Lillian Erickson, Quality Director, iO LifeScience

You are driving home after a busy day at work, trying to reset the fight-or-flight mechanism which has had you running from one fire to the next all day, when your attention is pleasantly diverted by the colorful new landscaping display in the road’s median-strip. You let your eyes linger just long enough to think, ‘that’s nice,’ when—boom!—you hit the Grand Canyon cleverly disguised as a pothole.

If you are a Quality Professional, your first thought is, “Why did they spend my tax dollars on flowers rather than filling in the pot holes in the road?” You know how to align resources with risk, but apparently the government hasn’t read the newest version of ISO 13485, released in Q1 2016. This version has several major changes, but perhaps the most impactful is the general requirement to use a risk-based approach when developing processes (not just products).

Some might take this to mean that they now have to perform a full-blown FMEA for each and every process at the company, and subsequently throw all of their resources uniformly at any risk which is identified. In fact, the opposite is true. A risk assessment can be as complex as an FMEA or as simple as asking yourself, “What could possibly go wrong?” For every risk identified, a score is quantified and once a collective range of scores exists, a determination is made as to which risks are acceptable, which require mitigation actions, and which must be eliminated entirely.

To illustrate this, we can go back to the roadway example from before. There are several hazards present on our city streets: material failures, potholes, gradient problems, debris, drainage issues, etc. If you are the city manager with a limited budget, you’re not going to divide it up evenly across each of those hazards. Hopefully you’re going to allocate it to the area of greatest risk to the population, while providing only the funds commensurate with risk to the other issues. In doing so, you may just end up with a surplus of both time and money which allows you to innovate new solutions, such as a self-repairing material which expands when minor cracks form in the road surface.

This same principal applies to the design and development of health care products. The process can be evaluated for risk and once a general roadmap is complete and marked with speed limit signs representing where the greatest risk lies, we can allocate our resources in an innovative, risk-appropriate way.

For example, traditional FDA Design and Development follows the Design Control/Waterfall method, requiring a fully vetted list of design inputs before any design outputs can be attempted. This approach disallows rapid prototyping and also discounts the reality that prototypes often lead us to more mature requirements. The waterfall method stifles innovation as full design control cycles must be completed before new ideas can be attempted. Using risk assessment, we can identify the key requirements the product must incorporate, allowing rapid prototyping and requirement updating, while phase-end controls are put into place to ensure that when a prototype is selected, the initial risks haven’t changed and all final requirements are met.

Approaching processes from a risk-based perspective ensures that resources are applied commensurate with risk. Innovation can only occur when we have the resources to step out of the mundane and focus on improvement. Critically evaluating our risk own risk can be an uncomfortable exercise at times as it requires honest acceptance of our flaws and weaknesses, but with it comes knowledge which brings strength to any company and allows the flexibility to not only keep up with innovation, but to lead it.


iO LifeScience connects and manages all the pieces you need – strategy, design, and engineering – to develop new healthcare innovations, creating inspired designs with compliance at the core. Our global team is united in a single mission to ensure the products we create are not only beautiful; they are also ready and able to make an immediate difference in more lives.