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Orthopedics' Future Hinges on Technological Improvements




Orthopedic companies should focus on value rather than product innovation in order to survive and thrive in the healthcare industry’s “new normal,” medical professionals contend.

The advice came from a panel of experts who attended Cleveland Clinic’s Medical Innovation Summit 2012. With attendance down due to Superstorm Sandy, the summit’s opening panel, “21st Century Orthopedics: Hands-On Perspectives from Clinical Leaders” extended to an hour, and the much-anticipated panel on the state of healthcare innovation was nixed. The opening panel nimbly addressed some innovation topics as well, adapting well under the extraordinary circumstances.

The panel’s central message was that product innovation will not be the main focus of the future in orthopedics, a sentiment Stryker Corp. CEO Kevin Lobo echoed later in the evening. Rather, said Joseph Iannotti, M.D., Ph.D., the practice of medicine must change. He said caregivers must change how they care for patients and how they get paid. Caregivers also must prove their methods and products are effective.

Medical device designers and manufacturers, meanwhile, must seriously focus on value.

Value is a simple equation, said Iannotti. It is the result of quality divided by cost. The questions manufacturers must ask themselves are, “What value does the new technology bring? Is it better? How? When is it appropriate to use? Will it improve efficacy?”

For Richard Parker, M.D., chairman of the department of orthopedic surgery at Cleveland Clinic, the future of innovation lies in regenerative medicine. Looking back over the past two decades, Parker noted how far technology has come. “There have been huge imaging improvements in MRI and 3D-CT [magnetic resonance imaging and 3D computed tomography] reconstruction,” he said. “We used to have to inject dye, but now nothing invasive is needed for imaging. Ultrasound [for orthopedic applications], too, has improved, and has been popular in Europe for years and is growing in popularity in the United States. Non-operative colleagues are perfecting indications for ultrasound imaging.”

The importance of imaging in orthopedics is great. In minimally invasive surgery, a preferable choice over major surgery, no surgeon can go in blind. “You still have to be able to see clearly,” said Parker. “There can be no blind cuts, even small incisions, without sight. There will be complications if you do that.”

Thus, over the next 20 years, innovation in orthopedics should happen in intra-operative imaging, and also smart implants that react cohesively with biological environments, interval procedures proprietary to or instead of arthroplasty, regenerative medicine, resurfacing (of bone), and alternative visualization in arthroscopy, among others fields.

With regards to regenerative medicine, (a heavy focus at the summit), Parker said, “We have younger candidates becoming candidates for arthroplasty. We need to figure out better ways to prevent that. Arthroplasties are great but can result in significant bones loss, deformity, and so on.” The field needs better regenerative biologic innovations—something other than total joint replacements, he added.

But total knee replacements or arthroplasty (TKAs) are one of the “highest value surgical procedures in terms of return on investment,” Iannotti noted.

Hip and knee implant procedures certainly are rising. A 2008 study predicted a Medicare bill of $50 billion for these procedures alone by 2030 if the trend continues. According to the study, the U.S. market for implants doubled between 2002 and 2005 to $5 billion. Zimmer Holdings Inc., one of the largest orthopedic implant manufacturers, doubled its net sales of implants between 2003 and 2007.

With an increase in TKAs, however, comes an increase in surgical complications. “In-vivo tissue healing is a huge market going forward,” said Iannotti. “There is variation on how people heal and how they injure. Non-invasive methodologies are a big opportunity. They may provide substantial outcome improvement.”

Parker also highlighted electronic medical records (EMRs) as an important item to watch, saying they are “not our burden, but a tool.” EMRs save time and space in obvious ways—they consolidate former paper records into an accessible computer database. However, there are legitimate concerns over information security and electronic failures that make more than a few hospitals and health care professionals loath to embrace them. Boston, Mass.-based Beth Israel Deaconess Medical Center’s computer systems frequently are infected with malware, according to chief information security officer Mark Olson, who participated in a panel in October on device and hospital equipment security. Such issues show why Parker characterized EMRs as “sometime-burdens,” but there is potential for improvement.

“The new era of healthcare will require measurement and proof of outcome, lower cost technology, better health records, and integration,” said Parker.

Point of care and home-care integrated equipment with EMRs ideally could improve accuracy of diagnosis and management as well as improve documentation, patient communication, and clinical efficiency and billing, added Iannotti.

Also in the realm of health IT (information technology) are smart implants—those with wireless connectivity (and therefore are vulnerable to malicious cyber attacks) or can adapt and react to different biologic environments. Will smart implants be a standard of care in the coming years, or will regulatory and other obstacles render them useless, moderator David Cassack asked the panel.

While Parker mentioned there is difficulty in bringing them to market in an ethical, evidence-based manner, Iannotti offered some advice to manufacturers: “Smart people will have to innovate, and be critical about what they have to prove before putting it on marketplace.”
















will smart implants be a stnd of care or do obstacles make them a non starter?

Parker: there is a difficulty in bringing them to mkt in ethical evidence based manner.

Iannotti: smart ppl have to innovate, and be critical about what they have to prove before putting it on mktplace.











