Emerging technologies and processes fuel orthopedic specialty

Emerging orthopedic technology, whether the next great implant or a new care delivery model, represents an opportunity to improve quality and access to care for patients with musculoskeletal disease. These innovations are the engine that propels the field of orthopedics forward.

“If we think through the history of our innovations, including our ability to make accurate diagnoses, the ability to use antibiotics appropriately for infections [and] the ability to do surgery with appropriate anesthesia, we have evolved to the point where we can do complicated surgeries and complex reconstructions in orthopedic joints and the spinal column and have an impact on patient’s quality of life,” Sigurd H. Berven, MD, professor of orthopedic surgery at the University of California, San Francisco, said.

Some people innovate because they want to do more in less time, according to John D. Kelly IV, MD, associate professor of clinical orthopedic surgery at the Perleman School of Medicine at the University of Pennsylvania in Philadelphia. “So, we turn to emerging technologies to streamline our practices and also to find the most effective means to treat our patients,” Kelly told Orthopedics Today.

Others simply want to advance the field. “Almost everything we touch, everything we do, could be done better,” said Kevin R. Stone, MD, an orthopedic surgeon with the Stone Clinic and chairman of the Stone Research Foundation in San Francisco. “The field of orthopedics, although in some sense is advanced, in other senses is primitive. We still put big metal implants into joints that have biologic problems. We still treat arthritis by telling people to wait, to reduce their activities and wait for their knee replacement.”

Clinical vs. process technologies

There are a lot of exciting clinical emerging technologies, according to Kelly, who is also the chairperson of FDA Center for Devices and Radiological Health Orthopaedic and Rehabilitation Devices Panel. New MRI sequences can precisely define pathology as well as reveal the integrity of bone and cartilage, he said. Stem cells, platelet rich plasma, bone marrow injections, scaffolds and gene therapy all promise enhanced tissue preservation and healing.

“Although crude and somewhat burdensome at present, computer navigation will perhaps prove most useful in the preoperative planning and templating of arthroplasty and ligamentous reconstruction,” Kelly said.

Although advances in clinical technologies are important, they are not the only way to innovate in medicine, according to Anthony M. DiGioia III, MD, a hip and knee surgeon with the Bone and Joint Center in Pittsburgh. Of equal importance are process innovations, which involves the use of a new or significantly improved service or care delivery method. Process innovations can also encompass significant changes in technique, technology and use of equipment.

Examples from outside of medicine include Henry Ford’s introduction of the assembly line, which brought the product to the person during fabrication.

“The lithography method used to fabricate microchips was a process innovation that has touched the lives of most people on the planet,” DiGioia said. Other examples include the Pilkington glass method and the methods used to produce the small disk drives currently used in some MP3 players.

Medical process innovations include multimodal perioperative pain management and rapid rehabilitation protocols for patients needing total joint replacement, which yield faster recoveries, shorter lengths of stay and better care experiences for patients, DiGioia said. New business models for health care delivery, like payment bundling and referenced-based pricing and new cost-accounting methodologies, may help innovation by determining the true cost to deliver care.

Better health care

Process innovations can improve health care quality, DiGioia said. For example, another strategy called “patient activation,” makes patients more active participants in their care.

In a study of 33,000 primary care patients enrolled in Fairview Health Services, a nonprofit health system in Minnesota, Judy Hibbard, DrPH, and colleagues at the University of Oregon demonstrated a link between patient activation and health care costs.

The results showed that in 2010, the patients with the lowest activation — those patients who were the least involved in their own care — had predicted health care costs that were 8% higher compared with patients with the highest activation scores. In 2011, patients with the lowest activation had 21% higher costs compared with patients with the highest activation.

DiGioia’s practice goes one step further with this process innovation.

“We call it co-design,” he said. “We actually have patients and families involved in designing the care delivery models. They are the end-users of the system, and until we understand and view the experience through their eyes, we can’t develop a value-based health care delivery system.”

Process innovation may soon overshadow technological innovations, DiGioia said.

