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By Nick Smith
The development phase of your new automated system is coming to an end. You’ve fine-tuned your IVD instrument with the help of your Original Equipment Manufacturing (OEM) partner, tested it thoroughly with your enthusiastic early access customers, and you’re all pretty confident that it will exactly meet the application needs of evolving diagnostic market trends. Your investors are eager to see how it performs, and you are anxious to kick-start revenue generation. It’s time to launch.
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.
By Laura Nea
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.
By Laura Nea
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.
By Andreas Schmitt
When you have a diagnostic lab instrument and want to make the move to automation, creating high-quality, reliable and intuitive robot control software that, optimizes throughput, provides process safeguards, and analyzes and presents results, is vital.
By Yves Wurmitzer
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.
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.
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?
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.
By Andreas Scheidegger
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.
By Nicholas Smith
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.
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.
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.
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.
By Manuel Bauer
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.
By Petra Popp
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.
By Petra Popp
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.
By Yves Wurmitzer
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.
By Yves Wurmitzer
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?
By Markus Vogler
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.
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.
By Markus Vogler
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.
By Markus Vogler
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.