Optimizing Regulatory Strategy & Dissecting Emerging Therapies

It’s an unfortunate reality that promising med-tech innovations can be undermined by the complexities of the regulatory clearance process. For one visionary company intent on pioneering early-stage heart failure (HF) diagnostics, their quest was twofold: to efficiently navigate the web of FDA regulations and to benchmark against novel therapeutic technologies in their space.

Background

Across the heart failure landscape, there are many technologies that target various facets of diagnosis, treatment, and management. This company had two innovations in early-stage HF detection:  

  1. An implantable monitoring electrolyte sensor.
  2. A non-implantable/wearable patch sensor.

Approaching the FDA for 510(k) clearance of these innovations was not merely about showcasing their creative technology; it demanded a bulletproof regulatory strategy bolstered by rigorous research and strategic investments.

Challenge

In the saturated market of HF diagnostic devices, how should they strategically position its implantable sensor by finding and leveraging ideal predicate devices to ensure their innovation passed the scrutiny of the FDA reviewer?

Solution with Basil Systems

Implantable Sensor: By using Basil Systems, the company swiftly compiled a set of promising predicate device candidates that would have taken weeks to find using the FDA’s own website. With high confidence they had found all potential candidates, they could now focus on narrowing the list. They undertook a nuanced analysis of eight pivotal devices – four non-implantable Electrolyte Sensors and four implantable Monitoring/Electrolyte Sensors. 

This holistic assessment encompassed device variations, clinical evidence, submission strategies, and device classifications – all of which were at their fingertips using Basil Systems. Gleaning insights across 20 different product codes, the company crafted a robust regulatory blueprint defining their device type, classification, and essential controls.

Screen Shot from Basil Systems Regulatory Module which encompanses FDA Medical Device data like 510(k)s and Clinical Trials. They also include the count of Regulations and some Post-Market Medical Device Data as well.
Figure 1. Search for "Heart Failure Diagnostic" in Basil Systems Regulatory module as of November 2023. Figure demonstrates the ease of finding and exploring relevant data in Basil Systems.

 Patch Sensor: Leveraging the foundational research from the implantable sensor initiative, the team further examined four predicate applications tailored for CGM/CR Sensor Products (wearable). They refined their regulatory strategy by concentrating on ten product codes and deriving the precise requirements for this unique technology.

Basil Systems then helped them anticipate FDA review times, aligning management expectations based on actual review time trends across their intended product codes.

Review times across different FDA product codes for medical devices, a screenshot pulled from Basil Systems Regulatory module typically utilized by regulatory affairs professionals working on medical device products.
Figure 2. Image from Basil Systems Regulatory module displaying the review time for product code MHX on median from 2017-2023 compared to Zoll's 253-day review time.

Results & Benefits

With Basil Systems’ 510(k) ecosystem tool, the company transformed its development of regulatory strategy. They reported greater than 50% reduction in their predicate device research, analysis, and selection process while delivering higher confidence in the completeness of the effort. This efficiency enabled more timely data-driven decisions that they feel helped bring their products to a faster market release.

A map of predicate devices for a 510(k) medical device application that was submited to the FDA. This predicate map i sof a Roche Diagnostic Heart Failure product and displays two predicates and one reference device. This was pulled from Basil Systems.
Figure 3. A predicate map for Roche Diagnostics Elecsys ProBNP II pulled from Basil Systems Ecosystem.

Conclusion

Harnessing Basil Systems was not just about optimizing regulatory procedures; it was about improving speed and confidence in bringing new heart failure diagnostics to patients who need them. In Basil, the company found a new resource that could deliver in-depth research with ground-breaking efficiency. Today, we are proud to see their innovations set new benchmarks in early HF diagnosis.

Want to see how Basil Systems can optimize your regulatory strategy and data search? Request a free trial here.