In vitro diagnostics is a global business. IVD manufacturers are looking not only at the United States but also to growing economies like China and India as their future markets. Bringing a new IVD product from laboratory to market has never been easy; it involves development and implementation of good manufacturing practices and sometimes multiple regulatory submissions. These efforts are often complicated by delays in the development process, high costs, errors in design, and delays in timely submissions.
Hiring a consultant for IVD test planning can be a good investment. This used to be the last option during the development stage a few decades back. But now scenarios have changed---the consultant can contribute to the new product long before the product reaches the final development stage.
Consultants can be beneficial to a company not only for regulatory purposes but also for general issues. By hiring a consultant, a manufacturer can gain access to the consultant’s skills, which the manufacturer may lack. A consultant can help the company in a myriad of general ways.

Accurate feedback and informed decision making
During product development, many factors need to be taken into consideration; therefore, important decisions should be agreed on by a team and not by one person acting alone. Input from multiple disciplines is needed. Acting as a support and utilizing his or her knowledge and expertise, the consultant can help in the decision-making process as products are being developed.
When consultants work closely with the R&D team, valuable feedback can be learned at an early stage. Early input can help to avoid mistakes during development and can have a major impact on overall product cost. In addition, feedback from consultants can serve to assure the development team that it is on the right track.

Filling the communication gap    
Consultants can perform in a communications role during project development. In many cases, scientists in the lab, engineers working on product design or software, and data analysts analyzing clinical-studies data perform their tasks in so-called “silos.” Each area expert may not be aware of the product design or expected product outcome. Consultants can actually connect the dots between different area experts and act as “communication gap” fillers. They can assure project continuity by increasing relevant exchange of data and communication that will ultimately lead to more effective project management and faster time to market. A consultant can also provide access to thoughts and concepts from other industries and sectors that are new to the IVD industry.

Save money and increase flexibility
Hiring an IVD consultant for a smaller company (with fewer than 50 employees) often makes sense until the cost of hiring a consultant exceeds the cost of hiring an employee.
Sometimes companies just don’t have enough work for a full-time employee. Consultants can help to fill the need without requiring the company to provide office space, insurance benefits, and payroll tax compensation. Even if the consultant is hired on an hourly basis, that arrangement will save the company more money than hiring a new employee. A manufacturer can hire a consultant for a specific project, and when the project is finished, the consultant can leave.

Big-picture views
Albert Einstein said, “The significant problems we face cannot be solved at the same level of thinking we were at when we created them.” Companies may have a small-picture perspective based on limited experience and may feel reluctant to make changes for fear of the unknown.
Consultants are constantly speaking with expertise in the field and can determine what is and is not working for their clients. This experience gives those consultants a big-picture view, which includes ideas, plans, and strategies that have worked over a broad range of practices and can be reliably adapted to a client’s practice.
IVD consultants can provide shortcuts that save valuable time, and they can assure their clients that changing their methodology will not cause them to crash but rather to reach potential new heights of business.

Performance across industries
Consultants have the rare pleasure of:
•    Helping multiple clients in the same area
•    Helping multiple clients facing similar problems across different areas
This allows them to recognize common problems with effective solutions by applying lessons learned in previous or concurrent applicable situations.

Goal-setting and strategic planning
One of the biggest benefits of hiring a consultant is to help a company clarify its near-term goals. Many companies have very little idea about their target population. They only focus on being excellent in technology without giving much thought to who should really buy their products. All strategic planning comes down to three basic questions:
1. Where we are now?
2. Where do we want to go?
3. How do we get there?
Most companies are pretty clear on the answer to the first question. They can tell everyone in great detail where they are in their practices, including all the things with which they are frustrated. But they will not have answers for questions 2 and 3. The consultant can support companies in identifying objectives that will help companies to meet their professional goals.

Building confidence
Another benefit of having a consultant is his or her ability to help clients believe that their plans will work. Confidence is of vital importance in keeping momentum, and it is the incentive to keep working the plan. Most confidence is based on experience. A consultant helps clients bridge the confidence gap. A consultant can help clients believe in themselves through encouragement and by relating stories of other companies who have succeeded by using the same tactics that the client is currently employing.

