Core Software Delivery and Customer Satisfaction Challenges
|Product Quality & Reliability Issues
|Time to Market Delays
|Missed User Needs
This page is designed to walk you through our Process Improvement Approach so you can see how we work, and what our solutions look like. At the end of the day, we’re here to help you overcome these challenges and implement Industry Best Practices for ongoing process improvement. Our solutions are designed to help your team shrink time-to-market, reduce costs and improve customer satisfaction with your products.
“Kris utilized the Risk Reduction Process successfully on a project which married numerous medical devices to a hospital system for the first time – with feature changes to all aspects of the system, and it’s been running flawlessly for several years now.”
Marketing Manager – Fortune 100 Medical Device Manufacturer
Product Quality & Reliability Issues
Several contributors could be the cause (incompatible development workflows/excessive changes during IV&V/failure in quality by design/premature design transfer and distribution/user unexpected interaction) and only a solid, collaborative assessment will help determine the root cause. This data allows our team to work with you on the best remediation plan – and that’s where the rubber meets the road – to get your team on the desired path, and meet your company’s software delivery goals.
When critical defects escape to production and are discovered in a clinical environment, they may cause critical systems to stop working, thereby directly impacting patient safety.
To show you how we help teams prevent product recalls, we will walk you through one phase of our process improvement program, which is designed to prevent critical defects from escaping to production. It’s designed for those defects reported as the root cause for the majority of FDA Recalls – which are attributed to abnormal system behavior or unexpected user interaction.
When we meet with a team to evaluate their challenges (necessary to determine the best solution) these are the steps we take.
We initiate an interactive Advantu and Customer Management and SME dialogue to ascertain known improvement areas needs.
We conduct a modified Quality and Compliance Due Diligence Evaluation and Gap Assessment – reviewing:
- Audit Findings
- Current and Past Issues
- Review of CAPA’s
- Effectiveness Checks
- Lessons Learned
- Cost of Quality Metrics
We create a modified fishbone diagram of causes and effects in order to trace the entire process – the recall prevention phase is an important aspect of the process.
Below is an example for when New Features (Requirements) are being added to an existing device or application – for a follow on release or system upgrade.
Recall Prevention Phase
1.Create list of all new features/functional requirements
2.Map each new requirement to the specific code necessary to function
3.Identify all the potentially impacted code for existing features – surrounding the specific code for the new requirements
4.Create ‘what if’ scenarios for all potentially impacted existing features & new requirements
5.Prioritize all scenarios utilizing Impact versus Probability Process
6.Feed all High Impact scenarios directly into R&D and SQE Plans
- SQE’s will create targeted negative test cases to isolate and expose hidden critical defects lurking in the code
- The Developers will write software specifications, detailed design documents and defensive code to cover edge cases before they become bugs in the code
- All low impact scenarios can be set aside – those areas can be safely tested with requirements based test cases
7.Update process documentation for ongoing process improvement training
For more details – schedule a Free Assessment.
Time to Market Delays
The most common contributors are defective procedures leading to design controls misses (lack of accurate traceability/poor risk mgmt/process deficiencies) and finding the culprit can be tricky if you’re not experienced with process improvement. The benefit of an independent assessment is the ability to more clearly see the forest from the trees – dispassionately. This allows us to work with you objectively to implement the right solution for your team and technology.
Our Consultants want to hear more about your time to market and forecast accuracy challenges, so we can work with you to craft the perfect on time solution.
For more details – schedule a Free Assessment.
System performance, response times and consistent user experience are near and dear to us. We’ve supported teams by creating a ‘real world’ performance plan (for both Dev & Test teams) where end user expectations are mapped out, built towards and tested against. With this approach you can build a product/system which meets your customer’s needs – so they can scale accordingly.
Go ahead & reach out to – schedule a Free Assessment.
Missed User Needs
We’ve observed multiple contributors for this issue (inadequate human factors input/missing user needs/missing system & sub-system reqts/confusing interfaces) so it’s important to have experienced process consultants review your overall process. We need to identify the key missing ingredients needed to bake this perfect User Needs Cake. Let us help you.
Reach out today and schedule a Free Assessment.. There’s a really good chance we’ve seen your issues before and we might surprise you with our (easier than you think) solutions.