For a medical technology, proving that something works in the lab is only the beginning. Before it can move towards clinical use, developers need to show that it can be manufactured consistently, under controlled conditions.
For Jessica Ossel, Quality Assurance Manager at SBMC, the difference can be captured in one shift. During development, the question is mainly: can we make it? Once clinical use comes into view, that becomes: can we consistently make it and prove it?
From lab development to clinical manufacturing
In early development, flexibility is part of the process. Production is often small-scale, methods are still evolving and the emphasis is on feasibility.
Clinical manufacturing requires a different level of control. Processes must be defined, results must be reproducible and equipment and production environments need to be controlled and suitable for their intended use. Critical parameters and controls also must be identified and documented.
In short, a development process has to become a controlled manufacturing process.
What does a cleanroom require from your manufacturing process?
Finding a suitable cleanroom is only part of the challenge, Ossel says. A company first needs to understand what its manufacturing process requires.
That may include a specific cleanroom classification or requirements for temperature, humidity and air pressure. Equipment also needs closer scrutiny: is it suitable for cleanroom use, does it require qualification, and what are the requirements for calibration and maintenance?
Utilities such as electricity, gases, water or exhaust systems can be equally important. The cleanroom cannot be considered separately from the process taking place inside it.
From research process to controlled manufacturing
The people working in the cleanroom are part of that process too. They may need specific training and gowning procedures, while material flows and individual production steps need to be clearly defined.
That can be a significant change from the development phase. Knowledge that may once have depended on the experience of an individual researcher increasingly has to be translated into procedures and work instructions.
The aim is not documentation for its own sake. It is reproducibility.
Qualification and validation: understanding what is critical
The challenge is not to control everything indiscriminately, Ossel stresses, but to understand what is critical.
“What can influence the product quality, product safety, product performance?” she asks. “Which equipment and utilities are critical for both manufacturing and release of your product? Which environmental conditions are relevant?”
Those questions determine what needs to be qualified or validated and which controls are required during manufacturing.
“Qualification and validation are not a tick-box exercise. They demonstrate that your process is understood, controlled and reproducible.”
That becomes increasingly important as a technology develops. Making a product successfully once is different from producing it repeatedly for a clinical investigation. Commercial production raises the bar again, as companies also need to supply the product reliably over time.
When should medtech companies prepare for clinical manufacturing?
For young medtech companies, timing can be difficult. They need room to experiment, but waiting until the first clinical batch is approaching can leave important manufacturing questions unresolved.
Ossel therefore advises bringing QA and regulatory considerations into the development process early. This can prevent problems later on and helps companies understand which requirements will become relevant, which parts of the manufacturing process may be critical, and what will eventually need to be controlled, qualified or validated.
This does not mean fixing a process too early or adding unnecessary documentation during development. It means developing with the next phase in mind, making the transition to clinical manufacturing clearer and more manageable.
Because the closer a medical technology gets to the clinic, the less it matters that it can be made once.
The real test is whether it can be made again, under controlled conditions, with the same intended result.