“I would say that in the next 5 years, innovations are going to be more focused on processes rather than technologies,” he said. “Surgeons have to broaden their perspective. It is not just what we do in surgery; it is not certain techniques and not just the technologies that we use.”

These process changes are critical.

“[We are spending] so much money but not meeting all of the basic needs of our end users — the patients and families,” DiGioia said. “That is actually a sign of a process defect. You are not connecting your resources to the needs of your end users.”

Key players

There are several key players when it comes to developing emerging technologies: physicians, industry and the FDA.

Physicians are critical in the development, adoption and use of emerging technologies.

“The surgeon has to be central in developing new technologies and driving innovation,” Berven said. “No one has more insight and direct knowledge of the needs of the medical and surgical community as well as the needs and values of patients.

“When we think of areas that want new innovations, new technologies, it is the combination of patient and surgeon that defines the space. They define the void where a new technology may be needed, understand the limitations of existing techniques and technologies and value an innovative change.”

Industry plays an important role, too. “The role of industry, I think, is to assist with technical expertise, especially as we are designing new innovations in orthopedics that may be highly technical and may require a high degree of engineering,” Berven said. Industry also provides the funding and the infrastructure.

“Surgeons, the physicians whose primary responsibility is patient care, simply do not have the infrastructure required to effectively and efficiently develop a new technique,” Berven said.

Even the FDA helps bring emerging technologies to the orthopedic office.

“Although people at times complain about the seemingly impervious nature of the FDA, I think their regulatory process has more often than not assisted in bringing new technologies to the forefront for clinical usage,” said A. Seth Greenwald, DPhil (Oxon), director of Orthopaedic Research Laboratories in Cleveland.

Barriers to implementation

While many applaud the FDA for helping to bring emerging technologies into clinical practice, others indicate that the regulatory process is a major impediment.

“The FDA process remains an enormous obstacle to new device introduction in the field,” Stone said. “The reason for that is that many of the procedures that are in place are excessively cumbersome and have not changed as the World Wide Web has become available.

“For instance, if you want to introduce a new product to the field, the sequence of testing of a safety trial and then a wide efficacy trial is a concept that was based on using a minimum number of patients to determine the desired outcome,” Stone said. “With the interconnected world of the web, if you could introduce a new product after the safety studies are completed, the efficacy studies could use crowd sourcing to determine the problems that might occur. This would be a much more novel, modern, quicker, better way of evaluating efficacy than the current FDA model.”

“The FDA has limited the ability of new products and potentially safe products to make it to the market through the stringency of the [premarket application] PMA pathway,” Berven said. “The PMA pathway can be a cost- and time-prohibitive barrier for some new technologies to be objectively brought to market.”

Global health care economy

As a result, more researchers and manufacturers are taking their devices overseas.

“We take devices and test them outside the United States in environments where the regulatory process is somewhat different, even though it is still vigorous,” Stone said.

For example, Aperion Biologics, founded by Stone, completed a safety trial in the United States on its new anterior cruciate ligament product. The company completed a successful prospective, double-blind trial comparing pig ligament and allograft in Europe and South Africa. Once the product secures CE-mark approval, the company will return it to the states to initiate its wide clinical pivotal trial in 10 sites for FDA approval.

This exodus of products and research means the United States now shares the title of leader in orthopedic innovation.

“I do not think the United States is the dominant place in the world for new innovations and new technologies, but I think the United States remains a major contributor,” Berven said. “New products and innovations come from around the world. We now work in a global health care economy.”

Making changes

As a result of these issues as well as the fallout from the problems with metal-on-metal hip implants, the FDA has sought to make significant changes.

“That has resulted in a re-look at their process of approval, for what might be considered higher risk products,” Greenwald said.

“[The FDA] has made a renewed commitment to be ethical and principled and to show public faith that their business is for one basic thing: for the safety and efficacy of products,” Kelly said. “I think that they have tightened the reins on some over the years because there were some issues with the integrity of the administration in years past.”

In 2011, the FDA outlined its plan to encourage biomedical innovation, which is focused on several items. First, the agency wants to overhaul the organization’s small business outreach. One step they have taken in that direction is to significantly reduce the fees for small or start-up companies, according to Greenwald.

