The current COVID-19 outbreak has impacted virtually every industry on earth, and orthopedics is no exception. There has been a significant and sudden decline in the volume of elective joint replacements world-wide as health systems rightfully prioritize their COVID-19 response. However, as the need for telehealth technologies becomes clear to health systems large and small, Formus Labs is well-positioned to help with recovery once hospital utilization returns to normal.
Moving forward, we would anticipate several key changes for orthopedics and digital health, as all efforts are made to reduce transmission risk and improve efficiency.
- A high uptake of remote-work and distributed solutions for patients, clinicians, and suppliers
- Optimization of the implant supply chain
- Efforts by regulators to streamline market approval for digital health technology, enabling the above
Here are some of the challenges and opportunities facing us over the next 12 months and beyond.
Around the world, non-urgent, elective surgeries have been deprioritized, putting most joint replacements on hold. While clinical staff may be redeployed to the COVID-19 response, patients must cope with delays in treatment, while implant suppliers are facing material declines in revenue over the next several quarters.
As a side effect of the reprioritization of hospital resources, non-vital clinical research has also largely halted. As a result, we expect delays in clinical trials to hold up the development and release of a wide range of medical technologies over the next 12-24 months.
On the regulatory side, the US Department of Health and Human Services (HHS) has relaxed HIPAA enforcement to give medical providers more telehealth options. While currently aimed at tools like FaceTime and Skype, this may signal a willingness toward a more flexible regulatory path for digital tools in the future.
For Formus, the immediate impact of COVID-19 is on our hip planner clinical evaluations. We are now focused on adapting our clinical evaluation protocol to utilize the clinical data we have gathered over the past 12 months, with the goal to complete our product validation on time. Our product development is otherwise unaffected and will be our focus for the next quarter.
Preparing for the Recovery
There will be opportunities in the coming months for digital health technologies to position themselves for the COVID-19 recovery. Once COVID-19 responses ease, there will be a backlog of elective surgeries in hospitals. Pre-operative planning software can help streamline the preparation, provision, and delivery of the backlog of joint replacements.
The current lull in joint replacement procedures offers a rare opportunity for a large number of cases to be planned in advance using pre-op planning solutions. Cloud-based platforms have a special advantage in allowing the clinician and their rep to plan cases remotely while travel and hospital access restrictions are in place. With the surgical plans and implants selected ahead of time, implant suppliers and hospitals have the opportunity to optimize their inventory and production (in the case of patient-specific custom parts) to efficiently address the backlog of cases once the situation allows.
The New Normal
It’s possible that social distancing practices remain in place over the longer term as we await a vaccine. However, the fundamental need for and value of joint-replacement surgery will also remain, continuing with current trends in aging and mobility. To meet this demand, changes in patient-surgeon-rep interactions and inventory management practices that are already happening are likely to accelerate.
The frequent movement of orthopedic sales reps between many different sites may no longer be tenable in a post-COVID world. As such, telehealth tools that allow surgeons and reps to plan, assist, and execute joint replacements remotely will be crucial. We already know that cloud-enabled pre-op planning software helps with the former. The need for remote execution could accelerate the integration of pre-op planning with surgical guidance and robotics along with the appearance of “virtual” attendees in the operating theater.
The existing practice of shipping consignments of dozens of implants between hospital sites for surgeries is not only hugely inefficient, but can also now be seen as a transmission risk. In reducing this risk, implant suppliers will look to streamline the orthopedic supply chain; delivering just the right implant to the right surgery at the right time. Pre-operative planning is crucial to this mission, accurately determining the right implants well in advance.
It is still early days in the fight against COVID-19 and lasting changes to public health and clinical practice are a given. Despite necessary short term pains, joint replacement surgery is not going anyway. However, the challenges we now face have created a huge impetus toward the acceleration and integration of telehealth technologies into current orthopedic practice, both clinically and commercially.
Formus, along with the rest of the orthopedic industry, will be working hand-in-hand with surgeons and health providers in the months and years to come to accomplish this mission. The road is likely to be long, but the future, ultimately, will be bright.