A leading manufacturer of medical electronics device found customers experiencing sudden death of their devices. While the result of failure did not critically harm its users, it did impact the credibility of the manufacturer in hospitals and senior care homes where it was being used. Buying partners suspended further transactions until the manufacturer was able to address this issue.1-2% of the products were experiencing such failures. While this was good, it also made the problem harder to solve. What might be the reason that a few of the devices failed – and not all of them?

The engineering team of the manufacturer leveraged Wynum’s intelligent assessment models to quickly identify what variables or factors they should focus on. As a result, a problem that would have taken 4-6 weeks to solve was addressed within 4 days.

Our customer was not only able to keep its customers, it also improved credibility by showing its customers that it truly understood its processes. As a result of this huge success, the company has expanded it’s use of the product. It depends on Wynum to continuously track its processes, maintaining continuous traceability so it can proactively assess and confirm its confidence on every lot manufactured.

While volatile demands have been a signature of COVID-19, the cost of meeting changing demands and the longer-term risks of these commitments seem to be in the minds of leadership of most organizations – not just the head of manufacturing. What are the operations or components of operations that are most sensitive to increases or decreases? What is impacted? Cost of manufacturing? Quality? Other costs?

The Wynum Solution generates operations plans and projected manufacturing costs based on forecasts. It also uses AI based models to leverage historic data on throughput, yields, and process variability to predict inventory scrap, expiry, rework, additional production volumes and the cost associated owing to these changing demands.

The software continuously tracks operations data to assess alignment between ongoing operations, forecasted demands and risks of cost and throughput deviations.

Finally, it also provides an ability to simulate scenarios – of increasing capacity, second source suppliers, changing supply chain, or changing demand forecast – to assess upside or risks in implementing them.

Our clients are seeing immense value in this information. It helps them in planning for changing scenarios and making data driven decisions, while knowing the risk associated with those decisions. For senior leadership, such a tool to improve risk visibility of decisions, is a lifesaver.

Regulated industries require periodic certification and compliance verification. Firms often perceive compliance management as a tax and a reporting burden. Consequently, firms orient their people and processes to track and monitor events post-facto. Incipient deviations are not alerted in time and corrective actions are often late. These result in scrap, lower yields, inconsistent quality, and often, lost productivity due to forensic and recall activities. Firms typically lose 5%-10% in operating margins due to poor or reactive compliance management. The additional risks of shut-downs, recall costs, litigation and product replacements are compounded for strictly regulated markets e.g. pharmaceuticals, medical devices, health diagnostics, and safety-critical avionics.

Wynum recommends six tenets to ensuring compliance:

• Establish repeatable, clear instructions that are standardized across operators and shifts
• Track and archive process steps continually
• Identify deviations early and deploy role-based alerting
• Facilitate collaborative assessment, recovery and remediation
• Learn to predict deviations and suggest recovery based on historical data and knowledge
• Generate any report, at any granularity, for any step, at anytime