Infection prevention in orthopedic medical devices, rigorous FDA regulations, & more: our AAOS 2017 takeaways

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The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of surgeons, medical device companies, thought leaders, and academics seeking the latest advancements and learnings in orthopaedic surgery. Leaders gathered together in San Diego from March 14th to the 18th.

The new T3 Labs booth (a first for us at AAOS) looks good, right?

Here are are a few of the highlights and insights from AAOS 2017, courtesy of Preclinical Testing Program Director at T3 Labs, Dr. Evan Goldberg.

What is happening in realm of orthopedic treatment & infection control?

Infection prevention in orthopedic medical device development was a huge topic covered in sessions and seemed to be in the forefront of many conversations. In order to improve the current standard of care and ensure patients do not develop a surgically acquired infection, innovators are producing new devices fixed with antimicrobial agents and antibiotic-eluting bone graft substitutes. Though everyone agrees there is a need for antimicrobial devices, there is much more rigor involved in gaining FDA approval for combination devices.

With a medical device the action is mechanical: a patient has a fracture and the device aims to fix it. If you add a coating or an antibiotic to kill bacteria you have to undergo separate measures to secure FDA approval since drugs are regulated in a very different way.

Since the incidence of infection is 10-20% how do innovators ensure the antimicrobial agent is actually making a difference? Clinical trials must be run on many more patients in order to prove the efficacy. This is a more strenuous process than simply inoculating the device or surgical site with bacteria, which can be done in preclinical studies- many must test their combination device on 1,000+ patients.

Because the process to take an antimicrobial orthopedic device from concept to commercialization is fraught with regulatory landmines, many young device companies are at a loss as to what the FDA needs from them to gain approval. The FDA is asking for more studies and posing even more questions than ever before- which has been a challenge for new companies.

What should a young medtech company do to ensure a speedy commercialization in order to not burn through time, resources, and capital? A pre-submission meeting with the FDA is a good start, but many companies have that and are still asked to take extra measures to reach commercialization. Engaging an experienced industry partner like the Global Center for Medical Innovation and T3 Labs can help streamline the developmental pathway.

“GCMI was instrumental in our early development including prototyping that led to a product candidate we could take into clinical trials. We used their space, cleanrooms, equipment and personnel to help develop and validate our product candidate and its value.” –Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc

You need a trusted partner in translating orthopedic innovations through the various stages of development- from concept to commercialization.

We know well the challenges of bringing new medical technologies from concept to cure to commercialization. This is why we provide the highest value preclinical testing and training services available delivering models, protocols, development insights, reliable data sets and more to support product refinements and preparedness for regulatory approval.

“The ability to smoothly work through the surgeries onsite was immensely valuable to our team and process. T3’s counsel on the proper model, along with the veterinary team’s commitment to understanding our product, how to implant it and where, and the team’s high level of surgical capability and quality systems gave us the ‘whole shebang’ in one preclinical relationship.” -Janet Krevolin, Ph.D. Chief Technical Officer of Bio2 Technologies

Related- Meeting the top needs in preclinical studies for orthopedic devices: the first structural, completely porous bioactive glass

If you are a physician innovator with an idea for a new orthopedic device, a medical device company gauging your product’s readiness for preclinical, or seeking a partner in gaining FDA approval for your combination orthopedic device, contact GCMI and T3 Labs today to learn how our expert team can help you take your concept through cure, preclinical testing, and commercialization as well as provide surgeons the bioskills training necessary for your particular device. “This is as close as you can come to a real OR experience.” – David Smith, Sales Manager, Stryker.