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IVD manufacturers hire consultants for various reasons. The challenge lies in selecting and making the most effective
use of the right consultant. (Photo by iStockphoto) |
According to an anonymous sage, “Things never seem to get easier, no matter how much you think you know.” That could definitely be applied to the experience of dealing with FDA. When a regulated manufacturer of IVDs or other healthcare products finally thinks it has things clearly defined and understood, the agency changes its policies or the way it operates, and the company has to discover how to deal with the bureaucracy all over again.
For companies in the IVD industry, learning to navigate this bureaucratic river could cost a huge amount of time and money, even leaving aside calculations of the loss of potential income. Sometimes, just trying to figure out how to redo what has already been done can be very expensive.
This is a situation in which using a good consultant can be extremely beneficial. But the question is how to find one—and extract the most value from the hire. Unfortunately, of the many, many consultants that claim they can provide the guidance and expertise regulated manufacturers seek, only some actually can.
Hiring the wrong consultant can be costly in its own right. So, the IVD company has to make sure it chooses the right consultant to aid in achieving its goals. The selection could be critical to the success of its project.
Dealing with FDA
The effort of finding the appropriate FDA regulatory consultant has been such a bad experience for so many companies that FDA itself has even issued a guidance document on how to hire a consultant. FDA is concerned that companies understand its requirements and hire the right experts to help them with compliance assurance and preparing the proper submissions. Using the right consultant can make FDA’s job easier.
While helping out FDA may not seem that important, a company seeking a 510(k) clearance or addressing an FDA-483 observation, if it is not in tune with FDA expectations, will find that discordance costly. FDA knows from experience that many companies make very good devices and tests but fall short in understanding agency regulations. FDA additionally knows that a good consultant could provide a company with the expertise necessary to avoid problems and bring the firm into compliance.
As a matter of fact, FDA requires companies with regulatory problems—those who have received injunctions or, in some cases, warning letters—to hire third-party experts to assist them in achieving compliance and then notifying the agency when that objective has been accomplished. Therefore, it is in FDA’s interest to instruct companies in the first place regarding how to go about retaining the services of a consultant that possesses the expertise the situation requires.
There is one more point that IVD manufacturers should be aware of when dealing with FDA. That issue is keeping current with FDA’s policies.
FDA regulations do not change often. Its Current Good Manufacturing Practices (CGMPs) are regulations that have undergone only one change since they were first implemented in 1978. However, over that time, FDA has altered its policies with respect to its interpretation and enforcement of the regulations. For example, the original CGMPs make no mention of validation. However, if a company did not validate its processes, it would would result in a warning letter or an injunction. This way, the policy becomes, effectively, regulation. Any company involved with FDA should understand that agency policies can change much more frequently than the regulations. Full recognition of this, along with a capacity to keep up-to-date with current FDA policies, could be critical factors in a company’s ability to remain in compliance.
Selecting a Consultant
How does a company find a good consultant? First of all, it should take advantage of industry collegiality and make inquiries of other companies it knows, including friendly competitors, asking them who they have used and would recommend. Also, FDA maintains a list of recognized consultants with which it has had experience. The agency can supply names of advisers the company might contact.
The first step in making the selection is to know the project well, and also the scope of work the consultant will be asked to handle. The project should be outlined in writing to ensure that everyone is on the same page and that the deliverables are defined. The manufacturer should be prepared to ask prospective consultants questions about their expertise, length of time providing consulting services, and client list, including what type of projects they have worked on and their success rate. References are good, but a consultant will usually provide a list of companies that were satisfied with their work, not those that were not. Although it is worthwhile to contact a reference in order to find out something about the experience of working with that consultant, the testimony should be viewed as an indicator rather than as a deciding factor.
The size of the consultant’s company could be a factor in the decision. Some operate as individuals and others as part of a group of consultants. Many consultants have what they call a network of colleagues who are not in fact staff but may be described as though they were somehow employees.
