Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve their market share. This is especially true when considering all of the communication channels concerned with the project, such as QA/QC, engineering, regulatory, marketing, sales, and so on. The inputs coming from other departments must exceed the quality they promise to ensure the final output (the product itself) will reflect that enhancement. Otherwise, the product will not perform as expected, and that can be traced back to improper documentation, organization, or a lack of feedback at every step of the process.

The design controls Dr. Simon reviewed in this week’s lecture demonstrate a comprehensive process to ensure that new products reach the market in a traceable, ordered manner. That is, many required input processes (namely, protocols & documents) and review processes to prove their output viability at all stages of the overall process waterfall, and how those outputs are the next phase’s inputs. These inputs incorporate a feedback loop coming out of each sub-process, where employees need to verify whether the outputs match their inputs. This is the quality control system within the design control/input system; teams need to review their work before passing it along & communicate any doubts to guarantee that it meets (and exceeds) the documented expectations. This continues through the Design Output, Verification, and Validation processes, where the design stage inputs must meet customer expectations within and outside of the company (specifications for the company, performance for the customer, respectively). Fail to take advantage, and the company risks a snowball effect that magnifies any shortcomings from said inputs/outputs.

 Quoting Dr. Simon: “Inputs must equal outputs.” 

This issue would become especially prominent if they were solely attempting to appease regulators without enacting an effective feedback system. If they are only fulfilling the barebones requirements of the inputs without attempting to enhance the results and exceed their input expectations via communication/collaboration, they will have an equally barebones output. Thus, a barebones product.

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are viewed simply as a regulatory burden rather than a way to augment product development. When companies end up integrating design controls into their product development culture, they become more than just about compliance, but are perceived as robust tools for communication, documentation, and risk management. 

An interesting adoption of design controls I have seen has been through digital quality management systems (eQMS) that automate traceability between inputs, outputs, and risk assemenets, rather than making them a post-hoc documentation exercise. Integrating design controls into the development workflow in such a way has received positive feedback from engineers, quality teams, and regulatory affairs due to both the efficiency and compliance provided by such a system. 

Importantly, there is also greater post-market success when teams utilize design controls in such a more cohesive way. A big part of this success comes from field issues being rectified quickly due to the traceability provided back to specific inputs and verification steps, allowing for continuous and swift iteration. 

Do you think smaller startups would gain a strategic advantage from realistically and efficiently using design controls? If so, what kind of advantage?

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to develop and execute a more custom project scope to satisfy a niche market in the medical device industry. As a result, marketing becomes a simplified process because the customers are specific. This understanding can save money and improve the return on investment. Customer interactions during the design controls can increase their loyalty. Larger companies are more likely to target a larger market with a broader customer base or add products to their existing product line to benefit their current customers. 

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To answer Krish’s question, I think that smaller startups can gain a strategic advantage if they integrate design controls early in their operations. Unlike large corporations that treat documentation as a compliance task, startups are smaller and easier to navigate. Thus, they can embed design controls directly into their development DNA, and this would allow them to be traceable. The flexibility of a startup and its development structures would make design controls advantageous and build a stronger foundation for growth. 

What has not been discussed yet is how design controls can be an institutional “memory” system. In other words, it can allow for continuity and organization. Startups usually have high employee turnover and evolving teams, so continuity can be a challenge with the changing staff. However, when design controls are built into digital systems from the start through an eQMS platform like Krish mentioned, then every decision and rationale is preserved. This allows compliance and learning from iteration instead of restarting when a new engineer joins. Thus, documentation becomes a knowledge asset and a map of how the company thinks. 

I think bigger companies use design controls as a check box and a way of insurance since they have so many moving parts together, but smaller companies can use them for traceability and accountability early on, so they don’t become a bigger company that treats them as check boxes. Proper due diligence and regulation can attract partnerships as well. Using AI to safely assist will also keep up with the changing times and allow design controls to be more of a helping tool than a burden. 

Another competitive edge is how startups can interpret compliance creatively. Design teams can use design controls as a feedback and innovation system. Failures and successes are documented, and successful patterns can be reused. 

Do you think the FDA should have incentives for startups that enhance design controls and the growth that they can facilitate? Would this help push innovation and maintain safety? Should smaller companies have different regulations for design controls than bigger ones? In what ways? 

I think it really depends on the company and how much they value quality in their process. Some teams tend to see design controls as just another set of documents to complete for FDA or ISO compliance, especially when project timelines are tight or management is focused on getting a product out quickly. But when design controls are applied with the right mindset, they can actually make development smoother. They help teams communicate better, keep track of decisions, and make it easier to trace issues back to their root cause. During my internship, I saw how linking test results back to specific design requirements made everything more transparent and organized during reviews. It not only saved time but also built more confidence in the product’s reliability. I do think the FDA could encourage innovation by offering incentives to startups that invest in strong design control systems. This could help smaller companies build a solid quality foundation while still allowing flexibility to grow. Having slightly scaled regulations for startups compared to large manufacturers might make sense, as long as patient safety and design traceability remain intact. Do you guys think most teams actually see the value in design controls, or do they still view them as just extra paperwork?

I believe that many businesses, particularly smaller ones that are under pressure to launch a product quickly, first view design controls as merely another regulatory box to check. It's simple to think of them as more paperwork rather than anything that truly facilitates the process. However, when used properly its obvious that design controls have a significant impact. They guarantee that teams stay organized and maintains consistency in documentation. I've found that businesses that take them seriously from the start identify problems early and have more efficient development cycles. Even though design controls may initially seem like a burden, they result in improved communication and less headaches later on.

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value accountability, learning, and growth will naturally treat design controls as part of the foundation and framework rather than just being in compliance with the law. If management sees these design controls as an obligation, the rest of the team will likely follow that same attitude and thus be prone to taking short cuts and checking off a box, which can have a negative impact. While it isn't always black and white, it is something to consider overall. Design controls, when thought through and properly implemented, can shape a company's culture overtime, especially when applied seriously. It creates positive habits, self reflection, accountability, and traceability that can carry over to each department within, rather than just engineering or quality assurance. This helps with keeping the company more consistent with a longer lifespan after a product's launch.

Following design controls intentionally is important for efficiency, even if it feels like it's there just for compliance. A lot of it feels like regulatory checkboxes, but it can benefit a project team if it is followed. In business, there can be pressure from other departments or from shareholders to reach a launch date on the market quicker. Design controls plays an important role in making sure that engineers can stand their ground when defending their designs. Using design controls are protection against being coerced into taking shortcuts to benefit the company at the cost of the product. Design controls have requirements which are approved, and each has identified risks. Companies who use design controls to their benefits often will have products which are safer and result in fewer surprises stemming from redesigns caused by pressure from marketing or other higher authorities.

I think many companies initially treat design controls as a regulatory checkbox, especially smaller startups rushing toward 510(k) or PMA submission. However, the organizations that truly excel in product quality recognize that design controls are not barriers but rather they are blueprints for consistency and communication. When done properly, these frameworks actually improve efficiency by reducing design rework, preventing scope creep, and ensuring design intent is traceable from concept through verification and validation. For instance, maintaining a Design History File (DHF) or using an integrated QMS platform (like Greenlight Guru or MasterControl) allows teams to spot inconsistencies early, streamlining both audits and design iterations.