Scaling up medical device production from R&D to manufacturing team and identifying the root cause of assembly issues
Role: R&D Engineer Co-op | Timeline: July - Dec 2018
Before
The Challenge
Prior to release, Nova Biomedical’s new osmometer was facing several challenges:
New technology integrating with legacy technology
Onboarding a manufacturing team, including technicians, to build a new product
Software integration
Onboarding new users to the technology
My role was to act as a liaison between the R&D department and the Manufacturing department to ensure that the meets the requisite specifications through diagnosis, testing, and advising.
The Work
Root Cause Analysis
I took the time to work with the R&D team to become an expert on the system. I investigated the CAD, learned how to properly use a functional unit, and understood how to take it apart and put it back together again.
We noticed issues with the devices and we were unable to identify a singular root cause.
Through the initial builds, I would individually check each unit and fix the unique problem that it had.
As we got closer to shipping the device, we realized we needed to create a controlled method to quality check the units.
The Work
The Solution
With the VP of engineering and my manager, I developed a solution:
We created a testing area specifically for the osmometers
I created a shortlist of issues that we commonly saw and the steps to mitigate them
Prior to running calibration or quality checks, the team would check the problem areas and ensure the units were aligned
Have electrical and software engineering teams upload the newest software build to the units
Run quality checks and box units that passed and reassess units that failed
The Work
Customer Solutions
One of the best experiences I had at Nova was getting to drive down to NY to install one of these units in a biotech facility. The trip put the work I was doing into perspective. I got to see how users interacted with the osmometer in a lab context.
The Work
Scaling up
After getting the first shipment of units out the door, I worked with the manufacturing team to find ways to make the production of the units more sustainable.
The checks that we implemented for the first build was put into formal Assembly Procedures. The manufacturing team also shared some design changes they felt would make the manufacturing procedure easier.
Conclusion
Key Takeaways
The main takeaway from this experience was learning how to communicate effectively with a wide variety of people, from the R&D team, to assembly technicians, to the customers in their lab. I’ve since grown my ability to take complex technical jargon and simplifying it to meet my audience where they’re at. I love getting to work with cross-functional teams to achieve the same goal and being able to communicate is pivotal.