Timeframes for the project should be established and candidate consultants asked how they will keep to them. In some cases, it will be easier for the consultant to stick to the project schedule than for the company to supply the documents necessary to get things completed.
A good connection between the consultant and the client is essential, whether communication is via telephone, fax, or e-mail, and responses to inquiries should be received in a timely manner.
The consultant’s relationship with FDA and record of relevant work is very important, of course, since the manufacturer may be using the expert to interact with the agency on its behalf. First and foremost, an FDA intermediary must be able to work effectively with FDA.
The last significant selection factor is the cost of the consultant. Services may be billed on an hourly basis, similar to the way attorneys do it, or on a project basis. In appraising competing fee arrangements when trying to select a consultant, it is important to compare apples to apples. If one consultant would charge on an hourly basis and another on a project basis, the company deciding between them should know what cap the one charging hourly is willing to put on the cost of his or her services if, importantly, there is a cap at all.
In this as in most things, one usually gets what one pays for. Though the haggling during negotiation of the fees may seem interminable, an experienced consultant will have a good idea of what the project will entail in terms of time and the work required, and will propose a fee that is fair to both consultant and client.
Using a Consultant
To navigate successfully the myriad IVD regulations, an IVD manufacturer may find it prudent to seek assistance from an expert consulting firm. Every IVD company is distinguished by its own set of specific circumstances, and its regulatory assistance needs will differ from those of other firms. A professional consultant will work with the client to create the proper balance of services that suits that client’s particular circumstances.
A good consultant will spend a lot of time asking questions and listening to answers in order to learn about the IVD company’s unique needs rather than walking in the door with a canned approach. This questioning will ensure that the consultant has full knowledge of the client’s processes before proffering advice. In addition to providing the requisite expertise in the IVD area, a good consultant acts as a motivator and a project leader for other members of the client’s team. Today’s clients want the experience-based knowledge possessed by the consultant, but they also want to be able to do things for themselves. They want to gather some hands-on experience during the project, and this is where the consultant’s prior experience and motivational attitude come into play.
The manufacturer should always plan ahead and not wait until the last moment to seek advice. It will usually be too late then, and issues will be harder to work around.
Also, companies are advised to confer with a well-experienced consultant before communicating with FDA. In many instances, companies seeking the advice of FDA and, finding the recommendation difficult to comply with, are nevertheless left with the feeling that they have no option other than to abide by FDA’s suggestions regarding, for example, the number of clinical studies or type of testing to conduct. Having a consultant on its side results in possible options being presented to the manufacturer, from which it may choose those most suitable for its business and for its product.
The manufacturing company should understand that getting its device 510(k)-cleared by FDA may be only the first step in complying fully with the applicable FDA regulations. It is incumbent on the company to understand the full set of regulations that may apply to its operations, including design control as well as manufacturing. The consultant, or consulting team, should be able to assist the company in understanding all aspects of FDA compliance. The issues covered would include the quality system regulation (QSR) and CGMPs for production and related operations.
Many IVD companies, particularly foreign companies that have achieved ISO 13485 certification, which is a requirement for putting the CE mark on their Type II IVD tests, are under the impression that they are now in compliance with the FDA QSR. This could be a major mistake and might result in a company receiving an FDA warning letter because of lack of QSR compliance. A company has to know not only the differences between the QSR and the standards in ISO 13485 but also how FDA audits of its operations would differ from an ISO audit.
Conclusion
The services of a consultant can be beneficial to a company that manufactures IVDs. A well-established consulting firm will have access to clinical study sites, key opinion leaders, and other testing specialists known to meet FDA standards of testing and data collection, while also ensuring that its client maintains full QSR compliance. Working with a good consultant is like having a very knowledgeable and highly experienced FDA representative in one’s corner. Such a consultant will question the client’s notification or application while in the process of assembling it, taking into consideration ahead of time all of the possible concerns FDA may have. He or she will also be able to respond to FDA concerns that may arise during the submission process, as well as after completion of an inspection.
Ultimately, a good consultant will prove to be worth more than the fees paid.
