Navigate the journey of the new medical device

The opportunity to bring a breakthrough medical device to market is both exhilarating and exhausting. Meticulous coordination of every stage of product design and development must be undertaken with an emphasis on usability as well as a clear view of what is required by regulatory agencies. Therefore, many aspects of the regulatory process go hand in hand with human-centered design, which puts usability at the forefront of all product development decisions.

Although it is intuitive to put the user first, it is essential to apply this mindset and methodology from start to finish, starting with the initial idea and extending to each prototype. of product, feasibility study, clinical trial, regulatory process, manufacturing ramp and commercial delivery. For SOTECH Health, a Dallas-based game changer in screening mass populations for COVID-19, the path to product realization is paved with seamless collaborations throughout the product development cycle.1

Start with the end game in mind

Anchored by a mission to return the world to pre-pandemic levels of normality, SOTECH Health has developed a point-of-care diagnostic test intended to quickly and accurately detect exposure to COVID-19 in densely populated environments, such as airports, businesses, cruise lines, schools and stadiums. Unlike existing polymerase chain reaction (PCR) tests and rapid antigen tests, which take time to produce results, SOTECH wanted to screen for COVID-19 in less than 30 seconds.

To do this, the test had to be simple, direct and capable of being self-administered. With this end state in mind, the company focused on a breath sensor system that works similarly to breathalyzers used to measure blood alcohol levels. In this case, however, SOTECH’s new device can detect certain compounds, called volatile organic compounds, which are emitted when the body is in distress. A highly sensitive electrochemical sensor looks for traces of certain chemicals in the sample, which indicates exposure to SARS-CoV-2, the viral strain that causes COVID-19.

The ability to leverage unique sensing technology, developed by the University of Texas at Dallas, gave SOTECH a market advantage. Additionally, an ongoing collaboration with UT-Dallas has streamlined the identification of location, temperature, humidity, and communication sensors for data collection and sharing using artificial intelligence (AI) models. created by SOTECH to evaluate results and better understand emerging viral hotspots.

While the idea behind SOTECH’s innovation is as simple as breathing, a myriad of product design and usability factors added complexity to the development of the reusable respiratory sensor device and disposable mouthpiece that accompanies him. As is the case with many new devices, there aren’t many existing predicates, if any, to inform product development. Instead, applying human-centered design principles is key to determining product form, fit, and function by asking the following questions:

  • To what extent does this product meet a specific need?
  • Is the device easy to understand and use?
  • Is the device appealing to intended users?
  • Can the device be efficiently manufactured in commercial volumes?

Designers and developers of Medtech devices must track everything in parallel, from human-machine interfaces (HMIs) and product functionality to regulation, manufacturing and marketing. For example, if there is an indication that a product will be launched in multiple regions, then consideration of geo-specific requirements and regulatory environments is crucial. Different design inputs, compliance standards, power requirements, and documentation are just some of the areas that need to be considered from the start.

Bringing in cross-functional teams with experience in various disciplines is key to validating an existing knowledge base while uncovering all areas of exposure as early in the development process as possible. Increasingly, this effort requires drawing on the skills and expertise of experts in ever-broader fields, including industrial design, mechanical and electrical engineering, software, artificial intelligence, management supply chain, testing and quality, the list goes on.

Align regulatory and design strategies for medical devices

Successful entries into the medical technology market typically rely on strong regulatory strategies that inform both product design requirements and development decisions. For this reason, due diligence is required to ensure that the business case has sufficient visibility into what is needed for regulation, backed by verified evidence and results.

As SOTECH Health’s device is intended for mass screenings, the team looked at the use of the product, starting with how someone would pick up and interact with the handheld device and disposable mouthpiece. In particular, the team wanted to assess whether someone could insert the mouthpiece unaided and then blow into the device for six seconds to produce an accurate result.

Ongoing testing and analysis plays an equally important role in helping product developers gather and correlate a body of substantial evidence, including design history files and quality testing, all of which are required for product development. regulatory review. For most new device developers, the type and duration of feasibility, usability, and studies will vary greatly depending on the device and its intent. Either way, these initial steps are critical because specific product design choices can mitigate or aggravate certain regulatory challenges. Feedback from testing plays a major role in continuous product improvement as well as finalizing regulatory submissions and preparing for mass production.

Designing for Manufacturability Accelerates Medical Devices to Market

As soon as regulatory approval is granted, medical technology companies must be ready to forge a fast and cost-effective route to market. SOTECH Health is no exception, which is why the company adopted design principles for manufacturability from the start. Optimizing product designs for production is the best way to avoid unplanned changes that can slow a product’s path to market or increase costs. Failures or delays in integrating design for manufacturability throughout the product development cycle often result in decisions about materials or product features that negatively impact cost, quality, and lead time. of placing on the market.

Another issue that can delay time to market while adding unnecessary costs is an insufficient understanding of how best to scale manufacturing to accommodate increased volumes. It is imperative to apply all lessons learned from low-volume production in clinical trials and early market ramp-up to shift production to semi-automated and then fully automated lines based on demand. The ability to make these transitions smoothly without requiring major modifications to tooling and fixtures is essential. The possibility of reusing these essential manufacturing auxiliaries, including specific equipment on the production line, will result in significant time savings and reduced costs.

SOTECH Health anticipates a rapid ramp-up upon receipt of regulatory approval. To this end, Phillips-Medisize is preparing access to its expanded global footprint, which includes world-class manufacturing facilities, innovation centers and cleanrooms in North America, Europe, Asia, India and in Mexico. Additionally, the team is prepared to leverage a combination of manual and fully automated production lines to manufacture large quantities of handheld devices and mouthpieces on a daily basis.

Additionally, the two companies are already looking on the horizon for ways to adapt SOTECH’s unique platform to screen for other respiratory diseases and conditions in the future. Following each step involves looking to the future without ever losing sight of the product vision or SOTECH Health’s transformative mission to change the world through the power of innovation.

For a list of the top 10 critical product journey success factors, please see the infographic below.

Author’s Note

1. SOTECH product has not been cleared by the US FDA or comparable regulatory agencies in other jurisdictions. The product is subject to emergency use authorizations in light of the COVID-19 pandemic. This article is not intended to make affirmative statements about the safety, suitability or effectiveness of the SOTECH product.


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