Reusability: Reliable Acceleration Of Medical Device Development
The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market.
For medical device manufacturers, reusability has huge implications when bringing a new product to market. If you already have access to a portion of the product data needed, it’s not necessary to repeat data collection and processing in order to satisfy strict regulatory requirements.
Rather than re-entering existing information to design a new product, or a variation of an existing product, it’s possible to leverage previously created data. Let’s look at how this works and at some of the other benefits of a robust reusability technology framework like Compass – a guided compliance tool developed by Cognition.
Zero Margin For Error
The margin of error is practically zero for new medical devices brought to market. Because if defects are not discovered and corrected during development, the consequences are patient injury or death, and the associated legal damages. That’s why data handling, and accurate compliance documentation is so critical.
Compliance is mandatory for clearance and approval in both the US and European markets through the Food & Drug Administration (FDA) in the US, and Notified Bodies in the EU. In the UK, registration is required through the Medicines and Healthcare products Regulatory Agency (MHRA).
And it follows that the more accurate and clear your documentation, the faster your device can move through the approval process.
Integration Of Risk & Requirement
It’s surprising how many companies rely on legacy tools, such as spreadsheets, to manage their product development and compliance.
Providing reports containing errors could derail product development and manufacturing, and manually building traces based on inaccurate data creates errors on top of errors that compromise the regulatory approval process.
Device manufacturers need a reliable system that truly unifies risk, requirement, and test management for a structured, automatically traceable, fully auditable, design control process.
Ready Made Reusability
Copy and paste, right? Copy the relevant data from an existing product spreadsheet and paste it into a new one. Done. Really?
In an industry governed by strict regulations, there’s a very real need to extrapolate risk mitigation. Manually transferring spreadsheet data comes with its own perils, and ultimately creates even more complexity and potential for error.
The alternative? Using a structured data environment, if you change one item, that change can be propagated wherever it’s used.
Automated Process & Workflow
Although a spreadsheet allows you to build lookup tables, you can’t incorporate different process flows that can be enforced and verified. Automated processes make it easy to apply best quality practices that ensure every change is accounted for, and nothing falls through the cracks: a master map and single point of truth where all actions and their impacts across a product’s development lifecycle are recorded.
Robust process workflow needs access and editability based on workflow state, user role, and ownership – something unavailable from a spreadsheet.
Expedited Time To Market
When users need to only enter something once, they can then be sure that the data, no matter how many places it exists, is always up-to-date and correct.
Manual processes and the lack of linkage between all compliance data makes product development – and critical traceability – highly error-prone, time-intensive, and complex, not to mention expensive.
However, when technology and process meet to create and maintain connections between diverse data, products can get to market faster with less risk.
And that’s a huge benefit for any medical device, medical professional, and patient.