“With increased personnel resources, they can be more assistive when new companies or small companies ask for advice on how to submit a product for review and approval,” Greenwald said.

Also, the regulatory body wants to create a rapid drug development pathway for critical targeted therapies.

“I think the FDA has appropriately created pathways for developing technologies,” Berven said. “It might be orphan-type technologies, the [humanitarian device exemption] HDE, for example. The FDA has created pathways for innovations in areas that might not be either profitable or might be otherwise limited by a potential recovery in investments. I applaud the FDA for making those efforts.”

The agency is focused on streamlining regulations. Last summer, the FDA issued a draft of investigational device exemption (IDE) guidance. The FDA wishes to partner with medical device manufacturers early in the clinical design process so that manufacturers can design clinical studies that will better support a successful future marketing application, which in turn, will accelerate IDE approval.

In addition, the FDA has established a subcommittee whose goal is to better evaluate regulatory issues related to the Center for Devices and Radiological Health.

Obstacles to innovation

Although the regulation hurdle is the largest barrier to innovation, there are other barriers. Patient physiology can be an impediment, Berven said. “In an aging population, sometimes even the best innovation is not going to be able to overcome illness, comorbidity, bone quality deficiency.”

Reimbursement of emerging technologies is another obstacle.

“If a new technology is not going to be reimbursed, then it is impossible for it to be effectively supported in the preclinical stages,” Berven said. “It is impossible to solicit industry support or financial support for a new technology that is not likely to be reimbursed.”

Factors that affect implementation

Several factors affect the adoption of emerging technologies. Clearly, regulation requirements are the most significant. But there are others, including patient preference — patients may request the latest technology despite a dearth of evidence of clinical benefit; the reputation of the technology’s advocates; compatibility with practice style; and the current litigation climate, according to a paper by James H. Herndon, MD, of the Massachusetts General Hospital and colleagues.

New technology is adopted in a stepwise fashion, Berven said. “There are early adopters of new technology and then there are physicians who wait for some degree of comparative evidence of efficacy and safety,” he said. “And then there are late adopters — people who only adopt after something has become the standard of care.”

The primary predictor of adoption is the level of evidence to support the new technology, Berven said. “Different physicians have a different threshold regarding the level of evidence that would drive them to feel either supported in adopting a new technology or compelled to adopt a new technology,” he said.

Disruptive technologies

The level of disruption caused by the new technology is also a factor that influences adoption. Disruptive technologies, a concept popularized by Harvard Business School Professor Clayton Christensen, are those that suddenly displace existing technologies. Perhaps a better description is transformational processes and technologies, DiGioia said.

“Transformational changes are going to challenge your organization,” he said. “It is going to challenge what we do on a day-to-day process.”

Mobile fluoroscopic imaging systems, the Surgical Implant Generation Network and the rise of ambulatory surgery centers are all disruptive orthopedic technologies, according to Erik Hansen, MD, and Kevin J. Bozic, MD, MBA, who published research on how these technologies have affected the specialty.

“In this article, we have applied the concept of disruptive innovations popularized by Christensen to the field of orthopedics to illustrate examples in which smaller, cheaper alternatives have improved access of care, increased patient satisfaction, and empowered clinicians to provide higher-quality, more convenient and efficient care to their patients,” the authors wrote.

Before the introduction of an emerging technology, it is critical to study the science behind it.

“Just because it is new does not mean it is effective,” Kelly said. “You always have to titrate the science and say, what is the track record? Laser capsular shrinkage was all the rage in the mid-1990s. We found that a.) It did not work and b.) It sometimes nuked people’s capsules.”

The true acid test in this decision-making process is whether the new technology is going to translate into better patient care, Kelly said. Some promising technologies have a tremendous abuse potential.

“Ultrasounds are a big boon for people to enhance their income,” he said. “However, they are not necessary for every patient.”

