Essential Tips for a Successful Launch of Your IVD Instrument

A PRACTICAL GUIDE TO SUCCESSFUL IVD INSTRUMENT LAUNCH RAMP-UP WITH YOUR OEM PARTNER 2 Five key ingredients for a successful IVD instrument launch include: retaining technical expertise, investing in training, forecasting accurately, ensuring regional focus, and managing the lifecycle of your platform. With this in mind, how can you best use the support of your OEM partner to simplify the launch process, accelerate revenue ramp-up, and position your platform for long-term profitable growth? This handy guide will help you to minimize risk and optimize revenue ramp-up with your chosen OEM partner as you go through the instrument launch process. 1. TECHNICAL EXPERTISE AFTER LAUNCH: WORKING WITH YOUR OEM PARTNER. You are ready to launch your IVD instrument platform, having worked for months, or even years with your OEM partner to reach this significant milestone. You’ve ticked all the boxes, from market research to exhaustively testing the trickiest of your customer applications. What could possibly go wrong? However good our record-keeping might be, technical expertise acquired during development very often includes information and knowledge that is not necessarily written down immediately in a way that is accessible to all parties who might require it, and in some cases might not be written at all. The first rule here is therefore to ensure that you retain the technical expertise at the core of your own development team post-launch, otherwise the knowledge gained through development and betatesting risks getting lost within months, ultimately resulting in a failed ramp-up post-launch. The experts needed here will also include key contacts with your OEM development partner as well as your early adopter customers. With time, observations regarding both the instruments and their applications will multiply, be consolidated into standard operating procedures (SOPs) and used to develop useful databases of FAQs. The precious triad that consists of your development team, your OEM partner, together with your first customers will ensure that these SOPs and FAQs are properly recorded and continue to be developed, minimizing the risks both at and after launch. The shortest recommended time for this team to stay together is around six months after launch. Provided that regular post-launch reviews are held, and instrument performance, consumables and application records are carefully monitored and stored, this will result in the growth of a valuable knowledge resource for your broader team. Securing access to your OEM partner and customer expertise during ramp-up implies that you have welldefined agreements in place, with clear specifications, so as to manage expectations. Even at this late stage, projects can fail due to the premature introduction of unrealistic or poorly-tested specifications for a particular instrument or application. Keeping your OEM partner and customers on board will therefore help significantly in reducing the risk of failure. Note that, whilst it would be useful for you to have separate people covering each specific expertise area in your own core team, several areas may be covered by a single OEM person or customer (see Table 1). When it comes to accessing people and expertise outside of your organiztion, it is critical that all parties have defined agreements indicating the extent of their respective deliverables. SOPs associated with instrument specifications, expertise and training will also figure in your Quality Management System (QMS) as part of the requirements for ISO certification and regulatory compliance. 3 Table 1: Outline checklist for retaining technical expertise. Expertise/team You OEM partner Customer Instrument hardware modules Instrument software modules Consumables development Overall platform development Application development Instrument SOPs Consumables / Application SOPs Service - basic and advanced Instrument service training Compliance - regional requirements Marketing materials Sales training Application training Table 2: Suggested areas in which to consider putting a training programme in place. Training area Basic Intermediate Advanced Instrument hardware Instrument software Applications / consumables Servicing Sales and marketing Regulatory compliance Quality Management System* *A Quality Management System is required for ISO certification, and will reference the trainings in all of the other areas. 