Nick Deeter starts OrthoPediatrics 2.0

NEW ORTHO PEDIATRICS COMPANY: WISHBONE MEDICAL (Orthopedics This Week)
WishBone Medical website
Nick Deeter on LinkedIN
Finally…another pediatric orthopedic company! WishBone Medical, Inc. has just opened in Warsaw, Indiana. And it’s been done by Nick Deeter, founder of OrthoPediatrics Corp.

“WishBone Medical is committed to providing anatomically-appropriate innovative implants and instruments in sterile-packed, single-use, disposable kits to surgeons that fix orthopedic problems in kids. These sterile kits will focus on minimizing disease, preventing infection, reducing overall costs for our customers and achieving the best outcomes for children who are still growing; because kids are not just little adults,” said Nick Deeter, founder, chairman of the Board and CEO of WishBone Medical, in the January 17, 2017 news release.
As indicated in the news release, “In 2006, Nick Deeter started OrthoPediatrics because he saw an unmet need in the pediatric orthopedic space. Nick felt the standards for treatment in children were unacceptable and that the use of adult medical devices in these children could not continue. These patients needed medical devices that were designed for their smaller anatomy and unique needs. Nick worked with engineers and surgeons to develop products that could meet the needs of growing children.”
“The pediatric orthopedic market is large ($1.4 billion globally) and growing at 10% per year. Unfortunately for the patient, 95% of the orthopedic implants going into children today are not specifically designed for them. Ten years ago when I started OrthoPediatrics, I felt it was unacceptable for a child to get an adult device that was bent, cut, and altered just to try and make it fit while ignoring the growth plates and possibly causing more harm. The large orthopedic companies ignore the pediatric market and focus solely on the adult market. There is still a lot of work to be done on behalf of our kids,” added Deeter.
Deeter told OTW, “I founded both companies and we are both dedicated to helping children with orthopedic issues. The business models used to achieve this wonderful cause of helping kids are dramatically different.”
Asked about challenges facing the pediatric orthopedic world now, he noted, “The main challenge is educating surgeons to use anatomically appropriate implants for the growing and morphing child. Ninety-five percentof the $1.4 billion market are still altering small adult products and jamming them into kids and hoping that they work. This used to be all pediatric orthopedic surgeons had to work with during surgery. This will change with the introduction of WishBone Medical’s innovative sterile packed, disposable kits with all the implants and instruments at their fingertips.”
 

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Why Is It So Hard to Innovate at Big Medical Device Companies?

Why Is It So Hard to Innovate at Big Medical Device Companies? (MDDI Online)
Read also… Life in an Orthopedic Startup – what’s it like?
Large medical device companies boast big R&D budgets and world-class engineers. So why does most of the innovation in medtech come from startups?

