I currently work in manufacturing at a cell-therapy company, and my duties during the production process includes collaboration with the quality department in real-time as the process is occurring. This is done by taking samples of cell solutions during a cell expansion process and delivering those samples to QC for viability and sterility results. The first complication with this is waiting for the sample’s results to be processed by QC, which is required for moving onto the next step but can easily be delayed if QC personal is untrained/inexperienced. Some small companies prefer hiring young employees who are fresh out of college with next to no experience, the reason being that they get paid the least and their young age is more ideal for health coverage providers. This can easily be overcome by hiring competent individuals who are familiar with working under time-sensitive processes and have more experience operating high-end analytical equipment.

Another conflict throughout the quality-manufacturing process, is that unlike commercial products, medical devices that are still undergoing clinical trials are more susceptible to having more dynamic protocols that are always being altered rather than consistent. This dependence on the trial-and-error technique can confuse many operators who must be retrained after each iteration when processing a single lot. A possible solution is to implement a more robust, repetitive protocol that allows operators to adapt to the conditions that entail each product. According to an online article on how to improve QC systems (written less than a year ago), prioritizing repeatability in a process can only lead to positive results in both the safety/efficacy of your product as well as in its documentation, making regulatory processes easier to overcome (1).

Are there any quality-improving techniques out there that can be addressed by increasing cost alone? For example, will solely investing in the use of more high-end equipment (such as a scanning electron microscope instead of an optical one) ensure better-quality results every time, or does something else need to be added?

(1) Johansson, Anna “How to Improve Quality Control in 5 Easy Steps”, Innovation Enterprise (Nov. 2017)