Close Up: genae and the Secret to MedTech Trial Success

jun. 29, 2020

In September 2019, genae joined the IQVIA Healthcare family. genae is a data-driven service provider with a focus on MedTech devices and technologies. In an industry largely focused on pharmaceutical trials, this MedTech capability is unique. We talked to Aly Talen, co-founder of genae & VP MedTech Strategy of IQVIA MedTech, about how its experts can help manage MedTech clinical trials with full-service CRO-support in every phase of the research process.

“Our MedTech expertise goes back to our foundation in 2005,” says Aly Talen, co-founder of genae & VP MedTech Strategy of IQVIA MedTech. “We first mainly worked on cardiovascular implants, but we have since expanded our knowhow to the full range of MedTech technologies, from orthopedics to neurostimulators. Naturally, all these devices require clinical trials as part of their development. However, most clinical trial and contract research organizations focuses on pharmaceuticals. Our specific MedTech expertise is unique. Our team now consists of 100+ professionals, of which about 50 are based in our headquarters in Antwerp.”

A Well-Kept Secret

For a hospital, there are only upsides to participating in a well-run clinical trial, specifically when it comes to clinical trials with novel Medical Devices. Being at the forefront of new technologies, expanded treatment options, the opportunity to become a leader and expert in a specific technology, and networking and development opportunities is not only important for the clinicians involved, but also for the reputation of the hospital.

The Challenge of Enrollment

genae, now IQVIA MedTech, can take care of the Regulatory Strategy, the study document creation compliant to the Medical Device Regulations, the site selection, the submission to the Medical Device Unit of the FAGG/AFMPS, and the overall set-up and execution of the clinical trial. “Our biggest challenge is enrollment, finding the right doctors and patients for trials,” says Talen. “Hospitals with a strong patient cohort selection for clinical trials definitely have the advantage. Usually, this is a result of a having a strong research advocate within the hospital. But software solutions such as the Forcea HealthReport Clinical module, and the effective and efficient patient identification and selection they allow, make a hospital’s decision to participate easier as well. Searching through medical records is a laborious and time-consuming process. Solutions such as Forcea HealthReport Clinical and its intelligent search engine makes the required information instantly available.”

The Impact of MDR/IVDR

One of the hottest topics in the MedTech world is the European Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR). Due to COVID-19, the MDR has been postponed with one year and will come into effect in May 2021, IVDR will follow in May 2024. The new regulations include expanded clinical evidence requirements and it will impact the industry significantly. “80% of the IVDs used to fall under self-certification. Only 7% will remain self-certified; the rest must be certified by notified bodies,” says Talen. “Due to the limited number of notified bodies, we’re expecting a certification bottleneck. At the same, stricter clinical evidence requirements means strong research partnerships with the industry and hospitals will become even more important. Either way, we’re ready to be the knowledgeable partner who can guide all our stakeholders through the clinical process as smoothly as possible.”