective that those regulations are there
for a reason. Patient safety always comes first. Manufacturing
Ditty: One of the things that can help with standardization changes are one of the largest causes of device recalls and it’s
is having better and fewer partners going forward. During up to us to be as efficient as possible. I don’t think we as an
the last two or three years we’ve seen how fast the supply industry can say, “The regulators are the reason we can’t get
chain is evolving. We hired our very first director of global things done.” Our history of improperly managing changes is
sourcing. We’ve never had that role before. It has evolved part of the reason the regulators are focusing on that, right?
even further, as now we have a supply chain council aimed I know it’s an exaggeration, but if there is a change request
at having standards so that we’re going out and buying that’s taking five years to move a machine, that’s not on FDA,
18 BONEZONE • August 2018SUPPLY CHAIN MANAGEMENT
that’s on the people that have that change control. A way to relationship to the next level—communication, quarterly
prioritize suggested changes is [to determine the] value, business reviews and making sure people go on site. Time,
impact and difficulty of the change. Clearly, if it’s going to communication and prioritization are key.
require design testing or regulatory submissions, it’s going to
be more difficult. There are a lot of changes that aren’t going to Ditty: Build a diverse team. Some of us came out of automotive
require those. We have to do simple business management and where it was natural to have quality, manufacturing, purchasing
not let those changes get hung up in the queue. and ad-hoc members as part of a collaboration team working
with the vendor. When working with a customer, you’ve got to
Ditty: I’d ask OEMs [to involve] us more and more in engage the right people and have the right talent. Actually talk
the feasibility stage. We’re the experts in forging, casting to your employees, who are the problem-solvers themselves.
and machining. We can help you with design-for-
manufacturability or other value creation that you want to Shankle: Your organization should have strategic objectives,
do at that particular point. which should turn into functional objectives. There should
only be a few, as you can’t have 100 people working on 100
Finch: Superior supply chain quality really requires a true different things. You’ve got to identify the vital few initiatives
relationship between the OEM and suppliers. What have and objectives to pursue.
you done, perhaps as an organization, that’s led to [successful
relationships]? Coberly: We have value streams that are aligned by customer
or product. By having those, we identify who we need to be in
Levy: You can’t have deep, strategic, collaborative relation- contact with at the development stage so we can have those
ships with thousands of suppliers. You need to have some design-for-manufacturing conversations. That same group
sort of process that says these suppliers are the ones that are can then carry it forward if we have a quality issue or an
going to be our strategic partners, and these are the ones improvement objective to work on with a customer.
that are more traditional in the relationship, and sort it in
that regard. For the suppliers where you do have more of Rob Meyer is Senior Editor at ORTHOWORLD. He can be reached
the strategic relationship, invest in the resources to take that at rob@orthoworld.com.
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