The digital future of surgery according to J&J

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The future of surgery (FastCompany)

While technology can help to simplify the complex, it is often hard to see those improvements in real-time. Health care is an exception. Anyone can appreciate breakthroughs that may save a life.

From VR that trains doctors in remote locations to 3D printing that creates customized surgical tools on demand, digital advances are making high-quality care and specialized procedures more accessible and effective. With a presence in nearly every operating room around the world, Johnson & Johnson is helping to shape the global surgical landscape. And by expanding its ecosystem of innovative digital tools, J&J is introducing exciting new treatments and education possibilities for surgeons and patients alike.
According to Euan Thomson, global head of R&D for Johnson & Johnson Medical Devices Companies, the key to ensuring such positive outcomes is to remain focused on two targets: patients and procedures. “The variables are patient selection, patient preparedness for surgery, and patient recovery plan after the procedure,” he says. “If we can engage with the patient and find out more about how the physician selected them, how prepared they were for surgery, and also gauge the recovery program after the procedure, we can start putting that information into the same database as the data from the surgical devices; then we’ll start to gain some insight around optimizing outcomes.”
LET’S GET PERSONAL
Patient empowerment is a point of emphasis across modern health care. J&J’s answer is Health Partner, a connected health platform with a different tool to address each of the three variables noted by Thomson: a website, TheHealthPartner.com, to educate patients before their surgery, a mobile app that guides them through surgical preparation and recovery, and a provider care portal, which is currently in development and being piloted in health systems, that connects them directly to their health care teams.
“We’re using advanced machine learning to provide a personalized experience for patients. As more patients use the platform, our system learns about the best way to serve information and support individuals,” says Jennifer Turgiss, vice president, behavior science and advanced analytics, Johnson & Johnson Health and Wellness Solutions. “A personalized experience means more relevant guidance, and a higher chance of helping that patient be successful.”

For teams at Penn Medicine Princeton Medical Center that have engaged their patients with Health Partner, the platform’s care portal has already proven to be a transformative supplement to post-surgical consultation. “The feedback we’re hearing is that it’s a tremendous help in between office visits to get information about how the patient is doing,” Turgiss says. “When the patient comes back in, they have a history of what they’ve been doing over the two or four weeks since a care team saw them last.”

DOCTORS HELPING DOCTORS
While the issue of patient comfort and compliance is one that receives plenty of attention in the medical community, what is less openly discussed is the performance of surgeons themselves. When the Johnson & Johnson Institute began offering the personalized performance management platform C-SATS in April 2018, it took a tremendous step towards making technical surgeon-to-surgeon feedback commonplace.
Created by a team of surgeons, biostatisticians, and engineers, C-SATS allows expert surgeons and trained reviewers to provide anonymous feedback to one another via shared video recordings of their procedures. It’s quite remarkable to think a system like C-SATS that provides oversight to a group of such highly trained professionals has been accepted by thousands of surgeons at leading institutions,” says C-SATS Co-Founder and VP of Performance Improvement at J&J Institute, Derek Streat.  “Once they start getting structured, comparative feedback about how they’re performing, something that typically ends once surgeons leave residency, they are empowered with specific, tangible insights to improve their skill, irrespective of their experience level.  Professionals striving for excellence in any field know that learning never stops.”
“Johnson & Johnson Medical Devices Companies’ digital ecosystem extends to surgeons and nurses learning the ins and outs of new procedures using one of today’s most talked-about technologies: virtual reality. While traditional surgical training can present a heavy burden of time, travel and setup, J&J’s immersive simulations significantly lower these barriers, allowing clinicians to train at their own pace.
“If you think about the learning journey surgeons have to go on, normally they would have gone into a cadaver lab with their attending surgeons [before heading] into a surgery environment,” says Sandra Humbles, vice president, global education solutions, Johnson & Johnson Medical Devices Companies. “We decided to help accelerate that learning curve [with VR].”
Surgeons who have had the opportunity to use the VR training technology have responded positively: A 2017 survey of orthopedic surgeons found that 80% wanted to use it frequently in their training, and 90% would recommend it to their colleagues. As with all of its digital health platforms and products, Johnson & Johnson’s scale as a global leader helps its VR training program make an immediate impact: To date, the technology is in use in Johnson & Johnson Institute facilities in the U.S., Brazil, China, Japan, Germany and Switzerland.
As Johnson & Johnson continues to expand its digital medical devices digital surgery solutions, its blend of size, purpose and legacy of groundbreaking innovations opens up unprecedented avenues for progress. “When I think about our opportunity to create platforms, it comes down to the scale of what we can achieve as an organization with the direct coverage that we have,” Euan Thomson says. “It gives us a singular opportunity to leverage advanced technologies, amalgamate data, and generate insight. It really is unique to J&J to have that opportunity.”

