08.12.22
Rank: #3 (Last year: #3)
$7.83 Billion
Prior Fiscal: $7.02 Billion
Percentage Change: +11.5%
R&D Expenditure: $497M
Best FY21 Quarter: Q4 $2.03B
Latest Quarter: Q2 $1.78B
No. of Employees: 19,500
Global Headquarters: Warsaw, Ind.
KEY EXECUTIVES:
Bryan Hanson, Chairman, President, and CEO
Ivan Tornos, COO
Suketu Upadhyay, Exec. VP, CFO
Kenneth Tripp, SVP, Global Operations and Logistics
Rachel Ellingson, SVP, Chief Strategy Officer
David Kunz, SVP, Global Quality and Regulatory Affairs
Sang Yi, President, Asia Pacific
Wilfred van Zuilen, President, Europe, Middle East and Africa
Commendations are in order for the prognosticators—authors like Philip K. Dick, Clifford Simak, Robert Heinlein, Michael Crichton, and others who envisioned 21st-century medicine long before its actual birth.
Simak, for example, concocted the idea for a regenerative tissue repair product (“Time is the Simplest Thing” 1961) half a century before the real stuff came along, courtesy of U.K. scientists.
Similarly, Heinlein wrote about sprayable skin for minor burn treatment (“The Puppet Masters” 1951), a full 67 years prior to U.S. Food and Drug Administration approval of Avita Medical’s spray-on skin system, RECELL.
Crichton beat AccuVein LLC to the punch for the automatic vein finder (40 years in advance), and Dick laid claim to artificial organs (“Cantata” 1964), electrical brain signal reading technology (“A Scanner Darkly” 1977), transdermal substance delivery (“Vulcan’s Hammer” 1960), and the artificial heart (“Dr. Futurity” 1960).
Curiously, though, none of these literary visionaries (or others) dreamed up a “smart” knee. The closest anyone came to such a whimsical notion was Martin Caidin, whose man-machine pairing in the 1972 best-seller “Cyborg” was later dramatized in the ABC series, “The Six Million Dollar Man.”
Alas, Caidin and his cohorts lost bragging rights to a self-assessing artificial joint that “talks” to doctors. Despite their impressive prophetic prowess, those authors never imagined—or perhaps never thought it possible—to combine sensor technology with an artificial joint.
William Hunter, however, knew better. He was convinced the combination was not only possible, but likely revolutionary as well.
The company Hunter founded a decade ago on his conviction is proving him right—the implantable sensor technology it developed could forever change the patient-doctor relationship, as it aims to improve healthcare outcomes through continuous data collection and analysis.
“The vision for this company is straightforward...let’s collect data from inside the body and connect that device to the internet,” Hunter, MD, said in a Deloitte blog post last fall. “Why is it that your refrigerator is connected to the internet, but your heart valve or your knee replacement isn’t?”
Good question but an irrelevant one now, since Hunter’s Vancouver-based company, Canary Medical Inc., won U.S. regulatory approval last summer for its proprietary implantable Canturio TE (tibial extension) sensor technology. Using 3D gyroscopes and 3D accelerometers, Canturio TE (CTE) measures, records, and securely sends to the Cloud a wide range of gait data. Surgeons can also compare post-operative gait metrics with mobility metrics collected before total knee replacement surgery.
The CTE’s high-fidelity sensors are modeled after drone guidance system mechanics, and collect 25 observations per second (similar to the human eye) to measure patient activity; three times a day, the CTE collects higher fidelity data at 800 observations per second. A pacemaker battery with a 20-year lifespan powers the device, enabling it to collect daily patient data for the first year after total knee arthroscopy (TKA).
Besides helping patients regain and maintain their mobility after procedures, Canary Medical’s sensor technology also could help surgeons better understand the causes of TKA complications such as pain, infection, or loosening.
“Every time the heel hits the ground, it sends a vibration wave up through the leg and into the knee replacement that can be measured by Canturio in a manner analogous to pinging a tuning fork,” explained Hunter, Canary Medical’s CEO. “Once we have enough information on normal versus abnormal vibration patterns, we believe we can identify potential problems with the joint—like loosening or even infection—using artificial intelligence to read and interpret the vibration pattern. It’s going to take data from about 1,000 patients before we can start doing that.”