How a consultant helps with regulatory matters
Coordinating projects in the early stages. Most of the scientists, engineers, and various experts are responsible for only a small part of product development. Not everyone on the team knows the expected final IVD product. Because individual experts have their roles at different times in the development process, continuity of design inputs to reach relevant design outputs may not always be the most efficient. Throughout the length of a project, the consultant works closely with each of the relevant team groups and acts as project coordinator to assure that input of various departments is on track with the project goals for the final IVD product.
Turning concept into final product. Development teams are not lacking for new product ideas. However, a concept alone is not sufficient for a product to be successful in the marketplace. Developing the idea into a product involves considerable effort from various team members, including scientists, engineers, and management. Consultants can assist with turning concepts into products by contributing significant expertise. One area in which a consultant can help is in navigating an uncertain regulatory environment. A solid regulatory strategy developed early can help to guide decisions early on, thereby helping to turn concepts into final products.
Making label claims. Every company wants an IVD product that contains unique or improved features over other marketed IVD products. Products containing too many label claims have not done well in the markets. Consultants can help with strategic selection and most effective definition of IVD product label claims.
Navigating regulatory hurdles. It seems as though new FDA regulations and guidelines are published every day. Regulations for laboratory-developed tests and research-use-only products are murky. Manufacturers developing IVD products must prepare for changes in regulation during the development stages. A consultant who works closely with FDA can help interpret current FDA thinking and should be able to help manufacturers maneuver the ever-changing landscape of IVD regulation.
Avoiding unfavorable outcomes. Product submissions can be complicated; some products fail to obtain FDA clearance or approval. This outcome means that time, money, and manpower have been wasted. A consultant well-versed in FDA requirements can help companies avoid unfavorable outcomes.
Performing in-depth analysis of a product. Consultants work with numerous companies and interact often with FDA. It is also their job to stay abreast of changing regulations and new guidelines. Consultants can help by performing in-depth analysis of a device, and can draft an appropriate regulatory strategy in accordance with current regulations. In addition, because the consultant has extensive expertise in drafting submissions, preparation and submission can be much faster than if a company tries to draft the submission without help.
Serving as U.S. agent. Foreign firms interested in marketing regulated products in the United States must identify a U.S. agent who will interact with FDA on behalf of the company. An IVD consultant can act as an official correspondent and U.S. agent for foreign manufacturers.
Obtaining approval for the IVD. Because there are so many pathways to clear an IVD, manufacturers must define an appropriate regulatory strategy before launching a product and evaluate which pathway will be less time-consuming and better suited to their business requirements. Consultants with years of experience can help by gaining an approval for a new product for less cost and time.
Ensuring global regulatory compliance. The global marketplace for IVDs means that products are subject to various regulations around the world. It is difficult for companies to keep track of changes in requirements. Companies can meet these regulations effectively by contracting for help with experts in the various national regulatory requirements.
Protecting goodwill. Recalls of IVD products may be caused by a design defect, contamination, or misbranding. In addition to enduring the tangible costs of a recall, a company may lose its goodwill in the process. A consultant can assist in recalls by helping to design a “recall strategy” and addressing issues in warning letters, thereby protecting a manufacturer’s goodwill.
Providing guidance during crises. In the event that the company receives a warning letter from FDA, it is important to address the findings in a careful and timely manner. An expert should be able to provide advice in handling these “crisis situations” so that negative impact is effectively minimized.
Assisting with new technologies and software. Consultants can help companies meet updated FDA registration and listing requirements, and they can help in drafting electronic submissions using the latest FDA software packages.
Easing the workload and burden. Large companies with many ongoing simultaneous projects can utilize the help of consultants to share the burden with full-time employees. By hiring a specialist in a particular field, a manufacturer’s full-time employees are able to work on other important projects.
Providing a diverse outlook. It is always better to have a third-party opinion during submissions. Consultants can offer new approaches to regulatory problems and are not jaded by historical issues.
Improving quality. It is very important to keep up with the international standards for record-keeping and documentation. Consultants can improve the quality of their clients’ submissions and documents by avoiding common errors and training staff on new regulations and advanced technologies.
Reporting adverse events. Sometimes IVD products require post-marketing studies and adverse-event reporting. If a company does not have prior experience in conducting or submitting clinical-trial or post-marketing data and is not familiar with the adverse-event reporting system of FDA, then a consultant with this skill set can help the manufacturer to fulfill FDA’s requirements.

Conclusion
Regulations and requirements for IVDs are getting more and more complex, which has led to increased costs and time to market. Companies can reduce costs and expedite product launch by strategically hiring consultants to complement the skills of full-time staff. The goal is to build an efficient team that can get the product to market in the most expeditious manner. It is recommended that the “A Team” acquire the help of a few expert consultants in order to meet the goals set forth by management early in the development process.
Sangram Yadav, MS, RAC, mdi Consultants Inc. (Great Neck, NY)