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This article was created for and commissioned by Johnson & Johnson.

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How Sales & Marketing can work together

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I have seen Sales and Marketing fight each other in Orthopedics companies for years.  Why is this?
Sales and marketing don’t get along because:
           — they have different objectives
           — and they don’t understand each other.
 
 
First, let’s look at the differences between Sales and Marketing and see why they don’t understand each other.

Both believe that they are more important than the other to the organization. Neither are right.  Marketing can be guilty of not listening to important Sales feedback because they think they know better than Sales. Sales can be guilty of ignoring Marketing because Marketing doesn’t really know the customer dynamics in the field.
Let me try to illustrate the differences. I am going to borrow Gary Vee’s sports example of how Sales & Marketing play the game.

Sales
Sales thinks they are special because they win daily. Sales has a short-term focus and is 100% accountability. The numbers are the numbers.  Sales is like the front offensive line of the football team. They grind it out each and every day.

However, Sales needs to understand the function of Marketing. One good execution by Marketing can change everything for you. Sales cannot do this.
Sales, this is why you must value Marketing.  Marketing can strike out over and over again, but then one day, one campaign can change the course of your sales trajectory forever – new branding campaign, a new KOL relationship, a well-executed conference, a new licensing agreement, or whatever.  Grand slam home run. Marketing literally has the potential of a Mike Tyson punch. You must appreciate their potential.
Takehome message:
Sales should respect Marketing’s ability to move the needle in a big way one day.

Marketing
Marketing thinks they’re special because they are creative, have fancy degrees and have a budget.   Marketing has a long-term focus and very little accountability. The Marketing budget has zero metrics. They really don’t have to win on a day-to-day basis so they don’t get the respect of the salespeople.  However, when they connect, they set up sales for big success.  Marketing gets credit for the Sales setup. Sales NEVER gets credit for the setup, only for delivering the numbers.
Marketing is like the spoiled wide receiver that can win a game with one play, but for most of the game, they’re irrelevant.

Marketing, this is why you must value Sales. Sales cannot tell management that the long-term payback for a campaign is going to be in the future sometime. Sales does not have that luxury. They have to perform on a daily basis.
Takehome message:
Marketing should respect Sales because they grinding it out each day and supporting your salaries and the company.

So, for your orthopedic company to be successful, Sales and Marketing need to work together and they must understand that they have two completely different functions – one short-term, one long-term, and one blocking and tackling, and one the occasional big offensive play.

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Group helps orthopedic surgeons to cut the middleman and reduce material costs by 50-80%

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OrthoDirectUSA® Launches a Revolutionary Franchise Opportunity for Surgeons that Guarantees to Reduce Healthcare Costs (press release)
OrthoDirectUSA® (ODUSA) announced today a new kind of business opportunity that equips surgeons to lead the organizational change process through ongoing education and coaching of hospital personnel which results in sustainable cultural transformation and a substantial reduction in supply costs.

