Project management of a medical device development starts with defining the project scope, selecting the team, identifying the value, and then launching the project. Agile and lean development methods are used to manage large and complex medical device development projects.
Kanban is a lean concept which helps in visualizing the workflow.
Here is an example of a Kanban board.
Kanban board can be as simple as the whiteboard with sticky notes. Trello, Leankit and Jira come with their digital Kanban boards.
Five properties of Kanban:
- Visualize workflow
- Limit work in progress
- Measure and Manage flow
- Make process policies explicit
- Recognize improvement opportunities
Scrum is a framework while Kanban is a visual tool. Kanban can be used in sync with Scrum, also called Scrumban.Where Kanban really stands out is that there are no time-bound events. Work is pulled from the product backlog and focused on finishing it. But scrum has sprints that have a limited time frame.
5S aims at reducing the wastage due to a poorly organized work area, such as the time spent in finding a tool. In order to organize the workspace effectively, the management should focus on using the 5S lean tool.
- Sort: Eliminate that is not needed
- Set in Order: Organize the remaining items
- Shine: Clean and inspect the work area
- Standardize: Write down the standards
- Sustain: Regularly apply the standards
4. Bottleneck Analysis
Finding out which step in the manufacturing process limits the overall performance.
5. Jidoka (Automation)
Design equipment to partially automate the manufacturing process. Partial automation is less expensive than full automation and improves the production efficiency.
6. Just-in-Time (JIT)
Customer demand must push the production process and not projected demand. This helps the organization in reducing its inventory and material cost.
Kaizen process is basically a continuous improvement process. It is all about continuously eliminating wastes from the production process.
8. Root Cause Analysis
It typically aims at finding the root cause of a problem and finding a permanent solution rather than finding a temporary fix, say, a Jugaad.Some common ways of finding the root cause is using the 5 Why methods, Fault Tree Analysis (FTA), Affinity Diagram, Pareto charts and fishbone diagram. Once the root cause is identified CAPA is implemented.Using a 5 Why methodology helps the identify the systemic errors rather than just blame it on the person responsible. Here is an example case study for 5 Why methodology.
Bus bar used in the electrical heavy industries is manufactured by an aluminium extrusion industry where I worked as an intern. So, the conductivity of a batch of bus bar produced by the extrusion company didn’t meet the client requirement as it didn’t meet the conductivity requirements.The client wanted the conductivity requirement to be 56%-58% IACS. The extrusion company where I worked did send them the bus bars with 56.4% IACS conductivity. However, when the client checked it with their machine it showed up 55.8%.
5 Why Analysis
Why was there a customer complaint?
-Because the bus bar failed to meet the conductivity requirements
Why was the conductivity requirements not met?
-Because there was a mismatch in the conductivity shown by the conductivity measuring instrument used by the extrusion company and the client.
Why was there a mismatch in conductivity?
-Because the results of the conductivity test performed before the aging process were not accurate
Why was the conductivity test not accurate?
– Because the conductivity testing machine was not accurate.
Why was the conductivity testing machine not accurate?
– Because there was a calibration error with the machine.Thus, it helped the extrusion company to come up with the root cause of the problem and fix it permanently.
Here is an example of fishbone diagram and the tracking list typically used in the industries for the root cause analysis.
FDA 21 CFR Part 820.100 discusses the Corrective and Preventive Actions (CAPA) typically used in the medical device industries. A product is subjected to CAPA in cases of non-conformance to the standard. 21 CFR Part 820.90 discusses about the various non-conformance and the need for a quality control in such situations.