A Medical Technology company is developing and distributing a clinical analytic device and assays for it. Performing multiple assays requires a powerful system to handle the tasks. Thus, The company needed new electronics development that would meet both legal and regulatory requirements. To upgrade the system, the company was searching for a competent IoT partner to ensure this was done compliantly and competently.

The MedTech company focuses on delivering point-of-care diagnostics tools for clinical diagnostics and research for both humans and animals.

The company’s primary product is a point-of-care immunoassay platform based on patented technology. The device enables fast, accurate, and affordable human & veterinary diagnostics, including:

  • human CRP
  • MxA
  • equine/feline SAA
  • canine CRP
  • equine IgG kits

Rise in medical laboratory testing

The clinical laboratory testing market size is said to reach $327 billion by 2028, with a rise in the prevalence of chronic diseases and the increasing need for advanced diagnostic techniques to drive market growth.

The growth of this market is accelerated by an aging population, rising prevalence of chronic and acute diseases, increasing burden of target diseases such as diabetes, and growing awareness about health & wellness among individuals.

Medical laboratory testing

In addition, the rising prevalence of cardiovascular disorders, the increasing need for early disease diagnosis & management, and the growing usage of molecular, pathological, and immunological tests are other significant parameters fuelling the global clinical laboratory tests market growth.

To meet this growing demand, the MedTech company has been developing and distributing its product, which provides a faster and cheaper alternative to a PCR test. In an effort to update their product, they selected Krakul as a partner for the project.

The challenge for Krakul

Referred to by a partner, Krakul examined the business aspirations of the MedTech company and how they could help with the product being offered to the key markets they wanted to enter – namely Europe and further worldwide.

Krakul began preparing in March/April 2021 for a project which would take around 4-5 months of work.

What type of solution was asked of Krakul?

The client was looking for a partner to help them with product updates.

The client company asked their manufacturing partner for tips on whom to contact, which is how they found us. The previous company produced all their hardware and firmware. Yet, they wanted a partner that could upgrade the device and scale it into mass manufacturing.

The main challenges they wanted to tackle were:

  • A slow user interface that was causing a poor user experience.
  • Upcoming EU regulations insist on supporting multiple languages in the UI (to service more EU markets).
  • The previous design suffered from some electromagnetic interference (EMI) issues and was not modular.

Subsequently, the client was looking for a more modular design, a more capable microcontroller (MCU) with added WiFi and Bluetooth support (especially for Over-the-Air updates).

After thorough analysis, did the problem seem hard to find a good all-encompassing solution?

No, figuring out a suitable solution was not difficult.

We worked with the client company to analyze the current designs to determine which MCU family to migrate to, especially cost-efficiency. The first solution we came up with was simple. Working through the requirements and the current design state, we concluded that the answer would benefit from a more thorough redesign.

We decided to go with a more in-depth reengineering of the product than was considered at first. This work requires openness from both sides, good communication, and a shared understanding of the vision for the product and the value provided to end-users, which the client company provided.

How much did the conclusion from the analysis differ from the original plans of the client company?

The more we dug into the current state of things, the more we realized that the system would require more powerful MCUs and components but with the same functionality as the current system.

The solution we ended up with was more thorough and all-encompassing than what we started with. In the end, we fulfilled the requirements and developed more powerful electronics for the system.

What was the approach?

To update one PCB, switch their current MCU to a more capable one and keep mechanical dimensions unchanged.

Planning and analysis to adopt our approach took a month to prepare. Creating an updated system plan and architecture with all the necessary details was around two months of constant back and forth.

With the current electronic component availability and our vast friendly suppliers and manufacturers network, this process was relatively smooth for the client.

What are the steps in building something like this?

Our typical workflows for a project of this magnitude are as follows:

  • creating a thorough understanding of the underlying problems,
  • understanding the product and the business strategy,
  • analysis,
  • creating a plan for the solution,
  • an iterative design and development process,
  • testing and validation,
  • and naturally, continued support.

What are the most critical details for a project like this?

Ensuring reliability and manufacturability, understanding the business needs of the client and the value created for the user. A product must always generate value.

Furthermore, iterations and testing play a big part in this process. Because we understand the business case, we always ensure the initial solution is well-thought-out and implemented with care. This, in turn, reduces how many iterations are needed and the amount of testing required. For instance, we planned for three iterations but only needed two in the end.

Concerning testing, it’s not a question of time taken but rather the outcome. We found no issues with the solution during our verification process, and the final verification took around two weeks.

How did the manufacturing process and handing over go?

Considering the state of the electronic component market and availability, very well. The device is still a work in progress, but we have weekly calls and constant communication back and forth.

We foresee no issues implementing our designs in the final product and are still supporting the client.

At Krakul, we are constantly on the lookout for new ways of generating value for users through our clients’ products and services. Because of that, development is never really finished. Products are manufactured and shipped, but there is always something (new) to improve upon.

Competencies used:

During this project, the team at Krakul used the following IoT competencies to bring this project to life:

  • RTOS
  • STM32
  • emwin
  • LCD
  • RFID
  • NFC
  • Azure OS



Are you looking for an IoT development partner for your business?

Whether you are planning to enter the market with a new innovative product or are looking for an IoT development partner for your existing devices, we’d love to hear from you.

Krakul has been developing custom IoT devices for customers globally since 2013.

Call us for a chat!