Changing face of innovation

Even the innovators will continue to change. “Innovators of the future are going to be people who are already inside existing organizations who take ideas and take resources that already exist but put them together in ways that other people haven’t thought about,” DiGioia said. “If you think about it, that is what the description of health care is or should be. There is so much money resources and technology resources, it is almost the perfect opportunity for innovators within the system to start thinking differently and start pulling people together and start pulling resources together to deliver new care delivery models, new payment models, new technologies and new processes.”

As the researchers continue to develop new products and ideas, the focus remains on improving the cost effectiveness and the value of care, Berven said.

“Where innovations are becoming important in this generation and generations to come are how can the innovations not only improve quality of life and longevity, but [also], how they can improve the value of care,” he said. – by Colleen Owens

Is the 510(k) pathway still a safe and effective method for approving orthopedic devices?

The 510(k) provides an intermediate regulatory pathway

Yes, the 510(k) process is a safe and effective method for approving orthopedic devices. The 510(k) process provides an intermediate regulatory pathway based upon a predicate or already approved device, therefore allowing reasonable scientific evidence to demonstrate substantial equivalence to a device with established safety and effectiveness. Without it, most orthopedic devices would not be on the market and our patients’ care would be severely limited.

The complexity of some implants and combinations of devices has become quite complicated, and the science and standards evaluating properties of implants has also advanced. These changes should drive improvements, not elimination of the 510(k) pathway.

While I admit the recent high profile failure of metal-on-metal hips appears to have had some relationship to the 510(k) process, I would like to point out that it is unlikely these problems would have been identified with an investigational device exemption trial with 2-year follow-up either.

The 510(k) process is responsible, depending on the source, for between 90% and 99% of orthopedic implants being used to help our patients today. In addition to common implants, custom implants and pediatric implants often depend upon the 510(k) process. Countless implants are responsible for millions of patients returning to activity after disabling injury or bone and joint disorders. Our patients need the 510(k) process to ensure the availability of implants to maintain their health and function. Senator Norm Coleman said, “Even though 99.6% of all devices approved through the 510(k) process have never been subject to a class I recall, the government is still calling for increased regulations.” This is an excellent track record.

Does anyone really want more government regulation on a process this successful?

John S. Kirkpatrick, MD, is a professor in the Department of Orthopaedic Surgery and Rehabilitation at the University of Florida Health Jacksonville.
Disclosure: Kirkpatrick serves as an FDA consultant on intermittent basis.

The process continues to evolve

The 510(k) process was established under the Medical Device Amendments of 1976. Under this process the 510(k) pathway has the goals of making certain safe and effective devices become available for end users and patients while promoting innovation in the medical device industry. From Jan. 1 to Aug. 31, 2013, 2,013 devices were cleared via 510(k) compared with 589 devices approved through the premarket approval process. Even though the greatest number of devices come to market through the 510(k) pathway, they account for a disproportionately small number of Class I recalls.

Currently, most problems occur when manufacturers submit a combination product that contains a biologic (i.e., growth factors) and a device (i.e., resorbing scaffold for musculoskeletal reconstruction) where there are predicates for the separate components, but no established predicate for the combination. Frequently, the combination product also lacks the standards or guidance documents to facilitate the evaluation of safety and efficacy.

Even where appropriate predicates exist, there are still many steps to assuring that a device is safe and effective through the 510(k) process, including scientific reviews and guidance or standards. The 510(k) process continues to evolve as signaled by the FDA’s issuance of orders for 522 post-market surveillance studies. I believe these kinds of studies and other modifications to the pathway will be more common place in the future. For these reasons I do believe the current 510(k) process is a safe and effective method for bringing orthopedic devices to market, with the caveat that the FDA continues on a path to evolve and adapt to the changing products that are being developed.

William M. Mihalko, MD PhD, is with Campbell Clinic Orthopaedics and is professor & JR Hyde Chairman, Director of Biomedical Engineering and Director of Adult Reconstructive Fellowship Program at the University of Tennessee Health Science Center.
Disclosure: Mihalko is a paid consultant, receives royalties and research of institutional support and is on the speakers bureau for Aesculap/B. Braun; and receives financial or material support from Surgical Solutions.