One challenge I always had as an executive in a device or pharma firm was figuring out whether I should hire a consultant or not. Now, as a business owner, that question can be even more pressing as any money spent on a consultant is money that comes directly out of my pocket. So what are some signs that it might be time to look outside for expert advice?
When you begin to perceive a significant opportunity or a threat is the best time to reach out for independent advice. For instance, let’s assume you’ve read my book Get to Market Now! and really like all the tactics and steps I provide on how to build quality by design into preclinical and clinical development programs. And yet, when you’ve tried to tackle this or something like it in the past, the effort has either not been successful or has caused resentment. This is a good trigger for bringing in an outside expert to help.
Such a trigger only means that the time is ripe to evaluation options; not necessarily to run out and hire an outside expert to conduct a big project. Instead, identify your single most important objective – is it to reduce your risk or to kick-start an initiative that will take advantage of a new opportunity? Perhaps you could hire the outside expert to conduct a cGMP quality system workshop for your staff or management team. Or hire the outside consultant to serve as in independent advisor while your firm does the work in-house or contracts a global scope of work to multiple regional consulting firms.
One of the most enjoyable jobs I ever had was when I was hired to advise a client’s senior management team whether their big, brand-name consulting company was blowing smoke – or at least not presenting all the options – during the course of a major six-month project. While at first this arrangement seemed like it might be fraught with tension, I was relieved to see how quickly it turned a routine project into a showcase for both the client and the larger consulting firm. Ironically, the consulting company was so pleased, they have since offered me multiple sub-contracting work helping them succeed as their own “back-pocket advisor.” It was, as the cliche goes, a win-win-win for everyone.
Don’t be afraid to seek outside independent expertise. Once you perceive something new coming down the pike toward you that may be a real threat or a good opportunity (or at least something where you want some level of insurance like my client in the example above), consider contacting an independent FDA consultant with expertise in that area. Ask them to help you assess risk, evaluate opportunities, and envision better alternatives.
If you like working with the consultant, go further and ask them to help you tackle the new opportunity or undertake actions to reduce risk. This could be a simple as creating a report, conducting an on-site compliance workshop, serving in a project assurance role or trusted advisor, fixing a previous consultant’s work, or simply making series of presentations and Q&A sessions to key stakeholders around the company.
Don’t get hooked into a long-term consulting dependency where your reliance on the outside expert grows deeper and deeper. Here are some tips to help you avoid the dependency pitfall:
- Knowledge transfer is crucial – make sure it is a defined outcome in any contract
- Have a clearly identified opportunity or threat
- Do your homework on the type of advisor to help you make better decisions
- Always take it one step at a time, assessing how comfortable you feel
If that sounds reasonable, check out my experiences and recommendations for selecting and evaluating consultants in the article, Choosing and Getting the Results You Expect from Consultants.
And don’t be afraid to contact me if you need independent advice to streamline FDA, ISO, ICH or IMDRF compliance efforts.