Originally Published MDDI October 2004

Q&A

Taking the Reins

CDRH's new director assumes control of a center facing numerous challenges. From implementing user fees to regulating combination products, Daniel Schultz has his work cut out for him.

Erik Swain

Daniel Schultz

Daniel Schultz has a lot of work ahead of him. Appointed CDRH director earlier this year, he must now oversee the implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which made some significant changes to how CDRH regulates the device industry. Most crucially, he has to shepherd the controversial user-fee program in a way that satisfies industry, Congress, and FDA staff.

Industry is upset at Congress's failure to provide promised appropriations. Moreover, it is distressed about the double-digit fee increases the program has seen each year since its inception. How well Schultz listens to industry concerns and to what degree he implements changes to the program will be crucial in determining his tenure's success. He has no time to waste on this issue; negotiations on amending the program have already begun.

But guiding the user-fee program is not the only challenge he faces. Other aspects of MDUFMA need to be implemented. CDRH will also need to keep up with rapid changes in medical technology. In addition, standardization and harmonization efforts are being stepped up. The center will need to find ways to attract new talent to help the center adapt to these changes.

And while MDUFMA has provided CDRH with more funds, there are still budget constraints and resource limitations. Fiscal confines create difficult choices about how best to regulate the safety and effectiveness of devices.

FDA believes Schultz is up to the task of sorting out all these issues for many reasons. He is a 10-year agency veteran with expertise in some of the areas that most need attention now. He joined FDA in 1994 as a medical officer in CDRH's general surgery branch. From there, he was promoted to chief medical officer in the center's Division of Reproductive, Abdominal, and Radiological Devices. Later he became director of the division. Then he rose to deputy director, and later director, of the Office of Device Evaluation (ODE). In his time there, he oversaw the review of applications for marketing clearance and began improving review times. In April 2004, he was named acting director of CDRH after David Feigal stepped down. In July, his position became permanent.

A physician, Schultz has experience in pediatric surgery and began his public service career in the Commissioned Corps of the U.S. Public Health Service. He spoke to MD&DI East Coast editor Erik Swain about his new post and the challenges it presents.

Q: Why did you want the CDRH director post? What do you think you can bring to the job?

A: First, I was asked to take on the position on an acting basis. The reason that they came to me was that a lot of the major initiatives that the center was pursuing were things that I was actively involved in. Most notably, [I was charged with] implementing MDUFMA, meeting the new performance goals, and making sure the user-fee program was working.

It felt like a natural extension of what I was already doing. We agreed that I would give it a try, and they would give me a try, and see if we matched each other's expectations. After three months, the answer was yes.

Q: To what extent do you intend to seek and incorporate industry input into your policy decisions? What kind of a role can industry play in helping you shape the future direction of the center?

A: I like communicating with people. I like hearing different ideas, both from within the center and from outside. I want people to get comfortable with telling me things, both what I want to hear and what I don't want to hear. I want to hear all sides of an argument before I make a decision. I am very anxious to work with industry. That is a big part of what I did as a reviewer, as a division director, and as an office director.

The question is, what is the most effective way to do it? We are working on that and figuring that out. I have had many meetings with industry. The larger companies have let us know what's going on in their corporate plans, which is helpful to a certain degree. It's a matter of finding out what they think is helpful, what their concerns are, and how to use their time to the greatest effect.

Q: Will you adopt new methods for interacting with industry?

A: No, the things we are doing now are useful. AdvaMed, MDMA, and various other individuals and groups have all come in with different suggestions. I am happy to hear from them, but we need to pick our battles carefully. For example, we need to determine when it is useful to have workshops, panel meetings, and so forth. A lot of these efforts are fairly resource-intensive in terms of people, time, and money. So I am not wedded to any particular method at this point.

Do I think industry input is important? Absolutely. Do I think it is mandatory for every single decision, especially operational decisions? Probably not. On the whole, my goal is to consider every relevant angle before I make a decision.

Q: What are your top priorities for your first year as head of CDRH?

A: Surviving (laughs). I think that clearly, implementing MDUFMA remains at the top of the list. I think it's vital to the future of CDRH. Without that program, we will have a difficult time achieving all our other goals. I see it as a means to an end.