2. INVEST IN TRAINING YOUR EMPLOYEES AND YOUR CUSTOMERS, WITH THE HELP OF YOUR OEM PARTNER. The more people and functions that receive basic product information and training, the more successful will be the post-launch ramp-up for your IVD system. Engagement in your organization can be increased by ensuring all functions have a very basic knowledge of what your new IVD system is supposed to do, with a simple explanation of what impact it will have in the diagnostic world, and higher levels of training can be reserved for specific functions. Use the expertise of your OEM partner to help put in place standardized and assessed product and application training for all functions, tailored to the right level. Recognise people’s training achievements as well, with rewards such as a certificate. One model could be to classify training levels as Basic, Intermediate and Advanced, for the different areas of instrumentation, applications and service. You may also find it useful to add the notion of Refresher training into this model, to maintain a specific level of expertise over time, as well as to keep up with the evolution of the platform and its applications. With larger teams, of say 10 or more people, we would recommend adopting a “train the trainer” approach, with allocated “Champions” within those teams. Making a similar programme of formal training available to your customers will also significantly reduce the risks associated with user error, and should be an essential part of the installation and ongoing process. You can work with your OEM partner to provide a comprehensive training programme within your organization and for your customer. 4 You might also like to consider which functions need to receive which level of training. A suggested matrix is shown in Table 3. Table 3: Suggested levels of training for different functions in your organization. Adapt this according to your specific needs. For example, you may only have capacity for only two levels of training. Function Hardware Software Applications Service Sales and marketing Regulatory OMS Service engineer Advanced Advanced Intermediate Advanced Basic Intermediate Intermediate Applications scientist Advanced Advanced Advanced Basic Intermediate Intermediate Intermediate Sales person Basic Basic Intermediate Basic Advanced Basic Basic Customer care Basic Product marketing manager Intermediate Intermediate Advanced Basic Advanced Advanced Advanced Back-office functions Basic Training is absolutely crucial to a successful rampup post-launch. When employees receive proper training, they are more likely to provide better customer service and information, so customers are more likely to make informed choices in your favour, ultimately leading to increased revenue. 3. IS YOUR FORECAST BRIGHT? FIND OUT TOGETHER WITH YOUR OEM PARTNER. Working with an OEM partner who understands the IVD instrument market can help you compare and calculate realistic forecasts according to market needs in particular application areas. Consider also that forecasting is more than just predicting when and how many of which instruments and kits may be needed in each geographic. It can depend on many different trends, including local economies, whether or not a particular type of IVD test is reimbursed by a particular government, or even the weather. Or a catastrophic global or regional event may occur, that can have either an almost immediate adverse or a positive effect on sales. The recent pandemic is one such example, where the need for COVID-19 research and tests quickly surpassed demand before the supply chain eventually caught up. Inaccurate forecasting can hit your inventory costs extremely hard, in turn affecting your cash flow and profit margins. This risk can arise with either underor oversupply. For example, an undersupply of the consumables kits which go with your new instrument platform will erode customer confidence, reducing ramp-up profits, and in the worst case may even result in competitors taking over what was to be your main market. On the other hand, an over-optimistic forecast for your instrument platform will increase your inventory costs dramatically, so be very wary of overpromising on numbers to your investors. Anticipating changes in demand is also key to getting the right raw materials at the best price. If you underestimate the need for a particular component of a kit, for example, you may end up paying more for it than if you had pre-ordered it. In turn, this may affect the production line, which may need to increase capacity temporarily, in turn increasing your manufacturing costs. Accurate forecasting would anticipate the likely demand for a given product so that you can obtain the appropriate quantity of raw materials at the most cost-effective price. You can also reduce the risk associated with forecasting and raw material supply for consumables and kits by planning for these to be manufactured in part or as a whole by your OEM partner. Next, your OEM partner will be able to provide you with an idea of the instrument spare part inventory that may be needed by the service team during the ramp-up phase, since they will have done due diligence on instrument robustness during development. This can drastically reduce downtime for customers, which is especially important when you are at that vulnerable stage between nurturing reference labs and establishing an installed base. 5 Table 4: Minimize servicing and supply chain risks by working with your OEM partner towards robust forecasting. Expertise key: +++ high contribution, ++ moderate contribution, + little or indirect contribution. Forecasting expertise You OEM partner Customer Instrument module forecast ++ +++ + Overall instrument forecast +++ +++ + Spare part inventory ++ +++ + Application-specific consumables forecast +++ ++ ++ Finally, the accuracy of IVD instrument forecasting can be greatly increased by using a modular approach to instrument development, since by definition there will be fewer variables to take into account. In effect, each module will arrive with its own legacy robustness data, allowing you to focus on your application, rather than on developing and assembling new parts for an instrument. In short, poor forecasting could destroy your business, so mitigate this risk by working closely with your OEM partner on getting the most accurate forecast possible (Table 4). 