Canary Medical is well on its way to that grand milestone, having licensed its CTE technology to Zimmer Biomet Holdings Inc. for use in the orthopedic giant’s Persona tibial baseplate. The sequential smart implant—Persona IQ—works in tandem with Zimmer Biomet’s remote care management platform (mymobility with Apple Watch) and other components of the ZBEdge Connected Intelligence Suite.
Touting it as the world’s “first and only smart knee,” Zimmer conducted a limited rollout of the Persona IQ last fall, shortly after its late summer de novo clearance by the U.S. Food and Drug Administration (FDA).
“Think of what [smart implants] bring to the table: A doctor will be able to see, on a daily basis, is the patient walking enough? Does the patient have a range of motion that dictates they’re doing well and on track? With all the other input they’re going to have with current standards of care, that [information] is very much an added bonus,” Zimmer Biomet VP of Smart Implants Jiny Kim told Inside INdiana Business. “That’s the super exciting part of [Persona] IQ—not only as the first smart knee—but that this component gets into the much larger ecosystem we’re creating that could, hopefully, in the future truly improve patient care. We think innovation is going to continue to happen in the orthopedic space and this is one of many [technologies] that’s going to get us there.”
Some of the other technologies Zimmer Biomet is counting on to keep it in the forefront of orthopedic innovation are the digital and robotic solutions comprising the ZBEdge Connected Intelligence Suite. Unveiled in March 2021, ZBEdge encompasses:
“The ZBEdge Connected Intelligence Suite enables healthcare professionals to connect the dots between procedural and patient care at every stage of the surgical journey,” Zimmer Biomet’s newly-appointed COO Ivan Tornos said upon the product’s introduction. “ZBEdge technologies are designed with the dual goals of reducing variability of care and enhancing outcomes.”
ZBEdge bolstered its outcome-enhancing abilities last year through an augmented robotics platform. In April and August, the FDA cleared Zimmer Biomet’s ROSA Robotics solution for partial knee and direct anterior total hip arthroplasty, respectively.
The ROSA Partial Knee System features proprietary 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, which may improve flexion and restoration of natural joint movement.
ROSA Hip is a fluoroscopy-based tool designed for direct anterior approach loyalists. It helps guide acetabular component orientation as well as intra-operative assessment of leg length and offset; the application allows clinicians to create a personalized surgical plan through the ONE Planner Hip. This pre-operative planner features a spinopelvic mobility assessment tool if both a sitting and standing lateral X-ray are provided with the anteroposterior X-ray, together with an auto-plan function that allows surgeons to potentially create a pre-operative plan within five minutes.
ROSA Hip also aims to improve procedural efficiency via a simplified setup that eliminates the need for pins or reference arrays and provides for an X-ray imaging alternative to computed tomography scans.
ROSA Hip was the fourth addition to Zimmer Biomet’s robotic surgical platform, which includes separate systems for total knee arthroplasty, as well as the ROSA ONE system for neurosurgical and spine operations.
“...the pipeline is really strong. That’s one of the things that has been a positive surprise during this COVID pressure. There has not been a reduction in demand on robotics, which is, to be honest, when we first started, I thought it would be the case, but we just haven’t seen it,” Zimmer Biomet leader Bryan Hanson told analysts earlier this year. “...in the U.S., we reached that 10% of total knees [is] being done robotically. It doesn’t sound like much...but that feels like a pretty good start. And the fact is it’s just the beginning of the journey. ZBEdge is getting a lot of traction. It’s creating brand awareness for this company to be a leading-edge organization and that does drive revenue growth for us.”
Significant revenue growth, actually: Zimmer Biomet’s FY21 proceeds climbed 12% to $7.83 billion due to improved elective procedure volume that boosted both operating profit ($780.1 million) and diluted earnings per share ($1.91).
