- Real-world data (RWD) and real-world evidence (RWE) are challenging to obtain, leading more than 80 percent of life sciences organizations to enter into partnerships with data science companies in 2022.
- The PINC AI™ OR Supplies Dataset encompasses inpatient and outpatient operating room (OR) supplies surgical SKU-level data and surgical timestamps linked to outcomes across more than two years of data cataloguing 900,000+ unique SKUs in nearly 2.8 million unique encounters.
- The PINC AI™ Applied Sciences (PAS) team is helping life sciences and medical device organizations address their RWD/RWE needs to support research efforts, solution development and regulatory requirements.
As life sciences and medical device organizations create medical solutions, they often wonder about data that indicates how often their devices are used during surgical procedures and what impact they have on patient outcomes. If your organization had the chance to get detailed visibility into surgical supply data that correlated to patient outcomes, how would you use it?
The PINC AI™ Applied Sciences (PAS) team is helping life sciences and medical device organizations access one of the most comprehensive OR supplies databases with supply data at the SKU-level linked at the patient and encounter level to clinical outcomes. This unique real-world data (RWD) provides insights into surgical outcomes with items easily searchable using manufacturer catalog numbers and each item includes device brand name, manufacturer, version, sizes and quantity of items utilized during a surgical procedure.
The PINC AI™ OR Supplies Dataset provides inpatient and outpatient OR supplies and outcomes across more than two years of data cataloguing 900,000+ unique SKUs in nearly 2.8 million unique encounters across the U.S. national footprint.
This kind of visibility into surgical supply RWD can help life sciences and medical device organizations generate real-world evidence (RWE) that details device utilization, provides insight into healthcare resource utilization and can reveal device impact on clinical outcomes. These types of insights have the potential to help life sciences organizations realize cost savings and even increase efficiencies. This novel dataset provides meaningful real‑world data insights with acute specificity.
Utilizing the PINC AI™ OR Supplies Dataset
Life sciences organizations are interested in analyzing real-world outcomes impacted by their solutions. They rely on RWD to provide the actionable insights needed to implement product, device and therapy modifications to improve solution efficacy and more importantly show a direct correlation with improved patient outcomes.
Here are a few ways life sciences organizations can utilize the PINC AI™ Healthcare Database with the OR Supplies Data.
1. Expanding Device Indications
Life sciences and medical device organizations consistently seek to streamline their processes, avoid additional randomized clinical trials (RCTs) and save money. By using RWD/RWE to support their device’s expanded indications for use, they can potentially avoid unnecessary RCTs, reduce their launch research spend and get their innovations to market faster.
These organizations want to better understand their device and the safety, outcomes and benefits to patients from utilization. Understanding these factors could allow the life sciences and medical device organizations to expand indications to align with outcomes and generate RWE to expand device utilization.
Their research efforts typically start with data analysis to generate evidence needed to support a regulatory filing for expanded device indications. They seek to identify additional patients that could potentially benefit from their device. Initially they seek to understand current evidence-based indications for their device and determine if there is any option for label modification while maintaining device safety and effectiveness.
The OR Supplies data can help inform their efforts. The SKU-level detailed data can confirm the use of their device in additional patient populations and conditions. This could prove that their device has similar safety and positive patient outcomes so that more patients could benefit from their device.
2. Supporting Regulatory Submission
The regulatory landscape continues to evolve, and life sciences organizations must align their research and medical solution development with the latest guidance. Payers, regulatory bodies and health systems are increasingly demanding proof that a medical solution delivers real value by doing what it is intended to do.
Thanks to the 21st Century Cures Act, more regulatory agencies are recognizing the promise of RWD/RWE. When combined with clinical trial research, it can shorten the regulatory approval process and increase the chances of U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulation approvals.
Organizations can use RWD from real-world outcomes extracted from the OR Supplies dataset to help support regulatory submissions demonstrating a specific medical device’s potential safety, effectiveness and ability to improve outcomes.
Typically, the FDA reviews medical devices and clears modifications like expanded indications or breakthrough designations through an appropriate premarket pathway, such as premarket clearance (510(k)), De Novo classification or premarket approval.
When a company submits an FDA 510(k) notification, its goal is to demonstrate that the new product that’s about to be brought to market is substantially equivalent to another legally marketed device. During this process, the device needs to meet specific criteria set by the FDA such as:
- The device has the same intended use and technological characteristics as the predicate device.
- The product has the same intended use as the predicate device yet has different technological characteristics and does not raise any new questions regarding safety and effectiveness.
- The data submitted to the FDA can demonstrate that the device is at least as safe and effective for use in patients as the marketed device.
Robust, SKU-level data like that contained within the PINC AI™ OR Supplies data can help life sciences and medical device organizations provide support that their device, down to the specific version, with expanded indications, is safe and effective as well as directly linked to improved surgical outcomes, thus helping to clear their product of further RCTs and additional testing.
Using RWD to Increase Efficiencies and Reduce Costs
RWD/RWE is shifting how life sciences and medical device organizations evaluate medical solution development and identify opportunities for repurposing existing medical solutions. Detailed datasets like the PINC AI™ OR Supplies Dataset provide the information needed to better understand the efficacy, safety and cost while supporting regulatory requirements needed for existing or potential new treatment options.
Data is a powerful and necessary tool to providing a more representative view of medical solution development, healthcare costs, resource utilization and enhancing clinical performance.
As medical solution development and expanded indication methods evolve, the power of RWD will continue to prove key in improving outcomes, generating patient-centered clinical trials, uncovering data-driven insights and expediting solution time to market.
For more on this topic:
- Learn how you can utilize the PINC AI™ OR Supplies Data in research and outcome improvement efforts to drive insights into surgical patient outcomes using precise SKU-level supply details and help support smarter healthcare decisions.
- Learn more about PINC AI™ Applied Sciences (PAS) and how you can use PINC AI™ Healthcare Data (PHD) to conduct evidence-based analyses of drugs, devices and disease states and accelerate medical solution development.
- Discover ways to leverage real-world data to save money, time and support solution development.
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