4 Ways Streamlined Data Collection Can Accelerate your Regulatory Submission
Streamlined data collection offers several advantages that can significantly expedite the regulatory submission process for companies operating in regulated industries, particularly for medical devices with breakthrough device designation and through the Transitional Coverage for Emerging Technologies (TCET) pathway. We share four ways that a streamlined approach helps get innovative devices to market faster.
1. Early Evidence Gathering and FDA Submission:
Initiating data collection early enables manufacturers to provide robust safety and efficacy evidence required for FDA approval. Proactively collecting clinical and real-world data helps address concerns upfront, smoothing regulatory review and expediting market authorization. Aligning data collection with FDA requirements streamlines submissions and boosts TCET pathway acceptance odds.
2. Enhance Breakthrough Device Designation Eligibility:
Data demonstrating significant clinical advantages strengthens the case for Breakthrough Device designation. This designation may accelerate FDA review timelines and may increase TCET pathway eligibility, particularly when showing improved patient outcomes or reduced healthcare costs.
3. Evidence Addresses Coverage Considerations:
Comprehensive data collection enables early consideration of factors like clinical benefit and potential harms, aligning submissions with TCET pathway requirements and expediting CMS coverage decisions. Prioritizing patient-centered outcomes data and designing clinical trials relevant to Medicare coverage decisions are crucial steps in this process. This includes selecting appropriate endpoints, patient populations, and study designs that address the clinical and economic value of the medical device for Medicare beneficiaries.
4. Early Engagement and Collaboration:
Robust data collection strategies enhance collaboration with the FDA and facilitate acceptance into the TCET pathway. Engaging early with regulators and stakeholders, including patients, clinicians, payers, and regulatory agencies, informs study designs and generates evidence that aligns with Medicare coverage considerations. Early engagement and providing compelling data builds trust, expedites reviews, and may accelerate market access for breakthrough technologies.
Conclusion
Overall, streamlined data collection helps expedite the regulatory submission process for medical devices with breakthrough device designation and through expedited pathways like TCET by facilitating faster evidence generation, real-time monitoring and adverse event reporting, efficient data analysis and reporting, enhanced collaboration and communication, and comprehensive data integration. By leveraging streamlined data collection processes, companies can accelerate regulatory approvals, shorten time-to-market, and bring innovative medical devices to patients faster.
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Be sure to take advantage of more insights related to streamlining your companies path to market by viewing the Medical Device Data and Evidence: An Integrated Approach Webinar hosted by Matter.
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