Software Life Cycle Management for Medical Devices

It’s important to medical device firms to ensure the safety and efficacy of their goods throughout the entire product lifetime, which calls for rigorous pre-market studies and post-market trials surveillance operations to monitor the performance of medical devices.

Several common phrases in the medical device development lifecycle must be performed regardless of the device’s intended application. A medical device’s software life cycle management process begins with the first concept. It ends with the final product-like concept, product design, prototyping, device testing, design verification and validation, and medical device in manufacturing.

Stages of Processing Medical Devices:

For a product to be effective and safe to use, the medical device software life cycle management process must follow a set of steps. A medical device’s design, clinical trials, risk management, and manufacturing are all included in this. To prepare medical devices for sale, the FDA, for example, has laid up five phases for processing them. Quality System Regulation (QSR) oversees “the techniques and facilities utilized in, as well as any controls employed for, the design and manufacture of all final products intended for human use.” FDA phases including:

• Initiation- Analysis of opportunities and risks
• Conceptualization – feasibility analysis
• Responsible for all aspects of product development, including verification and validation
• Validation for final certification and launch of the product
• Product delivery and post-launch evaluation

Agile Methodology in Medical Device Development:

It is possible to maintain medical rigor while learning, and requirements may be adjusted to a more appropriate solution using Agile. Medicalproduct development can be made more efficient by using an agile methodology.

• Quality
• Productivity
• Predictability
• Effectiveness of the product
• Safety

While the project is still in development, quality is being assessed. Since testing must be done in real-time, the agile approach incorporates “done” into the process. Medical product development can be influenced by questions about product safety, clinician-backed confidence, and customer opinion, and these are a few of many inquiries.

To achieve the desired outcome, creating limited feature sets without the flexibility to modify them and hard timelines and rigid budgets might be harmful. This has led to a rise in the popularity of agile product development as a method for producing medical products. The agile methodology enhances an engineer’s fundamental thought process by:

• Composing big issues into smaller tasks called storylines.
• Determining “Done” for each story
• Team members, management, and clients have improved visibility into project progress.
• Building goods consistently throughout the company and across all disciplines by following a consistent procedure.

In agile product development, the client is at the forefront. Volunteers and developers are encouraged to work together with success based on the end product’s safety and efficacy. This sort of project management method can be used in the development of medical devices by following a few simple guidelines:

1. Safety and Risk

   After identifying the end user’s demands, the solution must be designed to handle the problem at hand without subjecting the end-user to undue risk or danger.
   As part of the product development process, risk management activities must be included to guarantee safety and efficacy. Risk mitigations are translated into requirements, converted into agile stories, and handled like any other feature in the system. In stories, these safety standards are broken down into manageable activities that can be completed promptly.

2. System and Software Architecture
   

   The agile development process emphasizes this iterative aspect of system and software development. As part of the planning process, robust system and software architectures should be developed.

3. Team Synergy

   For product development to stay on schedule, team members must work together as a unit. Knowledge obstacles may be eliminated when everyone on the team understands what’s going on and how to get there. As a result of the collaborative nature of agile development, roadblocks are removed, and productivity is boosted. It enables engineers and managers to work across electrical and mechanical engineering disciplines by using agile development.

4. Feedback Loop

   In the early stages, stakeholders may provide useful input on prototypes that can help enhance and refine the final product before expensive V&V efforts begin. Additionally, FDA and ISO usability studies for medical goods provide additional avenues for gathering input. To test a functional prototype, the agile approach demands that the product be operational after each stage.

How much does it Cost to Develop a Medical Device?

You can’t cut corners by skipping the iterative development and testing phases. Before reaching the market, there are numerous aspects to consider, including technology and industrial design and safety and usability. The cost of developing a Class 2 medical device is about $30 million, of which $2-5 million is spent on development and engineering.

Final Thoughts:

The development of medical devices may be a difficult process, with various requirements depending on the industry you’re working in. To ensure that your product is compliant, it’s important to examine your region’s appropriate standards and regulations. Determining what sort of device you are producing will also affect the development and approval procedure that follows.

Dash Supports Quality throughout the Medical Device Life Cycle:

With its Quality Management Software (QMS), Dash Technologies provides medical device companies with an integrated framework for monitoring quality across the medical device life cycle compliant with the ISO 9001: 2015 requirements right out of the box. Medical device companies benefit from excellent visibility into their internal processes across the entire medical device lifecycle with our technology, which establishes a single source of truth by utilizing cloud storage to preserve quality documentation securely. You are looking for a QMS solution that combines your quality procedures with your product development efforts? Contact us today!