Bridging the gap: portable labs from concept to consumer

Insights
Micro-electromechanical systems (MEMS) are reshaping industries by making it possible to fit entire laboratory setups into handheld devices. By integrating mechanical and electrical components at the microscale, MEMS technology enables sophisticated, compact tools for healthcare, environmental monitoring, and beyond. However, bridging the gap from prototype to practical, user-friendly products remains challenging. This article explores how smart product development strategies can turn laboratory achievements into real-world solutions that meet practical demands and usability requirements.
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November 6, 2024

Reducing the size of the lab: how chip technology enables analysis anytime, anywhere.

Imagine a laboratory shrunken down to fit in your hand, but still able to conduct complex tests and analysis with minimal equipment. Portable lab technology allows for real-time analysis, reducing the need for sample transportation and providing immediate results, which is critical for prompt decision-making.  

The rise in technology and portable labs is no surprise. Advancements in microfabrication and nanotechnology have made it possible to integrate various laboratory functions into a single chip, significantly reducing the size, cost and complexity of traditional lab setups. This has coincided with a demand for rapid, on-site testing.  

The accessibility of this technology means it is fast becoming a norm and finding applications in various fields, including healthcare, agriculture, environmental monitoring and the food industry, among many more. It already underpins common diagnostic tools like COVID-19 and pregnancy tests. It not only allows for rapid diagnosis, but on-site analysis can also be used for proactive maintenance and more effective resource distribution.  

But it’s not without its challenges, particularly when taking a wide variety of possible lab applications and developing devices for real-world use cases. The labs use a wide variety of different technologies, ranging from optical spectroscopy to physical sensors and detectors. But incorporating and optimising these technologies into a portable and user-friendly device is no easy feat.  

Turning tiny tech into big solutions

Portable labs are just that – portable. But making the leap from developing chips to a finished product ready for end users on the market is a complex process with many challenges to overcome. Each product development project comes with unique needs based on the technology, user needs and compliance regulations, but there are universal challenges and considerations that affect all product development processes.  

Here, we will explore some case studies with unique challenges and then examine some universal considerations.

NeoSpectra scanner – portable grain analyser

Client: Si-Ware System https://www.si-ware.com/

Product: Handheld grain analyser

Technology: FT-NIR Spectroscopy, MEMS (micro-electro-mechanical-systems) Optical spectrometers  

Challenge: Si-Ware's MEMS sensors require a consistent optimal temperature to provide accurate analysis – all while being housed in a rugged, water and dustproof casing durable enough for farm life.

Solution: Our team overcame the complex task of engineering a device that provided suitable heat dissipation for the MEMS semiconductor chips produced by Si-Ware, without Pilotfish DIN to compromise the physical demands and ergonomic needs of farmers. We thoughtfully explored the needs of farmers in designing the device, integrating large scanners that can handle a variety of sample types. Our aim was to create a solution that is durable enough to thrive in the challenging conditions often found on farms, such as dust, moisture, and limited wireless connectivity.

Coloryzer – water analyser

Client: Ayxon-Dynamic https://www.coloryzer.com/  

Product: Portable water analyser

Technology: Optical colorimetry

Challenge: For correct analysis of water samples, the optical colorimetry needed absolute darkness, and the device also needed to be suitable for use case conditions – light, ergonomic and waterproof.

Solution: We designed an internal casing with an innovative magnetic sliding door, which not only provided the perfect solution to create the required darkness, but it was also made for easy one-handed use and removal for cleaning.  

PixoTest – a series of smart at-home testing solutions

Client: iXensor https://www.ixensor.com/ixensor_web/

Technology: The PixoTest® series by iXensor, including PixoTest® Mobile, PixoTest® BT, and PixoTest® Vision, redefines mobile health diagnostics by transforming ordinary smartphones into medical-grade diagnostic hubs. Leveraging the PixoTech® platform, each device serves specific needs:

  • PixoTest® Mobile turns smartphones into personal testing devices, displaying semi-quantitative results directly on the phone for convenient, at-home monitoring.
  • PixoTest® BT incorporates Bluetooth for seamless data sharing, ideal for decentralized clinical testing (DCT) and real-world evidence (RWE) gathering.
  • PixoTest® Vision offers an advanced, multi-user platform with an embedded display, supporting comprehensive family health monitoring.

Challenge: Key challenges for iXensor and design partner Pilotfish were creating user-friendly devices that could instill trust and encourage adoption of remote healthcare. The devices had to be universally compatible with varying smartphone designs, maintain consistent usability, and appeal to both home and clinical users.

Solution: Pilotfish addressed these challenges through an evolving, intuitive design approach. The PixoTest® Mobile overcame smartphone variability with a pressure-activated adhesive, adapting flexibly to different camera position. PixoTest® BT enabled standalone use, freeing users from specific smartphone setups and enhancing data sharing for clinical environments. A consistent design language guides user interaction across models, and PixoTest® Vision integrates both an embedded screen and Bluetooth, providing a sophisticated yet user-friendly interface for complex testing needs.

