A Whitepaper by Dr. Nancy J Stark
©2012 Clinical Device Group Inc, all rights reserved.
Device contract research organizations (CROs) play a different role in the product development cycle than drug CROs, and it is unrealistic to expect a drug CRO to deliver the service a medical device sponsor needs. In the drug world a CRO is used more like a Kinko's or a dry cleaners: the sponsor drops off the protocol on Monday and picks up the report on Friday. The CRO acts independently and is legally responsible for the sponsor obligations identified in the contract. [1. 21 CFR Part 312.52]
In the device world there is no possibility to legally transfer sponsor obligations to a CRO. The manufacturer may use the services of a CRO, but legal responsibility for sponsor obligations remain with the manufacturer. As a result, medical device CRO must serve as a consultancy; collaborating intimately with the manufacturer on sponsor responsibilities such as recording and reporting adverse device effects, investigator noncompliances, device deficiencies, investigator and study staff training to proper device use, and so forth. The device CRO-consultancy cannot act independently because the legal responsibility of their actions remain with the manufacturer.
Choosing a device CRO-consultancy
As the manufacturer you should choose a CRO-consultancy that complements your corporate personality, fills the knowledge gaps in your organization, and makes themselves readily available to you. Here are some specific characteristics that you can evaluate.
Device experience of top management
Does the CEO have medical device experience? The career history and experience of top management sets the focus of any company. When you are interviewing a CRO, be sure to ask for the CVs of top management. Have they worked for medical device firms? Have they worked in clinical research or regulatory roles? Are they sensitive to the differences in regulations between devices and pharmaceuticals? Without device experience at the top, you are unlikely to get device experience at the level of implementation.
CDG Inc—A Device CRO Here to Stay
CDG is a small, networked CRO offering services in biological safety, quality design, clinical research, statistics, audits, reimbursement, and clinical evaluations for medical devices. We have many clients who use us as a consultancy—they call for advice when they want direction about how to proceed.
We have been in business since 1990, and our President has been in the device industry since before Part 812 was final! Please call us to discuss consulting needs for your firm. Click here for more information or call 773-489-5706.
Size and power
How big is the CRO in terms of number of employees or annual gross revenue? Little sponsors get swallowed-up by big CROs. If your project is small compared to the other projects the CRO is running you will be ignored when bigger clients have problems and demand attention. The disparity in size leaves you with no power to demand immediate help. Small CROs will value your business and are more likely to make themselves available to advise you.
But in fairness, if you are a large device manufacturer you may be more comfortable working with a large CRO. Large CROs can bring more sophisticated electronic data tools, financial reporting tools, or other management advantages that small CROs cannot afford.
Progressive slices of the pie—estimates and schedules
In CDG's experience, device projects tend to be progressive slices of the greater pie. For example, the first project might be to review device biological safety, if that goes well we may be asked to review a protocol, and then to calculate an array of possible sample sizes, then to implement a study, and so forth. One project may turn into five projects or twenty-five project over time.
In any case, once you settle on some specifications the CRO should be able to give you an estimate and schedule. I am using the word "estimate" to mean the number of labor-hours it will take to complete the project and the word "schedule" to mean the overall duration of the project. For example, it might require 40 man-hours to write a clinical evaluation over a duration of ten weeks.
If the estimate and schedule are within 25% of the final cost and duration, the manufacturer has done a good job of planning and the CRO has done a good job of execution. But I promise you, there is no way the project will go to completion without a change in specifications.
Who will do the work?
It is key for the device manufacturer to ask, "Who will do the work?" Some large CROs have been known to show the CVs of device-experienced personnel during the negotiation phase, but then have another—device-inexperienced—individual actually do the work. It is understandable that personnel availability may change from the time a proposal is first discussed to the time the contract is finalized, but it is wrong to assign new individuals who don't have the necessary expertise.
During project negotiations be sure to ask the CRO if they have the expertise to do the work. And then don't hesitate to object later if the assigned individual isn't as skilled, thorough, or knowledgable as you need them to be. From time-to-time every company makes personnel adjustments and it should not become a big issue.
Poll Question: How did you use a CRO last year, if at all?
How did you use a CRO last year, if at all? Respond to the poll question and help us learn about our industry. Your answers are completely confidential and will be used only for my own research. The average responses will be posted in an upcoming whitepaper. Answer me here. —Nancy
Independent experts: one-person firms
Many of the finest medical device consultancies are independent, one-person firms. They have chosen an entrepreneurial lifestyle, preferring the independence of self-employment to the security of a routine paycheck. It is reasonable to ask what experience they have in the device industry, why they chose to work for themselves, and if they can commit to the duration of your project.
I've had some interesting bosses over the years. When I decided to become a consultant in 1990, my soon-to-be-ex boss told me that "consultant" was a code word for "I'm unemployed." I took that as a challenge and knew that I would have to work at building a business persona. It was important that manufacturers perceived Clinical Device Group Inc as a company that was here to stay.