How do you develop a groundbreaking medical device? If you work at a small company, the answer is put in a lot of blood, sweat, and tears (not to mention some of your own cash and probably a lot of sleepless nights). But if you work at a big medtech company, innovation is just an acquisition away.
That’s probably an oversimplification, but you get my point. Innovation in medtech these days typically starts from the ground up. The dirty work, in many cases, is done by a scrappy startup with a novel idea and the guts to chase it. As soon as the concept starts to show promise, one of the big guys swoops in to gobble it up, commercialize the technology, and reap the rewards.
What I don’t understand is this: If small companies working with a skeleton crew and a shoestring budget can churn out disruptive innovations on the regular, why can’t the biggest medtech companies, with their billion-dollar R&D budgets and world-class talent, do the same?
The problem seems to be the suits. Executives at big companies have to keep shareholders happy, and as such they’re often unwilling to step out on the limbs that lead to innovation.
“Large companies are very, very risk averse,” Giridhar Thiagarajan, an R&D engineer at Bard Access Systems (a division of CR Bard) explained while speaking on a panel at the MD&M East conference last month in New York City. “And usually innovation, at least new concepts and things like that, takes money and takes time, and usually that doesn’t float well when you look at it from a management perspective.”
Consider, he said, a project that’s an incremental innovation that’s going to cost $2 million versus a novel design that would be a big step forward but might cost $10 million and require a clinical study.
“The company’s going to go for the low-hanging fruit first just because everybody’s bonus structure, promotions, everything is tied to that. Once the low-hanging fruit dries up, then they’ll address the bigger projects.”
The problem with that kind of thinking is that with our healthcare system rapidly evolving to incentivize real innovation over incremental improvements, there will be less and less demand for that low-hanging fruit.
So how can big companies get back to the business of breaking the mold?
“The only way to break through and really be innovative and be creative is to really explore new spaces and connect dots that no one else has really connected before,” said Bryce Rutter, founder and CEO of Metaphase Design Group and moderator of the MD&M East panel. “It takes a lot of guts to do that, and I think organizations that are really good at it have a culture of accepting wild and crazy ideas and really letting them germinate.”
In some ways, big companies are starting to catch on. Case in point: the design centers that are cropping up at some larger firms. Also called innovation centers, these facilities typically eschew traditional office furniture like cubicles in favor of elements like beanbag chairs and communal tables. You might even find a Rubix cube. The aim is to create a safe space intended to foster creativity. But while the intentions behind them are good, design centers miss the point, as readers told MD+DI’s sister site, Qmed.
“You can’t just drop R&D teams into a snazzy new office space and have them innovate,” one anonymous commenter explained. “You have to clear the decks and allow the teams to focus, without the distractions of their everyday projects.”
In some cases, the big ideas are already there; it’s just that employees at big companies don’t have permission to pursue them. Rutter recommends putting a jar in your office, and anybody who pooh-poohs a moonshot idea has to put in a dollar. If saving money is the suits’ primary objective, it just might work.
Jamie Hartford is MD+DI’s editor-in-chief and also serves as director of medical content for UBM’s Advanced Manufacturing Group. Reach her at [email protected] or on Twitter @MedTechJamie.

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Study: The InSpace biodegradable balloon works well for massive rotator cuff tears

ORTHOSPACE: POSITIVE DATA FOR ROTATOR CUFF SYSTEM (Orthopedics This Week)
OrthoSpace website
It’s celebration time for the Italian company, OrthoSpace Ltd! They have announced the publication of long-term follow-up data for their InSpace System for the treatment of massive rotator cuff tears (RCTs). The research involved 20 patients in an open-label, single-arm, prospective.
“Massive rotator cuff tears represent a painful condition that can severely limit everyday activity. For patients who don’t respond to conservative therapy, there are currently no consensus guidelines for a preferred surgical option,” said Vladimir Senekovic, M.D., an orthopedic surgeon at the University Medical Centre in Ljubljana, Slovenia, and the principal investigator of the study, in the January 4, 2017 news release. “InSpace offers a less-invasive, low-risk and effective treatment option for patients living with this challenging condition. Our results with the system demonstrate long-term, sustained improvements in pain and shoulder function.”
As indicated in the news release, “The InSpace System consists of a biodegradable balloon spacer that is usually implanted arthroscopically. The device was rated technically easy to use by surgeons participating in this study and can be implanted in just 10 minutes. It represents a novel surgical option for the treatment of RCTs, a complex indication where existing surgical options are often associated with high failure rates.”
“An evaluation of the overall change in total CS [Constant Shoulder Score] from baseline showed that 18/20 patients (90%) had some improvement in their scores at one or more of the follow-up visits. Statistically significant improvement was noted in total CS at six months, which was sustained for up to five years of follow-up. Of patients participating in the final follow-up visit, 84.6% showed a clinically significant improvement of at least 15 points in their CS, while 61.5% showed at least 25 points of improvement. Patient-reported pain scores, ADL [activities for daily living] and ROM [range of motion] improved by a mean of 96%, 122% and 64%, respectively, from baseline. There were no complications or unexpected device-related adverse events recorded during this study.”
“These promising results continue to validate the ability of InSpace to provide a long-term, less-invasive, lower-risk surgical solution for patients living with the pain and disability associated with massive rotator cuff tears,” said Itay Barnea, company CEO. “Over 10,000 patients have been treated with the InSpace System since our European product launch in 2011, and we look forward to continuing to develop clinical research in support of the system and remain committed to improving outcomes for patients with this debilitating condition.”
Barnea told OTW, “It has been exciting to have robust clinical validity to the technology supported by multiple peer-reviewed publications in December.”
“We plan to continue the growth in the major European Union markets, as well as explore some new market opportunities in Latin America following recent regulatory approvals.”