4. USE YOUR OEM PARTNER’S REGULATORY KNOWLEDGE FOR GEOGRAPHICAL FOCUS Regulatory and registration requirements differ vastly across the globe when it comes to IVD testing and instruments, and each instrument will need to be registered in a specific regulatory area before it can be sold. Therefore, we recommend planning a geographically-focused market entry strategy as early as possible, and as part of your launch plan. This will help avoid unnecessary delays due to late delivery of the required technical documentation during the registration process. Working with an experienced OEM partner will help here, since they are likely to have a pretty good knowledge of the regulatory requirements in the different countries and regions where you intend to launch and implement your roll-out plan. Europe and the US have different regulatory processes, and within Europe there are also countryspecific differences. All other regions and countries have their own requirements, with some examples shown in Figure 1. Even the definition of a medical device varies between countries and regions, so it is recommended to create a regulatory plan for each area where you plan to launch, and given the complexities, to have a phased roll-out plan. Start in HC FDA CFDA PMDA TGA CDSCO EMA Swissmedic ANVISA Figure 1: Minimize geographically-specific regulatory risks by working with an OEM partner that has global and regional IVD regulatory expertise. (Source image: https://www.amwa.org/ page/regulatory123) a region where you are sure of having a combination of established reference customer expertise, readily available sales and technical support, OEM partner coverage, and a robust supply chain for both instrument and consumables. 5. USE TRIED AND TRUSTED PROCESSES FROM YOUR OEM PARTNER TO MANAGE LIFECYCLE EFFECTIVELY Instrument lifecycle can be simply expressed as several broad phases: development, introduction, growth, maintenance, and end of life (see Figure 2). To help you plan how you will support your platform after launch, through ramp-up and beyond, we have developed a practical guide to product lifecycle management (LCM), which you can download here. We recommend taking a long-term, holistic view of LCM, working closely with your OEM partner, so that you can manage every stage of the lifecycle, from having a thorough understanding of the current and future costs of product manufacturing and customer ownership, through to introducing new instrument and assay updates without disruptions in regulatory compliance. 6 When it comes to ensuring ramp-up of your revenue during the growth phase, post immediate launch, especially with IVD instruments, it is essential that your product continues to meet with quality compliance specifications, and that your customers are still happy with service and support levels. It is also important that you use an established LCM process to future-proof your platform, with plans to implement product improvements and evolve according to market trends and needs, whether working towards a better price point or towards a new diagnostic assay. Planned LCM helps ensure that instrument updates or changes maintain all compliance and safety standards, so that your customers remain confident in your products. Finally, a strong product management team is critical to effective product lifecycle management, collaborating across the organization and with your OEM partner, liaising with internal functions such as R&D, Quality, Operations, and indeed the customer, to help grow the instrument knowledge base and streamline the lifecycle management process. If you would like to see how the OEM partnership process works in practice, you can read about some of the OEM platforms Tecan has helped develop and check out some of our customer stories here. SUMMARY: OEM PARTNERSHIP FOR SUCCESSFUL IVD INSTRUMENT LAUNCH RAMP-UP. Whatever your requirements for an OEM partner, Tecan can work with you to provide the application knowledge and engineering expertise you need. Tecan experts bring over 40 years of experience in laboratory automation and OEM instrument development, manufacturing, and delivery. Synergence is Tecan’s unique approach to the development of OEM automated solutions for diagnostics and life sciences. Starting with your exact requirements, the service guides you seamlessly through your project, from product design to manufacturing, launch and post-launch activities. 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