IDEAL Biomedical
What Are Design Controls?
A repeatable process of innovation
Design controls are often perceived as a constraint on innovation. I provided a counterpoint to that perspective by asking, “Why Are We Controlling Design?”
To increase success and improve health outcomes with a repeatable process of innovation.
Design controls are a formal method to conduct product development activities. An example we are all likely familiar with is the method of scientific discovery. Before the scientific revolution of the 16th and 17th centuries, there was no agreed-upon method to conduct science experiments. Today we learn the scientific method in grammar school. This systematic process does not constrain the creativity of our scientific discoveries, but rather, it provides a repeatable process.
Design controls are a legal requirement in most of the developed world. In the USA, they are enforced by the Food and Drug Administration (FDA), Code of Federal Regulations, 21 CFR 820.30.¹ In the EU, requirements can be found in the MDR 2017/745.² These regulations are harmonized in a voluntary standard, ISO 13485 section 7.3 Design and Development.³ Largely misinterpreted, however, neither the FDA nor MDR requires a specific method. If the regulations were for conducting science experiments (hypothetically), they DO NOT state, “Follow the Scientific Method to a T.” What they do say (figuratively) is, “Have a method.”
What freedom!
Believe it or not, the requirements provide significant freedom to implement a creative and innovative design process. At a high level, medical device manufacturers are asked to, as part of their much larger quality management system (QMS) include the following items as part of design controls:
- Design and development planning
- Design input, intended use, and user needs
- Design output
- Verification of design outputs to design inputs
- Validation that the final device meets the user's needs and intended use
- Design review
- Design transfer to production
- Design changes
- Design history file
Beyond these requirements, the ISO Standard, FDA, and MDR do not prescribe a specific process to follow. However, the FDA, in an effort to be helpful, provided a guidance document that included one example of a process, a traditional waterfall method.
The FDA published Design Control Guidance for Medical Device Manufacturers, on March 11, 1997.⁴ On page 3, they showed the now infamous, Waterfall Model. What I want to highlight are these words in the fine print below the figure:
The development process depicted in the example … feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development. However, this detail has been omitted from the figure to make the influence of the design controls on the design process more distinct.
This is so important, I’m going to repeat it…
in the example, the iterative nature of product development has been omitted from the figure
This omission was intended to highlight the influence of design controls, NOT to take the iterative nature of design out of the process. It was not intended to represent the only method. It was one example.
There are advantages, however, to using the lexicon from a process that the FDA showed as an example. Rather than come up with some unique, outside-the-box method of design that no one understands, what I offer is a subtle change to unlock creativity while staying squarely inside the box of the waterfall example.
So wait, what are design controls? I’m still confused.
Design controls are a repeatable process of innovation to increase success and improve health outcomes. In addition to the references below, I have written a series on this topic which includes the following topics:
- Why Are We Controlling Design?
Increase Success & Improve Health Outcomes with a Repeatable Process of Innovation - How Early Should We Start Design Controls?
Convincing a Team It is Time Worth Investing - Enabling Evolutionary Design
A Tweak to the Waterfall Method that Changes Everything
References:
- Code of Federal Regulations, Title 21, Volume 8 [CITE: 21CFR820.30]
TITLE 21 — FOOD AND DRUGS
CHAPTER I — FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H — MEDICAL DEVICES
PART 820 — QUALITY SYSTEM REGULATION
Subpart C — Design Controls - REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, Section 7.3 Design and Development
- Design Control Guidance For Medical Device Manufacturers, Guidance for Industry, March 1997, Docket Number: FDA-2020-D-0957 Issued by the Center for Devices and Radiological Health
Thank you for reading.
health. happiness. kindness. respect. to every-being and all-things
- ajds
