The Key to Successful Medical Device Design? Stakeholder Involvement

Medical device designers often focus on the engineering side to ensure functionality and performance. The voice of the customer (VOC) is the major source of product requirement documents. Though VOC provides valuable information, some requirements could get lost due to assumptions made at the design level.

Jayaraman Kiruthi Vasan

Nowadays, design teams have great technical and project management skills that help minimize time to market. When it comes to implementing actual market requirements, these strengths must be channeled within the product requirement framework, which essentially interprets the end user requirements. A simple assumption early in the design process could prove costly; it might have ignored a vital user input requirement.

I can't emphasize enough the importance of capturing key stakeholders' input early in the product design lifecycle.



Internal users
Users within the company provide readily accessible information. Marketing people could provide input on user preferences, wish lists, competitor features, and pricing. Service people could offer suggestions on things like user workflow, implementing specific features, and reducing downtime. The manufacturing department could offer valuable advice on materials and components that would form the product.

External users
A product's success depends primarily on these users. Clinicians, nurses, patients, and biomedical staff members are in a better position to review a product's features, because they have access to different makes of similar devices. Feedback from these end users or end use facilitators would always be in line with the reality on the ground.

Targeted survey
Focus groups are a vital source of information. Group discussion produces valuable data and fresh insights. This qualitative research reveals user perceptions, opinions, beliefs, and attitudes toward the product. Therefore, it can help your forecast the anticipated user experience level.

Nothing beats field study for experiencing and understanding user requirements. Posing questions at the point of use could encourage potential users to demonstrate what they have in mind.

Design team
Teams of clinical specialists and marketing and sales personnel conduct surveys and focus meetings. The design team converts the product requirement outputs from these meetings into specific design specifications. This means the design team must have an in-depth understanding of a product's functionality and its intended use.

Every stakeholder must participate at various levels to identify, formulate, and freeze the product requirements, even though there could be some overlapping of interests.

I am sure many of us have played a role in such a participative model. I would like to know your experiences and how they benefitted your organization.

Focused on medical packaging design and technology?

Jayaraman Kiruthi Vasan, Consultant - Electromechanical Systems, Healthcare Technology Innovation Centre, Indian Institute Of Technology, Madras

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