Design Outputs
Congratulations. You’ve successfully navigated the pitfalls of the previous design control phases. You’ve now reached the Design Outputs phase. This means you’re ready to consider Design Inputs from all the stakeholders and implement your design into tangible outputs, using appropriate documentation.
Design Outputs are all about documentation. The FDA, ISO, and other regulatory bodies will judge your work in this phase through the tangible records your team assembles and provides. This documentation must support an objective review of multiple product design facets. Chief among them, are whether all your inputs have outputs, how well those outputs have satisfied those inputs, and how well your team identified and reviewed risks.
As part of the documentation process, specifications, drawings, and other tangible evidence confirms whether your product:
meets the original user's needs
is defined, in terms of the various risks to be controlled
is adequately documented
This brings us to the first pitfall to avoid in the Design Outputs phase.
Pitfall 1: Assuming that your current documentation is sufficient, excessive, or even relevant.
Launching a new medical device in the United States involves scrutiny by the FDA. You’ll be required to prove your product is safe and meets all applicable standards. By the Design Outputs phase, you’ve probably generated tremendous amounts of documentation. Ensuring this documentation is easily reviewed helps. However, why confuse a reviewer with a bunch of records that are not strictly needed to enable them to assess your device? You’ll be in for a rough time if those auditing your work cannot find what they want, or cannot understand why you’ve included superfluous details.
Product success in the Med Device world lies in your documentation, not your technology, as the FDA (or a Notified Body for that matter) will not approve your new product/technology on the merits or promise of its design. Finding a competent regulatory expert is extremely crucial during this phase, to guide you and your firm to the right level of quality and organization, and to prove your product has what it takes to succeed. Keep this in mind to avoid the risks associated with this pitfall.
This brings us to another important pitfall to avoid in this phase.
Pitfall 2: Assuming your third-party engineering partners know what is needed.
If you’re part of a large organization with orderly design control processes in place, the Design Outputs may seem routine, or even set in stone. For startups, it is a different story.
Often, when startups, investors, inventors, or individuals conceive a new product, they list key requirements, benchmark the competition, and conclude, “I just need a device that’s a little bit better than this other one.” After rapid iterations, they produce a satisfactory prototype, and the investors and inventors breathe easier, thinking that the hardest part is done.
Then, they seek additional support to supply the Quality or Regulatory expertise required to carry the product across the finish line.
The scenario becomes less ideal once the work begins, worsens over the course of several months, and culminates in an overrun of the engineering firm’s timing and costs, often requiring changes to the design, due to undefined risks or risk controls.
To appear broadly competent, many engineering firms may not admit when they haven’t completed a similar project. They’ll simply reassure you that they can do it, believing that if they admit their uncertainty, they may not win the bid. Hearing “we can do that” probably evokes a sense of security on the client’s part, but it cannot tell the client what working with them will be like, or how effective they will be until it’s too late. A poorly-chosen partner can quickly exceed initial internal estimates without delivering the expected progress, leaving everyone feeling disappointed.
Sadly, we’ve seen this process play out countless times, with hundreds of thousands of dollars–sometimes even millions–wasted. The client walks away with a cool prototype that they can’t do anything with, very often out of money, and with time lost.
What are the things that signify you’re dealing with the right firm? We recommend clients assess an engineering partner for evidence of the following:
a strong backbone of project management
a demonstrable portfolio of success with products and projects in similar categories
the breadth of products successfully launched
a seasoned, knowledgeable regulatory expert who has successfully submitted several 510ks
ability to tap into industry experts quickly, as needed
Put simply: a great idea and a proof of concept is highly promising, but it is only one component among several non-negotiable requirements needed to reach market readiness. You must task (and trust) your engineering partner to help navigate and overcome 80% of the risks in case you haven’t encountered them before
Lastly, do not make the mistake of believing this kind of work can be managed via a single simplistic, one-size-fits-all product, service, company, or process. If you’re feeling coerced into buying into a glitzy Engineering Firms’ proven process, marketing story, or “all in one” service offering, without seeing proof of concrete expertise and competence, this is a red flag.