Countdown To Savings: Cost-Efficient Medical Device Safety
Cognition has been a trusted resource for the largest and most prominent medical device and pharmaceutical companies for more than 20 years and pioneered Cognition Cockpit, an intuitive, web-based application empowering the Product Development Process (PDP).
The company’s SaaS-based ‘out of the box’ solutions – such as Compass – enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money; delivering their products to market faster with less risk.
Based on its enviable track record as a software and technology consultancy Synergio has been a long-term partner of Cognition to support the dynamic global medtech market.
Moonshots & Rocket Launch
In the medtech race to be first with the ‘moonshot product’, safety has to be paramount, but proving compliance and building in risk mitigation throughout the product development process doesn’t need to cost the earth.
So, what does a rocket launch have in common with the design and manufacture of medical devices?
On the face of it, not much, but when you consider the requirement of designing out faults and defects, and building a robust process of risk mitigation, then you get some sense of the shared issues, and the high stakes at play.
In both cases, human error, and that includes the user, can contribute to critical failure. The safety of people involved in the use of such products can never be compromised, and that’s why so much emphasis is placed on developing, designing and manufacturing products that are both fool-proof and future-proof.
Interestingly, ‘Failure Mode and Effects Analysis (FMEA)’ is a design review tool used to identify and correct all possible failures in a product, service, design or manufacturing process. This step-by-step approach was first initiated in the 1940s by the United States Army and further developed by NASA in the early 1960s.
Investing In Process & Documentation
As one of the most used methodologies for quality and reliability, FMEAs provide a way to systematically assess points of failure in a specific design, process, or system and list the consequences of these failures. When the failures have been identified, the risks associated with them can be evaluated, and a plan developed to discover, avert, and reduce the severity of the most critical ones.
But FMEA is just one, albeit important, stage in the systematic checks that need to be carried out. It is not enough to ensure compliance to e.g. ISO 14971. It only feeds into the actual risk analysis activities which need to be done to determine if anything could result in harm for the patient that is using your product. So these risk analysis activities, supported by e.g. various types of FMEA, hazard analysis and use error analysis can add up to significant amounts of money that are invested into process and documentation, rather than development of the product itself. So looking at the costly exercise that companies will have to go through, Compass software’s use of structured data items, links, documents, and reusable templates helps companies reduce time and resources required to complete critical risk management tasks.
|Requirement||Results using Compass|
|Reduce manual processes for managing thousands of risk files||
|Reduce errors with import rules, instructions, scoring algorithms, and managed risk libraries||
|Reduce risk management resource needs||
Companies also use Compass software as a formal report and documentation generator for risk and all other product development data items through source-agnostic data import from other systems.
The use of Compass software also results in significant time reductions, allowing engineers to spend more time engineering and less time creating and remediating documentation. In fact, we’ve developed a calculation tool that demonstrates how Compass can result in significant time savings compared to other industry software tools – up to 70% in some cases.
Translated to financial savings, companies could claw back millions of dollars simply by using Compass. In any currency that adds up to tremendous savings, and for a start up business that could spell the difference between success or failure, or at best, mismatched allocation of available investment funding.
Contact us to find out more about calculating the time and cost savings you could achieve with Compass.