SDLC Process Improvement for Medical Devices and Hospital Systems
SDLC Process Improvement starts with knowing what you want, then performing a gap analysis and making the recommended (best practice) changes to get there.
The more effective a team or process is, the shorter their time-to-market. Additionally, if product quality goals are met, then customers are happier and market share should increase.
So how do you achieve your SDLC process improvement goals?
By working with experts who’ve become proficient at analyzing processes, documentation, tools & skillsets (breaking everything down into core components) then, helping your team implement mutually agreed upon corrective actions, in order to meet your SDLC process improvement goals.
Here’s a happy client:
“Every day we are challenged with finding ways to improve quality of software development while decreasing time-to-market. Specific areas we focused on were automated tools for development and test, increased transparency and traceability, automated regression analysis and repeatable predictable outcomes.’
‘Charlie Gragg and his team assessed our current development and test situation and presented the best path forward for addressing our specific needs. If you have a similar need, Charlie is the right resource to meet your requirements.’
‘I highly recommend him and his team.'”
Vice President, Device Engineering, Hospital Products
Baxter Healthcare
Top Questions
- Will I be on time?
- Will I be on budget?
- Will the application function as designed?
- Will our device present an intuitive user interface?
- Will I have happy customers and increased market share?
Whether you’re creating a new application or adding features to an existing product line, we can help you implement Best Practices to solve your toughest product delivery challenges.
Our experience has shown that after collaborative Gap Analysis, the solution(s) yield distinct product delivery enhancements which can be individually implemented – successfully. Our bottom line goals are to help your team shrink time-to-market, reduce costs and improve customer satisfaction with your products (before & after you get FDA approvals).
**Software Development Lifecycle – Process Improvement Benchmarks**
- Conformance to IEC 62304 Software Development Lifecycle Management Processes
- Performing gap analysis of Quality Management Systems and procedures to identify improvements for alignment with:
- 21 CFR 830
- ISO 13485:2016
- ISO 14971:2012
- IEC 62304:2006.
- Implementing software lifecycle processes into existing QMS system procedures:
- For Safety Class A, B and C devices
- Performing gap analysis of Quality Management Systems and procedures to identify improvements for alignment with:
- IEC 62304 Core Lifecycle Processes
- Generate stand-alone procedures for addressing:
- Software Development Planning
- Software Risk Management
- Software Configuration Management
- Software Problem Resolution
- Software Maintenance
- Generate stand-alone procedures for addressing:
- Compliance to AAMI-TIR45 Guidance on the use of Agile practices in the development of medical device software
- Agile, evolutionary and hybrid lifecycle models
- Recommendations for compliance to International Standards and FDA guidance documents (for use of agile practices to develop medical device software)
Reach out for your free SDLC assessment! Contact us today!
Clients Who’ve Benefited
- Medtronic
- Baxter Healthcare
- Obalon Therapeutics
- FMC
- Zimmer-Biomet
- Hospira
What We Do
We Help You
| Reduce Time to Market | Improve Forecast Accuracy |
| Minimize Rework & Cut Project Costs | Increase Profits by Reducing Technical Support Calls |
| Improve Product Quality & Reliability | Enjoy Software Delivery Improvements – First 90 Days |
| Increase Team Productivity & Project Velocity | Improve Customer Satisfaction with Your Products |
How We Do It
Advantu’s Process Improvement Methodology draws upon the highly successful techniques of the Ishikawa Diagram and 5 Why’s to determine cause and effect relationships.
Advantu concentrates on the following major Process Improvement Categories:
- People
- Methods
- Environment
- Measurement
The initial Identification of possible Targeted Improvements is captured via Advantu’s Gap Analysis Process.
- Internal and External Audit Findings
- Review of Open and Closed CAPAs
- Past Lessons Learned
- Development, Manufacturing and Quality Team observations
The identified Causes from the above process are then decomposed into likely “Contributors.”
The “5 Whys” technique is then applied to the likely Contributors to identify the most beneficial improvement solutions. Typically these projects start around 3 weeks and will just need 2 hours per day of your team’s time.
The #1 Metric: does your product exceed your customer expectations?
The following is an example of Advantu’s “Cafeteria Plan” for Targeted Results Driven Process Improvement.
Cafeteria Plan for SDLC Process Improvement
| Problem | Contributor | Solution |
| Missed User Needs
“counter-intuitive user interface” |
Ineffective Human Factors Studies
Voice of the Customer Improvement |
Contact Advantu |
| Product Quality & Reliability Issues
“not-quite-perfect-functionality” |
Poor Risk Management | Contact Advantu |
| Performance Bottlenecks
“the never-satisfied customer” |
Inadequate Performance Planning | Contact Advantu |
| Time to Market Delay
“perpetual replanning” |
Ineffective Resource Allocation
Scope Creep Issue Correction – Induced Errors Missing/Late Design Control Deliverables |
Contact Advantu |
WHY WAIT ON SDLC PROCESS IMPROVEMENT?
If you’re experiencing these software development and product delivery issues – we know you’re under a lot of stress.
Here’s the good news – our experts have been helping teams address and systematically resolve these issues for decades – we can help you overcome your challenges and transition into a highly productive organization, capable of delivering quality products (on time) on a consistent basis.
Reach out today and request a Free Consultation. It’s a straight forward process, and we think you’ll agree – the earlier you start, the earlier you’re on the path to a highly improved process with a newly energized team – armed for success!
