Challenges and Solutions

We help you release Med Tech systems your customers (and the FDA) will love…

Don Canal, Senior Management, Clarify Medical Lina did a great job for us. Kris was great as well – very flexible and responsive to any issues. Great work and a great team to work with!”

We help our clients identify the high-risk areas in their code, reveal and mitigate hidden critical defects, and deliver reliable high performing devices on a routine basis.

Click these links to learn how we help teams overcome the following challenges:

Recall Prevention for Biotech (Medical Device) Systems

Challenges

High severity defects escape to production -> recalls / stop ship / FDA audits

  • R&D/QA teams’ inability to identify all high risk areas of the code and system
  • Cyber Security vulnerabilities with Medical Devices
  • Test plan is incomplete, doesn’t include targeted negative testing
  • FDA Submittal process – lack of knowledge (V&V differences)

Project delays, slipped dates, inability to accurately forecast timelines

  • Lack of understanding – what “not” to test
  • Critical defects discovered late in project or post release

Unexpected system performance issues

  • Nonexistent or incomplete performance test plan
  • Inexperienced load/stress testing team

Solution – Predictable Release Schedules and Increased Confidence

Identification of High Risk areas

  • Improve system reliability
  • Reduce test cycle times
  • Cut costly rework
  • Proper identification/remediation of Cyber Security vulnerabilities
  • Accurate, acceptable FDA submittal’s

Implement repeatable processes

  • Predictable schedules
  • Improve user experience
  • Training: FDA Audit Processes and Approaches
    • Inspection program put in place
    • Successfully complete inspections/audits
  • 30 years MedTech Experience – applied to your team
    • Increase Patient Safety
    • Recall reduction
    • Minimize stop ship occurrences

How does the recall prevention program work?

One – identify all high risk areas within the application, device and system

{if a new App: identify critical path, all ‘must work’ user and connected system work flows within the application, device or system}

{if existing App: identify all potentially impacted functionality}

 

 

Two – using inductive logic, create ‘what if’ scenarios for all critical path and potentially impacted functionality

Three – convert all ‘what if’ scenarios into targeted negative test cases (for R&D/QA teams)

Four – prioritize all targeted negative test cases utilizing probability versus impact process

Five – feed high risk scenarios/targeted negative test cases directly into R&D and QA Plans

Six – keep entire project team tightly focused on high risk plans and tasks until release

Seven – update process documentation for ongoing team training

Benefits 

  • Significantly reduced Time To Market
  • Measurably improved reliability and scalability
  • Increased profits and revenue via best in class processes
  • Predictable forecast accuracy and delivery dates
  • Increased confidence with new feature/product releases
  • Early critical defect detection prevents escalating cost and impact on deliverables
    • Contributes directly to recall prevention
  • Improved user experience and customer satisfaction with your products

 

Contact Judy Cirilos today – ask her to schedule a free recall prevention assessment!

judy.cirilos@advantu.com

858.275.2106

 

System Performance

The Advantu team has spent years developing a methodical approach to tracking down and mitigating system performance issues.  This methodology has been successfully applied to a number of systems in industries as disparate as cyber-security, agriculture and software as a service, as well as regulated industries such as medical devices.

By employing our extensive expertise gained through years of development and test experience – Advantu will help drive your project to completion, with dependable reliability and world class user experience.

We are your committed partner in resolving issues such as these:

Issues

  • Unacceptable user experience
  • Unreliable long term ‘up time’
  • Missing or corrupted data
  • Browser interface painfully slow
  • Reports take forever to load and display
  • Search feature / Print requests – take forever or time out
  • Multiple users cause serious degradation, freeze or system crash
  • System Navigation is so slow; you forget what you were doing

Solution – Quantifiable Performance

     System Analysis & Remediation

  • We will identify all the bottlenecks and system design shortcomings
  • Review findings with your team
  • Provide recommendations for remediation
  • Collaboratively determine the best action plan
  • Work with your team to implement corrective steps
  • Fully test the system against updated behavioral expectations
  • Ensure speed, capacity, data integrity and reliability exceed customer demands
  • Improve customer satisfaction with your products

 

Contact Judy Cirilos today – ask her to schedule a free recall prevention assessment!

judy.cirilos@advantu.com

858.275.2106

 

Test Automation

Issues

  • Attempting to Automate “everything”
    • Just because you have a hammer – doesn’t make everything a nail
  • Test engineer attrition (boring, repetitive work)
  • Using old tools – skill sets not current with new technology/capabilities
  • Not matching the tool to the project (not all tools are alike)
    • Generating too much overhead – reduced ROI
  • Little or no code coverage metrics
    • Do you know where you’re saving time – how much?
    • How much has code coverage increased?
    • How many more cycles are running?
    • What are your tangible benefits?
  • Lack of a Test Automation Plan – need to establish an initial program

Solution – Quantifiable Coverage

  • Create a Test Automation Program
    • Work with cross functional team to determine all automation needs – now and future
      • Regression test beds
      • Infrequently changing features/functionality
      • Support dev team build transitions (unit, smoke, entry/exit, etc)
    • Set measurable goals for your Test Automation Program
    • Get your design of test automation frameworks right
    • Review code being automated – match to appropriate automation tool
    • Select qualified automation engineers and train them
    • Ensure high quality of test data
    • Put together a complete Test Automation Plan
      • Compile list of Test Automation Goals
      • What should/can be automated
      • What not to automate
      • Test design prior to automating
        • Risk ID
        • Scenarios
        • Peer reviews
      • Remove uncertainty from automated tests
        • Avoid attempts to automate unstable functionality
        • Spot check (always passing) automated tests with ad hoc tests to verify results
        • Don’t automate chaos – if the QA process is chaotic, automating only creates faster chaos
      • Maintain scripts in a proper repository
      • Insist on thorough documentation covering all aspects of the program
      • Ensure project needs are met via automation
      • Identify and annotate all aspects of ROI prior to launch
      • Continually measure ongoing ROI – verify it maps to plan
      • Determine & list test automation plan success factors
    • Know when you are done with a project (start/end activities)

 

Contact Judy Cirilos today – ask her to schedule a free recall prevention assessment!

judy.cirilos@advantu.com

858.275.2106

 

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