Over-engineering in medical devices is more common than we think, and it can severely impact products and companies.
Today’s post is directed to all the people involved in the process of new product development, especially engineers, no matter their role—for instance, R&D engineers, founders, CTOs, project managers, and designers.
We all know the sentence, “the devil is in the details.” Well, over-engineering seems to be the natural solution, and R & D engineers might not even see it and do not see its associated risks.
Read this step-by-step guide to understand over-engineering in MedTech, its cause, and its effects.
What is over-engineering?
According to Wikipedia:
“Overengineering (or over-engineering) is the act of designing a product or providing a solution to a problem in an elaborate or complicated manner, where a simpler solution can be demonstrated to exist with the same efficiency and effectiveness as that of the original design.”
“…They (products) may become overcomplicated – the extra functions may be unnecessary, and potentially reduce the usability of the product by overwhelming lesser experienced and technically literate end users, as in feature creep“.
The term over-engineering is common in the context of software development, where I found a couple of sources that I like:
Here is a definition of over-engineering from Paweł Głogowski: Code or design that solves problems you don’t have.
Also, here’s a picture from a platform providing a collection of coding Q&A.
This picture was developed to explain what over-engineering in software development is. And it could be beneficial also in the context of medical device development. From left to right, the situation evolves with engineering dominating the space and becoming over-engineering, pushing design out of the column and surrounding the user.
MedTech overengineered products have many features and functions that the user does not value. Typical examples are extra functions that do not solve the users’ real problems or solve the issues in a minimal user population. Over-engineering frequently adds complexity to the product limiting usability and preventing customers from enjoying its full benefits.
Why is over-engineering common in MedTech?
I’ve worked with self-adsorbed and cave-dwelling engineers and even with narcissistic, egocentric, and sociopathic engineers, respectively, the second and third columns in the previous picture.
Only some R & D engineers belong to these two categories, but unfortunately, this is not sufficient to prevent over-engineering.
Usually, over-engineering happens without engineers having bad intentions. After all, nobody wants to develop a medical device that is complicated, full of awkward functions, and with poor usability. Over-engineering develops because a core principle (customer focus) is not “lived,” and we do not put in place systems to avoid its development.
Main causes of over-engineering
The leading cause of over-engineering in MedTech is the lack for more customer focus. Customer focus is the core principle that the team should live.
Customer focus is critical in the process of new product development, and it is a barrier to deviations like over-engineering. Lack of customer focus produces various sub-causes that will help generate over-engineering. Here are other sub-causes of over-engineering in MedTech.
Not well-defined customer’s problem
If a specific customer’s situation has not been identified and classified as worth solving, how do you know which features to prioritize?
A problem not clearly identified and defined can promote over-engineering simply because the team will end up designing a product or a feature that could solve a problem not crucial to the customer.
Poorly defined user requirements
Vague, ambiguous, and unclear user requirements can generate over-engineering. This is because the development team will translate them into design inputs (specifications) according to their interpretation, which might be different from the one of the customers.
In this case, the engineers might develop more than what is really needed based on speculations.
Focus on outputs instead of outcomes
Outcomes are what your customer wants. Typically, it is the solution to a problem or a need. Likewise, the output is a feature, a functionality, a specification, and it is solution related.
Some marketers, losing the customer focus, use the outputs to produce unique selling points. These USPs, if not based on real customer needs, are weak.
This approach can also produce over-engineering since the team will focus on shipping technical features without considering the actual value for the customer.
Poorly conducted VOC
If at the end of the first steps of the VOC, you cannot produce a clear, complete, prioritized list of user requirements, the base for the new product development is not solid.
Therefore, over-engineering can quickly develop because the engineers are free to speculate about customers’ needs, and there is no evidence supported by the VOC to align the team. Uncertainty leads to designing more elements than necessary.
Few iterations
Medical device development is a highly iterative process with frequent loops. It isn’t easy to find a solution to all user’s requirements on the first attempt.
The iteration process helps to assess the design, validate the features, and increase concept maturity. Also, few iterations can lead to over-engineering due to a lack of feedback and testing.
KOLs influence
The involvement of only a group of KOLs in developing a new medical device can encourage over-engineering since KOLs might require features and functionalities that are not valuable for mainstream customers.
Safety
The safety and effectiveness of Medical Devices are critical to obtaining market registration from the authorities. Over-engineering happens because the development team wants to increase the safety profile while trying to anticipate remote risks and prepare for the unknown.
Conclusion
To conclude, over-engineering in MedTech has the potential to harm your new product and prevent you from getting a proper product-market fit.
Unfortunately, over-engineering is not an exception. It is vital to know not only what it consists of and the leading causes but also the consequences and how to prevent it, which are the topics of my next post.
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Thanks for reading.