 
ODUSA is a consulting service that grows the skill and expertise of hospital personnel and leverages our contextual knowledge of the medical device industry to connect surgeons, hospitals and ambulatory surgery centers directly to various device manufacturers. By eliminating the middlemen and investing in their own personnel, Providers can have more control to proactively manage their supply chain and realize savings of 50% to 80%.
What’s the Problem Today?
Physician employment, bundled payment and gainsharing do not adequately engage, equip or empower physicians to lead. Consequently, the collaboration between surgeons and healthcare leaders is not very effective.
The OrthoDirectUSA® Solution:
A strategy that utilizes ownership, through a franchise business model, to create sustainable economic alignment between hospitals, surgeons and suppliers. Following their system guarantees to lower supply chain costs by 50-80%.
“The idea of developing a turn-key consulting business for qualified surgeons and former medical device reps made a lot of sense to us” says OrthoDirectUSA® founder Thomas Mitchell. “This idea is what led to the launch of ODUSA Franchise, LLC. The franchise structure successfully aligns all of the stakeholders, with the hospital’s mission and vision at the forefront, and delivers on-going organizational education to achieve process improvement and significant cost reduction. Unless everyone involved understands, “What’s in it for me,” nothing will happen. Healthcare is no different than any other market sector, economic alignment is a prerequisite to initiate and sustain long-term behavior change.”
Their Franchisees are trained and equipped to be more effective leaders as they take ownership in implementing the proven ODUSA change process.
“OrthoDirectUSA helped me establish a new way of thinking about how I work with the hospital. They have challenged me to become a more effective leader, which meant I first needed to become a student. I had to develop a different mindset. I can tell you this – Their system absolutely works, and our hospital is experiencing the benefits!”, says Dr. James Mahalek, Franchise Owner.
An ODUSA franchise allows qualified surgeon investors to participate either by owning or partnering in a business opportunity. The ODUSA Franchise combines a unique strategy and a proven process with a structure that is safe and legal for physician participation. ODUSA does not sell any medical devices and is vendor agnostic, therefore, we are not considered a Designated Health Service (DHS), which means Stark Law is not applicable.
This business model brings qualified surgeons together with former traditional sales reps in a free enterprise opportunity to lead transformational change. The franchisee will be supported by the extensive experience of ODUSA and its trademarked ORDT® (Operating Room Device Technician) certification and training program.
Why Surgeons?
ODUSA recognized that surgeons are uniquely positioned to lead the operational and clinical transformation efforts that value based reimbursement requires. They are at the intersection of where clinical, technical and financial decisions are made. To successfully transform the healthcare value chain, surgeons must lead and stay engaged to sustain long-term value outcomes. ODUSA intentionally seeks early adopters who desire to model the mindset and behaviors necessary for organizational change.
How it Works:
ODUSA’s vendor neutral process disrupts the traditional supply chain by allowing Providers direct-access to medical devices from manufacturers at wholesale pricing. The unique alignment structure creates economic incentive for surgeons to work collaboratively with hospitals to reduce procurement costs and improve service-line efficiency. Their change process cultivates teamwork and behavior change through on-site education and mentoring.
“Economic alignment is a prerequisite for any sustainable enterprise,” says OrthoDirectUSA® founder Thomas Mitchell, president and CEO. “OrthoDirectUSA has identified the right structure (free-enterprise) and enabled the right people (Surgeons & former sales reps) to work on the right problem (eliminating waste and redundancies that exist in the traditional supply chain) at the right time to meet the demands created by value-based reimbursement.”

Visit ODUSA Franchise site at http://odusafranchise.com
About OrthoDirectUSA®
Founded in 2008 in response to the high and often hidden cost of the traditional supply chain that contributes to exorbitant implant prices, OrthoDirectUSA® set out to disrupt the medical supply business with a new business model. Approximately 45 percent of the manufacturers costs are attributed to selling and general administrative expenses (SG&A) – the majority of which are selling costs. ODUSA offers Providers the opportunity to reduce procurement costs by eliminating traditional middlemen and connecting them directly to various manufacturers for device procurement at wholesale prices.
ODUSA derives no compensation from any medical device companies. Therefore, FDA registered medical device manufacturers are continually desiring to participate in their model and their pool of alternative suppliers is constantly growing. They give Providers more options to procure high-quality, safe devices at wholesale pricing levels — saving them 50% or more.
Media Contact: Matt Mitchell
Franchise Operations Officer
260-433-2536
OrthoDirectUSA® Phone: 888-600-4611
OrthoDirectUSA® Email: [email protected]

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10 best new Spine Technologies in 2018

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TEN BEST NEW SPINE TECHNOLOGIES FOR 2018 (Orthopedics This Week)
 
Augmedics
Winning Technology: xvision™
Inventors and Engineers: Nissan Elimelech, Stuart Wolf, Elazar Gerland, Nessi Benishti, Tsur Herman, Ziv Amitai, Ron Zaidman, Daniel Messinger, Natalie Starodubsky, Yaacov Rothschild, Asaf Asban, Nitzan Krasney, Dekel Matalon

