Originally Published MDDI March 2005

Guide to Outsourcing

Outsourcing Regulatory and Legal Functions: Choose Carefully

With more and more resources being devoted to R&D and marketing, medical device companies are seeking outside help with regulatory and legal issues.

Erik Swain

The medical device industry is full of regulatory and legal complexities. So much so, in fact, that even the largest firms may not have in-house staff with adequate expertise in certain areas. As a result, countless regulatory consultants and law firms are offering a variety of services to the device industry. And in recent years, some contract manufacturers have begun to offer regulatory services as part of their full-service packages. Chances are, at some point your company will need to look outside for these services, no matter how large or small your operations are, and no matter what kind of products you produce.

“Companies seek outside help for a variety of reasons,” says Schuyler Ritter, executive vice president of marketing and sales for regulatory consulting firm Beaufort Advisors LLC (Norfolk, VA). “It depends on the availability of their internal staff, the specific expertise required, and the timeline for addressing an issue, be it conducting a clinical trial, improving quality assurance, or getting a product to market. Some companies may not need to go outside all the time, but for certain projects, they do.”

In addition, many start-up companies have little in-house regulatory and legal staff, and, in some cases, none at all, so their need for outside assistance with such matters is obvious.

“A lot of them just don't have the in-house expertise to handle the FDA regulatory process, and many have absolutely no idea what they need to do,” says Sheila Hemeon-Heyer, director of regulatory services for MDCI (North Attleboro, MA).

But midsized and large firms often need to look outside as well. They may opt to have skeletal legal and regulatory staffs, choosing instead to beef up resources for functions like research, development, sales, and marketing. Some firms may be venturing into new product areas that existing staff has little or no experience with. They may have an unusually complex FDA application that requires extra help with information gathering or extra assurance that everything has been done properly. Or, they may be in need of counsel specializing in food-and-drug law if FDA takes enforcement action against them.

Choosing Regulatory Help

Often the tough choice, then, is not whether to contract with a law firm or regulatory consultant, but which one to choose when the time comes.

Making a poor choice can cripple a device company. Not only can it mean money wasted on paying someone to do a poor job, but it can mean a delay in getting a product to market or even a denial of FDA approval. And, if the lawyer or consultant rubs FDA the wrong way, it can lead to the device company having a strained relationship with the agency, which is never good.

Therefore, there are a number of issues to consider and questions to ask when hiring outside regulatory or legal help.

On the regulatory side, there are many services a device company could have a consultant perform. So both sides must be on the same page about what duties are expected and what sort of price is reasonable.

One of the most important issues, says Ritter, is whether “there is a good fit between the business styles of the device company and the consultant. Do both think about business in the same way? If you expect the very best results at the very best prices, that's probably not going to happen.”

Device companies must also discern whether the consultant has the time to do the necessary work. What sort of workload does each of the consulting firm's members bear? Do they have enough time to do your job in a proper and timely manner? Will you be able to get in touch with them whenever you need to?

Crucially, device companies must assess the consultant's expertise and determine whether it matches their needs. Does the consulting firm focus on 510(k) applications, or does it specialize in longer and more-complex regulatory processes, such as premarket approval (PMA) applications? Do its services cross over into quality assurance and clinical research? Does it specialize in handling particular kinds of products? Where do its technical capabilities lie?

To get the best answers when selecting a consultant, a device firm should provide as much information as possible about what it is trying to achieve. “For example, you need to explain your goals and timeline for marketing a product. You need to ask what is the best regulatory path to get it to market with the indications you desire,” says Ritter. “Then the consultant should be able to identify the regulatory challenges you will face and prepare a strategy, including the project timeline and costs, for achieving your goals.”

Barry Sall, senior consultant for Parexel Consulting (Waltham, MA), agrees. “It's very important that you make clear what the deliverables are,” he says.

Understanding FDA

Some consultants say that expertise with a specific kind of product is not absolutely required as long as related technical capabilities are there and the firm has a strong understanding of how CDRH operates and what it expects.

“Good regulatory sense and technical abilities can be adapted very well,” says Sall. “But at the very least, make sure you get a regulatory consultant with device experience, and not one that is more on the [pharmaceutical] side. That's also a complex arena, but it's very different. Applying a pharma mind-set to device situations can lead to difficulties.”

Hemeon-Heyer agrees. “It's important to find a consultant that has a good track record at FDA. You don't necessarily need someone who is an expert in your technology, as long as he or she has done work in that broad product area.”

Also crucial, says Alan P. Schwartz, executive vice president of Mdi Consultants Inc. (Great Neck, NY), is finding a regulatory consultant who has experience working with FDA and understands what the agency expects.

“If a consultant doesn't understand how to deal with the agency and what is important to the agency, you will not be able to have a satisfactory regulatory process,” he says. “Most companies don't understand how to negotiate with FDA when it's needed. There is a way to negotiate regulatory issues in a way that satisfies FDA and keeps the company in business. A lot of these processes are not simple, but they are not brain surgery and they can be understood and learned.”

