Jesseca Lyons, a Mechanical Engineer, discusses challenges in determining user needs for medical devices. She highlights using Root Cause Analysis, guiding customers through defining user needs, and the importance of understanding the problem before solving it. Lyons emphasizes the significance of identifying core user needs early in the design process to avoid pitfalls and ensure successful outcomes.
User needs must be defined early in the development process to align with real user problems.
Balancing technical precision and user-friendly language is crucial in crafting user needs for medical devices.
Deep dives
Understanding User Needs and Design Controls
User needs are a critical aspect of developing medical devices, ensuring they meet the requirements of the end users. In a podcast episode featuring Jessica Lyons, a mechanical engineer with extensive experience in gathering and defining requirements for medical device development, user needs were highlighted as a fundamental aspect of the design process. Key points discussed include the importance of defining user needs early in the development process, common pitfalls in crafting user needs, such as being overly technical or not aligning them with the actual problems users face, and the necessity of involving cross-functional teams in identifying user needs to ensure a comprehensive understanding of user requirements and preferences.
Challenges in User Needs Definition and Ownership
Challenges in defining user needs often stem from a lack of clarity on ownership within organizations. The podcast emphasized the importance of determining who is responsible for overseeing and articulating user needs, highlighting the benefits of involving various stakeholders, including marketing, sales, customer success, and engineering teams. By engaging multiple perspectives and sources of user feedback, companies can better capture diverse user requirements and preferences. Additionally, it was noted that user needs should focus on identifying the underlying problems to be solved, rather than jumping to solutions, fostering a more user-centric approach in product development.
Balancing Technical Detail and User-Friendly Language in Design Controls
An important aspect discussed in the podcast was the challenge of balancing technical precision with user-friendly language in design controls. While engineering expertise is crucial in crafting user needs, there was an emphasis on the necessity to communicate these requirements in a manner that is easily understandable to end users and stakeholders from various backgrounds. By simplifying technical language and ensuring that user needs address the core problems without prescribing specific solutions, medical device companies can enhance collaboration and alignment across functions, ultimately leading to more effective product development.
Iterative Approach to User Needs Validation and Design Inputs
The episode also highlighted the significance of an iterative approach to user needs validation and design inputs. By regularly validating user needs through interactions with end users and stakeholders, companies can ensure that the identified requirements align with user expectations and address genuine needs. Moreover, the discussion emphasized the importance of formulating design inputs that directly correspond to user needs while allowing flexibility in exploring various solutions. This iterative validation process enables continuous refinement of user needs and design inputs based on evolving insights and feedback, contributing to more tailored and user-centric medical device development.
What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode.
Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. During today’s conversation, you’ll learn more about how Jessica is thinking about challenges in getting to user needs, using Root Cause Analysis to get to true user needs, and determining who will be interacting with the medical device and which ones are users.
Some of the highlights of this episode include:
Themes that trip people up regarding user needs and how Jesseca helps them
Fears about problems during FDA inspections and 510k submissions
What Jesseca thinks of when she thinks of user needs
Guiding a customer through figuring out a user need
What makes it difficult to get to user needs
An example of a standalone design input
When to stop divergent thinking
More user needs pitfalls
Which people are users
Memorable quotes from Jesseca Lyons:
“Most of the time, our user needs aren’t really doing a good job of telling us what the user is actually looking for; what problem we’re trying to solve.”
“I always found it interesting that we were so willing to solve a problem before we really understood what the requirements were.”
“Anyone who comes in contact with your medical device could be a user.”
“Every fear is a legitimate fear.”
“Your design inputs shouldn’t be so restrictive that there’s only one right answer.”