The process of developing and launching a medical device literally requires thousands of cumulative hours focused on deep user research, scrupulous testing and detailed reporting. And though technological advancement is always top of mind for design teams, the lengthy device development process is not always conducive to evolving medical device technology.

This is where a competitive technology teardown comes in.

A detailed, performance-based teardown gives the new development team clarity and confirmation on how an outcome is achieved. This process is also an extremely efficient way to benchmark the minimum performance expectations.

During this technology teardown process, the team will start to converge on the approach to their application of their technology/treatment. This in-vivo convergence is a wonderful thing to watch.

What Is a Technology Teardown?

A technology teardown isn’t simply breaking down the product into its constituent parts to understand the BOM and COGS. It’s a focused effort on how performance is achieved.

During these teardowns, you can expect there to be instrumentation involved, such as flow meters, sound meters, light meters, VOMs, oscilloscopes and possibly a patient simulator. The devices will be operated through their entire range of operations where observations and measurements are noted.

A product teardown is designed to examine every single aspect of the device — from the performance right down to the smallest details, like the components on the circuit board. All of this information is then used to inform product requirements.

Macro vs. Micro Product Teardowns

Product teardowns can be broad or incredibly specific.

A macro, competitive technology teardown will focus on the entire product performance and how it’s achieved. Performance testing several competitors at once is the best method to analyze weaknesses and opportunities. The information gleaned from a macro teardown ultimately helps the team engineer a better device.

Though the approach is the same, micro teardowns are generally centered around one specific discipline, such as improving the user interface, lowering production costs, improving cooling requirements/methods or improving a specific mechanism. A micro competitive teardown can have a more Kaizen event feeling, but it is no less valuable.

How to Conduct a Product Teardown That Leads to Innovation

A technology product teardown integrates competitive product comparisons, performance analysis and benchmarking to fully understand a product’s strengths and weaknesses. This knowledge is distilled and will find its way into line items in the product requirements document (PRD).

Every teardown follows roughly the same pattern. Similar to Kaizen events, teardowns are action-focused and typically last a few hours to a day or so. Properly done teardowns will include all the key stakeholders, encourage listening, provide a safe space to brainstorm and allow actionable ideating from all participants.

5 Steps for Conducting a Successful Medical Device Product Teardown

When planning for the teardown, create an agenda and purpose statement. These are crucial to the event’s success.

1. Gather the Right People

With the technical teardown purpose clearly stated, now you know who to invite — people who will add value to the discussions. The invite list will certainly include the research and development members, possibly the human factors engineers, and production crews. The attendees may also include leadership like the CEO and COO, marketing, sales, supply-chain and customer support — depending on the objective. Even though the people in this second group may not have hands-on design roles, these are individuals who have valuable perspectives.

2. Give an Overall Critique

Start with a high-level overview of the product or system so that everyone understands its indications for use and clinical purpose. This will give a foundation for understanding why the original technical team made some of the decisions they did throughout development.

This overview will include a high-level description and general critique of each product. At this stage, you should be formulating a general critique of the product as you deliberately move through every phase of use applicable to the teardown objectives — no matter how small or insignificant it seems. This may even include unboxing, removing packaging and even unfurling twist ties. Analyze each accessory and ask “why?”. At each step, note what works and what doesn’t and begin to discuss possible ideas and solutions that could be applied to your project.

For a micro teardown the subcomponent/assembly may have been removed from the product or left in for a performance evaluation. In any case, frame or classify the sample before disassembly so that all participants understand what they are looking at.

3. Run a Complete Performance Test

Turn the device on and interact with it. Run the device through all its functions as well as the entire operating range.

Insist that all participants take part. Interacting with the device allows the participants to understand the product in more detail (i.e., to personally feel the discomfort of an awkward situation or realize a disconcerting connection).

4. Begin the “Teardown” From Top to Bottom

After conducting a high-level critique and performance assessment, the actual “teardown” takes place. Disassemble the product carefully and completely to break down the inner workings.

Teardowns can be done on new or used products. In most cases, there’s an advantage to tearing down a device that’s been well used. It can illuminate weak components and common user issues that a new device will not show. Whether the product is new or used, proceed with caution and wear applicable personal protective equipment (PPE).

Dive into the details: component selection (custom or commercial), feature robustness, type of materials and lubricants, source of vibration (and why), wear points, components critical to performance, needed tolerance for success, number of connections, number of different voltages or power requirements, efficiencies, etc.

5. Report and Integrate Your Learnings

In order to capture the rich discussions, it is best to record the entire teardown. Video allows the camera to zoom in on the subject at hand while recording the conversation.

At the end, the facilitator will compile everyone’s notes and video(s) into a single competitive teardown summary report. The purpose of the report is to align your development team and inform creation of — or modification to — your project’s PRD.

3 Ways Product Teardowns Bring Value to Your Development Project

A product teardown can be an expensive event — initially. However, teardowns are valuable not only to improve your product and make technological advances, but to save time and money throughout the rest of the medical device development process.

The insights and granular information you gather during a teardown will lead to:

1. A Head Start on Prototyping

A product teardown provides a benchmark for the design team that will decrease the time spent on preliminary engineering prototypes. With a teardown under their belt, the design team will be on the same page with the fundamental elements and will be working on the innovation portion of the product.

2. Team Agreement on Performance and Features

Teardowns allow the entire team, decision-makers included, to weigh in and actually see what creates the performance. Having everyone in the same room allows decisions to be made faster. Once again further clarifying the product requirements and design inputs.

For example, in a product teardown for an orthopedic walking boot, “comfort” will be a topic of discussion. The concept of comfort must be put into measurable and observable terms in order to design for it. The purpose of a walking brace is to immobilize the ankle region. Well, immobilization is inherently uncomfortable. During the teardown, the team can agree on features/specifications that quantify the needed padding around bony protrusions and make the liner breathable.

3. Narrowing Down the Product Requirements

At the most granular level, teardowns allow product requirement refinements to organically develop. Teardowns provide an outlet to diagnose minor issues that can cause lingering problems.

Reviewing a product returns log or complaints analysis report prior to a teardown will give the team additional product improvements to consider as the teardown progresses. All of the outcomes from the teardown should find their way into the PRD.

Teardown to Build Innovative Medical Devices Faster

A competitive product teardown is all about understanding a product (idea) relative to the existing competition. This leads to greater usability, better product-market fit and more innovative medical devices.

Innovation doesn’t always look like high-tech touch screens and sleek metal housings. Sometimes innovation means putting a larger manual on/off switch on a device because that’s what is easiest for the user.

Product teardowns allow development teams to get into the minutiae of products, understand exactly how users and patients feel while using them and then engineer the final product based on those requirements.

Though the moniker teardown sounds like reverse engineering, a detailed competitive teardown is an exceptional tool that enables better collaboration, kick-starts innovation and, ultimately, results in a higher-quality medical device.