It is becoming more important, Hemeon-Heyer notes, for 510(k) applications to be put together correctly the first time. Firms looking for a consultant to help with a 510(k) need to find someone who knows what needs to be in the application and who can also write well.

“One thing we are seeing is that FDA is getting more strict about the quality of the documents they receive,” she says. “That's because they have to meet certain time frames under MDUFMA [the Medical Device User Fee and Modernization Act of 2002]. One way to do that is to kick out bad submissions. It's not an official policy, but I've been told by reviewers that they will only send one letter requesting additional information, and then if it's still not right, [the submission] gets a ‘not substantially equivalent' decision. That means you really have to put the time in and make the submission as good as possible up front.”

Choosing Legal Help

When looking for outside legal counsel, relevant experience is the most important criterion.

When there is government enforcement action or litigation relating to regulatory compliance, it may be a good idea to seek outside counsel with experience in food-and-drug law, says Larry R. Pilot, a partner at the Washington, DC, law firm of McKenna Long & Aldridge. In-house counsels, he says, tend to be most knowledgeable on the legal aspects of business-related issues. If a major issue outside that scope arises, bringing in an outside counsel may be the best strategy.

“You'll want counsels who not only represent themselves as capable in that area, but who, after you do due diligence, can prove that they are in fact competent,” Pilot says. “If it's an administrative law issue, you want someone who really knows the issues relating to the functions of FDA and the responsibilities of a [device] company.”

Regulatory Help as a Bundled Service

In many cases, firms that provide outsourcing of regulatory functions also integrate them with other services. A common model that many of the larger (and some smaller) regulatory consulting firms follow is to have a regulatory team, a quality team, and a clinical research team.

“All three groups can talk to each other, which is helpful initially when trying to determine what needs exist, and then again once the process gets moving,” says Sall. “When I am preparing something for FDA, if I need some information about clinical research or quality issues, I can get it by walking down the hall for 30 seconds. We can make sure we are all working toward the same goal and coordinate efforts. It helps to reduce time and waste and gives customers a better value.”

Some firms integrate regulatory services with legal services. One model, at Hogan & Hartson LLP (Washington, DC), has lawyers and regulatory professionals working together under one roof. “Small start-ups can use us as their regulatory affairs department,” says Jonathan Kahan, a partner. “We can do just about any service, from work on quality systems, to PMA applications and IDEs, to intellectual property.”

Another model is an alliance between a law firm and a regulatory consulting firm. In the case of law firm Baker & Daniels (Indianapolis) and regulatory firm Aventor (Washington, DC), the companies took the model one step further—the former acquired the latter.

“Combining regulatory and legal helps a company achieve whatever objective it sets for itself,” says Bradley Thompson, a partner at Baker & Daniels. “Having the traditional regulatory consultants with strong science and technology backgrounds, as well as legal skills, at our disposal opens [client] companies up to a wider range of strategies and opportunities.” In addition to legal and regulatory work from afar, Baker & Daniels also enables customers to temporarily bring one of the firm's employees on-site, full-time, if they are shorthanded in-house.

A newer trend, or at least one that hasn't been promoted until recently, is for contract manufacturing firms to offer regulatory services to customers as part of a turnkey package. One advantage is easy access to all the manufacturing and quality system information that needs to go into an FDA application, since all of that is handled by the contract manufacturer.

“It's a great convenience to have, for example, the protocol development process integrated with the regulatory affairs process,” says Don Young, senior vice president of quality assurance for Avail Medical Products (Fort Worth, TX). “In many cases, the information you need for an application is located in a number of different organizations. In this system, it's all self-contained. The customer has one point of contact, and the information flow is enhanced. You also don't have to worry about tribal knowledge being lost in personnel transitions.”

Another full-service contract manufacturer offering regulatory services is the OEM/Industrial division of B. Braun Medical Inc. (Bethlehem, PA). As Braun also has a division that manufactures and markets its own products to hospitals, it has a number of experienced regulatory personnel at its disposal. “Using our service might allow you to get your 510(k) through more quickly,” says Ronald B. Earle, group senior vice president of the OEM/Industrial division. “A full-service company that has a regulatory group is more likely to make your application a priority, because it stands to benefit the sooner the product gets market approval.”

Conclusion

There is no perfect formula for finding the right outside lawyer or regulatory consultant. The right match varies based on the device company's in-house capabilities, the type and complexity of the products it makes, the type of regulatory and legal paths most appropriate for those products, and the firm's budget for outside contractors.

What is clear, however, are the consequences of choosing the wrong partner or tackling the issues in-house when no one on staff has the proper skills. “It saves a lot of money when you do it right the first time,” says Hemeon-Heyer. “Spending money to do a better job on an FDA issue may seem like an expense you do not want to pay, but in many cases it's something that needs to be done.”

Erik Swain is East Coast editor of MD&DI.

Copyright ©2005 Medical Device & Diagnostic Industry