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Reducing risks in IVD instrument development

By Nicholas Smith 


The In Vitro Diagnostics (IVD) medical device market is fast-paced and highly competitive, with new and advanced applications appearing every day. High technical risks, cost overruns, schedule delays and missed end-user targets are just some of the pitfalls that can derail a project or lead to an unsuccessful product. Moreover, the expertise requirements and regulatory landscape for IVD medical devices continue to grow in complexity, making it even more difficult for a diagnostics company to keep pace and bring its platform solutions to market in a timely manner and with the appropriate mechanisms in place to fully support the customer. Here we take a closer look at why a systematic risk-based development approach is essential for IVD device development, and how the right OEM partner can be crucial for success.

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Five secrets to a successful IVD OEM partnership

By Nicholas Smith

You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned in vitro diagnostic device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. You may need to react quickly to unexpected circumstances requiring rapid changes in the throughput of your instruments. What else should you take into account when selecting an ideal OEM partner?

Every partnership has two sides and each must work together to reach success. In this case, there is the OEM partner and an OEM customer. Would any OEM partner fit with any OEM customer? There are several success factors that OEM customers and OEM partners need to consider to develop a successful partnership.

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Seven elements for successful IVD instrument development with your OEM partner

By Nicholas Smith 

You have made the decision to enter into the development of an IVD medical device for your customers. You have learned that inviting an OEM partner into your project could be beneficial to reduce risks and fill expertise or skill gaps, but you are still hesitant. What are the key elements that you should consider to ensure the success of the collaboration?

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Things to consider before introducing lab automation to in vitro diagnostics

By Nicholas Smith 

If you’re thinking about automating your in vitro diagnostic (IVD) product it can be hard to decide whether to outsource to an Original Equipment Manufacturing (OEM) partner or keep the development in-house. While the familiarity of a DIY solution might be appealing there are a number of hidden pitfalls that could hamper your progress.

Finding the right OEM partner for your IVD medical device could give you the edge by avoiding these pitfalls and giving your project a speed and performance boost needed to help you get to market faster.

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The ups and downs of DIY lab automation

By Nicholas Smith

With open source software and high quality off-the-shelf components, do-it-yourself (DIY) lab automation solutions are trending. While developing lab automation in-house might seem attractive at first glance, the road is littered with hidden pitfalls that can derail internal projects. Finding an Original Equipment Manufacturing (OEM) partner can be a cost-effective way to circumvent the pitfalls and mitigate risks by working with a trusted automation expert.

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Why you should consider product lifecycle management experience when selecting an OEM partner

By Micaela Wochner

As a diagnostic product moves through its lifecycle, its development, engineering and customer support needs change. In order to extend the period of product profitability and customer loyalty for as long as possible, you must start planning for the next evolution of the product from the beginning. Involving an OEM partner in your product lifecycle management (LCM) from the start can help you create products that are easier to service at a lower cost and with fewer long-term risks.

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Product lifecycle management: why it matters for the IVD industry

By Micaela Wochner

For product manufacturers in the medical and diagnostics equipment industry, developing an effective product lifecycle management process is no longer a “nice to have” but a “must have”. From managing the cost of product ownership to transitioning product updates without disruptions in regulatory compliance, a long-term holistic view of product lifecycle management can help you maintain customer loyalty and build trust in new product development.

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Molecular diagnostics – a closer look at sample to answer

By Nicolas Smith

How to overcome challenges like inefficient workflow and a lack of suitably trained staff is the question increasingly facing laboratories in markets ranging from diagnostics to food and beverages. Could sample-to-answer systems be the answer?

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Three considerations for reducing risk of ‘just-in-time’ inventory control

By Severin Heynen

As labs face tighter profit margins and the need to minimize cost of goods, there is increasing pressure to implement more efficient and responsive mechanisms for procurement and inventory management. A large proportion of annual spend goes towards consumables like disposable pipette tips, microplates and kits. Procurement strategies based on lean and ‘just-in-time’ principles can improve cost-efficiency by reducing overhead and warehousing expenses. However, this often comes with a significant risk: without enough data about both availability of consumables and what you have in stock, you could run into costly unexpected out-of-stock scenarios. Here are three essential questions to ask when looking to reduce the risks of creating leaner, ‘just-in-time’ procurement processes.

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How to secure long-term performance of OEM components for automated liquid handling

By Claudio Bui

When you design a complex laboratory automation system or device, every OEM liquid handling component that you integrate into it should be reliable, dependable and expected to perform to the highest industry standards.  Subpar quality is not an option. If the intended use of the system includes critical tests for clinical diagnostic purposes, the consequences of failure or poor performance of liquid handling components could be more costly than you bargained for, including irreparable damage to your company’s reputation and even worse – it could pose serious risks to patients’ health. Integrating components into your system that are reliable and have a durable design should be an essential consideration.

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The next giant in genome sequencing? China

By Nicholas Smith


As  sequencing grows significantly in China, how are Chinese home-grown companies making the most of it?



In December 2017, the UK and China announced a joint initiative to advance collaboration in science and innovation¹. The first bilateral science and innovation strategy of its kind to be developed by China jointly with another country, the UK-China Joint Strategy for Science, Technology and Innovation Cooperation builds on existing collaborations dating back to 2014, and represents yet another step change in China’s efforts to grow their leadership in healthcare markets. On the back of initiatives such as this, China’s home-grown companies are forging new partnerships internationally, and are well positioned to flourish as a result.

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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

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The leader in next generation immunodiagnostics

By Nicholas Smith

Jeff Bishop, Vice President, Research & Development, Singulex, explains the proprietary single molecule counting (SMC™) technology which has become today’s gold standard for immunoassay technology.

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