Getting to market in time with a fully functional IVD instrument that is automated requires precision planning and laser focus at all stages of development. At the onset of your project, it is important to weigh the development risks and consider the impact those may have on time it takes to introduce your instrument to market. One of those development risks to evaluate is whether partnering with an OEM developer with automated liquid handling experience is a viable option for your project. Or if the option to develop your instrument in-house is the best way to proceed.
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.
From top global instrument makers to smaller startups, life science companies face a challenge when developing and launching new IVD products in a fast-paced market. How do you create a product that meets market needs without overdeveloping it? You want a development effort that keeps costs in a profitable range while still delivering value to your customers. And you want to launch your new product within a window of time that makes it unique on the market.
As we saw in part 1 of this blog series, liquid chromatography-tandem mass spectrometry (LC-MS/MS) is potentially the new gold standard for therapeutic monitoring of immunosuppressant drugs (ISD). However, for this technology to become widely adopted, the methodology needs to be standardized globally, including addressing bottlenecks both at the pre-analytical stage of sample preparation, and within the process itself. Here we take a look at the top four pitfalls to avoid when implementing LC-MS/MS for ISD monitoring.
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.
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.
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?
Introducing a new in-vitro diagnostics (IVD) lab automation solution can add an entirely new dimension to your existing product portfolio and business. Launching a complete system that provides harmony between chemistry and assay workflow, instrumentation, software analysis and reporting is a complex endeavor that demands careful planning and execution.
It can be easy to dismiss outsourcing lab automation in favour of seemingly less expensive do-it-yourself (DIY) solutions. However, outsourcing is more cost effective than it might seem. By taking advantage of the expertise of Original Equipment Manufacturing (OEM) partners, who can also offer a variety of flexible financing options, outsourcing could well be the right solution for your business. Here are some of the main ways in which OEM partners can make your automation project more cost-effective.
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.
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.
The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe’s new In Vitro Diagnostic Regulation (IVDR 2017/746), it’s crucial that diagnostics businesses critically evaluate their entire supply chain to close any gaps and ensure IVDR-compliance can be maintained throughout the device lifecycle. An important question to ask is whether outsourcing your IVD projects will help or hinder your efforts to comply and remain competitive in this shifting regulatory landscape. In the final blog of this 2-part series, we consider the advantages of partnering and the factors that are crucial for success.
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.
Is your business IVDR-ready, or are there treacherous gaps in your strategy? This November marks the halfway point in the five-year transition to the In Vitro Diagnostic Regulation (IVDR) 2017/746—a major regulatory overhaul that calls for reclassification and recertification of all IVD devices registered in the European Union. With its expanded scope and more stringent requirements, IVDR impacts the entire supply chain. The May 2022 transition deadline may seem a long way off, but there’s no time to lose. In this 2-part series, we help you take stock of the situation, with a special focus on how to prepare when it comes to managing OEM relationships and new partnerships.
Innovating, developing and bringing a new automated liquid handling product to market quickly, before requirements and needs change, is no easy feat. A software development kit (SDK) supporting your platform and components enables your developers to spend less time worrying about how to control robotic components and more time creating optimal interactions between the end-user and their application. Let’s look in more detail at what a robotics SDK is, what features it should have, and what benefits the right SDK can bring to your development timeline.
Advances in the treatment of disease, such as the many different types of cancer and cardiac diseases, mean that organ and bone marrow transplantation is on the rise.1 This rise has in turn generated an increased need for accurate immunosuppressant drug (ISD) monitoring. This 3-part blog series will walk you through the challenges of adapting gold standard mass spec methods such as LC-MS/MS for ISD monitoring, and explore ways to avoid the associated pitfalls.
Lab automation and liquid handling solutions are evolving rapidly, shaped by many of the same forces and disruptive technologies that define the fourth industrial revolution. Alongside Industry 4.0, you could say that the era of Liquid Handling 4.0 has arrived. In today’s fast-paced environment where engineers need to develop and adapt analytical platforms rapidly to address new markets and ever-changing applications, the choice of core robotics architecture and components can be crucial for success. Here are some important questions to ask when selecting OEM components and robotic platforms for automated liquid handling.
Your diagnostics equipment business is growing in leaps and bounds. And no wonder—BCC Research reports that the global market for in vitro diagnostic (IVD) products is growing at a rate of 6.7% and should reach $102 billion by 2022.¹ The faster your diagnostics equipment business grows, the harder it may be to deliver the level of service your customers expect. The right service support partner can help you keep pace with growing demand.
Here are six essential criteria to consider when choosing a partner.
Customer service has become a crucial battleground for all types of industries, including life science, medical diagnostics and pharma. A study by NewVoiceMedia1 revealed that customer service plays a significant part in overall customer experience, which is costing companies more than $75 billion a year. Some 67 percent of customers have become “serial switchers,” willing to switch brands because of a poor customer experience, according to the study. Lackluster customer service almost guarantees that the next time your customers have a need they will look elsewhere.