Tami Harel, Nitzan Krasney, Chen Landoy-Eini, Nissan Elimelech, Robin Young, Dekel Matalon, Asaf Asban, and xvision™

xvision-spine system (XVS)™ is an augmented reality surgical navigation system that is designed to give surgeons a form of “X-ray vision.” Using extremely fast processing capabilities, the XVS system superimposes patient CT data, in real time, onto a heads-up display while also accurately determining the position of surgical tools real-time. The net effect is that surgeons can simultaneously look at their patient while also seeing the anatomy below and the position of instruments—without averting their eyes to a remote screen.
A recent study of using XVS in surgery found: “Overall screw placement accuracy was 96.7% and 94.6% when employing HGS and GS grading respectively. Insertion accuracy was non-inferior to MN pedicle insertion when compared to both GS and HGS scores. When compared to RN insertion, accuracy was found to be noninferior when employing the GS score, but superior when employing the HGS score. Lastly, accuracy results were found to be superior to free-hand insertion. Accuracy results were not found to be inferior in any comparison. User experience analysis yielded ‘excellent’ usability classification.”
https://www.augmedics.com/

DiFusion Technologies, Inc.
Winning Technology: ZFUZE – PEEK COMPOSITE
Inventor: Derrick Johns, Joseph Crudden, Ph.D.
Engineer: Sriram Sankar, MS

Robin Young, Sriram Sankar, MS, Joe Crudden, Ph.D., and Derrick Johns

ZFUZE is a revolutionary new biomaterial. It is a blend of a base PEEK polymer and “negatively charged zeolites.” Negatively charged zeolites are specialty molecules change the surface topography, charging characteristics, and pH of the resulting implant in a manner which improves long-term patient healing. ZFUZE is NOT a COATING, or a SURFACE TREATMENT. It is, instead, an entirely new LOAD BEARING BIOMATERIAL and can be utilized across multiple orthopedic applications. ZFUZE solves the one setback PEEK had in non-osteointegration, while maintaining attractive and similar bone modulus and visualization benefits.
In two major animal studies of ZFUZE, investigators have found that the implants have “hydrophilic” surfaces which encourage early cell adhesion and osteoblast proliferation. Why? The presence of negatively charged zeolite—which resulted in reduced inflammation and fibrous tissue yet more bone”. Further, radiographic has highly indicative of “osteoconduction”. The company is seeking an osteoconduction claim with the FDA. In its bare essence DiFusion “fixed-PEEK” by adding a known hydrophilic negatively charged particle to plain old inert and hydrophobic PEEK and created a negatively charged osteoconductive biomaterial which is not recognized as a foreign body by the immune system.
http://www.difusiontech.com/?password-protected=login&redirect_to=http%3A%2F%2Fwww.difusiontech.com%2F

Green Sun Medical
Winning Technology: Green Sun Medical Dynamic Scoliosis Brace
Inventor and Engineer: Matthew Thompson

Sigurd Berven M.D., Jamie Haggard, Cynthia Ansari, Robin Young, Matthew Thompson, and Green Sun Medical Dynamic Scoliosis Brace

Green Sun Medical has developed a comfortable, dynamic scoliosis brace for Adolescent Idiopathic Scoliosis (AIS). The brace applies continuous corrective pressure to the spine while allowing the patients to move and function as normal teenagers. While wearing the brace, sensor data will be transmitted through Bluetooth to mobile devices and then accessed with a cloud-based server. Physicians will be able to monitor their patients in real time to ensure that they are receiving the proper treatment. The patients will have their torso 3D scanned to allow for assembly of a custom fit ring system made from modular parts. A comfortable and breathable cover will help make the brace much less noticeable than current plastic braces.
http://www.greensunmedical.com/

K2M, Inc.
Winning Technology: MOJAVE™ PL 3D Expandable Interbody System
Inventors: Khalid Abbed, M.D., Sabatino Bianco, M.D., Egon Doppenberg, M.D., Scott Dhupar, M.D., Gregory Lanford, M.D., Steven Ludwig, M.D., Thomas Morrison, M.D., and Brian O’Shaughnessy, M.D.
Engineers: Jennifer Moore, Jordan Floyd, and Brad Vinckier

Robin Young, Samantha Ballway, Konrad Linke, Eric Major, and MOJAVE™ PL 3D Expandable Interbody System

The MOJAVE™ PL 3D Expandable Interbody System is a 3D-printed fusion device which allows surgeons to independently control anterior and posterior heights in the lumbar spine. This capability is not available with any other product on the market today.
The MOJAVE PL 3D features infinite adjustment capabilities within its expansion range – which gives surgeons the versatility to match the device to the patient’s anatomy by adjusting lordosis—up to 18 degrees. MOJAVE PL 3D’s instrumentation includes an inserter with a port for expanding and locking and an expansion driver which addresses lordosis, height, as well as posterior expansion.
The MOJAVE PL 3D Expandable Interbody System is built using an advanced 3D printing method which creates structures with greater porosity than implants fabricated using traditional manufacturing methods. Starting with a titanium powder, the MOJAVE PL 3D endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.
http://www.k2m.com/

