Research and concept phase of Design and Development

[Jeevan Jyoti]

Hi everyone,
I want to understand that is the research and concept phase for the medical device needs to be managed under QMS? if yes, then what sort of controls needed to develop?

We have a company's lab situated interstate and they just research and works on initial concept of medical design. Do I need to show them under our QMS? They might be developing test protocols but they will get validated during design and development stage gates.
Please advise.

Thanks

 

[ChrisM]

In general it is down to you to determine what, if any, parts of the concept phase, come under the control of your QMS. Once you have given it a "project number" and have a defined set of product requirements, then the project would normally be expected to come under QMS control - although there is still nothing from preventing a decision being taken to cancel as it will be uneconomic/unprofitable etc.
Irrespective of the QMS, it is of course always a good idea to document what you are doing during the concept phase and to hold reviews, so that you have evidence to call the project off if it's proving "impossible", or to assist with managing it if it does turn out to be viable and becomes a formal project.

 

[Jean_B]

Research feeds concepts, and there are two concepts that must have a successful marriage: technical possibility of the mode of action and commercial desirability of the results of that mode of action.
As such that phase feeds (user) needs, and the translation of needs into design inputs marks the start of QMS control, because that is where regulations want you to apply controls to achieve the safety and effectiveness characteristics.

However, if you don't control the concepts (not for quality but for truth, or perhaps better said general applicability with absence of falsehood) you might go down a dead end or land in fraud.
For example Theranos had a highly desirable result for mode of action, but any sane scientific minded investor would want to see that mode of action in actual action a few times. However, the one-drop-prick was what sold it (results of the mode of action), and the actual mode of action of bulk tests on such small a sample with comparatively accurate results to larger quantity samples was what should have been observed.
Appropriate controls for such cases rarely work from the mindset of quality that designs and develops, where you must believe it will work; it's more about the controls you would apply to see whether it's a magician or a hustler playing the shell game.

 

[Ed Panek]

We usually dont enter QMS Design Controls until at least one hurdle has been passed. The early sandbox work (feasibility) is not very controlled. Once the design team has selected an idea (or ideas) and starts to make volume components purchases for testing we would enter design controls. Thats because I want to start taking credit for the testing.

 

[Tidge]

Once the design team has selected an idea (or ideas) and starts to make volume components purchases for testing we would enter design controls. Thats because I want to start taking credit for the testing.

This is the key IMO. If there are activities taking place in any given phase, the QMS is supposed to exist so that there is a way to evaluate what happened in that phase. As a practical matter, the "first phase" of development doesn't need the sort of planning and documentation, unless of course a later phase activity intends to skip such things with the rationale "it was done in the concept and feasibility phase".

I've never worked in an organization that was mature enough (both in the CMMI sense of the word, and the way individuals worked as a team) to leverage effective project planning in a concept phase such that project plans could harmonize with what might be recognized as an activity governed by a QMS process. My experience has been more typical that engineers think of themselves as wizards or artists whose creative process shouldn't be observed too closely, when the reality has been more closely aligned with tinkering and WAGing... let them have this sort of freedom in the concept phase, because soon enough they'll have to act like engineers.

 

[Jean_B]

You'd have to backthink from regulatory submission - where the regulation boiled down only cares about safety and effectiveness: anything going into your submission must be under quality management system to support authenticity, accuracy, and adequacy (unlike AAA games) to assure attainment of sufficient safety and effectiveness.
This is why it's important to jump ahead, walk every path back, and only then have work go forward.