The process of developing a medical device is complex and requires careful consideration of various factors to ensure the safety, efficacy, and compliance of the device.

Whether you are a startup entrepreneur, a product manager, or a senior medical device engineer, asking the right questions at each stage of the development process can help you make informed decisions and avoid potential pitfalls. Design Engineer, Elena, shares some critical questions to ask yourself when developing a medical device to ensure a successful outcome:

What is the problem or need that the medical device is addressing?

Understanding the problem or need that your medical device is solving is the foundation of the development process. For a medical device to be successful it needs to deliver clear value to the key stakeholders, starting with the user. Ask yourself: What is the unmet need in the market or clinical practice that your device is addressing? Who are the target users or patients? What are their pain points and challenges? Don’t start with what it does but rather define who it’s for.  Will my solution lead to better outcomes, or lower cost, or both? Why? What is my evidence?

Understanding the problem or need in detail will guide the development process and help you create a device that truly addresses the intended market or clinical need.

What are the regulatory requirements and standards for the medical device?

Medical device development is one of the most regulated sectors in the world and so regulatory compliance is critical. Every device is different and has its own regulatory strategy and framework. Ask yourself: What are the regulatory requirements and standards that apply to your device? What are the FDA regulations, ISO standards, or other applicable guidelines that you need to follow? Are there similar products on the market that have already been successfully approved?

Understanding the regulatory landscape and ensuring compliance from the early stages of development can save time, resources, and potential setbacks down the road.

What are the technical specifications and performance requirements of the medical device?

Defining the technical specifications and performance requirements of your medical device is crucial for ensuring its safety, efficacy, and performance. Ask yourself: What are the key technical features, functionalities, and performance metrics that your device must meet? What are the engineering, design, and manufacturing considerations that need to be taken into account?

Defining clear technical specifications and performance requirements will guide the development process and help you create a device that meets the desired performance outcomes.

What is the intended user experience of the medical device?

Considering the user experience of the medical device is essential for its success in the market. Ask yourself: How will the device be used by the intended users? What are their expectations, preferences, and limitations? How can the device be designed to be user-friendly, intuitive, and safe?

Understanding the user experience and incorporating user feedback into the development process can result in a device that is well-received by users and meets their needs effectively.

What are the potential risks and mitigation’s associated with the medical device?

Every medical device development project carries certain risks. Identifying and mitigating potential risks associated with the medical device is crucial for its safety and efficacy. Ask yourself: What are the potential risks, hazards, and failure modes associated with the device? How can these risks be mitigated through design, testing, and validation? What are the contingency plans in case of unforeseen issues? These risks can stem from the market, competition, intellectual property, technical feasibility issues and more. Once risks are identified, you can then decide whether to pivot or proceed with a clear understanding of the risks and potential costs that will be involved.

Conducting thorough risk assessments and implementing appropriate mitigation’s can minimize the risks associated with the device and enhance its safety and efficacy.

What is the intended market and competitive landscape for the medical device?

Understanding the market and competitive landscape for your medical device is crucial for its commercial success. Ask yourself: What is the target market for the device? What are the market trends, dynamics, and opportunities? Who are the competitors and what are their offerings?

How does your device compare to existing solutions in the market? You should also consider the size of the competition and whether they are direct or indirect competitors. Understanding the market and competition will help you position your device effectively and create a compelling value proposition for potential customers.

What is the business model and commercialisation strategy for the medical device?

Developing a medical device requires careful consideration of the business model and commercialization strategy. Ask yourself: What is the business model for your device? Will it be sold to hospitals, clinicians, or directly to patients? What is the pricing strategy?

Should it be done?

You should consider the environmental impacts of the project and, if the project should be done at all or, if the problem could be met in a different way that doesn’t compromise the environment? Asking sustainability focused questions from day 1, rather than trying to reverse engineer solutions when the process is further along, could save a substantial amount of cost and time throughout the project.

As a design engineer it is important to always be questioning yourself throughout the entire process. This not only ensures compliance, efficacy, and safety, but also ensures you aren’t developing a device that the world and users don’t need.

Medical Device Design Development Engineer, Elena Slobodyuk Elena Slobodyuk 31 July 2023


Get in Touch with Elena Slobodyuk

Elena graduated from Loughborough University in 2017 with a degree in Product Design and Technology. Since, she has worked as a Design Engineer working at a consultancy designing children’s car seats before working as a designer and product lead at a start-up where she oversaw product development from concept to manufacturing of prosthetic limbs, with a heavy emphasis on user-centred design and human factors in addition to involvement with business development activities to grow the company.

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