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The Bone Glue category could grow to $1B for fracture fixation

BONE GLUE MARKET: $1,032.9 MILLION BY 2024 (Orthopedics This Week)
Organic…not just for milk anymore! Patients want natural alternatives to conventional cements when it comes to surgery, say market watchers at Persistence Market Research, a New York firm providing market research reports and consulting services. These analysts indicate—in a December 21, 2016 news release— that “the global market for bone glue is currently valued at US$ 600.6 million, and is expected to reach US$ 1,032.9 million in revenues by the end of 2024.”
As indicated in the news release, “Their document, entitled, ‘Global Market Study on Bone Glue: Rising Adoption of Bone Glue for Orthopedic Surgeries Expected to Boost Demand for Bone Glue over the Forecast Period,’ has estimated that the global market for bone glue will register a CAGR [compound annual growth rate] of 7.0% during the assessment period of 2016-2024. Prevalence of bone related disorders continues to be on a rise, urging manufacturers to come up with advanced glues. Preference to bone glue remains higher for adhesion procedures in arthroplasty surgeries. By the end of 2024, the application of bone glue in arthroplasty surgeries is slated to surpass 40% share of global market value, rendering it as the most prominent application for bone glue adhesives.”
Analysts from Persistence Market Research told OTW, “While doing some orthopedic devices reports, we came across some new opportunities for internal fixation procedures using bone glue or bone adhesive that sticks to bone and reunites fractured bones without using internal fixation devices. Also, there has been increasing need to replace internal fixation devices plates, screws, rods, pins, wires and similar devices. However, due to reluctance and apprehension of using metals inside the bone, patients mainly prefer minimally invasive procedures. While analyzing the opportunistic scenario for bone glue in orthopedics, we selected to approach this topic for our report.”
“Increasing cases of multiple fracture injuries and arthroplasty procedures is expected to drive demand, which, in turn fuels growth of the market for bone glues over the forecast period. Moreover, there are increasing instances of osteoporotic fractures of spine and lower extremity in growing geriatric population. Such factors have led various companies to engage in R&D [research and development] practices for bone glue to provide an effective absorbable glue for fractured bone fixation procedure.”
“Orthopedic surgeons should consider a bone glue, which has good fatigue strength and does not dissolve in the surrounding liquid. Bone glue should have good post-operative visualization on X-ray and should possess low viscosity formulation, which can be easily delivered through an injection during minimally invasive surgery. Bone glue should further possess anti-microbial properties to eliminate any risk of infection during or after the surgery.”
“These glues are majorly considered in osteoporotic fractures, multiple fractures, arthroplasty procedure and other fractures, and procedures.”

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DePuy Synthes acquires the assets of Interventional Spine

DePuy Synthes Enters Asset Purchase Agreement with Interventional Spine (HealthPointCapital)
DePuy Synthes (Johnson & Johnson) entered into an asset purchase and development agreement with Interventional Spine, Inc., a U.S.-based manufacturer of expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion.
Interventional Spine offers expandable cage technology that provides tactile feedback to surgeons, and features a continuously adjustable design, allowing the device’s height to be customized to the patient’s anatomy. The company’s implant lines are designed to maximize bone graft contact and containment in order to help encourage bone growth and fusion. The company was founded in 2000 as “Triage Medical, Inc.”, changing its name in 2006, and is headquartered in Irvine, CA.
Under the terms of the asset purchase, DePuy will acquire Interventional Spine’s facet screw system for open and percutaneous spine surgery, a type of MIS procedure that aims to reduce the risk of complications and improve outcomes by utilizing small skin incisions without cutting the patient’s underlying muscle.
Through this deal, DePuy expands its expandable cage offerings to its core spine platform, a segment management believes will be help drive future growth.

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