Getting your device to market is a huge accomplishment. It also comes with a new set of considerations. The reimbursement and regulatory landscape can change. Patient safety monitoring is required and safety concerns can emerge that need to be addressed. Or product adoption rates could be lower than anticipated. Our Medical Device and Diagnostic Solutions can help you through all of these scenarios and more during the post-market stage of your product’s life cycle.
Extended support for product access and adherence
Smart solutions to keep track of your device
Comprehensive, continuous regulatory support
Continuous Market Support
Now that your device is on the market, the stakes have changed. People are using your device every day or may run into barriers to access your device. We provide end-to-end patient support services, including a highly efficient reimbursement service, field service and nursing support programs to assist clinicians and patients with the use of your products as well as Patient Assistance Programs (PAPs) and co-pay services. In addition, our agents work with patients, providers and insurers to help overcome access barriers to your medical product.
Product Vigilance and Patient Safety
Robust, predictive post-market surveillance solutions are available to monitor the in-use safety of your device. This approach facilitates compliant product safety and performance in accordance with changing regulations while making it possible for you to reduce costs and the demand on your resources.
Gone are the days of reactively collating and reporting adverse events, such as device malfunctions or patient injuries that trigger product returns, modifications, exchanges and recalls. Instead, your post-market patient safety efforts are proactively managed by safety data specialists under one standardized system utilizing today’s technology to seamlessly harness, consolidate and analyze data, as it is reported. This provides product vigilance and patient safety that enables you to monitor your device in near real-time the entire time it’s on the market and set conditions that readily flag safety issues. That’s intelligence you can use to keep improving the safety of your device.
Product vigilance and patient safety services
- Case Intake/Call Center
- Case Management
- Medical Review
- Aggregate Reporting
- Signal Detection
- AI-Driven Automation Intelligence
For commercial success, real-world evidence (RWE) is vital to maintain a competitive edge, support new indications and expand to new patient populations. You need proof to support new product claims and value propositions. Healthcare providers looking to purchase your device seek reassurance of its benefits observed in patient applications. Regulators require data to satisfy safety and efficacy concerns as part of a conditional Marketing Authorization Application (MAA).
Now, you can benefit from the same insights, support and expertise for your post-market studies that you received during your pilot or pivotal trials. Expect accelerated trial design and patient recruitment techniques that boost your post-market studies as well as access to our team of regulatory and commercial specialists to help you define your strategy, develop and synthesize evidence, and communicate value.
Studies that help you leverage evidence
- RWE Studies
- Interventional Studies
- Observational Studies
- Virtual & Hybrid
- Database Analyses, Treatment and Utilization Patterns, Natural History and Other Supplementary Studies
Post-Market Support for Recalls, Audits and Obolescence
While your product is on the market, you may encounter regulatory, quality and commercial matters – such as recalls, audits or obsolescence. From addressing a 522 safety concern to making plans to properly sunset your product when the time is right, our advisors can help you navigate a broad variety of commercial scenarios easier.
Support that keeps on giving
- New Labeling Claims and Expanded Indications For Use
- Audit Preparation and Support
- Recall Support
- Obsolescence Planning and Preparation
- Training Program Design and Implementation
- Remediation Program and Correcting Quality System Compliance
- Strategic Reimbursement Assessments
- Payer Initiatives and Reimbursement Strategies
- Payer Insights and Payer Mix Analysis
- Pricing Strategies
- In-country Legal Representation (i.e.: EU authorized rep/importer of record)