I want to continue to develop the center in a way that allows us to deal with new technologies, and that deals with the realities of the total product life cycle—not just premarket and postmarket. The total life cycle of the product may include new iterations of the same product.

I would like to improve our expertise in those areas. We have to track the systems in place, and new data, and we have to communicate with firms about those things. All of that takes resources. Unless we have them, we will struggle trying to keep up, and that, to me, would be extremely unfortunate.

We need to make [MDUFMA] work and to make sure industry gets what it expected out of it, as well as Congress, the American people, and us. It could be a win-win for everybody.

Q: What do you think is at stake if things go wrong with the implementation of MDUFMA?

A: Based on current forecasts, we would not be able to continue to hire staff. We would not be able to update our infrastructure, including information technology. And we would not be able to have innovative programs like the Medical Device Fellowship Program to ensure we have adequate resources to deal with new technologies.

All these things are in jeopardy. We would become more of a bureaucracy that would not necessarily add a whole lot [to industry], as opposed to what we can and should be: a vibrant partner and a part of the process to help develop new technology and to get it to market.

Q: What are some other significant challenges facing the center?

A: Keeping up with new technologies is a global challenge. We are trying to harmonize with the rest of the world. We are actively involved in that. It is a long and sometimes tedious process, but we need to continue our partnerships in those efforts. We would actually like to expand our activities in that area, if possible.

We also want to provide additional guidance to communicate to industry and the public. And we want to continue developing initiatives like MeDSuN [the Medical Device Surveillance Network]. The challenge is to figure out what we can do when.

Q: Industry has not been happy with the user-fee increases. Do you foresee changes being made to that program?

A: I think that the program itself has developed in a certain way with the input of industry. Certain aspects of it were perhaps not foreseen, in terms of how the fees were going to increase as they have in the last year.

It is absolutely critical to make sure we get the congressional appropriation that we need to make the program whole. That is certainly an area where industry has been concerned. It is not seeing the same commitment on the appropriations side as on the user-fee side. The “why” is something that others could explain better. From where I sit, I need to find a way to make [the program] succeed.

One thing that I find somewhat troubling is when people tell us we are doing too well and that we might not need all those resources. I will not go back to folks to say, “Don't do such a good job so we can get more money.” I hope people on the outside do not expect us to do that. We will do the best we can with whatever resources we get.

Q: How satisfied are you with the progress of the implementation of the rest of MDUFMA? Are there any issues that still need to be addressed?

A: That was a big bill that had a lot of things for us to work on. We're doing a good job, and a lot of people have expended a lot of energy to get it right. I know there has been criticism on both sides. Our goal is to be fair. We want to make sure that products, when used and sold, are safe and effective, and that is what we intend to do.

Third-party inspection is a difficult program that will take a while. We will have to spend a lot of resources to get it off the ground. How much of an impact will it have? It's hard to say at this point.

We are also putting out guidances for the pediatrics portion of the law. As a former pediatric surgeon, the idea of more, and more-explicitly labeled, products for children is near and dear to my heart. Overall, we have put out a lot of guidance and done a lot of work related to MDUFMA, and it seems things are going well.

Q: Has the ODE improved its performance to your satisfaction?

A: Yes. It has done and is doing an excellent job in making progress to meet the [performance] goals and figure out how best to use its resources. The goals are based on receipt cohorts, which makes it hard to know where we are at any particular time.

A lot of these goals won't come to fruition for a couple of years down the road. We are trying to figure out other ways to measure them in order to be able to do them. The center has done a good job identifying specific needs in areas of expertise to fill gaps, though we clearly have a long way to go there. And even if we fill all of them, we need “bench strength,” so someone can step in if one person leaves.

Q: How would you assess the performance of the Office of Compliance? Industry sometimes complains about inconsistency in inspection practices and enforcement. Is there room for improvement?

A: There is always room for improvement. One thing we are trying to do is to implement a new risk-based strategy. That will be helpful in terms of having the right procedures and using our limited resources in the right way. We can't get out to inspect everyone in the short term.

In terms of consistency, there are a number of different districts and a number of different people in each district. Total consistency is not something we can aspire to. What we can do is have good communication within the center through the management of ORA [the Office of Regulatory Affairs]. We need to make our expectations as clear as possible, so people know where the center is coming from, and figure out what bears watching so we can do something about it.

