Imagine that a renowned surgeon has a game-changing idea that will improve the lives of many patients worldwide. It will take him three years of hard work — forging partnerships and burning through a lot of cash — before senior executives and engineers from leading medical equipment companies agree to test the first prototypes. Designed by Leuven MindGate member Comate, the Gripper and the EsySuit change thousands of lives, every day, all over the world.
How long does it take for a patient to walk again after invasive hip surgery? Thanks to this surgeon and Comate, your guess is probably wrong.
Having a hip replaced is no walk in the park for patients. Beyond the trauma of surgery, the rehabilitation process can take months before patients return to their normal activity routine. But have you ever considered what hip surgery is like for orthopedic surgeons? It turns out that the patient is not the only one to feel discomfort during surgery.
To improve patient outcomes and help surgeons deliver the best care possible, a Belgian orthopedic surgeon teamed up with Comate’s engineers to design an innovative medical device that brings needed relief to surgical teams. Meet the Gripper, the surgical tool that helps patients to walk again only 90 minutes after invasive hip surgery.
Professor Kristoff Corten, M.D. and Ph.D. in Medicine and Orthopedic Surgery, says the idea for the Gripper was borne out of necessity. “As a surgeon, I’m always looking for the best outcome for my patients, which pushes me to find the most advanced techniques available. Yet in this case, I found there wasn’t anything on the market that would do the job.”
Hip replacement surgery is one of the most successful surgical procedures. But with conventional techniques, surgeons often have to damage various muscles around the hip joint with large incisions, and there’s always a risk of post-operative limping. Developed many years ago, the Direct Anterior (DA) approach helps improve patient outcomes. However, the procedure isn’t straightforward. It requires prolonged surgical times, with a high risk of unintended muscle damage.
To improve the DA protocol, dr. Corten spent many years of research developing the Efficient Direct Anterior (EDA) approach for hip surgeries. In EDA, a surgeon makes a smaller incision, which minimizes the risk of muscle damage and supports enhanced patient recovery. However, in order to obtain a perfect view of the different anatomical landmarks during an EDA procedure, a surgeon must open up a gap between muscles and safely hold all the muscles aside.
“As a surgeon, I’m always looking for the best outcome for my patients, which pushes me to find the most advanced techniques available. Yet in this case, I found there wasn’t anything on the market that would do the job.” – Prof. Dr. Corten
This necessity presents a major challenge. “If I wanted to apply this technique for my hip replacement surgery, I needed several retractors — to keep any muscular tissue out of the way during the operation,” says dr. Corten. “It’s crucial to have a clear view on the surgical site.” As a result, during an EDA procedure surgical assistants must hold each of these retractors, while remaining still for hours. “Due to non-ergonomic positions and because assistants don’t always have perfect visibility of the surgical field, it presented a big burden for me and other surgeons to obtain the good view required to perfectly insert the implant components. This potentially leads to non-optimal outcomes, which in my mind was simply not acceptable.”
Holding a retractor in a stable position is the mentally exhausting for a surgical team. The surgeon wants to focus on the implants, but if the surgeon’s view is obstructed, it becomes much more difficult and tiring. In addition, for the assistant there’s no possibility to be proactively involved with the process due to the non-ergonomic, static position required to hold the retractors. Plus, EDA requires more people around the operating table, which increases the risk for sterilization errors and increases costs. “For these reasons, the EDA approach struggled to make breakthroughs, despite its appealing muscle-sparing aspect,” says dr. Corten.
Based on dr. Corten’s ideas, the Gripper is a medical device that makes the EDA approach much more reproducible, muscle sparing and efficient. The EDA hip procedure is currently having a breakthrough in more than 22 countries all over the world. “With the EDA approach supported by the Gripper, I believe we have found the answer to economic and ergonomic sustainability of hip replacement surgery,” says dr. Corten. “The surgical trauma is reduced — or surgical times are reduced — and optimized ergonomics allow the surgical team to do more and do better.”