Solid performances in all five reporting franchises benefitted Zimmer Biomet’s bottom line as well. Leading the charge was Other (robotic systems, surgical, bone cement), which increased sales 26% to $595 million, followed by S.E.T. (sports medicine, biologics, foot/ankle, extremities, trauma, craniomaxillofacial) which grew proceeds 13% to $1.72 billion.
Spine & Dental matched S.E.T.’s gains, surging 13% to $1 billion, while Knee sales swelled 11 percent to $2.64 billion, and Hip revenue rose 6 percent to $1.85 billion.
Spine & Dental’s double-digit growth was its first profit in four years—revenue previously fell from $1.06 billion in 2017 to $897 million in 2020, according to company data. The decline was likely the driving force behind Zimmer Biomet’s decision last winter to spin off the Spine & Dental unit into a standalone company, ZimVie.
The spinoff, announced in February 2021 and finalized roughly 12 months later, allows Zimmer Biomet to focus on its core capabilities (hips, knees, extremities, biologics, etc.) and better positions the new firm for greater spine and dental market share. “We expect these two companies, with their simplified operating models and reduced complexity and increased focus, will be able to grow revenue, margin, and earnings per share faster than they would if we remain combined as one company,” Hanson told analysts.
ZimVie is led by Vafa Jamali, who was chief commercial officer of Rockley Photonics and previously held leadership roles at Medtronic plc, Covidien, Cardinal Health, and Baxter International. The firm rounded out its C-Suite team last fall, adding Richard Heppenstall as executive vice president and CFO; Vincent Binetti as general manager, Bone Healing; Indraneel Kanaglekar as senior VP and president, Global Dental; Heather Kidwell as senior VP and Chief Legal and Compliance Officer; Mike Minette as senior VP, Strategy and Corporate Development; Ann Vu as senior VP, Regulatory Affairs and Quality Assurance; and Rebecca Whitney as senior VP and president, Global Spine.
$7.83 Billion
Prior Fiscal: $7.02 Billion
Percentage Change: +11.5%
R&D Expenditure: $497M
Best FY21 Quarter: Q4 $2.03B
Latest Quarter: Q2 $1.78B
No. of Employees: 19,500
Global Headquarters: Warsaw, Ind.
KEY EXECUTIVES:
Bryan Hanson, Chairman, President, and CEO
Ivan Tornos, COO
Suketu Upadhyay, Exec. VP, CFO
Kenneth Tripp, SVP, Global Operations and Logistics
Rachel Ellingson, SVP, Chief Strategy Officer
David Kunz, SVP, Global Quality and Regulatory Affairs
Sang Yi, President, Asia Pacific
Wilfred van Zuilen, President, Europe, Middle East and Africa
Commendations are in order for the prognosticators—authors like Philip K. Dick, Clifford Simak, Robert Heinlein, Michael Crichton, and others who envisioned 21st-century medicine long before its actual birth.
Simak, for example, concocted the idea for a regenerative tissue repair product (“Time is the Simplest Thing” 1961) half a century before the real stuff came along, courtesy of U.K. scientists.
Similarly, Heinlein wrote about sprayable skin for minor burn treatment (“The Puppet Masters” 1951), a full 67 years prior to U.S. Food and Drug Administration approval of Avita Medical’s spray-on skin system, RECELL.
Crichton beat AccuVein LLC to the punch for the automatic vein finder (40 years in advance), and Dick laid claim to artificial organs (“Cantata” 1964), electrical brain signal reading technology (“A Scanner Darkly” 1977), transdermal substance delivery (“Vulcan’s Hammer” 1960), and the artificial heart (“Dr. Futurity” 1960).
Curiously, though, none of these literary visionaries (or others) dreamed up a “smart” knee. The closest anyone came to such a whimsical notion was Martin Caidin, whose man-machine pairing in the 1972 best-seller “Cyborg” was later dramatized in the ABC series, “The Six Million Dollar Man.”
Alas, Caidin and his cohorts lost bragging rights to a self-assessing artificial joint that “talks” to doctors. Despite their impressive prophetic prowess, those authors never imagined—or perhaps never thought it possible—to combine sensor technology with an artificial joint.
