This is a series of blogs geared around accelerating product development through clinical study (animal, cadaver, or FIM).
Successful medical device companies have been developing products for decades but along the way some have developed quality systems no longer adequate to achieving competitive speed to market in the current landscape. There are many reasons for this:
- additions due to internal issues,
- embracing all FDA “suggestions” for improvement,
- general institutional scope creep inside the best intended methodologies of creating safe, effective, and approvable medical devices
The results have yielded quality and regulatory requirements that far outweigh the minimum requirements of the FDA or other regulatory systems. Both result in an overburden on development projects.
One way to speed development is to outsource it to capable partner companies.
In many cases they are streamlined to do it better. This is not exclusive to medical devices as small companies are always more nimble, but medical devices are competing in an already highly-regulated landscape. Bringing a medical device to market is onerous, but the established companies have made it difficult for themselves.
Since speed to market means greater market share for new products, we wanted to find out how to accelerate that timetable. One of the ways? Right-size your quality system for the kind of study you are doing.
What causes scope creep in a quality system?
We list several ways to add items to a quality system: FDA suggestions and internal issues that need addressing among just a few. But often steps are added to a quality system that are relevant for one kind of project but not another. Especially in established companies, quality systems are built to accommodate every possible situation from concept all the way through manufacturing. In reality, not every system works for every project.
For example, if the goal of your project is strictly clinical, why would a company insist a manufacturing quality system be included in the program? When you lay out the project at the front end, you should identify what elements of a quality system you need to accomplish your goals for the project.
As with every other form of scope creep, one small addition does not a problem make. However, tolerating small additions leads to many small additions, which makes a huge problem when taken in the aggregate. From the project manager’s or QMS responsible person’s perspective, here are some good questions to ask:
- Are additions to the quality system really needed for each product being developed?
- Is there a definition that is clear enough to define a quality system that works for speed?
- Does this element of the quality system have broad application? Or could it be applicable in only this instance?
How can scope creep be prevented?
It is very hard to remove elements that have been added to a quality system. Perhaps the reasons for adding it aren’t known or were thrown in because of a specific situation. One rule to consider for quality systems is to make it just as hard to add items to the quality system as it is to remove them. In this case, an ounce of prevention on the front end can be worth millions of dollars of cure on the back end.
When you create an addition to your quality system, identify why you are creating it. Then identify which product goes with a particular quality system attribute. For example, if you know on the front end that your product will have to go all the way through manufacturing, then you need to put it through manufacturing quality system at some point anyway. So, you might as well include that system on the front end.
The trick is to find a quality systems expert that understands the differences between these types of systems and can help you define the minimum quality system in a product development with the need for speed.
How do you overcome hurdles in removing scope creep?
In your quality system, define how to remove requirements up front as one of your processes. This would be spectacularly pro-active and almost unheard of. One way to motivate such behavior is to have the quality system owner have their bonus affected by product development speed. Most quality systems people are policed by lack of quality “issues” but speed to market is rarely assigned to a quality system executive. But they have a great deal to do with speed to market. Yes, this creates conflict of interest, but best to deal with it.