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How do you ensure a successful route to market for point of care testing?

May 5, 2021 9:44:04 AM / by Carla Elizondo

Bridging the bench to bedside gap with point of care testing 

One barrier to closing the bench to bedside gap is the burden of large-scale laboratory testing limiting access to diagnostic testing at the point of need in a range of sectors, from human diagnostics to agriculture. 

 

 

Point of care testing (POCT) has been shown to be of utmost importance in situations where rapid medical decisions are required or in low-resource settings. Although we do not yet have the perfect POCT device, technological advances in the biosensing sector and a greater awareness of the importance of practical and future-proof solutions is driving innovation in the medical devices industry. 

 

Despite being highlighted as a key player in the human diagnostics market, microfluidic POCTs are still limited to early development stages. Common pitfalls in the road to market arise with system complexity making the tests difficult to use and not amenable to large-scale production. We have highlighted the main requirements for a successful POCT device and how design for manufacture plays a key role in its delivery.  

 

 

What makes a successful POCT device? 

The World Health Organisation has outlined ‘ASSURED’ criteria for the benchmark global requirements for POCT devices. 

  • Affordable: Low cost, and at a price-point suitable for its target market.
  • SensitiveHigh sensitivity to the target marker for accurate results. 
  • SpecificSpecificity to the target marker that is reproducible. 
  • User-friendlyEasy to use and low-complexity sample delivery with a clear result.  
  • Rapid and robustTest times of  less than 5 minutes. 
  • Equipment-freeNo requirement for costly or complex machinery requiring trained staff. 
  • Deliverable to end-users: Accessible directly at the point of need. 

 

In the competitive route to market, a POCT that does not meet all of the above requirements will likely fail to succeed in reaching its target market. However, with the complex goal to provide accurate and highly sensitive testing, in minutes, in limited-resource settings, successfully meeting all of these targets can prove a difficult feat. It is possible to deliver a POCT that does not meet these benchmark criteria, but it is likely that commercialisation would be significantly more challenging and associated with higher risk. 

 

 

What is the key to successful device development? 

  • A strong interdisciplinary team 
  • Reliable lab bench-based assays 
  • Comprehensive understanding of the end user 
  • Clear communication and clarity between all stakeholders 
  • A core development principle of design for manufacture 

One of the key factors in the development of a successful POCT device is the experience of the team working to develop it. An interdisciplinary team with a wealth of varied experience can open new opportunities and collaborate to develop and customise powerful and accurate solutions for specific applications. Employing a strong network of experts striving to meet each of the ‘ASSURED’ criteria increases the chance of overcoming roadblocks by optimising time and resources.  

 

A reliable and optimised lab bench assay is another key component for the successful development of a POCT device. It is vital to have a complete understanding of the expected protocol steps and reagent volumes before initiating the design of the device that can successfully perform the required steps, whilst also reducing the project development timeline.  

 

The goal for a POCT device is to provide an easy solution for diagnostic testing directly at the point of need. Often, the intended end-users are not trained to operate complex scientific equipment. A successful POCT is simple enough to operate for an untrained person to consistently attain an accurate result. To achieve this, the number of user steps required should be kept to a minimum, with automated elements incorporated into the overall system. This helps limit human error and deliver reproducible results in all conditions, especially lower-resource environments. These factors are often governed by regulatory bodies, such as the FDA Clinical Laboratory Improvement Amendments (CLIA) that define a complexity score for each POCT. 

 

Employing robust and proven processes from existing solutions on the market increases the chances of success in the large-scale delivery of a POCT device. By building upon a core principle of design for manufacture, the resulting device is scalable and sustainable for the future.  

 

 

What are the common roadblocks and pitfalls of device development? 

It is not simply a competitive market that can block the successful development of a new POCT, but rather several more complex and multifaceted factors. Time to market is often the biggest focus at the detriment of prioritising an optimal, market-ready product. New products often require a key technology breakthrough or design to be successful. However, one of the biggest risks to a development project is trying to incorporate too many new ideas into one device. The most successful developments are built on tried and tested design features, without being overly reliant on innovation to achieve success. The advantage of working with known technology is that, often, high-volume manufacturing methods and processes are already in place. This, along with significant amounts of testing data and evidence, can significantly de-risk the validation and verification process. 

 

One of the biggest causes of project failure is the lack of a scale up strategy, which is key in achieving a high-volume delivery whilst maintaining low device costs. For so many system designers, design for manufacture is an afterthought which can become costly and a barrier to large-scale production. 

 

Collaborate with us 

 

 

  • Concept to commercialisation support, delivering high-performance market-ready solutions. 
  • Uniquely positioned to offer the highest quality experience for product development. 
  • Design for manufacture in everything we do. 
  • Custom, optimised designs tailored to you and powered by 3D Graphene Foam. 
  • Dynamic pricing to support you from small-scale prototyping to large-scale biosensor and microfluidic device production. 

Supported by an interdisciplinary team with more than 60 years collective experience in developing POC microfluidic devices, we can deliver high-performance, market-ready solutions for your application. We can offer you a fully customised and optimised design, with our team working hard to identify all the best solutions for your project. All our device development work is done in-house, meaning you are supported by our team throughout the entire project, removing the need of  balancing multiple partners.  

 

From small-scale prototyping to large-scale biosensor and microfluidic device production, our approach is tailored to you. Our services are dynamically priced as we remain flexible throughout the duration of our collaboration to ensure that you receive the support you require.  

 

With design for manufacture in everything we do, you can trust that the product we deliver will have a production process designed to deliver a highly successful POCT device. We appreciate that demand in the medical sector can fluctuate and, with our design for manufacture ethos, your device’s production will be flexible and fully adaptable to the changing markets and environment. 

 

We are always excited to get on board with new applications and their many challenges. Contact us today to find out how we can support you in developing the next generation of diagnostic testing.

 

 

 

Tags: Gii-Sens, Point of Care

Carla Elizondo

Written by Carla Elizondo

Carla is the Market Engagement Executive for Integrated Graphene