The PixoTest® series exemplifies how smart design in mobile diagnostics can make healthcare more accessible. By ensuring user trust, simplicity, and seamless data integration, iXensor and Pilotfish have set a high bar for future at-home diagnostic solutions.

Blueprints for success: perfecting product development

Each device comes with a unique set of needs, but there are universal challenges and considerations when making the jump from the lab to portable hardware devices that will satisfy and appeal to end users.  

Environmental influences

One of the challenges facing LoC and portable lab technology is the impact of external environmental factors. A fundamental goal of the technology is to ensure that the results obtained in a controlled laboratory setting can be replicated outside when they face real-world variables such as temperature and humidity.  

To tackle this, designers and developers need to understand vulnerabilities of technology and what influences could potentially interfere with accurate results. These then need to be mitigated in the design process and tested. It’s here the adage ‘fail early, fail often’ comes into play. If you can test prototypes early to assess for weak points, you can prevent more costly and time-consuming errors down the track to ensure reproducibility of results  

User testing

A clear benefit of LoC devices is that they can be run by anyone – not just scientists in a lab. But this also means that user-friendly interfaces and operation become paramount when labs transition into consumer-centric devices. This also includes understanding and predicting (often unpredictable) user behavior, causing adaptability in design.  

To do this successfully, user testing early in the process is vital. Devices aren’t developed in a vacuum. End users have interacted with and become accustomed to certain design principles and expectations based on earlier experiences. And while some things are intuitive to industry experts, they may not be to others. This is why it’s important to involve users throughout the design process, so designers can understand preferences, challenges, and overall usage pattern and refine their concepts and designs.  

There are many ways to conduct user testing, including surveys and focus groups where developers can measure metrics such as task completion time, error rates, and user satisfaction, guiding hardware refinements. Early feedback helps identify and address issues, reducing development costs and time-to-market

Certification

Your device needs a market, and all markets have strict certification requirements to ensure that the device follows established technical standards, safety regulations and performance criteria. The process can be time-consuming and costly, so it’s important that compliance is not left as an afterthought and is considered in the initial planning and budgeting during product development.

There are many different types of certifications covering everything from electrical safety, electromagnetic compatibility (EMC), wireless communication, environmental impact, and more. Different regions and industries also have their own regulatory bodies responsible for hardware certification, such as the FCC (United States) or CE (European Union). Achieving certification can be complex, often requiring extensive testing, evaluation, and documentation to meet stringent criteria, all of which needs to be factored in early in the process.  

Accessories to complete the product offering

The importance of accessories is often underestimated. It’s great to have a device that can scan and analyse data – but factors like a charging cradle, protective case, and user-friendly instruction manual significantly contribute to the overall user experience.

These accessories enhance usability, convenience, and product longevity. A well-thought-out accessory strategy should be an integral part of hardware development, ensuring that users have everything they need for seamless interaction with the device.

Production

Prototyping and testing

Prototyping presents a paradox; prototypes are often more valuable when they fail than when they succeed. Failure uncovers potential flaws that can be iterated and rectified before heading into production, while success might mask underlying issues, leading to a false sense of security.  

The challenge lies in aligning the prototype's purpose with both the client's desire for a functional product and the development team's need to name and mitigate risks as early as possible. It is therefore important to identify the purpose of the prototype, is it for internal testing, or a piece designed to impress potential investors?  

Once the prototype’s purpose is defined, it’s then important to ensure that the chosen materials and methods are proper for the tests it will undergo.  

Ultimately, prototyping is an iterative process that must carefully balance risk mitigation with time to market.  

Pilot run as a path to mass production

A pilot run is an opportunity to check that everything is working properly and to set up processes for a smooth shift to mass production. This phase is not just about being ready for the market; it is also the time to improve the Standard Operating Procedures (SOP) and Standard Inspection Procedures (SIP).

Standard Operating Procedures (SOP) are detailed guides that outline the exact steps to be followed to complete a task consistently. The initial assembly line setup offers an opportunity to find improvements and uncover any discrepancies to ensure smooth operations in the later mass production phase.

Standard Inspection Procedures (SIP) are set protocols that provide a roadmap for quality inspectors to follow, ensuring a thorough and uniform approach to their assessments. Quality control is essential, with checks performed both on incoming components before assembly and on the final product. This phase is critical for defining acceptable quality standards for shipping products and aligning expectations between manufacturers and clients. Ensuring consistency across all inspection points, especially when dealing with global supply chains, requires significant knowledge and coordination.  

Challenges in mass production

When the time for mass production arrives – it's not always smooth sailing, no matter how prepared you are.  

The first key challenge of mass production is ensuring consistent quality. A solid SIP in your back pocket is essential, but it’s important to ensure all your networks are working within the same standards and not swapping components or materials without sharing that information.

Speaking of components, that is another challenge. Securing a consistent supply of components, especially specialised or custom parts, can be challenging. Fluctuations in demand, limited suppliers, and geopolitical tensions can lead to shortages and delays.

Next steps

Are you ready to transform your idea from a lab into a portable device that can succeed in the market? Get in touch with us to discuss how Pilotfish can help you in bringing this idea into reality.