Breakaway Simple

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Taking the pratical approach to medical device product development

But this is the way we’ve always done it…

We hear these words several times a week. In our consulting practices, business, and service groups, the need to cling to old ways of doing things is ever present. No one likes change. Even if the current practice is the source of the problem, why change?  It is always a challenge when we go into a new client company and because we see the situation with fresh eyes, we recognize the issues, redundancies or inefficiencies that the folks there for years may not recognize. Sometimes, what happens is the people do know the issues as well…but are not able to make the changes. Sometimes they have chosen to not speak up. However, sometimes they are so close to the problem, they can’t see the forest for the trees. This puts the outside consultant into a unique role. While not everyone is glad to see you, you have been brought in for a reason.

So how do you go about change and keep the company you are working with in compliance, and also happy for the help?

1. Start with a gap analysis to identify issues.

2. Do a systems analysis to identify the issues that make things much more difficult that they need to be.

3. Create a plan to fix the issues and introduce best practices where possible

While the people in the trenches need to see the gaps, the executives need to see the gap and systems analysis and endorse the plan. Miss any one of these key elements and you are not serving your client well. Involving the “doers” in the company in the creation of the plan is a key to success, and without executive support, the plan will fail.

Does this mean that you do an overly cumbersome analysis for every project? Not at all. Whether it is an overall evaluation of quality systems or product development / design control, or a regulatory project, these three steps apply. If you haven’t done this, you won’t be able to effectively articulate why change in a plan, strategy, or system will help and defend against the statement….”but this is the way we’ve always done it”.

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