The journey from idea to a ground-breaking finished product was not easy. The concept for The Gripper did not begin to take shape until dr. Corten spoke with Comate. “I had an idea, but I needed a partner to translate it into a tangible prototype,” he recalls. “Comate was able to visualize the idea, and through a structured process they defined exactly what the product would be able to do.” Comate provided its expertise about potential materials and production techniques, as well as trustworthy suppliers. Its engineers came up with technical solutions, and its designers made it fit perfectly for users.
Dr. Corten’s idea for a better retractor system was brilliant, but it was a long and intensive journey from his concept to the approved device’s commercial launch. The Gripper project burned through a lot of cash while the Comate team worked with dr. Corten to develop a marketable product. dr. Corten even took out loans to keep development on track. Through the hard times, the team remained motivated, uplifted by the fact that it was making process and that major medical device companies, such as Zimmet Biomet, Stryker, Smith & Nephew and Depuy Synthes (Johnson & Johnson), were eager to test the prototypes.
“For me the most surprising part of this endeavor was how easily the engineering team of Comate understood my ideas and needs and translated this into such an intuitive product,” – Prof. Dr. Corten
The team built hundreds of prototypes, and in the final phase of development, it set up test panels for preclinical and clinical trials in different countries to generate as much feedback as possible and to fine-tune the product. “For me the most surprising part of this endeavor was how easily the engineering team of Comate understood my ideas and needs and translated this into such an intuitive product,” recalls dr. Corten.
After three years, the team had met ISO 13485 standards and received required approvals from the EU and the U.S. FDA. “It’s still is the most exciting endeavor in my professional life because the intense collaboration with Comate led to one of the most exciting and wanted new products in orthopedics over the past years,” says dr. Corten.
The Gripper attracted tremendous interest at the American Academy of Orthopaedic Surgeons’ annual meeting, and the first batch of 20,000 grippers was released worldwide in 2017. The entire team is now working full-time to introduce the internationally patented system to surgeons in all four corners of the planet. “I’m proud that we created a product that helps hundreds of nurses, surgeons and most importantly: thousands of patients all over the world,” beams dr. Corten.
“It’s a deeper purpose that I share with Comate: to be able to actually make a difference in a person’s life.” – Prof. Dr. Corten
Today, the Gripper has changed hip surgery in operating rooms all over the world. The Gripper tremendously improves the surgical process, both for the patient and the surgical team. Instead of suffering through a long operation, damaged muscles and a tiresome revalidation process, patients can now walk, even 90 minutes after a hip replacement procedure. “This is game-changing in Orthopedics,” dr. Corten says. “It’s a deeper purpose that I share with Comate: to be able to actually make a difference in a person’s life.”
The benefits of this innovation extend beyond minimizing damage to muscles during hip replacement surgeries. Shorter operation times also reduce mental and physical exhaustion, meaning that medical teams can now do more with less. Surgical team members experience less fatigue and are better motivated, which also provides better economic outcomes for hospitals.
Dr. Corten and Comate also setup a long-term collaboration partnership, MedEnvision. It serves as a medical device incubator to help surgeons find solutions to turn their ideas into products.
The MedEnvision team has created other products that enable standardized surgical procedures. For example, EsySuit simplifies the surgical draping process, and it has been incorporated with the EDA hip procedure. The teams closely work together to further elaborate on other products and procedures, such as total knee arthroplasty and shoulder surgery.
Working with MedEnvision has further deepened Comate’s knowledge of designing devices for the medical market, keeping into account the ISO 13485 standards, ergonomics that relieve the surgeon’s tasks and the overall well-being of the patient — the team’s primary benchmark to evaluate all of its design decision.
To make these innovations possible, no magic is involved. Comate brings in specialists from different field and leverages their expertise and experience. In the end, it’s not about thinking outside the box. It’s about trying, doing and persevering, and about forgetting there ever was a box in the first place.
Putting sharp minds from different areas of expertise together is what sparks true innovation. There are many brilliant ideas from brilliant scientists that could create such a positive impact. If only they would team up with a partner that can help them to translate this idea into a viable product.
Text and pictures: Comate
Original article: https://www.comate.be/blog/medical-device-patients-can-walk-only-90-minutes-after-invasive-hip-surgery/