If you’ve been researching BalancedBack®, you may already know that it involves traveling to the Cayman Islands for surgery. (And if you haven’t yet visited our site that explains the details of that experience and information about myself and the rest of our medical team, please take a look.) We’re often asked why it’s necessary to travel for surgery. The short answer is that the U.S. is slower than other countries when it comes to adopting new medical technology, and the approval process takes time. Meanwhile, as we work toward government approval here in the States, you can still get safe and effective total disc replacement surgery in other countries where the implant has been approved for clinical use.
The long answer has to do with the complexities associated with the U.S. approval process for new medical devices. The information below will give you an idea of the challenges involved in innovation that make traveling for medical care not such an uncommon occurrence.
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Making Total Disc Replacement Surgery Available In The U.S.
In the U.S., bringing a medical device from concept to market means getting approval from the Food and Drug Administration (FDA). To do that, manufacturers need to follow one of two processes:
- Gain 510(k) clearance for a medical device that can be shown to be “substantially equivalent” to a device that was already on the market before 1976, the year key amendments were made to the Food Drug and Cosmetics Act of 1938. An example of this would be proposing a cervical plate (an implant that provides stability for fusion in the neck) that may be somewhat different from the type currently available but similar enough that it would not be considered a new device. If the device is deemed to be substantially equivalent, a manufacturer can gain approval to market the device by showing equivalence and safety, without the requirement to conduct clinical trials for efficacy. By definition, all 510(k) technologies (the vast majority of spine systems available today) are equivalent to systems that were on the market before 1976.
- Gain Premarket Approval (PMA) for a new product. If the device is different—if it uses different materials or differs in design, for example—the manufacturer must navigate the FDA’s Premarket Approval process. This process generally starts with collecting pilot data, followed by clinical trials under an FDA Investigational Device Exemption (IDE), followed by a follow-up and review period, and finally leading to a Panel Meeting and potential approval. The process is highly uncertain, because requirements such as “valid scientific evidence” are not well defined. Navigating the PMA process takes approximately 10 years and manufacturers must spend as much as $100 million dollars bringing a single technology to market via this process. FDA staff, presidential administrations, and government policies change along the way, and it is not uncommon for a manufacturer to be denied approval over relatively minor issues. It’s not surprising that very few IDE/PMA processes are completed in the United States.
So what does it take to get the required “valid scientific evidence”? That’s where the hurdles begin.
The Path To An FDA Trial
FDA trials—which is where the valid scientific evidence comes from—are complicated in practice and large in scale. A trial may require up to 400 patients (200 for the proposed new device and 200 for a control group; in the case of total disc replacement surgery, that means fusion patients). And if the results are not statistically significant, you may need to begin again on another 200 patients.
Trials like these are conducted at multiple medical centers, usually in academic settings staffed with research assistants. Prior to the study, everything about the device and the trial process must be set in stone:
- The participating medical centers must be approved.
- The parameters for a successful trial must be defined.
- The design of the device must be finalized and cannot change throughout the trial.
- The procedure used to implant it must be documented and finalized. (It must also be taught to the research center staff in advance of the trial.)
- The instruments to be used during the procedure must be defined.
For a trial to be considered successful, the procedure must be conducted the exact same way for every patient involved, and according to a strict set of rules.
For many new medical device manufacturers, however, the real challenge is getting to the FDA trial. Often, devices like this need to have a history before they will even be considered for a trial. That means having done a number of cases using the device already—which, without FDA approval, must happen in a setting outside the U.S. This is the reason the vast majority of new technologies are innovated offshore, with Europe historically offering the most advanced medical care.
As previously mentioned, a major challenge with the U.S. system is that the cost of these studies can be hundreds of thousands of dollars per patient. The average cost to develop new medical devices in the U.S. is estimated at $94 million. Because expenses are so high, the process is so long, and the outcome is so uncertain, there is very little capital available to sponsor new technology. Large companies focus almost exclusively on 510(k) products in order to provide returns to their stockholders. Venture capital—once the foundation of medical device innovation—is largely unavailable today because the life of most VC funds is shorter than the FDA cycle. In other words, venture capitalists must raise funds from investors, invest in companies, help the companies succeed and grow, sell the companies to large corporations, and pay back their investors—all in a time that is less than the FDA IDE/PMA cycle of a typical orthopaedic device.
BalancedBack® is different from traditional artificial disc replacement (which was first done in Europe), and we’ve been developing the device for many years.
With the BalancedBack® technology, we have taken an entirely different approach. As far back as 10 years ago, we started treating BalancedBack® patients in South Africa. This experience gave us the confidence to build a center closer to the United States, in the Cayman Islands. Cayman is a British Overseas Territory governed by British Law, with a regulatory body similar to our FDA—the Cayman Health Practice Commission (HPC). HPC regulates our work like the FDA but with two important differences: (1) we are able to collect data under more reasonable clinical protocols and (2) the healthcare system in Cayman allows us to offer private-pay procedure directly to U.S. patients at very affordable prices. We’re continuing to build up our successes today in the Caymans. We are also taking steps to design an appropriate FDA study in advance of submitting our PMA application, using our Cayman experience as the foundation.
BalancedBack®: A Medical Breakthrough In Spine Surgery
In the past two decades there have been only minor innovations in spine surgery, in part because of the complexity of the spine (multiple joints all working in conjunction with one another) and in part because of the stifling environment created by the FDA. Today, the FDA seems more receptive to encouraging innovation, which could result in a marked increase in the number of new medical devices that come to market—not just as they relate to the spine, but to all areas of medicine. Companies like ours are renewing interest from the finance community, by bringing the capital requirements for new technology back down to reasonable levels.
The first heart transplant was done in South Africa, the first joint transplants (hip and knee) were done in England, and the first artificial disc replacement originated in Germany—all of these life-saving technologies are commonly used in the United States today. The FDA may be the gold standard of approvals, but every new innovation has to start somewhere.
BalancedBack® is one of the many new medical devices helping people as it travels the road to approval in every market around the world. If you’d like to know more about the BalancedBack® procedure, visit our website or contact us.