
Outsource Selection? Consider a Checklist Manifesto Part II
In Part I of my blog (March 19) on using a checklist manifesto for medical device development, we looked at Competency, Performance and Effectiveness and how these relate to the outsource selection process.
Now, let’s unpack Flexibility and Balance, my final two recommended elements of outsource selection within this outsourcing checklist:
Flexibility
What exactly is flexibility? I looked up the definition and one particular meaning stood out: susceptibility to modification or adaptation. In reality, every outsource project will experience some level of modification or adaptation within the design, schedule, funding and even the pricing of the project. It is this susceptibility that—good, bad, or indifferent—welcomes the spirit of flexibility.
A particular element to evaluate from each potential outsource partner is the ‘measure’ of flexibility within the organization. To start, I recommend a simple exercise to consider how flexible your own organization is as a whole. If internally your company is so structured that being too flexible is almost considered disruptive, then selecting an organization that matches your organization may be worth considering. The opposite scenario is equally valid: if your company is highly flexible, you’ll want to match that in an outsourcing partner. However, because projects are subject to modification, then obtaining a better understanding of this internal measure of flexibility requires; 1) evaluating all correspondences in the spirit of flexibility, and; 2) asking questions in relation to how the outsource company is considered to be flexible. Obviously, it is much better to isolate this measure prior to signing up for a project.
So, let’s give an example: The signing of a Non-Disclosure Agreement (NDA) with the potential outsource company is commonplace in order to exchange protected information for Outsource Selection. Note how that process transpires. Do not get me wrong, an NDA, even a Mutual NDA in some applications, is vital and most necessary. But, if getting beyond the NDA was painful, then one might deduct that the level of flexibility exhibited here may carry over into elements of the actual project.
By nature, some programs require a great deal of flexibility. For example, on the manufacturing side of the business, a program may ramp up over several years. During this time, limited low production runs is common while the product is getting introduced and accepted into the marketplace. In my experience, most outsource manufacturing operations have difficulty in managing this type of start/stop production and may not be as flexible as others. Look for one that can accommodate the starts and stops.
Balance
You have heard it said before that ‘every customer is equally important’, or ‘every customer is treated the same’, right? Most live by this basic business philosophy without question. But, in the context of selecting an outsource partner when hundreds, even millions of dollars are in consideration, one should consider how an outsource company keeps ‘balance’. To do this, consider breaking this element of Outsource Selection into two areas: 1) internal balance; and 2) external balance.
Internal balance has to do with how the outsource company balances its own priorities. In particular, its own business, its own employees, its own affairs, even its own community participation. If the overall balance level here is healthy, then one can deduce that the chance will be great that the same level of balance will be applied to their customers. The internet can provide some information, but as mentioned in the first blog, visiting the potential outsource company is instrumental to obtaining some of this information first-hand.
External balance considers elements mostly from previous customers’ experience and testimonials. When reading posted testimonials or calling references via phone, pay attention to the notion of balance. Usually, this comes in the form of connecting multiple areas the outsource company did well, ultimately to a successful outcome. Balancing the program, the changes within the program, the shift in milestones, the delivery dates, the holiday schedules, the personal time off, the program costs, the…you get the idea.
In conclusion
Let us not forget the importance and significance of the second half of the title of Atul Gawande’s The Checklist Manifesto—How to Get Things Right. At the end of the day, getting things right is a big deal. Furthermore, Gawande describes that all learned occupations have a definition of professionalism, a code of conduct. Three such codes of conduct include expectation of selflessness, skill and trust. Of special interest is a fourth expectation, one which aviators possess: discipline—the “discipline in following prudent procedures and in functioning with others”. We work in a highly regulated medical product development and manufacturing environment which requires an uncompromised level of discipline in outsource selection. Is it not interesting, however that the next element, as mentioned by Gawande, is functioning with others. Functioning with others with the idea of getting things right…now that is something. Choose wisely during outsource selection.
Charles Garcia is a former VP Business Development at StarFish Medical. He encourages prospective clients to use his outsourcing checklist when considering and comparing service providers for medical device design, development, QMS, and manufacturing needs.
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