Tips for Unbiased Medical Device Product Design
Various factors affect a Medical Device’s innovation process. It is often seen that media, business trends and profitability influence innovators. At times, the innovations can be biased towards a particular class of people.
Intentionally or unintentionally, a device which has been developed with a biased mindset will upset a particular set of people. As an innovator, it is essential to ensure that your device is beneficial to all users and enhances patients’ care/recovery journey.
So, how do you ensure that the medical device is unbiased?
Well, don’t worry, we have put together a few tips for you:
- 1. Include Diverse groups:
While performing clinical trials, human factor testing, and other pre-market activities, make sure you include diverse groups. Try involving small populations of large demographics. This will help you ascertain key facts and enhance your product’s efficacy. For example, EU MDR makes it mandatory for manufacturers to use ISO 62366 as a harmonised usability/HFE standard.he authorities expect a manufacturer to consider diverse device users from
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Professional backgrounds
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Socioeconomic backgrounds
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Ages, Disabilities etc.…
- 2. Read and Cite Other’s work:
As a researcher and innovator, you might be reading various literature reviews where different creators would be working on similar products. Every creator might be getting different outcomes and results, and you should make sure that you read such literature. This will help you understand and dig deeper where you will be able to assume certain outcomes and avoid wasting resources. Since you referred to someone else’s study, it is important for you to give due credit and cite their work.
- 3. Fair Outcomes:
Not all results or outcomes will be favourable; if there is something unfair, report it. Report the shortcomings and let the community be the decision-maker. When correct outcomes are reported, the community will help you understand what can be done better or needs improvement.
- 4. Stakeholders as Inventors:
Who doesn’t like to be included in a study or have an opinion?
Well, as an innovator, it is important for you to ensure you include your stakeholders as co-inventors. This will give the stakeholders a sense of belonging and responsibility. There is a strong possibility that you will be able to improve your study and create a bias-free device with a few extra numbers of inventors.
- 5. Start with Fair play:
You, as an inventor, should begin your work and project with fair play. Don’t let any bias dominate the decisions or the process flow of invention. When fair play is given importance, every step will drive you towards creating an unbiased device.
- 6. Quantify Fairness:
Numbers play a significant role. Do a benchmarking activity to understand what is to be done and achieved. Apart from the statistics, try developing a framework that will help you to justify fairness in the numerical method.
Medical Device innovation requires time and effort. For entrepreneurs, it is relatively straightforward to develop and create their innovative devices, but too often, they are then faced with key hurdles in the form of commercialisation and market access!
Don’t worry; connect with our experts today, and they will provide guidance as well as effective solutions to overcome your regulatory hurdles.
Feel free to connect with us
Email us: mdd@mddltd.com
