By David Keller
As a healthcare instrument moves through its lifecycle, its engineering, development and customer support need to progress in parallel. In order to extend a product’s profitability for as long as possible and to maintain customer loyalty, you must plan for its evolution from the beginning. Involving an OEM partner in your product lifecycle management (LCM) from the start can help you to create products that are easier to service with a lower total cost of ownership (TCO), with fewer long-term risks.Involving an OEM partner in your product lifecycle management (LCM) from the start can help you create diagnostic products that are easier to service at a lower cost and with fewer long-term risks
Besides planning for market growth, product evolution and cost control, involving an OEM partner in your LCM planning at an early stage helps you to manage regulatory compliance more effectively. This is especially important with the sweeping changes underway in Europe, where the new regulatory framework for in vitro diagnostic medical devices – in vitro diagnostic regulation – has resulted in a lot of additional work for manufacturers. Similarly in the US, the FDA is taking action to improve the quality, safety and effectiveness of medical devices under its Quality Management System Regulation, aiming to harmonize US and global device regulations. In a changing regulatory landscape, involving OEM partners early in the development process is essential to ensure products maintain compliance throughout their lifecycle.
Product LCM stages
By planning for the entire lifecycle of a product – from conceptualization through to the design, production, distribution and service phases – you’ll be on your way to a lower TCO and greater customer loyalty. Consider the planning required during each of these periods in a product’s lifecycle.
Pre-launch
The development of any new product begins with an idea. This phase of innovation is usually followed by analysis of market potential and how the product could meet market needs. The next step is design and development, in which the initial conceptualization is developed into prototypes. This entails many activities – such as identifying requirements, creating concepts, and testing or validation – before manufacturing begins. There are many complexities to consider at this stage – from product development and regulatory compliance to human resource and supply chains – and an OEM partner can help with this, delivering value by working together to address these challenges.
Launch
The product is then manufactured and launched to the market. Accurate forecasting and budgeting are required at this stage, as is the ability to scale up manufacturing in response to demand.
On market
At this point, the product is in the hands of the end user. Collecting data about possible failures, maintenance rates and user experience, and working together with your OEM partner will enable you to rapidly address any issues and plan for future developments.
Phase out
As the product reaches maturity, plans for retiring, recycling or disposing of it come into play. End of life (EOL) starts when users no longer have a need for the product, or a new technology has been released that makes it less desirable. At this stage, your OEM partner can help you to transition to a successor product, which may incorporate components that continue to meet end-user needs or reflect adjustments based on market feedback.
What to look for in an LCM partner
How can you find the right OEM partner to help you develop a product LCM plan? It’s important to spell out the key aspects of your LCM that need to be considered when engaging with a partner for your healthcare instrument. Consider each of these factors.
A holistic approach to LCM
It’s important to find a partner who considers the entire product lifecycle, not just a single component or step in the process. You want a product development partner that helps you keep the product supported during its growth period, as well as implementing a phase-out approach as the product nears the end of its lifecycle.
Regulatory compliance knowledge
The right partner has regulatory expertise and keeps you updated on any changes in laws or regulations that might affect your product’s compliance. Even more, a trusted partner proactively presents plans for how to rapidly adapt to changes with the least impact on your bottom line.
Safety compliance
It’s important that your partner provides components and protocols that you can rely on to provide results that are safe, dependable, consistent and reproducible. You don't want to have concerns that supplier components or documentation will risk your product’s safety and compliance status.
Risk mitigation
You want a development approach that includes planning ahead and keeping you informed about any potential concerns in order to mitigate risks before they occur. The right partner will have a thorough approach to communication, documentation and data management that minimizes your risk.
Product development
Product development is rarely a case of launch it and leave it. You’re undoubtedly planning a product that continues to meet user needs as it moves through its lifecycle from launch to market, right through to phase out. Product updates and fixes will become necessary, and your partner should provide expertise and support to help plan for these phases.
Future-proof planning
Beyond just meeting the immediate specifications, your OEM partner should provide a forward-looking approach for the next step in product development. By offering strategic insights and guidance about impending market changes, technology advancements and adoption potential, you’ll be positioned to plan a product roadmap that stays ahead of the curve in customer demands and regulatory changes.
Rapidly adapt to changes in market or policy changes
When changes do come – expected or unexpected – your partner should be at your side to help ensure any adjustments to the product get implemented quickly.
Creating efficiencies
Beyond just supplying a component or providing support during product development, an OEM partner that is focused on product LCM helps your team save time and makes processes more effective, ultimately reducing a product’s TCO. The goal is to improve design efficiencies or find better components that can help reduce your costs, whether in capital, time or manpower. There is now also a suite of digital tools available to product developers and manufacturers that can guide better decision making with more data and, ultimately, unlock even greater productivity.
Considers your end-user’s needs
Your LCM partner should know the importance of brand reputation in the marketplace. It is vital that every component added, changed or removed throughout the entire product lifecycle helps to support your product’s image in the marketplace. Every installed instrument requires support for parts and maintenance over its lifespan, even as it nears EOL, or following decommissioning.
Supports your business plan
Finally, the right LCM partner is one that helps you to achieve long-term business growth. By supporting you in identifying new markets or product areas – including ‘easy wins’ for adapting or refitting your products for additional markets – your partner can help you take your business in new directions you may not have considered before.
When you look at the design, development, manufacture and updating of a product over time, it’s evident that your LCM process needs to include working closely with OEM partners. Consider what bringing the right partner in from the start can mean for the success of your product during its entire lifecycle.
Discuss your needs
Tecan understands the intricacies of product development and anticipates future trends to ensure the best return on your investment. If you’re wondering how we can provide the next level of support required to ensure a successful product LCM, please contact us to discuss your needs.
About the author

David Keller
David Keller is Head of Customer Product Management at Tecan and leads an international team of professionals in managing daily interactions with OEM partners. Together with his team, he provides comprehensive management support across the entire product lifecycle, ensuring compliance and the highest levels of customer satisfaction. David has over 20 years of experience in the medical technology sector, and his expertise spans commercial operations, customer relations, service management and product management. He rejoined Tecan in 2013, marking his second tenure with the company.