Step one: Bring an innovative, feature rich, effective solution to the market.
Step two: Become the leader and maintain market leadership by attaining credibility and sustaining go-to-market speed.
Step three: Maintain that position in our continuously evolving market.
Our client – a medical device provider, approached us seeking to further establish the credibility of their device. The vision was to submit their medical device for De Novo review. The De Novo process is a path to classify medical devices and provide reasonable assurance of its safety and effectiveness.
The Food and Drug Administration did not require their device to be vetted this way. In this case, the client was proactively going through this process. By proactively seeking this approval, they would be setting the baseline for their competitors to be approved. Their ask was this: that Unify One Solutions partner with their team to gain the desired class III premarket submission classification.
Collaborating with the quality assurance manager and legal submission team, Unify One Solutions adjusted their agile product development and deployment to be more agile. Together, they produced all required documentation for the FDA’s De Novo submission process and ensured that the product feature enhancement software life cycle met FDA guidelines and customer expectations. This was achieved through emphasis on the following federally accepted consensus standards: IEC 62304, ISO 14971, and ISO 13485.
After establishing three focus points – process, documentation, and functionality, Unify One Solutions created a gap analysis. This provided the client with a product road map from current to future state. Our team also supplied a framework for independent code review, offered turnkey consultation that created a process to collaboratively implement customer ideas and provided recommendations for strengthening cyber-security controls so that they met current trends and FDA requirements.
This new streamlined process allowed our client to reach necessary deadlines to meet class III FDA Pre-Market submission criteria while also increasing the frequency of new product features and enhancements to stakeholders. The new process gave them the ability audit the entire workflow from end to end.
Attaining FDA approval meant the client would be able to show the efficacy of their product to customers and gain an edge over their competition. They also gained a marketing advantage none of their competitors had. Now they would be the only manufacturer in that market that was approved by the FDA.