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By Claudio Bui
With complex products like laboratory instruments used to automate genomic testing, time to market is often a critical factor in determining whether or not to go ahead with product development. The obvious problem is that as projects become more complex and involve more teams with mixed competencies, calculating the time to market becomes more challenging. Based on my experience, here are some of the top reasons why companies significantly underestimate their time to market projections. If you can avoid these common pitfalls when launching new lab instruments and genomic tools, then the risk of your project being delayed is significantly reduced.
Get genomic instruments to market faster by understanding the most common causes of product launch delays in this market.
1. Lack of core competence
While companies thinking of producing automated genomic testing equipment almost certainly have deep knowledge in their core subject areas, such as in vitro diagnostics or next generation sequencing, complementary skills or experience in aspects of instrumentation automation may be lacking. This gap is particularly insidious and risky. It creates a complete blind spot, which means that critical aspects of the development process and product lifecycle may never be included in the strategy.
2. Extended and repeated planning phases
Lack of expertise in developing lab instruments often results in increased uncertainty, leading to hours of meetings and ultimately making it extremely difficult, if not impossible, to make confident decisions. If during the discussion phase you realize that some expertise is missing, it is often worth closing that discussion until you have a chance to find and consult with relevant experts in the field for the testing equipment and related process automation. Although this takes time, it will lead to better outcomes and allow your teams to continue work in their field of expertise on other aspects of the project.
3. Prototyping challenges
Prototyping is an essential phase in any design project. The ability to prototype quickly and iteratively to improve ideas is an excellent approach to develop solutions quickly. To prototype quickly, you need to have the right tools and components at your fingertips, which can be a challenge in the competitive and fast-paced genomics environment. At this stage of development, the right partner can really help move things along. If your company has expertise in genomic testing, look for a partner who complements you—not only with automation experience, but also with a good understanding of the life science industry as well as the needs of your clients.
4. Regulatory hurdles
Regulatory compliance requires special attention, particularly if the equipment is marketed in regions with differing legislation, or if it needs to fulfill the requirements of an in vitro diagnostic (IVD), medical device, or lab developed test (LDT). Unfortunately, regulatory hurdles can be difficult to identify until the end of a project, when it becomes extremely costly to make any potential changes. The key to avoiding costly issues is to be clear about the use of your instrument from the very beginning and consult with regulatory experts. If you realize that you need to partner with someone to develop your instrument, be sure to ask about their regulatory expertise and relevant experience.
5. Starting from scratch
Adapting genomic testing and diagnostic assays in-house often means starting instrument development from scratch. This is inevitably going to take a long time and will increase your time to market. Where possible, consider whether pre-built solutions or components can help get your project moving more quickly. These might be specific elements of an instrument, such as liquid handling, that are already available and can be quickly integrated into designs and prototypes. An example is Tecan’s Cavro® Magni Flex, which is a flexible, off-the-shelf, liquid handling development platform for incorporation into OEM instruments. Using a readymade solution means that you don’t have to reinvent the wheel, but you can combine pre-developed solutions in a unique way.
6. Time divided between projects
Time allocation is another common cause of delay. When companies use internal teams to develop new instruments, it is rare that all team members are dedicated full time to the particular project. This can lead to conflicts and delays that are exacerbated by some of the other points mentioned here, such as lack of experience and core competence. It is important to identify where time commitments could become an issue, and where bottlenecks may occur, so that you can make contingency plans. Once you’ve identified these potential issues, it could be very useful to contact a potential partner and find out how they would be able to deliver. Even if you don’t use them at the beginning, it can be very reassuring to have a plan B that could ultimately rescue your project.
7. Unforeseen development needs
It is easy to overlook critical aspects of lab instrument development when conducting a project in-house. For example, software is often included as an afterthought, meaning that not only is it not fully tested, but it late introduction also increases time to market. A trusted partner will be able to provide streamlined solutions such as the MAPlinx Development software. This gives higher level robotic functions while making programming for the customer easier with a worktable editor wizard and a 3D simulator. This means less time needs to be devoted to the intricacies of software development and more time can be spent creating the best user experience.
8. Under estimating NPI
NPI or new product introduction is the process of taking a product from concept to a reproducible finished product that is ready for manufacture. The processes for mass production of instruments are vastly different from producing a few prototypes; many factors have to be taken into consideration before a prototype is ready for mass production. Unfortunately, this critical step to actually getting a physical product to market is often overlooked meaning that there is no time allocated in the project plan, leading to a delayed time-to-market. Working with an experienced partner can help mitigate this as they will have the experience needed to take care of NPI efficiently.
9. Shortcuts in validation and testing
We sometimes see that when companies are developing instruments in-house and become confronted with delays, the development phase that suffers the most often includes critical verification and validation activities. This can lead to some very costly errors and potentially irreparable reputation damage, as products are rushed to market without being thoroughly tested. Particularly in the case of genomic testing equipment, the consequences could be serious. It is almost never worth skimping on these vital performance and quality tests, even if it means your instrument could get to market sooner. With a trusted OEM partner, not only are they in a better position to quickly validate instruments using tried and tested validation procedures, but all of their components have been pre-validated. Take the soon to be released Cavro Magni Flex with Air Restriction Pipettor technology, which has been built, tested and proven to provide exceptional results for genomic testing applications. To develop and validate a solution like this, from scratch, would take months if not years of development time. By working with a partner, much of the hard work has already been done for you, before you even start.
10. Integration challenges
A rather surprising source of delays is integration, particularly compatibility challenges between existing tests and instruments and new solutions in development. A lot can be overlooked when it comes to integration, especially if you have developed everything yourself. However, even a minor hiccup at this stage can throw your project timeline off significantly, leading to your product arriving to market later than planned. A trusted partner who understands your technology can anticipate integration challenges, increasing your chances of delivering a fully functional product on time and on-target.
Tecan’s off-the-shelf solutions
Tecan is a trusted partner for many manufacturers needing an OEM solution. Our range of off-the-shelf development platforms will soon be expanded with Air Restriction Pipettor technology in the latest Cavro® Magni Flex — an ideal feature for genomic testing instruments. Still trying to figure out if you should develop your instrument in-house or engage with a partner? Talk to one of our experts about your needs.