Our device and drug teams work closely so the diagnostic device and drug are literally made for each other – maximizing the likelihood of successful patient outcomes.
The best of both worlds
Device consulting expertise meets clinical development excellence
Biopharmaceutical therapeutics increasingly target specific genetic abnormalities, and determining whether those abnormalities exist and whether the proposed therapy will work requires a companion diagnostic device to identify specific genetic, proteomic, or gene expression markers.
Many of our people come from sponsor companies, so they know what to ask up front: What indication provides the best return on investment? What claims make sense? What about pricing, and ensuring that your device will qualify for separate reimbursement?
- In just the past five years, we have performed more than 170 medical device studies – from cardiovascular to orthopedic to companion diagnostics
- We understand the differences among categories of medical devices and diagnostics
- Our regulatory professionals track the latest U.S. and European policy shifts and regulatory requirements
- Our focus is biotech, and we help small, highly innovative companies manage the entire device development process
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We were testing an autologous chondrocyte transplantation system to repair damaged knee cartilage. Patients felt great after treatment and saw no need to make follow-up visits – but the FDA required us to track results for seven years.
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Safe or not?
In a recent trial of a new device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint was easy to measure. However, assessment of the safety of the device in terms of postoperative complications was more complex.