Q: With combination products becoming more prominent, CDRH has to work closely with other FDA centers. How are relations with them, and how do you expect CDRH's relationships with them to change?

A: I think that, in general, our relationships with other centers are good. In terms of our ability to interact with other centers efficiently and effectively, we are getting better. But we still have a long way to go. We have the Office of Combination Products to act not only in terms of helping to adjudicate jurisdictional decisions, but also to facilitate interaction between the centers. The drug-eluting stent experience was very positive. It was also very time- and resource-intensive. We need to build on that experience and apply those lessons to other areas.

One area that I am taking great interest in is tissue and tissue-engineering products. We are going to establish a working group with CBER [the Center for Biologics Evaluation and Research] specifically about tissue-engineering products in the near future. These are the kinds of efforts we need. When we see areas of overlap, we should be able to recognize them and figure out ways to get the right people to the table as quickly as possible.

Q: The two most prominent combination products that FDA approved have had postmarket manufacturing issues. Is that an indication that the approval process was too quick? Are there other lessons to be learned?

A: We always look at the postmarket experience to see if there are lessons we can learn and do it right the next time. I think there will be some times where we see things come up by the size and nature of the postmarket experience, as opposed to the premarket experience. That is, there might be events that are quite serious but, because they occur at such a low rate, are difficult to pick up in the premarket evaluation.

On the other hand, in the case of the Boston Scientific product, the stent itself was not the problem. It was the delivery system that had some problems. So that is something we will absolutely pay more attention to in future applications. That's not to say we didn't the last time, but we learn different things as we go along.

With the J&J product, we learned the importance of starting postmarketing studies as soon as possible after approval. It was not until there had been a few thousand implants that the postmarketing studies were initiated. I'm not blaming the company or us for that. But this is a new territory. We are seeing products achieve significant volume and quick market penetration in ways we had not seen before. We are learning how to deal with these breakthrough, practice-changing types of products that also happen to be combination products that involve other centers. We want to build off those experiences and get it right the next time.

When we reviewed the Boston Scientific product we applied what we learned from the J&J product. We will apply what we learned from the Boston Scientific experience when the next product comes along. The issue of when a product is ready to go to market is a core of our business. That is almost never an easy decision, especially when we are dealing with breakthrough, novel products.… But every time we must think about whether we are getting it right.

We don't want to keep valuable products off the market. On the other hand, we need to do our due diligence in terms of protecting the public health. That dilemma keeps us on our toes.

Q: What can CDRH do to keep its reviewers and inspectors abreast of rapid changes in medical technology?

A: There are a number of things we can do. Part of it is making sure that when we encounter expertise in other areas—whether other parts of FDA and HHS or outside—that we can access it as quickly and efficiently as possible. Part of it is hiring individuals with recent training who are up to date on the latest technologies. Part of it is helping our own staff keep up to date by providing them with the time and the resources to do so.

We are involved quite heavily in professional development. Some would argue it's still not enough. But it is a focus for us and we clearly need to continue doing it. We do have to look at it in terms of the overall resources of the center, and that's challenging.

Q: Your background is with the ODE. How have you been able to familiarize yourself with the activities of other CDRH offices and divisions since becoming the center's director?

A: A lot of it has been on-the-job training. This position forces you to become familiar with everything that's going on. I've made it a point to educate myself about all the different offices. I've met with the office directors and division management and tried to familiarize myself with the different programs they're involved with, what their challenges are, and what their needs are.

A lot of the learning comes from dealing with the issues that come through my office on a daily basis, whether they have to do with compliance, personnel, or even buildings. Each time something comes through, I learn at least one thing that I didn't know before, and try to understand it better for the next time.

I have a lot of helpful people around me. [CDRH Deputy Director for Policy] Linda Kahan is as knowledgeable about the regulatory process as anyone in FDA. [CDRH Deputy Director for Science] Lillian Gill has a broad background in compliance and is heavily involved in strategic planning. I have office directors that have a tremendous amount of expertise as well. Having these kinds of people is a salvation in terms of making up for the things I am not familiar with.

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