MiRus, LLC
First Winning Technolgy: MoRe® (EUROPA™ Pedicle Screw System)
Inventors: Jay Yadav, M.D., Noah Roth
Engineers: Wayne Gray, Josh Gunn, Brett Cain

Mahesh Krishnan, Robin Young, Kornelis Poelstra, Wayne Gray, Jay Yadav, M.D., Josh Gunn, Brett Cain, Noah Roth, and MoRe® (EUROPA™ Pedicle Screw System) (Images are the copyright material of MiRus, LLC and protected under international copyright laws. Copy, download, or reproduction of these images in any way whatsoever without the express written permission of MiRus is prohibited.)

The EUROPA™ Pedicle Screw System is the smallest thoracolumbosacral pedicle screw system on the market yet it is two to three times stronger and four times more fatigue resistant than standard Titanium and Cobalt Chromium pedicle screw systems.
The EUROPA™ Pedicle Screw System’s polyaxial pedicle screws are made from Titanium and the rod components are made from MiRus’s novel proprietary metal alloy, Molybdenum-47.5Rhenium (MoRe®, ASTM F3273-17).
MoRe® is pure (99.99%) molybdenum and rhenium. It hydrophilic and a superiorly bio-friendly alloy. It contains no Nickel. Biomechanical and biological testing has shown that MoRe® is stronger, more fatigue resistant, less likely to generate wear debris, more osteoconductive, and biofilm resistant than Titanium and Cobalt Chromium.
Because of MoRe®, the EUROPA™ Pedicle Screw System is the world’s smallest, strongest, fatigue resistant, wear debris resistant, bio-friendly construct.
Second Winning Technology: GALILEO™ Spine Alignment System
Inventors: Jay Yadav, M.D., Angad Singh
Engineers: Angad Singh, Daniel Burnham, Alex Panter, David Harrison

Angad Singh, Daniel Burnham, Alex Panter, Jay Yadav, M.D., Noah Roth, Robin Young, Mahesh Krishnan, and GALILEO™ Spine Alignment System (Images are the copyright material of MiRus, LLC and protected under international copyright laws. Copy, download, or reproduction of these images in any way whatsoever without the express written permission of MiRus is prohibited.)

The GALILEO™ Spine Alignment Monitoring System provides real-time measurement and monitoring of segmental and/or global spine alignment without repeated imaging.
The system uses disposable, miniaturized sensors and advanced sensor fusion algorithms to measure vertebral and spinal alignment in the sagittal plane. Each sensing module is battery-powered and communicates wirelessly to a tablet display.
Simulated clinical use testing using radiopaque Sawbones® and cadaver compared manual Cobb angle measurements of Lordosis and Kyphosis on lateral fluoroscopic images to the values measured by the GALILEO™ Spine Alignment Monitoring System. In benchtop testing, the mean difference between the reference values and the system measurements was 0.0 degrees with a standard deviation of 0.9 degrees (n= 90).
In simulated use testing on Sawbones®, mean difference between the cobb angle measurements and the system measurements was 1.5 degrees with a standard deviation of 1.9 degrees (n = 30). Concordance Correlation Coefficient between the two groups was calculated to be of 0.9934 (95% CI: 0.9867 to 0.9967) indicating strong agreement between system and radiographic measurements. In simulated use testing on a cadaver, mean difference between the cobb angle measurements and the system measurements was 0.3 degrees with a standard deviation of 2.6 degrees (n = 19). Concordance Correlation Coefficient between the two groups was calculated to be 0.9728 (95% CI: 0.9379 to 0.9882), again indicating strong agreement
Benchtop and simulated use testing above have demonstrated high accuracy and repeatability of the technology for real-time intra-operative monitoring of spine alignment with reduced reliance on intra-operative imaging.
https://mirusmed.com

Power T Handle, LLC
Winning Technology: Power T Handle
Inventors: Kevin Cahill, M.D., Ph.D.
Engineers: Steve Marinelli