William Hunter, however, knew better. He was convinced the combination was not only possible, but likely revolutionary as well.
The company Hunter founded a decade ago on his conviction is proving him right—the implantable sensor technology it developed could forever change the patient-doctor relationship, as it aims to improve healthcare outcomes through continuous data collection and analysis.
“The vision for this company is straightforward...let’s collect data from inside the body and connect that device to the internet,” Hunter, MD, said in a Deloitte blog post last fall. “Why is it that your refrigerator is connected to the internet, but your heart valve or your knee replacement isn’t?”
Good question but an irrelevant one now, since Hunter’s Vancouver-based company, Canary Medical Inc., won U.S. regulatory approval last summer for its proprietary implantable Canturio TE (tibial extension) sensor technology. Using 3D gyroscopes and 3D accelerometers, Canturio TE (CTE) measures, records, and securely sends to the Cloud a wide range of gait data. Surgeons can also compare post-operative gait metrics with mobility metrics collected before total knee replacement surgery.
The CTE’s high-fidelity sensors are modeled after drone guidance system mechanics, and collect 25 observations per second (similar to the human eye) to measure patient activity; three times a day, the CTE collects higher fidelity data at 800 observations per second. A pacemaker battery with a 20-year lifespan powers the device, enabling it to collect daily patient data for the first year after total knee arthroscopy (TKA).
Besides helping patients regain and maintain their mobility after procedures, Canary Medical’s sensor technology also could help surgeons better understand the causes of TKA complications such as pain, infection, or loosening.
“Every time the heel hits the ground, it sends a vibration wave up through the leg and into the knee replacement that can be measured by Canturio in a manner analogous to pinging a tuning fork,” explained Hunter, Canary Medical’s CEO. “Once we have enough information on normal versus abnormal vibration patterns, we believe we can identify potential problems with the joint—like loosening or even infection—using artificial intelligence to read and interpret the vibration pattern. It’s going to take data from about 1,000 patients before we can start doing that.”
Canary Medical is well on its way to that grand milestone, having licensed its CTE technology to Zimmer Biomet Holdings Inc. for use in the orthopedic giant’s Persona tibial baseplate. The sequential smart implant—Persona IQ—works in tandem with Zimmer Biomet’s remote care management platform (mymobility with Apple Watch) and other components of the ZBEdge Connected Intelligence Suite.
Touting it as the world’s “first and only smart knee,” Zimmer conducted a limited rollout of the Persona IQ last fall, shortly after its late summer de novo clearance by the U.S. Food and Drug Administration (FDA).
“Think of what [smart implants] bring to the table: A doctor will be able to see, on a daily basis, is the patient walking enough? Does the patient have a range of motion that dictates they’re doing well and on track? With all the other input they’re going to have with current standards of care, that [information] is very much an added bonus,” Zimmer Biomet VP of Smart Implants Jiny Kim told Inside INdiana Business. “That’s the super exciting part of [Persona] IQ—not only as the first smart knee—but that this component gets into the much larger ecosystem we’re creating that could, hopefully, in the future truly improve patient care. We think innovation is going to continue to happen in the orthopedic space and this is one of many [technologies] that’s going to get us there.”
Some of the other technologies Zimmer Biomet is counting on to keep it in the forefront of orthopedic innovation are the digital and robotic solutions comprising the ZBEdge Connected Intelligence Suite. Unveiled in March 2021, ZBEdge encompasses:
- The ROSA Robotics platform
- Anatomical visualization and guidance tools Signature ONE Surgical Planning, the iAssist Knee Alignment System, and Optical Navigation mymobility patient engagement with Apple Watch
- Data services and analytics including the OrthoIntel Orthopedic Intelligence Platform and Omni Surgical Suite integrated operating room
“The ZBEdge Connected Intelligence Suite enables healthcare professionals to connect the dots between procedural and patient care at every stage of the surgical journey,” Zimmer Biomet’s newly-appointed COO Ivan Tornos said upon the product’s introduction. “ZBEdge technologies are designed with the dual goals of reducing variability of care and enhancing outcomes.”
