Contract research organisations (CROs) are an important part of the medical device industry value chain. Many medical device companies, large and small, rely on their services, whether for help obtaining regulatory clearance or for designing and managing clinical trials. The quality of these key industry relationships, however, is threatened by the pressure to cut costs during an unprecedented economic downturn.
That is why, says Jeffrey Roberts, regulatory consultant at Medical Device Consultants, it is more important than ever for CROs and medical device companies to focus on maintaining a productive relationship and continuing to find ways of working together that are a win-win for both parties.
As a full-service contract research organisation, Medical Device Consultants Inc in North Attleboro, MA, US provides a specific set of services primarily to medical device companies in the US and internationally.
"There are regulatory affairs activities, which means working with our clients who are mostly manufacturers to achieve medical device clearances and approvals with different regulatory agencies around the world," says Roberts. "We also have a clinical services department that designs and executes clinical trials for manufacturers. Plus we have a quality assurance department for manufacturers who want a full quality system implementation compliant with the US Food and Drug Administration (FDA) or European regulations."
Roberts specialises on the regulatory side. Clients tend to fall into a couple of categories. Many are comparatively small start-up medical device companies where a few specialist professionals – medical professionals, business managers, engineers, marketers – have got together to develop a product.
"They have a medical indication and technology they want to market, and achieve clearance for, but don't necessarily have the resources available to do all of the regulatory clearance work or clinical trials work," says Roberts.
Other clients are larger, established companies that either lack expertise in a certain area, or don't have enough resources at the time to do the work, or find it more cost effective to outsource that part of their operation.
Whichever type of client, they are unlikely to have escaped the effects of the economic downturn. Medical device manufacturers are taking a close look at how efficiently they spend their money, says Roberts. Some companies just don't have the funds to go forward with new products. Others are cutting back on what they do.
"Existing and potential clients are contacting us, and we're writing proposals, but the prices are just not what they can afford at this time," he adds. "So we've seen some downturn in the industry."
In the kind of economic conditions that businesses are operating in at the moment, relationships count, and it is often a question of leveraging that relationship to discuss what can be done to add value and arriving at a suitable compromise.
"As a CRO what we try to do in this climate is to be flexible," says Roberts. "We see if we can reach a common goal with the pricing, the timing and the deliverables."
Roberts has one client, for example, where in the past he would normally deal with the whole regulatory process. That would include writing a European submission; invariably a substantial document which takes some time to produce. Now, following discussions with Roberts, the client is taking on slightly more of the submission work and doing more of the writing, but still consulting Roberts for guidance with respect to that submission.
"Another good example of how a flexible approach can deliver value is a company in Asia that we work with," he says. "They were not in a position to have us write a 510K device clearance for the US FDA. What they did, however, is to sit with me while I explained in a consulting capacity every element of the 510K, how to write it, how to be successful in doing that, how to take the information they had and present it in an appropriate format. So we can provide the kind of expertise they require and that is appropriate to their circumstances given the market conditions."
CROs: adding value
Even if some companies are putting the manufacturing and production of medical devices on hold, they are still able to add value through obtaining clearances, notes Roberts. So, for a nominal amount, which although not inexpensive is not budget breaking either, they can contact the CRO to help obtain clearances for devices, which is one way to add value to their products and company.
"That's a strategy some manufacturers are using in this difficult economy," says Roberts. "They say: "Let's just get clearances now, and we'll talk about manufacturing and producing the products and all the downstream marketing activities, afterwards. But at least we can go forward, and we're still building and investing value into the company by getting regulatory clearances"."
There are also cost benefits obtainable from using a CRO, emphasises Roberts, which can be particularly attractive at times like these.
"If a manufacturer wants to carry out regulatory clinical services, they have to hire people. They need the necessary documentation and support elements to maintain that within the company," he says. "It's cheaper to outsource certain elements to us because they're just paying for the task, or project, that we're providing. So there is definitely a saving there."
Inevitably, some companies are under a lot of pressure at the moment. Although there may be a temptation to tighten the focus on core activities, and really pare down costs, it is also essential to maintain productive relationships with the people in your value chain. And that means focusing on communications.
"It's like any kind of relationship," says Roberts. "Communication is so important. For example, we put ourselves in the client's shoes. We make sure that we know what they need, what type of price they can afford, and whether we can work within that range.
"Timing is a big issue with what we do for our clients. So when we get the initial enquiry, we talk to the manufacturer, discuss all the elements of what is required, what they need to provide, how long it takes. Although we'll generate proposals, it doesn't just end at the proposal stage. We'll call back, follow up, discuss what tasks could be done at a later time or needs to be done right now, and look at potential pricing alternatives."
In the process of compiling a six-volume regulatory submission for a client, Roberts explains that there is plenty of room for error in the regulatory submission and clearance processes, so an effective dialogue with the client is essential. "I look at what the client has and then generate a list detailing everything that the client needs to provide, whether it is software validation, test reports, general information, and so on, in order to allow us to create the necessary compliance documentation," says Roberts.
The need for effective communication extends beyond the CRO-client relationship too. "My responsibility is to be responsive and work with outsourcing groups where needed. I visit the outsource group, speak to the project managers to get the information," Roberts adds.
Ultimately, stresses Roberts, there is no magic solution to maintaining effective relationships in tough times.
"It always comes back to communication," he explains. "If you're not in contact with the clients and other parties involved, in writing, email, over the phone, through meetings, if you don't communicate well, you are going to have problems."
If medical device manufacturers do pay attention to the dialogue process, then it is likely to benefit their business, not just in the short term, but also in the longer term as the economy picks up again.