Medical Device companies utilize consultants for various reasons, including: a lack of technical expertise within the company, avoidance of hiring full-time employees for a relatively short-term project and gap analyses for FDA readiness or notified body audit. Have you ever been tasked with choosing a consultant to help with a critical project, but the consultant you selected failed to meet your needs? Not to worry, you’re not alone. Unfortunately, consultants sometimes make commitments for work they are not qualified to do. Here are four critical areas to consider when selecting a consultant to help ensure a positive and productive experience.
1. Defining the project scope
Ensure that the scope, timeline, roles of the consultant/ internal company team and deliverables are crystal clear during consultant interviews and defined within the consulting contract. Do you need advice or suggestions to be carried out by your internal team? Or is “hands on” work required (writing procedures, conducting training, executing audits, etc.)? I’ve discovered that “hands on” can mean something entirely different to your company and the consultant, and if it’s not clear who is doing the actual work, your internal resources may end up doing the work that was intended for the consultant.
Once the project scope has been clearly explained, ask the prospective consultant to provide a brief document describing how they would approach the project. This will be helpful later on when drawing up the contract. Ask which software or systems the consultant will be using to keep your project on track. A consultant who does not have any version of project management on their own laptop, or is unfamiliar with such tools, is a red flag.
Make sure you select a consultant or consulting firm that matches the size of your project. Select and interview three to five companies, based on the size and complexity of the project. If the project primarily involves working at your location, consider the additional cost and travel time from where the consultant(s) is located. If the project allows for working remotely, focus more upon the project management aspects mentioned in the previous paragraph, and how your company will communicate with the consultant.
When selecting your consultant, don’t base your decision on word of mouth, or someone that you pick randomly online. Interviewing is an important part of the selection process. Be wary of a consultant who talks more than listens, especially if the conversation is about their illustrious career. This person should be focused on the scope of your project and asking questions about your company and the project team. You also need to beware consultants with a patronizing attitude. If you are an experienced medical device professional and the consultant starts to explain the definition of GMP, the consultant has not taken the time to understand their audience. Any consultant that is this disrespecting deserves to be chopped from your list of potential service providers early.
Don’t limit interviewing to the experience of the lead consultant or owner of the consulting firm. Make sure that you also have a resume or CV for each of the other consulting members that will be working on your project. Imagine the dismay of your internal team when you discover that the owner of the consulting firm has hired friends or former colleagues with little or none of the needed expertise. To prevent this scenario from occurring, include a technical person on the interview team in order to challenge the expertise of the consultant. This will help you identify a firm that knows all the right buzz words, but lacks the knowledge to accurately implement the deliverables and reduce regulatory risk within your company.
Ask for and check references for past clients for whom they have done similar work. Ask for examples of work reports that the consultant has completed for other clients—with any confidential information removed. This is critical in determining if the final job will be “fluff,” or real solutions for your company. It will also avoid the “one size fits all” procedures and processes that can rarely be beneficial for your company’s needs. Ask for examples of “out of the box” thinking and best practices that they’ve implemented. How do they remain current on the regulations and standards?
Cost should not be the only determining factor in selecting a consultant. When you’re choosing someone to pave your driveway, you may be able to get away with this. When choosing a consultant for your medical device company, you definitely want a number of bids, and you want to ensure that each party is bidding against the same scope and deliverables. However, choosing the least expensive bid over the one with the most expertise and best reputation may cost your company more in the long run if the work isn’t properly done or completed on time.
Contracts must be very specific with regard to milestones, timelines and deliverables with respect to the payment schedule. What recourse does your company have when a consultant assures you during the interview process that they can meet your every need and then doesn’t. No company wants to have to pay for work that hasn’t been done and may never get done.
Be clear about work accommodations – office, cube, conference room, phones, access to printers and company databases, so that there are no misunderstandings once the job starts or excuses for why the work can’t get done “under these conditions.”
Choosing the right consultant for your company is critical. They don’t come cheap, and if the work could be accomplished by your staff, you would not be hiring a consultant in the first place. If you are careful in your selection of a consultant or a consulting firm, you may be rewarded with a new partner that can help you grow your business for many years.