ZBEdge bolstered its outcome-enhancing abilities last year through an augmented robotics platform. In April and August, the FDA cleared Zimmer Biomet’s ROSA Robotics solution for partial knee and direct anterior total hip arthroplasty, respectively.
The ROSA Partial Knee System features proprietary 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, which may improve flexion and restoration of natural joint movement.
ROSA Hip is a fluoroscopy-based tool designed for direct anterior approach loyalists. It helps guide acetabular component orientation as well as intra-operative assessment of leg length and offset; the application allows clinicians to create a personalized surgical plan through the ONE Planner Hip. This pre-operative planner features a spinopelvic mobility assessment tool if both a sitting and standing lateral X-ray are provided with the anteroposterior X-ray, together with an auto-plan function that allows surgeons to potentially create a pre-operative plan within five minutes.
ROSA Hip also aims to improve procedural efficiency via a simplified setup that eliminates the need for pins or reference arrays and provides for an X-ray imaging alternative to computed tomography scans.
ROSA Hip was the fourth addition to Zimmer Biomet’s robotic surgical platform, which includes separate systems for total knee arthroplasty, as well as the ROSA ONE system for neurosurgical and spine operations.
“...the pipeline is really strong. That’s one of the things that has been a positive surprise during this COVID pressure. There has not been a reduction in demand on robotics, which is, to be honest, when we first started, I thought it would be the case, but we just haven’t seen it,” Zimmer Biomet leader Bryan Hanson told analysts earlier this year. “...in the U.S., we reached that 10% of total knees [is] being done robotically. It doesn’t sound like much...but that feels like a pretty good start. And the fact is it’s just the beginning of the journey. ZBEdge is getting a lot of traction. It’s creating brand awareness for this company to be a leading-edge organization and that does drive revenue growth for us.”
Significant revenue growth, actually: Zimmer Biomet’s FY21 proceeds climbed 12% to $7.83 billion due to improved elective procedure volume that boosted both operating profit ($780.1 million) and diluted earnings per share ($1.91).
Solid performances in all five reporting franchises benefitted Zimmer Biomet’s bottom line as well. Leading the charge was Other (robotic systems, surgical, bone cement), which increased sales 26% to $595 million, followed by S.E.T. (sports medicine, biologics, foot/ankle, extremities, trauma, craniomaxillofacial) which grew proceeds 13% to $1.72 billion.
Spine & Dental matched S.E.T.’s gains, surging 13% to $1 billion, while Knee sales swelled 11 percent to $2.64 billion, and Hip revenue rose 6 percent to $1.85 billion.
Spine & Dental’s double-digit growth was its first profit in four years—revenue previously fell from $1.06 billion in 2017 to $897 million in 2020, according to company data. The decline was likely the driving force behind Zimmer Biomet’s decision last winter to spin off the Spine & Dental unit into a standalone company, ZimVie.
The spinoff, announced in February 2021 and finalized roughly 12 months later, allows Zimmer Biomet to focus on its core capabilities (hips, knees, extremities, biologics, etc.) and better positions the new firm for greater spine and dental market share. “We expect these two companies, with their simplified operating models and reduced complexity and increased focus, will be able to grow revenue, margin, and earnings per share faster than they would if we remain combined as one company,” Hanson told analysts.
ZimVie is led by Vafa Jamali, who was chief commercial officer of Rockley Photonics and previously held leadership roles at Medtronic plc, Covidien, Cardinal Health, and Baxter International. The firm rounded out its C-Suite team last fall, adding Richard Heppenstall as executive vice president and CFO; Vincent Binetti as general manager, Bone Healing; Indraneel Kanaglekar as senior VP and president, Global Dental; Heather Kidwell as senior VP and Chief Legal and Compliance Officer; Mike Minette as senior VP, Strategy and Corporate Development; Ann Vu as senior VP, Regulatory Affairs and Quality Assurance; and Rebecca Whitney as senior VP and president, Global Spine.