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)
The process of bringing a new IVD product or system to market involves many crucial milestones. During product development, it is important not only to optimize the IVD's design, but also to anticipate the many requirements that must be satisfied to allow successful market introduction. Regardless of where it is in the process, and whether it is attempting to commercialize a novel and innovative first IVD device or manages an extensive product line, an IVD manufacturer may consider outsourcing some of the work to a contract research organization (CRO) or regulatory consultant.
The decision to outsource and selection of the most effective consulting firm or independent contractor can be difficult undertakings. So can vendor management. Some basic information can clarify the consulting process and help managers to ask the right questions and get the most out of consulting services.
When to Work with a Consultant or CRO
As medical and IVD technology continues to advance and product development becomes more complex, outsourcing to a consultant can provide a number of strategic benefits. The need to hire additional in-house staff may be eliminated, for one thing. Also, leveraging an outside expert's knowledge of regulatory requirements enables significant reductions in cost and time to market to be realized. In fact, consultant expertise may prove valuable throughout the development process.
Early in Product Development. Early in the development of an IVD instrument, reagent, or assay, the regulatory landscape may be murky. Often, no clear FDA premarket review pathway can be identified, particularly for a new diagnostic marker. The explosive growth of molecular diagnostics and personalized medicine, moreover, means that regulatory questions and concerns are evolving rapidly. FDA requirements advance along with technology and healthcare delivery capabilities; the agency's OIVD is continually assessing and redefining regulatory requirements for bringing new IVD products to market. A knowledgeable consultant can advise the manufacturer about this changing landscape and serve as a guide through it.
In certain cases, where the technology of interest is novel and no applicable guidance document exists, companies can benefit from early interaction and discussions with FDA, both formal and informal. Pre–investigational device exemption (IDE) meetings and other unofficial exchanges with the agency can serve to acquire feedback, opinions, and guidance. An experienced consultant knowledgeable in IVD matters can provide insights into the agency's current thinking based on experience with prior submissions or discussions with FDA about similar products.
Even before the manufacturer approaches FDA, that experienced consultant can help it determine how its new product may be classified, based on the desired claims and intended use or uses. A regulatory strategy may include commercialization of the IVD through a CLIA laboratory pathway or through traditional 510(k), de novo 510(k), or premarket approval (PMA) routes. In any case, a consultant can help define and confirm project requirements and outline a realistic budget and timeline for gaining FDA clearance or approval. The consultant can also provide an independent assessment of the company's overall business plan assumptions.
With this type of well-defined regulatory strategy in place, the manufacturer is well positioned to approach FDA with a recommended path and clear questions for discussion. The consultant can act as liaison during formal and informal FDA negotiations and pre-IDE discussions, and can maximize the value of the FDA interaction by presenting the client's case in concert with precedent data.
Throughout the Design Process. As product development progresses, the consultant can provide guidance on risk assessment, establishment of design controls, and maintenance of the design history file, all of which become the foundation for future regulatory submissions. He or she can provide valuable support and assistance to ensure compliance with FDA's quality system regulation (QSR). Most important, the consultant can supply an independent opinion regarding the link between customer input and the specification-setting process.
For the Clinical Trial. If clinical data are needed to support an IVD regulatory submission, lend authority to a scientific publication, or drive physician adoption, the manufacturer may choose to outsource some or all of the design and conduct of the clinical study to a contract research organization (CRO). A CRO experienced in IVD studies can help throughout the process. Early in the study design, a CRO can assist in formulating clinical study end points, determining the appropriate number of patients or patient samples, selecting study sites, and determining likely study duration. A CRO can also help define the clinical trial strategy that will be most appropriate and effective for a particular target market. European requirements for clinical data may differ significantly from FDA requirements, for instance. Efficiencies can be realized by seeking guidance from a consultant well versed in the requirements of various countries.
In Preparation for a 510(k) or PMA Submission. Even if a product's regulatory landscape is clearly defined and the type of submission or documentation required to gain marketing clearance or approval in the United States, Europe, or another part of the world is known, outsourcing the development, preparation, and submission of regulatory documents to a consultant or contractor may still be wise. This is especially so if the internal regulatory affairs staff is small or has limited experience in writing regulatory submissions.
A seasoned consultant can work with the in-house team to review, prepare, and submit a reviewer-friendly document designed to address regulatory agency concerns effectively and minimize additional questions. He or she can draw upon the experience of writing and submitting possibly hundreds of successful submissions and documents for U.S. and international agencies. Also likely to have experience dealing with agency reviewers, such a consultant should know how to present the product and product data so as to expedite the submission.
During Times of High Workload. Larger or more-established IVD manufacturers, even those with internal regulatory and clinical trial staff, may still need to turn to an outside consulting group, especially during times of peak workload or during integration of a new and unfamiliar technology or product line. An independent consultant can be brought up to speed quickly, enabling projects to be offloaded from staff members so that they can focus on other critical activities.
In a Time of Crisis. A consultant can be a valuable resource following regulatory inspection or receipt of an FDA warning letter. As an outside observer, he or she can provide objective, unbiased, and impartial advice and guidance, helping the client address any manufacturing- and quality assurance–related (QSR and GMP) issues.
Selecting the Right Consultant or CRO
It can be difficult to decide which consultant best meets the company's needs or the requirements of its specific situation. Choices range from independent consultants to large multinational firms.
Ultimately, the client-consultant relationship is built on trust, with successful bonds often forged over time. The best consultants, whether individuals or consulting teams, are expert at building a client-focused culture of collaboration. IVD manufacturers should give careful thought to the purpose and nature of the relationship, and be clear about expectations. They should consider half a dozen key things when interviewing potential consultants.
