Gaining a Competitive Edge with Basil Systems

Medical device markets are complex, fast-moving, unforgiving – and very competitive. For a company spearheading innovations in the field of transcatheter valves, understanding the competitive landscape was crucial. Other companies had products on the market, each with different designs and approaches, and new innovations were constantly in development across the industry.

Background

The company is a leader in several aspects of heart valve diagnosis, management, and treatment. This particular team was developing novel transcatheter valves with unique features, aiming to distance their products from competitors. As the team contemplated how to identify and develop truly novel products in the crowded market, they needed to thoroughly understanding all of their competitors’ products and strategies.

Challenge

With multiple competitors both large and small offering various transcatheter valve designs and delivery methods, the challenge was to grasp the full landscape of related technologies. Historically, this would have meant multiple parallel research efforts across numerous disconnected data sources to cobble together a comprehensive competitive landscape.

Pulled from Basil Systems regulatory module is a natural language search for transcatheter valves across all FDA databases including the 510(k) databases, clinical Trials, Regulations and more across the FDA.
Figure 1: A search result for "transcatheter valves" in Basil System's regulatory module. In one search you can quickly establish the complexity of a topic and start exploring relevant data sources.

Solution with Basil Systems

Utilizing Basil Systems, the company was first able to quickly and confidently define the entire potential “universe” of competing devices, using natural language full-text searches to find any and all related FDA applications. Then it was straightforward to reduce the list to the most relevant and important competing devices that included valve leaflet modification features.

The company then assessed each competitor’s regulatory pathways, including key clinical work, applicable guidance documents and consensus standards, total timelines from submission to decision, and subsequent modifications and supplements. All of this was fast and simple using Basil Systems.

Image taken from Basil Systems regulatory module for medical device data from the FDA and shows a supplement timeline for a transcatheter valve.
Image pulled from Basil Systems Regulatory module on Medical Device data from teh FDA, this is a clinical trial filter for clinical evaluations.

The Basil Systems clinical tools facilitated a holistic view of all related clinical studies, assessing their design, status, and outcomes. They could also conveniently find and review clinical research on other transcatheter valves, enhancing their competitive landscape analysis.

Then they used the Basil Systems Post-Market module to rapidly find, assess, and compare all safety-related reports and events, examining MDR (adverse event) trends by type, time, company, and product, digging into rich analysis of the codes and narratives when needed. This was done using device safety reports and field corrective actions from multiple geographies.

An image pulled from Basil Systems post-market module which shows all of the adverse events across heart valves in the last 2 years pulled from FDA's MAUDE database for Medical Device post-market data.

This comprehensive assessment was completed in an unprecedented short time, allowing the company to understand the intricacies of the regulatory and clinical pathways used by each competitor, and providing a clear window into the reliability and quality issues of competing products on the market.

Results & Benefits

By using Basil Systems, the company learned timely new insights into numerous competitor strategies, with easy-to-use documentation of the intelligence gained. This knowledge helped identify potential regulatory hurdles and successfully develop innovations that addressed areas where competitors had struggled. The efficiency boost to their research translated into a much higher confidence in their competitive insights versus their previous approach doing manual searches on FDA databases and clinical sources, empowering the company to make informed decisions faster.

Basil Systems enabled the company to not only be better informed but to remain a step ahead in the fiercely competitive cardiac valve market. By materially reducing the time required to perform essential regulatory, clinical, and safety research on competing technologies, the company could channel its time and money into more effective product development priorities.

See firsthand how Basil Systems can give you a competitive advantage. Request a free trial here.