Kevin Cahill, M.D., Ph.D., Steve Marinelli, Ed Karp, and Power T Handle

The “Power T Handle” is a single-use device that allows surgeons to manually insert screws in either a traditional fashion or with power using the integrated power capabilities. The device mimics the footprint of traditional surgical instruments while also providing critical tactical feedback when desired and seamless on-demand power.
The “Power T Handle’s” power option provides surgeons with low-speed, high-torque output and requires no processing or “turnover” before or after use, including no battery recharging. It The handle works with existing orthopedic instruments including surgical taps and pedicle screw instrumentation from spinal implant manufacturers through an industry standard quick coupling connection.
Other surgical power tool options are cumbersome, require specialized adaptors, power cords and do not preserve surgeon tactile feedback during screw placement.
http://powerthandle.com/

RTI Surgical, Inc.
Winning Technology: TETRAfuse® 3D Technology
Inventors and Engineers: Jeffrey Trudeau Michael Kakuk Stephen Horvath Katie Barron Michael Carter Brent Skaw

Brent Skaw, Camille Farhat, Mike Eriksen, Robin Young, Steve Horvath, Bob Housler, Michael Carter, and TETRAfuse® 3D Technology

TETRAfuse 3D Technology is the first 3D printed polymer-based interbody fusion device to incorporate a nanoroughi surface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEKii.
It is radiolucent, allowing better visualization of the implant and fusion response when compared to metal or metal-coated interbody fusion devices.ii It has bone-like mechanical properties, which help minimize potential risk for subsidence.ii Its unique nano-roughi surface exhibits decreased bacterial adhesion and growth when compared to PEEK.
TETRAfuse 3D Technology is featured in the growing Fortilink® series of devices.
Fortilink-C IBF System for anterior cervical discectomy and fusion (ACDF) surgeries.
Fortilink-TS IBF System for transforaminal lumbar interbody fusion (TLIF) or bilateral posterior lumbar interbody fusion (PLIF) surgeries.
Fortilink-L IBF System for lateral lumbar interbody fusion (LLIF) surgeries.
http://www.rtix.com/en_us/

Simplify Medical, Inc.
Winning Technology: Simplify Cervical Artificial Disc
Inventor and Engineer: Yves Arramon, Ph.D.

David Hovda, Yves Arramon, Ph.D., Brian Polonet, Kelsey Welch, Thomas Rawles, Tapela Mavudzi-Dahlborg, Robin Young, and Simplify Cervical Artificial Disc

Simplify Disc is a three-piece, non-metallic cervical artificial disc comprised of Polyetheretherketone (PEEK) endplates with a ceramic core.
Simplify Disc is designed to be MRI-compatible, including minimal artifact, thereby reducing or eliminating the need for future CT scans and the risks associated with ionizing radiation.
The PEEK-on-ceramic materials of the Simplify Disc were chosen for enhanced durability and lower wear rates, with no metal wear from the articulations. The bone-contacting surface of each endplate is coated with biocompatible porous titanium to promote stable bony ongrowth.
The Simplify Disc is designed to mimic the natural motion of the spine. The disc is designed for maximum range of motion without anatomic constraint: ±12° flexion/extension, ±12° lateral bending, unlimited axial rotation, and a limited amount (<1.6 mm) of translation in the horizontal plane.
The ceramic core is semi-constrained by the retention ring, allowing for a self-centering mobile core. Simplify Disc has variable center of rotation which mimics the natural motion of the spine. The heights of the Simplify Disc range from 4mm to 6mm to match the anatomical size of native discs. The Simplify Disc has completed enrollment of the 1-level FDA Clinical Trial and anticipates enrollment of the 2level FDA Clinical Trial by the end of 2018.
https://www.simpligymedical.com

SurGenTec
Winning Technology: Alara Access Needle
Inventors and Engineers: Travis Greenhalgh, Andrew Shoup

Andrew Shoup, Travis Greenhalgh, Tom Bishow, and Alara Access Needle

The ALARA system is an inexpensive solution to provide radiation reduction to the surgeon which any surgeon, hospital or ASC can afford or have access to.
The system allows the surgeon to navigate the correct trajectory quickly to save time in the operating room.
The ALARA Target Needle has a built-in depth stop and neuromonitoring capabilities which helps ensure safe placement of pedicle screws.
The ALARA extension arm allows the surgeon to maintain a safe distance to decrease radiation exposure significantly while finding the right trajectory while placing a needle. The handle is durable, rigid and can be disposable.
http://www.surgentec.com

Tyber Medical LLC
Winning Technology: ProTi 360 (TyPEEK) Interbody Systems
Inventors: Jeff Tyber
Engineers: Matt Atoulikian, Chandler Kline, Chris Faresich, Dan Hickey, Ph.D., Bess Lorman, Gary Thomas, Tom Fosberner, Jeff Tyber, Mike Black, David Gerber, Kristin Jinx

