The Emphysys Rapid Solution Blueprint – Part 2

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The first blog in this three-part series highlighted some challenges in bringing a novel medical device concept to fruition. It also introduced the Rapid Solution Blueprint, a five-pronged, customized approach created by Tecan’s technology development group Emphysys to accelerate technology development in the face of adversity. This blog explores the first two arms of the Rapid Solution Blueprint – ‘literature review’ and ‘phenomena to understand’ – in more detail, emphasizing how this vital cog in our development machine can help us solve just about any problem.

Navigating roadblocks in technology development: a recipe for success

Samuel Bruce, Senior Mechanical Engineer at Emphysys

Above and beyond

Before we get into the nitty-gritty of the Emphysys Rapid Solution Blueprint, it is worth highlighting the importance of collaboration in technology development. Entering a partnership is a huge decision for a customer, marking the moment when they fully entrust their project into the hands of an external company. At Emphysys, we understand the magnitude of this commitment, and we aren’t afraid to step out of our comfort zone to ensure we outperform the projections of each and every client. As alluded to in the opening, we have explored – and will continue to develop – the best methods to achieve this, including the Rapid Solution Blueprint, a powerful tool when in the hands of our talented team.

Branch 1: Literature review

The first step when encountering a problem in technology development is to research what information is already available. Why reinvent the wheel if there’s no need? This stage is especially pertinent when the device is an evolution of a current design, but is also essential when building an instrument from scratch. Basically, we are looking for published literature on similar or related products, design concepts of components that are relevant to the product, and publicly available information on rival offerings in the same realm. This helps us form a detailed picture of what information is out there already, and garner more depth on scientific concepts to propel us forward.

Exploring these avenues is essential to compile all the relevant time- and money-saving possibilities – including previously made mistakes and solutions – as well as any fundamentals that may have been missed. It will also help to uncover any safety concerns or variables affecting efficacy. In a recent project, for example, we had to investigate how cannula diameter and length affected the flow of certain biological liquids. Rather than going through the laborious rounds of testing ourselves, we first looked into the existing literature, and found most of the answers we needed. Of course, we checked our sources thoroughly, and took everything with a grain of salt – as we always do – but, certainly in this case, it served as a perfect foundation for our line of questioning, consolidating the rounds of testing we needed to do.

Branch 2: Phenomena to understand  

After establishing the theoretical groundwork, we tighten our thinking caps and familiarize ourselves with the relevant tests and inevitable failures. The failures are dissected in detail, exploring how and why they didn’t work, and how to use this information to pivot and progress. We break down this branch into five smaller subdivisions:

  • Have all tests failed? Or are there some successes that can steer us in the right direction? If there is a 100 % failure rate, did they all fail in the same way? For example, in our cannula/flow experiments, did it clog at the same position every time? There are usually many variables that can make it difficult to pinpoint where and why something happened, but this branch ensures we are thinking more than ‘pass or fail’, but rather how and why it did.
  • What methods are used to clear, reset or overcome a failure? This branch is about teasing out the characteristics of a failure, and part of that is figuring out how to fix it. Back to our cannula/flow example again, when a clog appeared, what was the best method to clear it: flushing the tube with air or saline, or pushing a rod through the line? Or maybe it was a failure in the software, and simply reconfiguring several variables would suffice.
  • What are the anatomies of the failure? This branch explores the physical components of the failure, and whether it is destructive or fundamentally modifies the hardware. These changes could be obvious – something bent or broken – or subtle, for example, slight alterations in a surface finish that renders the device no longer compatible with the application.
  • What constitutes a failure? This one is similar to the previous branch, but delves deeper into actually defining a failure. A failure could simply be that the device isn’t working as well as you want, or its efficacy has dropped over time. Will this continue and lead to further issues, or has it self-limited? Even then, maybe it is still clinically acceptable and therefore not actually a failure.
  • Can a failure be detected early? This one is reasonably self-explanatory; is it possible to identify and mitigate a failure before it happens? To use our cannula/flow example one more time, are there any measurements – such as pressure or flow rate – that signal something is awry? Basically, we are looking for any anomalies in the technology’s input or output, or changes in the operating environment.

As you can see, Emphysys’ Rapid Solution Blueprint is about asking the right questions for a given problem; find the answers and you’ll find the solution to your stumbling block. The two branches discussed here focus on the information that is already out there, and how to look at it from a different perspective. The next blog delves into the final three arms, which use this information as a foundation to launch into more inventive methods to overcome the issue.

Download the Emphysys Rapid Solution Blueprint and take the first step toward transforming your medical device development strategy.