When out-sourcing to a new independent expert, look for signs of someone trying to create a business: do they have a business name, business cards, a marketing effort, a website, a brochure, conference booths, speaking engagements, and the like? Look for people who have actually worked in the device industry and understand how devices are conceived, designed, tested, investigated, and commercialized. Independent experts run businesses themselves and will bring a sensitivity to the business needs of your organization.
Many independent experts form relationships with other independents and work together to provide services to clients beyond their own specific expertise. Ask what services they can provide to you directly via employee or sub-contractor, and whom they can refer to you. They can often provide you with a full range of clinical and regulatory services just like any other full-service CRO through their strategic alliances.
If the experts are in a network, who is the project leader on their side? How will communications flow, knowing that the experts may live in different states? Will you have direct access to the project implementers? Think of the management model used in most organizations; the doer in clinical research is free to send an email to the doer in regulatory affairs, but the managers of both functions are copied to keep them in the loop.
Who will bill whom? I follow a general contractor model: my sub-contractors bill CDG, CDG in turn bills the manufacturer.
Do you need (or want) separate non-disclosure agreements (NDAs) from each sub-contractor? Occasionally manufacturers want NDAs from each sub-contractor, but more commonly the primary NDA requires CDG to have NDAs with each sub-contractor so that the requirement for confidentiality flows through.
Contribution to the industry
I have had an independent expert walk away from a contract in the middle of a project in order to take a job. I respect everyone's need for security, but it is dishonest for experts to present themselves as consultants who are here to stay, and then betray that promise.
Businesses who are committed to their industries show it by finding affordable ways to demonstrate that commitment. CROs or consultant may offer public presentations, contribute written articles, participate in standards development, or find other ways to give back to the industry and to mentor younger persons. Looking at the CRO's commitment to the industry is one way to judge their staying power.
Standing and reputation
"Standing" refers to the reputation of the CRO or consultant in the eyes of clients and peers. For older CROs or independents standing may be self-evident; for younger CROs or independents you may want to ask for references.
I have had the unusual situation of a client asking me if I agreed with the opinion of another consultant. I did not, and cited the regulations on which I based my opinion. For the manufacturer it was a question of whom to believe. It is useful if you have confidence in the advice the CRO is giving you.
Project Management for Clinical Studies
Stark NJ,Project Management for Clinical Studies, Clinical Device Group Inc, Chicago, IL (2003).
Probably the most overlooked aspect of device investigations, project management is absolutely essential if a trial is to be implemented on time and with care. The book follows the usual outline of any project: conception, planning, implementation, reporting, and close-out; but focusing on clinical research. It gives sample planning forms, Gantt charts, budgets, methods for cost analysis, reporting metrics, and sample CRO contracts. If you are in management you should insist your staff read this book, it is my personal favorite of all the books I've written.
290 pages, perfect bound, illustrated, ISBN 1-889160-09-1. Table of Contents. $250 USD.
A bidding process is a process where the submits a bid for a job or project. The process requires strict specifications for the project (i.e. the sponsor must know exactly what they want) and works well for "cookie-cutter" investigations. The idea is that bids are obtained from several potential suppliers and the "best" bid is accepted, where "best" is some combination of people, resources, and cost.
It's a personal choice on the part of CROs, but I rarely participate in bidding situations. I have put many hours of original research and considerable proprietary business practice in a bid, only to have the project go to another party and my proprietary information used as a learning tool for the cheaper firm. In one case the sponsor decided not to out-source at all, but to do the clinical trial in-house based on what they learned from the bids they solicited.
If you use a bidding process, it's important to play fair and ethically. Sponsors and manufacturers get reputations among CROs, too; and you don't want to risk being in a situation where no-one of quality will contract with you.
Larger CROs will often travel to the manufacturer's site and make a capabilities presentation. Smaller CROs will often host a capabilities meeting, but the cost of travel is the burden of the manufacturer. Most frequently the meeting takes place by teleconference. No matter how it is arranged, the CRO should be able to make a presentation reviewing their company history, business model, service capabilities, technology capabilities, and resources.
If I travel to a conference I may learn, say, four new things. If it cost me $2000 in travel expenses to attend, then a new piece of information costs me $500. As a CRO, I have an unspoken rule of thumb. I will give away two new pieces of information to a potential client to establish credibility, but no more.
As the manufacturer, you are engaging the CRO in conversation so as to assess their knowledge, confidence, organization, and corporate personality. You should expect to learn a couple of new things during the meeting.
Website, brochure, company information, references
There are many ways for a CRO to present their capabilities with professional, take-home, printed materials. Whether it is a simple file folder, a four-color glossy, or an electronic brochure, you are looking for a material that describes the CRO's organization, presents its vision and mission, describes it scope of services, and tells you who they are.
 21 CFR Part 812.32 Transfer of obligations to a contract research organization.
Nancy J Stark, PhD
President, Clinical Device Group Inc