The Emphysys Rapid Solution Blueprint – Part 1

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This is the first blog of a three-part series that delves into the medical device landscape, touching on the challenges of bringing a new concept to market and investigating a fresh approach to streamline this process. 

Mapping minds, building devices: a strategic approach to healthcare innovation

Samuel Bruce, Senior Mechanical Engineer at Emphysys

The long road to success

Transforming a novel idea into a proof of concept for an innovative medical device is no mean feat, requiring the combined efforts of scientists, engineers, project managers and regulatory experts to deliver a safe and compliant product on time and within budget. Of course, a new device must solve the problem it was designed for, but getting it there is a high-stakes journey, with potentially dire consequences if the wrong path is taken. Some projects may be clear cut – where a process is already proven, and a customer simply wants to develop technology around it – while others are more convoluted, calling for a combination of research and ideas to form a novel clinical solution.

Regardless of the project, a clear development plan is needed, even if the end product looks different to the original concept, as a project takes inevitable twists and turns in response to unforeseen challenges. A systematic approach is therefore crucial to guide the project along at every stage, marrying expertise with management to build a product that makes a lasting impression on the healthcare landscape.

Identifying prospective roadblocks

This ethos was tested like never before when Tecan’s technology development group, Emphysys, was mid-development of a radio frequency (RF) medical device, and hit a major roadblock. Emphysys is an industry-leading technology developer in healthcare and MedTech, making the company no stranger to developing new technologies for complex devices. The company even specializes in high output RF energy for various treatments on tissues – and is equally comfortable in just about any niche, from microfluidics to embedded control systems – but this project warranted a complete re-think of the process.

The customer already had a benchtop system for various applications – such as clotting prevention during surgery, and uses in dentistry – but wanted to expand its functions into other RF enabled surgical procedures. A candidate therapy was identified that had never been performed using this particular type of RF device before, making for an extremely complicated development process with no previous model to build on. The team at Emphysys went through the standard engineering process – define the problem, brainstorm, design and prototype, optimize, iterate, etc. – but the vast number of variables made it challenging to determine how each input affected the outputs. For example, even slight variations in RF voltage altered the effect on the tissue sample, while the type of tissue resulted in enormous disparities, with fibrous and adipose tissues responding differently. At this point, the team decided to take a step back and re-visit some of the critical questions involved during the early stages: What tests do we need to perform? What types of tissue can we use? And what literature is available that has already investigated these issues?

Emphysys Rapid Solution Blueprint

It’s certainly not unusual to be posing these questions mid-development, and knowing how to answer them quickly and accurately can be the difference between sink or swim for a project. This is where Emphysys turns not only to its multifaceted team, but also to its signature formula: an elaborate framework entailing an intricate series of questions and considerations that allow the team to navigate just about any clinical problem during the development of a medical device. Exploring these avenues helps to prove relevant hypotheses right or wrong using a calculated and methodical approach, and investigate every factor to find the best solution to each problem. This process has been carefully cultivated over time, and is used with precision on every project the team embarks on.

The framework has since been labeled the ‘Emphysys Rapid Solution Blueprint’, which starts with five main branches that expand into smaller divisions. The five overarching themes include:

  1. Literature review – understanding what has already been published
  2. Phenomena to understand – looking at previous test outcomes and anomalous results
  3. Brainstorming on device fundamentals – gathering and understanding the basic physical principles that guide the technology
  4. Lab testing to further understanding – evaluating outputs and methods of action
  5. Simulation to further understanding – exploring all the different elements

The engineers at Emphysys certainly perform many of these steps almost intuitively, but organizing them into a clear framework gives them a go-to guide – or at least a starting point – to overcome challenges before they significantly impact a project. Of course, it may be more useful to some projects than others; some programs, for example, may have no literature, because they haven’t been studied yet, and so this arm might be unnecessary. However, building a clear road map – or the Rapid Solution Blueprint, in this instance – can help to mitigate risk during the development of a medical device.

Emphysys’ diligent approach was able to solve this frustrating roadblock for its customer, preventing the project from idling and allowing development to continue. The company’s methodical process is the result of years of experience – entailing a wide array of customers in different niches – which the engineers continue to refine with every project. The Emphysys Rapid Solution Blueprint is their customized approach, which they apply to each project to optimize efficiency and ensure every angle is being assessed. What is the result? Accelerated development of each technology, delivered on time and within spec.

The next blog in the series will dive deeper into the first two arms of the Emphysys Rapid Solution Blueprint, investigating the crucial research stages that ensure a cost-effective approach to the practical phases that follow.   

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