Iannotti: in-vivo tissue healing huge market going forward. There is variation on how people heal and how they injure. Non invasive methodologies are a big opportunity. They may provide substantial outcome improvement.






ways of improving ongevity of component lifespane
Revisit Biologic ingrowth
Smart0instruments in surgery
Smart implants that react to biologic env
Interval procedures propr to or instead of arthroplasty:
Biologic (regenerative med)
Partial/focal
Resurfacing
Intra-operative imaging to improve surgical technique:
MRI
alternative visualization in arthroscopy
assessing tissue quality at margin of lesion in restorative procedures etc
Function;
2nd gen PSI to optimize surgical care of deformity/defects;
Influence post injury states
Speed healing, shorten recovery



21st Century Orthopaedics: Hands-On Perspectives from Clinical Leaders
Two renowned orthopaedists provide their unique outlook on the strengths and challenges in the orthopaedic field and how the climate for innovation holds the potential for extraordinary change
Joseph Iannotti, MD, PhD, Chair, Orthopaedic and Rheumatologic Institute, Cleveland Clinic
Richard Parker, MD, Chair, Orthopaedic Surgery, Cleveland Clinic (Head Team Physician for the NBA's Cleveland Cavaliers).
David Cassack (Mod)

Iannotti:

Changes in ortho surgery, and globally in terms of how we will need to change our practice in medicine. We will get paid predom on proving value, how we take care of patients, and proving what we do is effective. We will have to prove it on the level of the individual caretaker.
Surgeon vs doc – shouldn’t be that way. SHoujld be inpatient, outpatient, surgical, non-surgical integrated. Home care too. Nursing.
Innov over past 2 decades has improved outcomes in Sports injuries, trauma, reconstructive surgey, MS surgery, & speed of recovery, (as a resident, ACL tear was a death sentence for career – brace or cast for long time. Now, no brace or cast).
Total joint arthroplasty – TKAs - highest values surg procedures in terms of return on investment. Joint replacements have gone up (total cost of hospitalization cost of hip/.knee joint replacements in 2007=$50b. As a result of increase in problems and surgeries, healthcare costs have risen. Expected to reach 4.4 trillion in 2018.
Future paradigm for healthc are delivery will change how/whwre we innovate in next 20 yrs
Cost – quality of outcomes – patient safety (totality; value) – patient experience
Value = quality/cost
What VALUE does the new tech bring? Is it better? How? When is it appropriate to use? Will improve efficacy and effectiveness.
These rules will apply to healthcare provider, system, industry, innovator, innovation and new tech.
What us ortho/Rheumatologic institute (ORI) doing to manage ortho clinical practice?
Use of electronic medical record
Practice and disease specific automated data collection
Point of care and home care integrated with the EMR resulting in improved accuracy of diagnosis and mgmt, improved documentation, patient communication, clinical efficiency and billing.

EMR is not our burden. It’s a tool.
Control of cost and quality: optimizing value
ORI MS care is multi disciplinary. Spectrum is v broad.
New era of healthcare will req measurement/proof of outcome, lower cost tech, better health record and integration.

Parker:

in ortho, we focus on quality of life. Oncology, TJA, fracture etc saves lives, but we also
Over last 20 yrs, we’ve focused onunderstanding anatomy/pathophysiology of disease/injury.
ACL, ortho oncology, fracture patterns and sub classifications are is perfect egs of how we’ve grown in understanding, and thereby innovated
Huge imaging improvements (MRI, 3d-CT reconstruction). We used to have to inject dye, but now nothing invasive is needed for imaging. Also ultrasound (pop in Europe for years, and growing here). Non operative colleagues perfecting indications for this.
We’ve been focused on ‘how to’ do stuff
MIS – you still have to be able to see clearly. No blind cuts, small incisions, without sight. There will be complications if you do that.
Next 20 years:
ways of improving ongevity of component lifespane
Revisit Biologic ingrowth
Smart0instruments in surgery
Smart implants that react to biologic env
Interval procedures propr to or instead of arthroplasty:
Biologic (regenerative med)
Partial/focal
Resurfacing
Intra-operative imaging to improve surgical technique:
MRI
alternative visualization in arthroscopy
assessing tissue quality at margin of lesion in restorative procedures etc
Function;
2nd gen PSI to optimize surgical care of deformity/defects;
Influence post injury states
Speed healing, shorten recovery

We’ll need to do more with less. Expected to be paid for performance. Shared risk. Comparative effectiveness.

Mod: outside Cleveland clinic, we tend to see doc as central fig of innovation. What does she need, want, what will appeal to doc? What role do you see surgeon in?

Iannotti: surgeons must understand there are changes on horizon.
Surgeons: ‘sometimes wrong but never in doubt.’

Mod: how do you make internalizing output from broad sets of data from outside t practice (as a surgeon)

Parker: more younger ortho surgeons are evidence based driven. We’re starting to get some data on ortho inpatient activity, we have to learn what to do w/ data, partic around arthroplasty. Understanding how to deal with outliers (surgeons) and giving them tools to bring them up to above average arena.

Mod: what stands out as striking unmet needs?

Parker: we have younger candidates becoming candidates for arthroplasty. We need to figure out better ways to prevent that. Arthroplasty’s are great but can result in sig. bones loss, deformity etc. Regenerative biologic innovations. Something other than TJRs.


Iannotti: in-vivo tissue healing huge market going forward. There is variation on how people heal and how they injure. Non invasive methodologies are a big opportunity. They may provide substantial outcome improvement.

Mod: will smart implants be a stnd of care or do obstacles make them a non starter?

Parker: there is a difficulty in bringing them to mkt in ethical evidence based manner.

Iannotti: smart ppl have to innovate, and be critical about what they have to prove before putting it on mktplace.