Spring is Here, But It’s Time to Plan for Respiratory Season
by Scott Robitaille
It’s May! The days are longer, the weather warmer, and the flowers in full bloom. While many industries embrace a seasonal slowdown, IVD manufacturers, particularly regulatory and clinical operations teams, must take a different approach. Respiratory season may seem distant, but now is the time to prepare if your team intends to launch or expand clinical trials for respiratory assays.
Whether you are developing point-of-care or lab-based diagnostics for Flu A/B, RSV, STREP-A, SARS-CoV-2, or emerging respiratory pathogens, initiating planning during the second quarter is essential. The clinical and regulatory steps required to get a study off the ground demand foresight, coordination, and lead time that many teams underestimate.
Why May Through July Is the Strategic Window for Clinical Trial Planning
Too often, manufacturers wait until the third quarter or later to begin preparing for studies aligned with respiratory season. At that point, regulatory and operational hurdles can delay enrollment until winter, when symptomatic patient volume begins to decline, especially in southern states.
This is the ideal time to:
- Secure IRB approval and finalize site contracts
Institutional review board approvals and contract negotiations can take several weeks or even months, particularly with large health systems or academic centers - Engage the FDA through a Pre-Submission (Q-Sub)
If pursuing a 510(k) or De Novo pathway, early FDA engagement can clarify expectations related to study design, comparators, and statistical methodologies. - Finalize protocols and site training materials
Having a well-designed protocol that meets regulatory expectations, along with fully prepared training documentation, allows for a smoother site initiation process. - Conduct feasibility assessments and onboard clinical sites
High-volume respiratory care sites must be identified and vetted, and agreements should be in place early to ensure enrollment starts when patient volumes peak.
How MDC Associates Can Help
MDC Associates specializes in supporting diagnostic manufacturers through every stage of the IVD lifecycle, with deep expertise in respiratory clinical trials. Our team brings more than 35 years of experience in regulatory strategy, clinical trial execution, and FDA submission preparation.
We can support your efforts in the following ways:
- Regulatory strategy and submission support
We assist in protocol development, Q-submission planning, and direct engagement with FDA to reduce review risks and maintain momentum. - Clinical trial start-up and management
From feasibility through enrollment, our team can lead or supplement your clinical operations to ensure timelines stay on track. - Proven expertise in respiratory studies
Our experience spans CLIA-waived point-of-care tests as well as complex molecular platforms, enabling us to anticipate and solve challenges before they impact your program.
Prepare Now to Avoid Delays Later
While your team may be focused on current initiatives, now is the time to plan for respiratory season. When the first wave of symptomatic patients arrives, your study should be enrolled, not still in site setup or regulatory review.
Let’s schedule a call to review your clinical development plans for the second half of the year. A brief conversation today can position your program for a successful respiratory season.
Contact us today to get started:
📧 Email: bd@mdcassoc.com
🌐 Website: www.mdcassoc.com
Why MDC Associates?
- Accelerated Path to Market: Over 35 years of IVD expertise across a broad range of technologies and applications, guiding you through regulatory and clinical processes efficiently.
- Regulatory Expertise with Continuous FDA Engagement: Our established, positive relationship with the FDA helps you navigate submissions like Pre-subs, 510(k), De Novo, and PMAs smoothly.
- Practical Quality Expertise: We help you achieve your quality objectives without overwhelming your team with too much too soon. From eQMS to MDSAP and ISO audits, get expert advice and hands-on support.
- Extensive Clinical Site Network: Access a trusted network experienced in supporting high-complexity assays, CLIA-waived tests, and OTC diagnostics, providing fast and reliable performance validation.
- Your Trusted IVD CRO: Beyond strategy, we work as part of your team to execute critical steps in regulatory submissions, clinical trials, and quality systems compliance.