IVD Experience. Whether a firm or an individual is under consideration, the manufacturer will want to work with someone possessing significant knowledge and skill concerning IVD products, something that can be gained only over time. IVD devices and systems continue to increase in complexity, particularly in the point-of-care space. Thus, the integration of multiple system components grows more important. For example, a diagnostic system can comprise a range of readers, cassettes, and chemistries that often are developed or provided by several development partners or vendors. A skilled IVD expert will be able to help the manufacturer design, implement, and manage a regulatory program that will ensure that the final integrated product meets requirements.
Expertise and Track Record. The consultant should understand the intricacies and complexities of the manufacturer's technology. This is especially critical for groundbreaking molecular diagnostic, genomic, and personalized medicine applications. IVD industry veterans are desirable. A consulting firm with which the manufacturer has had a positive prior experience is likely to offer a consultant who will be a good fit. In the case of an unknown firm, turnover and employee retention rates are indicative of the health of the organization.
And it is important to remember that each consultant is a service provider requiring documentation under the QSR.
Depth of Service. While an independent consultant or a single person from a large firm may be suitable for certain short-term engagements, finding an individual who can adequately support a complex project—one involving a combination of quality systems, regulatory strategy, and possible clinical trial development—throughout the entire process may be difficult. A team approach may be the best consulting solution for longer, more complex engagements.
Responsiveness and Accessibility. A consulting partner simply has to be responsive. How quickly the prospective vendor answers phone calls and e-mails during the selection and interview process is a good indicator. It is important that the individual or firm have a communication and technology infrastructure—e-mail, Internet, document transfer, Smartphone, administrative staff, and so on—sufficient to meet the needs of the client's business.
Personal Relationship. A successful consulting relationship is established over time, built and reinforced through mutual understanding and trust. Calling on a consultant for business advice, guidance, and support is as much a matter of personal as of professional trust. The best consultant or contractor will do more than just complete assigned tasks; he or she will understand the client company and its business needs and will work to contribute significantly to its success.
Industry Reputation. Whether the consultant or firm is well respected in the industry and by relevant regulatory authorities and whether he or she can demonstrate a record of accomplishment with similar or comparable device approvals and clearances are important matters for consideration. The IVD manufacturer should search the online FDA database of cleared and approved devices, which often will provide insight into a consultant's involvement with other submissions.
Perhaps the candidate consultant actively participates in industry and professional organizations or speaks and publishes on relevant topics. The manufacturer might ask for references and a summary of achievements if this sort of background would influence the decision.
Managing the Project
Once the consultant has joined the project, everyone involved should be on the same page. Too many consulting engagements begin without a developed project plan or statement of work, which is a disservice to both client and contractor. The project plan should comprise a work breakdown, deliverables list, schedule with milestones, outline of team members' roles and responsibilities, and list of employees eligible to assign work to the consultant, along with a communication plan. It may also include specific terms and conditions, pricing, and the identification of any key project assumptions or challenges. The plan may be as simple as an e-mail, or it may be part of a larger, more formal proposal document. Regardless of its size or formality, it will serve as the foundation for the project and will support the client's and consultant's mutual understanding of the work required and how it will be performed.
A clear project plan, with measurable objectives and milestones, is an essential first step toward a successful project, and the consultant can help develop it. Implementation of the plan should proceed smoothly if the client and consultant have clearly defined the enterprise at the beginning. The project manager can be someone chosen from company staff, or the responsibility may be offloaded to the consultant. Whoever is chosen, it is imperative that the responsibilities and expected outcomes associated with this role be defined in the project plan.
The project manager ensures that communication is regular and consistent, that the project sticks to the agreed-upon schedule, that financial budgets are accurate and costs on target, and that issues or concerns are addressed and resolved. Effective communication is part and parcel of good project management; communication channels should remain open throughout the project. The consultant will rely on company management to keep the project team informed about any business or financial changes that may affect the project plan. At the same time, management should expect the consultant to provide periodic updates and status reports, and to clearly communicate both alterations in the program, such as changes in personnel, budgets, timelines, or resources, and any new regulatory requirements or concerns that may affect its ultimate success.
Different stakeholders will have different measures of project success. A CEO's desired outcome may be 510(k) clearance. The director of quality and compliance may be thrilled with clearly written QSR documents and procedures. The vice president of marketing would like to see broad claims and a speedy regulatory approval, enabling the company to get to market before the competition. The chief financial officer will call the project a success if it finishes under budget or within forecast margins.
Regardless of how success is defined, when the project is completed, company managers should review the performance of the consultant and the project team and appraise the interactions between them. They should find that:
• The means and frequency of communication were sufficient to keep everyone up-to-date on project status.
• The key deliverables defined at the outset of the project were delivered on time, and the quality and content of documents are appropriate.
• The consultant either confirmed the assumptions made at the beginning of the project or provided meaningful new input that enabled management to change the project's course with confidence.
• Product submissions were accepted for review, and their content was complete and well organized.
• Regulatory reviews, clearances, and approvals occurred within typical time frames.
• The consultant was viewed as a resource who added value to the process.
• The company gained useful experience and know-how as a result of engaging an industry expert.
The increasing complexity of IVD product development affords many opportunities for turning to an outside expert for help. Once the decision to do so has been made, assessing the quality, credibility, knowledge, and skill of consultants or contractors who might help becomes important. A well-run development project requires effective communication and efficient, hands-on management. It is also important that company leaders take time after the project concludes to identify the problems encountered and note the elements that worked well. Then, the next project will run like a well-oiled machine.
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