That’s a great question—and one that every real-world engineering team faces. In practice, it’s all about finding a balance between user-centered design and business feasibility. Engineers should absolutely advocate for the ideal design that best meets user needs, because that’s what ensures safety, performance, and long-term trust in the product. However, they also need to recognize that projects exist within constraints—budget, timeline, materials, and market demand all shape what’s realistic. The best approach is collaboration and compromise. Engineers can work with business teams to prioritize which user needs are critical versus nice-to-have. By clearly explaining the trade-offs (e.g., how cutting a feature might impact usability or safety), teams can make informed decisions. In the end, adapting to business limits doesn’t mean giving up on quality—it means finding the smartest way to deliver a safe, effective, and marketable solution.

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromises between the two may result simply in less convenient user experience. However, cutting corners with medical devices can have a direct impact on patient safety and clinical outcomes. Thus, the degree of adaptability in the medical devices industry must be critically considered. 

Medical devices, like products of other industries, must also operate within certain margins, but they cannot be too expensive, as this would prevent patients from benefiting from them. Thus, rectifying cost, usability, and safety are imperative. Through early planning, iterative prototyping, and early clinical/patient feedback and testing, it is possible to understand the intrinsic utility and design purpose to ensure critical aspects are preserved and that if compromises happen, developers can clearly understand what they can affect.

In light of this information, I wonder if there should be a hard set line between ethical and regulatory boundaries that engineers must not cross, even if the product commercially fails?

I think this is a great question to consider since it is something that most of us, as engineers will eventually face. What is more important, user needs or the business limitations/needs. I think, in a consumer-seller relationship, the seller should focus almost completely on consumer needs, while considering their business needs but being a bit more adaptable. The one thing to consider is that the customer needs and business limits (like timeline, budgets, etc.) are generally addressed pre-project as part of the planning process prior to any commitment form either side. This makes it so that there is not a need to really change much during the actually engineering process when making the medical device or other product for the customer. From an engineering perspective, this would be the ideal case. However, in the case where user needs do clash with business goals, let's say a project is taking too long, it is difficult to determine. Is the user of high importance to the company (meaning do they have a big name), what are they using the device for, and could there be changes made to align with the business goals that could slightly change but still align with the user needs. In my opinion, as a business it is important to stay true to your goals, but adapt to what a customer might want, especially if the customer may be a big-time partner or someone who might come back to you in the future for another project. In this case, I think the customer needs win over business goals because they serve as the future of the company if you look forward.

Engineers should "fight" for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will complement business goals. For example, designing a medical device which takes into account rather simple "quality of life" details like ergonomics and ease of use, it will allow for better clinician adoption and stronger brand reputation. Building trust with clinicians through design benefits the business in the long-term. On a larger scale, safety of a device will translate to less recalls in the future, which will save the business money. Cutting corners can only produce marginal benefits in the short-term, which will become irrelevant in the long-term. Using evidence to support design and communicating the importance of capturing user needs for advancing a businesses' goals is a good strategy for when business and design does not align. Communication between teams in design and business are important to further advance the shared goal of bringing a device to market.

I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative. I also like the emphasis on how pre-planning can help avoid most conflicts before projects even begin. Another aspect that can help is data-driven design control, since this would make the tradeoff process more objective instead of emotional. 

 Dr. Simon made it clear that design controls have documentation, including design inputs, outputs, verification, validation, and risk management files. These are checkpoints that teams can use to illustrate the “why” behind each decision that is made. Each of these also ensures that user needs are met and everything has a proper rationale, turning subjective ideas and decisions into objective actions. This allows for proper communication between the engineering team and the management team. 

What hasn’t been discussed is how quantitative tools can be used to make balance actually measurable. The Design for Manufacturability (DFMA) analysis and cost-risk modeling can show teams how changing a material might affect usability or safety. User needs and business goals become data points in the system instead of competing priorities this way. Thus, to answer the initial question in the discussion, ensuring proper documentation and discussion allows for a balance between user needs and the ideal design. Both sides are fighting for their proposal for a reason, and having all the documentation properly laid out helps immensely in proper ranking between the two sides. 

I think engineers should be the translators between technical design and business possibilities. Instead of just pushing for their ideal product, they can use concrete evidence to show how good design will lead to good business. They are key in understanding patient safety and bringing this understanding to the business side. I also think AI can play a role in finding the ideal and commercially viable product as well. With the advent of AI, a whole new perspective can be seen with the proper machine learning algorithms, boosting creativity and productivity. 

Do you think companies should have “impact justification” for whenever user-need specs are changed for cost or timeline reasons? Will this slow projects down or make them more efficient? How can AI be incorporated into disputes to allow for the most ideal and cost-effective solutions? 

To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development process. From any viewpoint, the ideal position is that the device proposed not only is specified by the user or customer, but also satisfies those necessities to the best of its ability. With that said, there can be some restrictions and constraints in manufacturing costs, materials, timelines or even just the feasibility of what is being asked. Engineers and developers should fight for the ideal design, but it must be backed up with concrete evidence and research. This is especially important not only to satisfy the customer needs, but to ensure that it is accomplished with integrity and safety as well. I do believe there will, most of the time, be comprise that arises between both parties, but teams can prioritize user needs into categories (such as must haves or what would be a luxury to have) in the design control process. Again, all this said, safety should not be compromised to establish these goals.

In practice, successful design teams balance user needs and business realities through structured trade-offs rather than choosing one side completely. Engineers should advocate strongly for essential user requirements—those that affect safety, performance, or regulatory compliance—because compromising these can cause product failure or recalls later. However, for non-critical aspects like aesthetics, extra features, or premium materials, it’s reasonable to adapt to business constraints such as budget or timeline. The key is early, transparent communication across functions: marketing clarifies market expectations, management defines business limits, and engineering quantifies how design changes affect usability or compliance. This evidence-based negotiation helps ensure that while the product meets user needs in core functions, it also remains viable and profitable to produce. In short, engineers shouldn’t fight blindly for the “ideal” design, but rather for the design that best satisfies user safety and performance within realistic business parameters.

I think the best way to balance user needs with business limits is to acknowledge that both sides are part of the design problem. In class, we have gone over how the design begins with user needs but that doesn't mean that "ideal" user-centered version of the device is always realistic in the real world. Companies still need a device that can actually be manufactured, sold, and financially sustained long-term. So, I don't necessarily think it's engineer's vs business, it's more about making decisions as a team with reasoning behind them from each perspective. Engineers should advocate for the features that impact safety, human factors, and the function of the device because those are directly tied to clinical outcomes and success. But for other preferences, like comfort upgrades, cosmetic enhancements, and convenience features, it makes sense to adjust or scale back when cost or timeline gets tight. Not every desired feature has equal weight. Overall, I think the best products are the ones where both shape the design before it locks, instead of one side forcing changes at the end.