Jeff Tyber, Nadav Tomer, Robin Young, and ProTi 360 (TyPEEK) Interbody Systems

The Tyber Medical TyPEEK Interbody System is a spinal fusion interbody device comprised of a poly-etherether-ketone (PEEK) core surrounded on all exterior-facing surfaces by an integrated titanium surface layer designed to enhance primary implant stability and stimulate accelerated osseointegration.
The 360° integrated titanium surface layer is applied using a proprietary substrate preparation treatment that primes the PEEK surface to interlock on a mechanical and molecular basis with a modified titanium plasma spray coating, resulting in unparalleled bond strength.
This novel coating approach creates hierarchical surface roughness with features extending from the macroscale to the nanoscale, providing increased surface area for the attachment of proteins/cells and stimulating enhanced osteogenic activity from adhering cells to promote direct bony on-growth.
The Tyber Medical TyPEEK Interbody System combines the radiolucency and desirable mechanical properties of a PEEK core with the roughness and osteogenic activity of a 360° integrated titanium surface layer to deliver an optimized interbody spacer that promotes rapid and long-lasting fusion across the entirety of the implant.

 
CONGRATULATIONS to all of our winners for 2018!
Rewarding Innovation and Perspiration
This 2018 annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products to treat back care. To win the Orthopedics This Week Best New Technology Award for spine care, a new technology must meet the judges’ following criteria:

Be creative and innovative.
Have long term significance to the problem of treating the diseases of the spine. Does this technology have staying power?
Solve a clinical problem. To what extent does this technology solve a current clinical problem or problem that is inadequately solved today?
Does it have the potential to improve standard of care?
Is it cost effective?
I would use it.

Our expert panel scores every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.
We and our panelists were impressed that inventors—despite ever growing hurdles to innovation and entrepreneurism in spine—still managed to create a solid group of new products to submit for the 2018 Orthopedics This Week Spine Technology Awards.
Submitters
A record 31 companies submitted their best ideas for the 2018 BEST SPINE TECHNOLOGY award. We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year.
The Judges
Our intrepid panel of eight judges were:

(L to R): Paul A. Anderson, M.D., Scott Boden, M.D., and Boyle Cheng, Ph.D.

Paul A. Anderson, M.D.: Dr. Anderson is professor at the University of Wisconsin School of Medicine and Public Health and nationally recognized expert in spinal trauma and complex cervical spine disorders. His research encompasses spinal fixation implants, the artificial cervical disc and basic research in disc regeneration. His current projects include: Sleep Disturbance in Orthopedic Patients Continuous Motion Analysis of the Human Spine and a Classification System for Lumbar Degenerative Disc Disease
Scott Boden, M.D.: Chairman of the Department of Orthopaedics, Director of Emory Orthopaedics & Spine Center and Chief Medical Officer Emory University Orthopaedics & Spine Hospital, Dr. Scott Boden is one of the founding fathers of modern spine surgery. He is an internationally renowned lecturer and teacher and is one of the world’s top spine surgeons and researchers.
Dr. Boden’s research currently encompasses cell/molecular biology of osteoblast differentiation including study of the mechanism of action of bone growth factors (BMPs), the design and development of small drug-like molecules that will enhance bone formation locally, regionally, and possibly systemically, animal models of spine fusion to understand the biology of the healing process and test the efficacy of various bone graft substitutes and outcomes research relating to spinal disorders, diagnostic imaging, and utilization of health care resources.
Boyle Cheng, Ph.D.: Dr. Cheng is Professor of Neurosurgery at Drexel University – Allegheny General Hospital. He is the Director of Research for the Neuroscience Institute at Allegheny Health Network and maintains an adjunct appointment in the Department of Biomedical Engineering at Carnegie Mellon University. His grant-funded research has included topics including the evaluation of anterior cervical disc replacement in a sheep model, biomechanical studies of a biased angle posterior cervical system, facet motion preservation technologies as well as dynamic and physical modeling based on specimen specific imaging and kinematic studies.

(L to R): Reginald Davis, M.D., FACS, Ira L. Fedder, M.D., and Jeffrey A. Goldstein, M.D.