The syringe pump is the workhorse of any automated liquid handling instrument. A single syringe pump may complete one cycle every second, and as many as 4 million cycles in its lifetime. Keeping your pump syringes and components in top condition will allow them to run smoothly and deliver their best performance. Over time, syringes may start to wear, and therefore volumetric and positional precision and accuracy are likely to decline. Maintenance and replacement will restore its performance.
The impact of pump pressure sensors on your automated liquid handling pump performance is often underestimated and underappreciated. The saying, “You don't know what you’ve got ‘till it's gone” applies to many things in life – including fluidic pumps. When device sensors are doing their jobs, the end-user will never know, but when the sensor feature fails to perform, the consequences can be costly and catastrophic. Today’s smart technologies empower pressure sensor functionality more than ever. Why are pump pressure sensors essential for automated liquid handling systems? What benefits do they offer? How do they increase functionality and address process security risks?
With high-throughput genomics impacting every corner of biology, the demand for more efficient Next-generation sequencing (NGS) workflows is growing rapidly. Automating the process of NGS sample preparation is crucial to avoid inaccuracies due to human error, bottlenecks that delay sequencing results, and the additional expense of re-running sequences. What are the most important factors for an engineer to consider when selecting a pump to meet the stringent performance required for an automated NGS library preparation system?
Today’s hematology labs are faced with escalating demands to deliver robust and accurate blood test results quickly. At the heart of automated diagnostic systems for blood analysis are liquid handling pumps, which must deliver precise and accurate results every time. As well as being reliable, they must also be affordable and easy to maintain. Unfortunately, not all pumps deliver to these exacting standards. What are the most important factors for an engineer to consider when selecting a pump to meet the stringent performance required for a hematology automation system?
From the perspective of a lab automation systems engineer, specifying the optimal liquid handling pump and associated fluidic components is often central to the design process, especially for products that will be used in a clinical lab or other highly regulated environments. What questions should you ask in order to select a pump that can handle all of your system’s intended applications? Here’s what our liquid handling experts from Tecan's OEM Partnering team have to say.
Anatomical pathology labs face ever-increasing pressure to meet demands for enhanced throughput, improved quality and cost savings. Additionally as we saw in the previous article in this series, anatomical pathology has to adapt to disruptive new methods that replace or enhance traditional ones and automation that will play a key role in reducing waste, error, and hands-on time. Employing automation solutions built for traditional methods can result in compromises in compatibility, throughput, and quality, which mean that novel solutions may be required. In this case, it may be time to consider partnering to develop the automated pathology system that delivers the performance a modern anatomical pathology lab needs.
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?
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.
The demand for advanced medical and diagnostic testing continues to accelerate. Laboratories, hospitals, and emerging consumer genomics companies are demanding quicker test sequences resulting in the design and development of new innovative and responsive test protocols. These new tests include the handling of a wide array of fluids. The measurement, monitoring, mixing, and controlling of solvents, salts, detergents, acids, bases, reagents, and additives is critical in all liquid handling lab environments.
The anatomical pathology – or histopathology – services sector is projected to grow, but histopathology labs the world over are struggling in the face of shortages in trained pathologists, increasing regulatory pressure, changing reimbursement policies, and shifting paradigms in healthcare. Modernization of this highly conservative field is imperative. What are the key drivers of change in the industry, and how can anatomical pathology labs prepare to embrace the future? Will automation and digitalization offer a solution?
The last decade has seen dramatic changes in the world of diagnostics, with experts even referring to the present time as the start of the fourth industrial revolution. Digitalization, along with other technological advances such as the increased use of automation and robotics, machine learning, artificial intelligence and cloud computing, is impacting every industry from manufacturing to pharmaceutical biotechnology. These technologies, as well as breakthrough research in various fields such as gene editing, stem cell technology and regenerative medicine, are having a huge impact on the clinical diagnostics industry.
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.
Similar to the highly competitive automobile industry, clinical laboratories and manufacturers servicing the clinical diagnostics and life science markets, are always under pressure to increase quality and reliability. Likewise, they must at the same time cut costs and bring new products to market in a climate of rapid global change and increasing regulatory pressures. Specialist car manufacturers are leading the way with innovative new approaches to cope with the challenges. Those who are successful have learned how to be more adaptable and how to get their innovative products to market faster.
The world of diagnostics, like so many other industries, is entering what leaders in the World Economic Forum are calling the fourth industrial revolution. Digitalization, robotization and automation have given rise to highly flexible “smart factories” as well as laboratories that can handle both routine/high volume analyses and highly customized analyses at competitive prices. This is coupled with an ongoing integration of the entire value chain – from subcontractor to customer.
When introducing a new product to the automated liquid handling market, getting there first with high quality and reliable hardware is vital to capturing and maintaining early market leadership. How can you gain that advantage when you have to balance requirements for customized high-performance robotics against an accelerated product launch?
When developing a liquid handling instrument, it is important to be first to market for early market leadership. Dr. Claudio Bui, Head of Product Concepts, Tecan, considers key elements to completing a project quickly and efficiently, including common pitfalls.