This is case study talks about my effort in designing the first ever MVP for the life sciences SAAS solution from scratch before it was acquired by Deloitte. When it was an still at nascent idea stage.
I have been working on this product from past few years and there are few other things in pipeline to view other related work with regards to this product. Click on the following links
(To comply with my non-disclosure agreement, I have omitted and obfuscated confidential information in this case study. All information in this case study is my own and does not necessarily reflect the views of client or product.)
Over the period of 6 months, we were responsible for planning, estimation, and delivery of design. I was involved in selecting research methodologies and conducting stakeholder workshops. I was working closely with the team of highly experienced visual designers (Nakul Pathak, Anuja Job and others) and front-end developers for maintaining the quality of implementation.
The pharmaceutical industry is heavily regulated and is constantly challenged by ever-evolving stringent (FDA, IEC 62304, IEC 60601, ISO 1497 ) regulations. It becomes absolutely critical for healthcare software/device organizations to ensure compliance. These standards aim to ensure the safety and reliability of medical devices, and require developers to enforce mature processes, and document the execution of certain safety measures and procedures.
One the primary goal of this tool was to bring together various entities and teams who are responsible for quality management. There multiple users within the system who are responsible for various tasks.
1. Quality Manager
2. Business Analyst
3. Test lead
4. Tester
5. Reviewer
* System Admin
What is IEC 62304? : IEC 62304 is the international standard that defines software development life cycle requirements for medical device software. This standard provides a common framework for companies to create software and is salable depending on the level of injury the software can cause.
When the client came to us the initial task was to make the UI “prettier”. When we did the heuristic analysis and had initial discussion with founders we realized that there are major functionality, usability and strategy level changes needs to be made in the product before we go to the market.
“We had breakthrough in communicating value of design and we aligned leadership and stakeholders to invest in user research and defining the overall approach. We spent next few months redefining UX Strategy and completely changing IA instead of doing some UI enhancement as agreed earlier. ”
Our goal was to create a quality management product for life sciences industry which will increase efficiency significantly of the digital product development. The product will take care of all the regulatory restrictions and information and will make quality testing easier. It will make an internal and external audit easier by documenting and streamlining the process of development, testing and reviewing. It will make QM, Test lead, Testers, reviewers and auditors real-time update of the status of the product.
“Traditional Computer system validation has not seen any innovation in years. It still relies on unnecessary manual paperwork, longer approval times, farther release dates and overall inefficient system ”
Multiple levels within the organization are responsible for computer system validation :
Corporate / Business unit
Site / department personnel
Quality assurance / regulatory unit
IT departmen
Hierarchy of information : Within each organization system validation happens at every stage and of each and every component. These also apply to multiple releases and every minute change in the system, processes, use cases, scenarios or flow. These lead to a huge list of evidence/reports documented at every stage.
Within each organization system validation happens at every stage and of each and every component. These also apply to multiple releases and every minute change in the system, processes, use cases, scenarios or flow. These lead to a huge list of evidence/reports documented at every stage
As discussed above there are multiple primary users of this platform. Though the role of Quality Manager is essential and key for the whole operation to run successfully. Quality Manager is responsible for delivery, timelines, quality assurance, work allocation to developers & business analysts, managing releases and keeping track of performance and defects.
“Traditional Computer system validation has not seen any innovation in years. It still relies on unnecessary manual paperwork, longer approval times, farther release dates and overall inefficient system ”
Within each organization system validation happens at every stage and of each and every component. These also applies to multiple releases and every minute change in the system, processes, use cases, scenarios or flow. These leads to huge list of evidences/reports documented at every stage.
Managing requirements is the primary and most essential task for the quality managers. Every component in the platform can be linked back to requirement. It is the starting point of the lifecycle.
The tree type folder structure allows QM to easily navigate between groups of requirements. Still it could be daunting task to find out right requirement quickly. The specially designed filter panel allows QM to quickly filter requirements based on more than 6 variables.
Even though QM carries out various important tasks throughout the lifecycle of system validation. But not all the tasks are as frequent.i.e. Even though creating new release and carving out new testing strategy is very important task but it is least frequent task in the system.
Though what does QM does on daily basis?The current dashboard takes care of various aspects of the project. i.e. current releases workload, timelines, number of defects, how each release is performing, performance of testers and reviewers.
One of the key lessons I would take away from this project is validating our assumptions with users is utmost important. Subject matter experts should not be the final verdict for insights. Even though SMEs had spent decade working in the domain, but observing users will give you insights which could transform your product.
Lean into the habit of iteration, build, test and repeat. As designers we all like building stuff, creating new concepts and ideas. we love jumping into a newer challenge and solving bigger messier problems. But solving detail level problems is as much as important. In spite of trying multiple options while creating information architecture for QM. Halfway through the project, we found a problem in our current way of grouping entities which could optimize the workflow and reduce the number of steps. we ended up changing the majority of our IA and product. Now spent more time with the detail and test often
As discussed above there are multiple primary users of this platform. Though the role of Quality Manager is essential and key for the whole operation to run successfully. Quality Manager is responsible for delivery, timelines, quality assurance, work allocation to developers & business analysts, managing releases and keeping track of performance and defects.