Reginald Davis, M.D., FACS: Dr. Davis is the Director of Clinical Research at the Laser Spine Institute. He first made his mark as part of the elite medical team that performed the 22-hour, historic surgery to successfully separate conjoined twins at the Johns Hopkins Hospital. Today Dr. Davis is one of the most published spine researchers and most recently brought his thoughtful, methodical approach to identifying, evaluating and implementing new technologies in the ambulatory spine surgery setting. Dr. Davis is active in numerous professional societies including the Florida Neurosurgical Society and the American Board of Neurological Surgery.
Ira L. Fedder, M.D.: Dr. Fedder is a fellowship-trained orthopaedic surgeon with Towson Orthopaedic Associates in Maryland. Dr. Fedder is experienced in all aspects of spine and neck problems including the treatment of arm pain, cervical disc herniations, myelopathy, cervical stenosis, leg pain and weakness, lumbar stenosis, sciatica, lumbar disc herniations, tumors, and infections. He is also author and co-author in dozens of clinical studies, a consultant to young technology companies and a frequent presenter at surgeon meetings.
Jeffrey A. Goldstein, M.D.: Dr. Goldstein is the chief of the Spine Service for Education and program director of the Spine Fellowship in the Department of Orthopedic Surgery at NYU Langone. Dr. Goldstein is a particularly active researcher in the areas of biomedical materials and devices and participates regularly in clinical trials. Dr. Goldstein is also the author of numerous book chapters and articles that have been published nationally and internationally. He is the winner of the Leon L. Wiltse “Best Paper” award at the annual meeting of the International Society for the Advancement of Spine Surgery. He was selected by New York Magazine and Super Doctors as one of New York’s “Best Doctors” and by Castle Connolly as one of America’s “Top Doctors.” Finally, Dr. Goldstein serves on the editorial and advisory boards of The Spine Journal, the International Journal of Spine Surgery, the Global Spine Journal, Spine Surgery Today, and the Bulletin of the Hospital for Joint Diseases, and is on the review board for Spine.

(L to R): Scott Webb, D.O. and Hansen A. Yuan, M.D.

Scott Webb, D.O.: Dr. Webb is Surgical Director of Florida Spine Institute and participates in several research projects including motion preservation and minimally invasive surgical techniques for the treatment of spinal stenosis and back or neck pain. Dr. Webb performed the first Facet Joint Replacement in the Lumbar Spine in both Romania and in the United States. He received his Honorary Doctorate (Honoris Causa) from Victor Babes University of Medicine. He is a member of the North American Spine Society, American College of Spine Surgeons, American Osteopathic Association, American Osteopathic Academy of Orthopedic Surgeons, and American Academy of Orthopedic Surgeons.
Hansen A. Yuan, M.D.: Dr. Hansen A. Yuan is the retired Professor of Orthopaedic and Neurological Surgery at the State University of New York Upstate Medical University. Dr. Yuan has trained thousands of surgeons from around the world and has advised hundreds of young medical technology firms. Dr. Yuan has authored more than 100 articles and many abstracts published in peer-reviewed journals. He has been a contributing author of 16 chapters to medical books. Dr. Yuan researches in the areas of degenerative disc disease, scoliosis, and bone healing and bone substitute. In North America and Asia, universities and hospitals invite Dr. Yuan as a visiting professor. Many times, he has been a Presidential Guest to the Republic of China speaking on Orthopaedic Surgery.
 

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Zimmer Biomet using the Apple Watch to collect data from 10,000 joint patients

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Zimmer Biomet launches clinical trial with Apple Watch (MassDevice)
Zimmer Biomet (NYSE:ZBH) said today that it’s launching a clinical trial using the Apple Watch to help hip and knee replacement patients that could enroll as many as 10,000 patients.
Using the orthopedic giant’s MyMobility app and the Apple Watch, the study aims to evaluate the app’s utility in improving outcomes and lowering costs, Warsaw, Ind.-based Zimmer Biomet said. The study will incorporate patient feedback and continuous health and activity data from the Apple (NSDQ:AAPL) device.
“We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons,” president & CEO Bryan Hanson said in prepared remarks. “At Zimmer Biomet, we are committed to improving care decisions through digital health and we are thrilled to launch one of the largest evidence-gathering clinical studies in orthopedic history.”
“We believe one of the best ways to empower consumers is by giving them the ability to use their health and activity information to improve their own care,” added Apple COO Jeff Williams. “We are proud to enable knee and hip replacement patients to use their own data and share it with their doctors seamlessly, so that they can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”
The 16 study sites include academic centers, hospitals and group practices or ambulatory surgical centers in California, Colorado, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania and Utah, Zimmer Biomet said.

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