Much like many other business and research-related terms, “contract assay development” can involve any number of interconnected, complex activities. At its core, though, it can be defined simply: contract assay development is the outsourcing of assay development.
In practice, an organization that needs one or more assays developed for their platform may contract with another organization to do the necessary research and development, select the materials, and fine tune processes to make those assays a reality.
Why Outsource Assay Development?
There are several reasons why a company may choose to outsource assay development. The most obvious one is that the company lacks the internal resources to do it in-house. Companies that are just getting started often choose this route. Established companies do, too, but often for different reasons. For instance, instrument companies that decide to expand their product lines to include reagents may elect to explore this option.
But even companies who have their own experienced internal assay development capabilities may choose to have some of their assays developed by an outside contractor. Sometimes the contractor will have experience with an assay that has proven difficult to develop internally. At other times, companies will be in the midst of a launch of a new platform that demands the focus of all internal resources, but an existing platform may need one or more new assays to keep that platform competitive until the new platform is ready for the market. Another reason may be that R&D funding is constrained, and the contractor may be willing to self-fund the development projects in exchange for enhanced future product royalties. (Note that this option only works for well established companies with thousands of platforms already in the market.) Outsourcing allows established companies to expand their assay development capabilities without taking on new staff and adding overhead. In some highly regulated labor markets, this is an important advantage.
Benefits of Contract Assay Development
Outsourcing may provide a company with numerous benefits. One benefit is that the contracting organization could have its experience base expanded. There are many ways to develop an assay, and no single approach is optimal in every situation. Internal developers tend to wear down each other’s rough edges and converge on consensus opinions in regards to assay development. Time and budget considerations tend to reinforce these opinions in to standard practices; eventually, they become the norm and difficult to change. Outside contractors will have done the same thing. However, contract assay developers may have a broader range of inputs to inform their practices; at times, these practices may be more effective or efficient than a contracting organization’s “baked in” practices.
Outsourcing also provides an opportunity to benchmark internal assay development. Every organization believes that they have formulated the best practices for assay development. Without the ability to compare those practices to those of another experienced organization, however, that belief is just an opinion. It’s somewhat like learning a new language: the use of our native language seems intuitively obvious. We don’t often stop to consciously evaluate the mechanics of our language—we simply speak it like we’ve always done. However, when we begin learning a new language, we’re forced to confront its structure and usage. Oftentimes, it’s helpful to compare the new language to our own to explore the similarities and differences. By learning a new language, we begin to evaluate the mechanics of our own language more critically. Working with an outside assay developer is a lot like that: it allows an organization to see its own processes in a more comparative and critical light.
No organization has a monopoly on creativity. Outsourcing allows the contracting organization to tap into the minds of experienced professionals with different histories and perspectives. This can lead to new inventions that, due to the nature of contract relationships, may well belong to the contracting organization. (Of course, ownership of inventions should be spelled out in detail in the contract before any development is done.) The client may also be free to use that innovation in other assays in their portfolio. A novel way of providing liquid, ready-to-use standards for one assay may be applicable to an entirely different assay that was not even part of the contracted work.
Outsourcing may also provide an improved time to market. Immunoassays have multiple components and processes that must be functional to make the product meet its design specifications. Even with the best planning, development, and manufacturing processes in place, existing assays will need occasional tweaking. Some organizations have enough assays in the market that a dedicated technical support organization can do the necessary adjustments. In smaller organizations, there is a great temptation to stop work on a new product to shore up an existing one. Outsourcing tends keep the focus on the new product.
Dispelling the Myths
Despite the benefits of using an assay development contractor, some potential users still perceive risk. Oftentimes, organizations opt to invest capital into their own internal R&D—they seem to perceive this larger budgetary outlay as “safer.” The reality, however, is that investing in contract development is investing in your own internal R&D. The interaction with a competent and experienced contract organization naturally expands the tool set of the internal R&D group. It allows objective, data-driven benchmarking. Many organizations who outsource even report that they come to view their contact assay development partners as an essential part of their own internal organization.
Fear of competition with internal R&D also makes some organizations leery of outsourcing. The fact is, external R&D can never totally replace internal expertise. It will always be a supplement. While resources will be needed to fund and oversee the outsourced process, there is never a guarantee that the funding that enabled the contractor to be hired in the first place is always going to be available. If all the development money is funneled into internal development, and that funding contracts, it may mean reductions in local staff. That contraction breeds resentment and distrust in the local labor pool on which the company depends. It may be better to have a business-to-business arrangement with an outside partner to smooth over some of the ebbs and flows of development funding.
Another myth: outsourcing will expose the company’s R&D secrets to the outside world. Contract organizations live or die on their ability to keep confidential information safe. Trying to gain short-term advantage by misusing a client’s proprietary information is commercial suicide. Moreover, the scientists in every organization are working with just about the same materials and knowledge base. What appears to be a great secret is often common knowledge in the industry, and it looks like a great secret only because no one feels safe talking about it.
Finally, there is the argument that outsourcing is just too expensive. Competent development talent does not come cheap whether it is internal or external. One of the ways of looking at the economics of outsourcing is to consider not only the cost and overhead of doing the development work, but to look at the cost of delaying the work until internal R&D resources can do it. It does not take too many quarters of missed sales of a product that was delivered later to more than make up for the outlay in outsourcing. In addition, there are significant market advantages to being in the market sooner than later.
Conclusion
There are many benefits to be had from contracting with a competent outside assay developer. As we’ve seen, many of the myths and concerns about hiring a contract assay developer just aren’t true.
In Part Two of this series, we will examine some of the criteria to consider when choosing a contracting partner, as well as some of the challenges inherent in working with an outsourced project.
DCN Dx is an international leader in the contract development and commercialization of rapid diagnostic tests at its ISO 9001:2015 and EN 13485:2016 certified facility in Carlsbad, Calif. The company’s team of in-house scientists and engineers develop and integrate all aspects of assay systems, including cassettes, sample handling devices, and reader systems. Since its founding more than 12 years ago, DCN Dx has been committed to furthering the rapid diagnostic test market through the continued evolution of technologies and applications related to lateral flow assays.
Contact us about your assay development project today.
