Building Medical Device Innovations Together
Client Ask: “We need to gather clinical data through a retrospective study to meet the needs of publication for market access and clinician adoption. We also need our initial CE Mark.”
Client: Spinal implant devices
Initial Service Areas Identified: Clinical research services
Client Ask: “We need to gather clinical data through a retrospective study to meet the needs of publication for market access and clinician adoption. We also need our initial CE Mark.”
Client: Spinal implant devices
Initial Service Areas Identified: Clinical research services
“Telos became our clinical department. We would have never been able to puruse the CE mark without their clinical expertise and navigation.”
~ Sr. Director of Regulatory & Clinical Affairs
How We Partnered
Situation
In 2018, Integrity Implants was successfully commercializing FlareHawk in the US. Their next frontier was Europe and they needed a CE mark. Integrity had an aggressive timeline of months, not years, to get an EU clearance for their flagship product.
Since FlareHawk is a uniquely-designed interbody fusion cage, the typical approach that manufacturers use for demonstrating equivalence to competitive products and leveraging their published clinical data was not an option. Integrity needed original, quality clinical evidence on the FlareHawk device…fast.
Clinical Data Challenge
In late 2018, Integrity engaged Telos to plan and execute a clinical study to gather data to support a CE Mark.
Telos jumped into action and put together a plan for a retrospective study to collect US post-market clinical data that included:
- Fusion rates
- Patient-reported outcomes scores
- Any adverse events
Telos then used their expertise and integrated approach to also assist Integrity:
- Advice on how to screen clinical sites
- Assistance with creating case report forms and a database
- Providing on-site monitoring and CRO support for each clinical site
There are always hiccups along the way and clinical studies were new ground for Integrity. Telos provided the proper guidance and corrective actions at each site to ensure an adequate amount of high-quality data was collected through the process.
It was an astonishing feat, but the study was completed within an aggressive deadline. Integrity expects to receive the CE Mark soon.
Services Provided as a Result of Our Integrated Approach
- Clinical Research Services 100%
- Evidence Services 60%
- Regulatory & Quality Services 90%
Client Successes & Results of Partnering with Telos
- On-site monitoring and CRO support for each clinical site
- CE Mark approval in process
- Plans for additional prospective registry study to generate additional post-market clinical follow-up evidence