The Consultant, the FDA, and You

Eeny, meeny, miny, moe

To which consultants do I go?

Do I use one near or far?

Or one who has passed the “Bar"?

Should I hire one who is quiet and meek or one loud and bossy should I seek?

How do I know of their knowledge?

When I'm not certain they went to college?

The final selection-does it really matter?

Theirs are the only wallets that seem to get fatter!

Selecting a consultant may not be as arbitrary as the above rhyme — but choosing the right consultant could be extremely important to the future success of your medical device manufacturing business and your present finances.

Dealing with the FDA is not very easy, especially for smaller companies who do not have experienced staff. Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.

There are many consultants out there and knowing which one to select can make the difference in addressing the FDA’s concerns. Just because a consultant understands the QSR/cGMP (21CFR820) they may not have the experience in looking at a 483 observation and understand what the FDA is expecting to see in your response. Just telling the FDA you will address the observation will not “DO” for the FDA. The FDA wants to see that understand what your deficiency is and that you are know how to correct it and assure that it was implemented.

The FDA is expecting that a company do its due diligence and retainer a consultant who has the expertise in dealing with FDA compliance. Like all vendors the FDA QSR requires that you quality your consultants. Getting the consultants credentials is part of this due diligence.

There are, in the FDA's opinion, three types of consultants, the ideal being highly qualified in all three areas.

Regulatory consultants specialize in 5l0(k) and PMA issues, GMPs and/or device labeling. Quality consultants are adept at GMP auditing, writing, and revising procedures. Technical consultants basically know how to find problems and fix them.

The FDA's guide, “Selecting a Consultant,” states that although the agency cannot recommend or endorse a particular consultant, it can offer criteria to consider:

• How long has the consultant worked with device-not drug--GMP regulations?
• Is their knowledge current?
• How does the consultant know CDRH's "current" policies and interpretations are for device GMPs?
• Does the consultant sponsor or participate in training courses?
• Are they frequently asked to give presentations at FDA- or Industry-sponsored seminars? What have been the reactions to these presentations?
• The consultant must be able to communicate problems and provide solutions in a clear, concise manner and in such a way that the company knows how to perform corrections the "right" way the first time.
• Has the consultant been deposed or testified as an expert witness either for the FDA or for industry?
• Obtain a list of the consultant's clients over the last several years. Check these references!
• What types of certifications does the consultant have? Are they certifications recognized by professional societies?

These recommendations are logical. Unfortunately, the need for such has been accelerated by the red tape and regulatory environment that inflated the increased use of consultants.

Getting Value-Rather than Settling for a Necessary Evil

Consultants can offer real value to a company beyond the needs imposed by the FDA. These include someone able to communicate with the FDA who can pre­vent the issuance of a Warning Letter ­ or worse, an FDA injunction against a company that has neither a failed device nor serious injury complaint.

Consultants can be cost-effective, expedite your project, cut through red tape, reduce the need to hire new employees and get the knowledge you require online quickly. Additional selection criteria- when, who, and how can make the relationship most productive for your company.

When do you need a consultant's services could be the most important question. An outside opinion on a difficult problem or an independent internal audit may be the first step to preventing a situation from getting out of hand.

Why do you need a consultant: If you cannot bring yourself to realize a consultant is required in certain situations, it could cost you more in the long run.

Who you hire is tantamount to your well-being, both to assure the project is done correctly and that it is money well spent. Consultants’ fees are usually related to their level of experience and the size of their support organization.

There are reasons why people prefer the Hyatt to a Motel 6-the same theory applies to any type of service, especially consultants. But higher fees do not always assure quality work or that the information you require is available.

How to identify a consultant is crucial. The Internet, professional journals and organizational lists are all ways of finding consultants, yet word-of-mouth is by far the most valuable.

A Productive Partnership

As the FDA recommends, checking references is important. How long has the consultant worked for the company, doing what kind of work? Is the consultant on a retainer agreement or would the company rehire them as needs require? Of course, consultants will tend to supply you with names only of satisfied customers, but a truer picture of capabilities and qualifications emerges from references that cover several areas of consultation.

Good rapport is paramount to success. Both you and the consultant must understand what you expect for your money. There is no reason a consul­ tent should not be able to estimate the cost of a project.

As with anything else, if it sounds too good to be true, it probably is. If a consultant promises you anything regarding the FDA, like they could get a 510(k) reviewed in three months, I recommend you start looking for a new consultant.

The need for consultants does not look like it will diminish any time soon. But the relationship need not be a one­ sided affair you wished you'd never started. A long-lasting relationship with a good consultant can be beneficial for you both.

The guest blog was written by Alan Schwartz, vice president and founder of New York-based mdi Consultants, Inc. He has been consulting with medical device manufacturers since 1978. For more information, visit mdi Consultants  or call 516-482-9001.

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