Device and diagnostic manufacturers may use the new group to support the full product lifecycle, which includes global clinical trials, health economics and pricing and market access tools.
“The device and diagnostic development model can differ significantly from that of pharmaceutical companies, both in complexity and time to market,” said Elizabeth Thiele, President, Icon Commercialisation & Outcomes. “Operating under specific medical device SOPs and ISO certification, our new Medical Device & Diagnostics Research team has the expertise and flexibility to help manufacturers take time and cost from their development programmes and maximise the value of their products.”
Icon’s Medical Device & Diagnostics Research group will be led by Vicki Anastasi, VP, Medical Device & Diagnostic Research, who has over 20 years of medical device and diagnostics experience. The group is comprised of a team of dedicated project managers and clinical operations professionals as well as regulatory and strategic consultants.
Anastasi told Outsourcing-Pharma.com that the new group "is structured specifically to meet repeated demands from our clients.
The devices and diagnostics coming to market are more valuable than ever. It's not uncommon to see $100 million products, though that would have been unheard of even 3 years ago. While clients are generating more in sales, weighing heavily on their profits are the demands from regulatory agencies, payers, and investors. The ability to ask the right questions, design the best protocols, and collect and manage the clinical evidence (efficacy, safety, and health economics) that meets regulatory and reimbursement demands is a need for our clients.
In addition, there are a number of obstacles to bringing medical devices to market. Anastasi told us that some of those major obstacles that all device companies face, regardless of size or indication, and how Icon has helped to solve these obstacles:
- Health economics and market access: Icon has a dedicated commercialisation and outcomes group that understands the global reimbursement environment and asks the right questions early in the development process to define a device's value proposition.
- Variance in global regulations: Icon has medical device offices in the US and Europe and has conducted trials in North America, South America, Europe, and Australia;
- Technology that keeps pace with innovation: Icon has a number of proprietary software programs for clinical trial management, including ICONIK for patient-centric monitoring; ADDPLAN for the design, simulation, and analysis of adaptive trials; and Firecrest for interactive investigator and site training; and
- De-risking development: Icon is an expert in adaptive designs and patient-centric/risk-based monitoring. Adaptive designs build an insurance policy around clinical data by allowing for mid-trial adaptations that improve the chances of trial success or allow the trial to terminate early, if warranted. Patient-centric/risk-based monitoring allows companies to more efficiently deploy resources to the sites that need it most and to do so in real time. Such an approach helps companies to control costs and timelines.