Services

Regardless of whether you are developing a new or next generation product and regardless of how far you have progressed into your (final) design phase, I can come on-board and analyze your product from a usability, and safe and effective use perspective and provide you with the input you need to make sure your User Interface product is sufficiently designed for the intended user and the intended use environment and that your documented evidence is sufficient and adequate to withstand regulatory scrutiny. 

An independent product, or product documentation review, can help you understand whether you have succeeded in adhering, traceably, to the required level of Human Factors Engineering and risk management guidance. 

A review can give you the confidence that your submission process will be successful. 

With a product (documentation) review i can identify areas where you’re designed can be improved or where your documentation lacks evidence. 

I can review your design process to determine whether your efforts to develop a usable and safe product are in line with the expectations of regulatory reviewers and guidance from Human Factors Engineering standards and regulations. 

I can help you embed good Human Factors Engineering and usability risk management processes into your R&D and manufacturing organizations by training your Engineers, Quality management, Risk management and regulatory staff.

I can (help) write procedures and templates that will incorporate good Human Factors Engineering into your process.

I can help you with the strategy, planning and execution of the complete  usability engineering effort, making sure that Human Factors Engineering is applied when and where necessary and useful.

I can help your organization with training on Human Factors Engineering principles, benefits and guidelines. 

When your team starts to understand the added value and regulatory necessity of applying user centric design principles, you will start seeing an increased focus on those things that matter to patient safety. 

Fatc: Formative evaluations (e.g. user observations, A/B testing and  expert interviews) should be considered throughout the design and development process since they generate valuable input for design definition,  improvements and for identify potential use errors that could be mitigated by making adjustments to the device interface. 

Formative usability evaluation increases the knowledge of the safety of your device or application and, by identifying the strengths and weaknesses of your product, it helps you to  design and plan an appropriate and proportional final, summative usability evaluation. 

The FDA, CE and other notified bodies often want to see how your design has been influenced based on the results of these studies.

I can help your design team and verification engineers by designing, planning, conducting, and reporting  appropriate and effective formative validation.  

The summative usability evaluation is the formal validation study conducted on the final version of the product. These studies have to follow Human Factors Engineering requirements as defined in the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. 

Human Factor Engineering activities ideally are designed and implemented in a one size fits all format from the get-go. This will ensure that the process yields the evidence, and uses the terminology that is required to launch the product in regions governed by different regulations and guidelines (e.g. CE,  FDA, and China).  The remaining region-specific work usually is limited to the format of some of the final reports and, depending on the choices you’ve made earlier in the process, a repeat of the summative Usability validation study. 

Even if you didn’t plan to cover different regions from the start,  the available data can still be captured in a format that allows branching out, provided the usability risk evaluation and usability verification evidence is available.  Maybe I can help re-write you Human Factors Engineering evidence into the appropriate format. 

As a Start-up company the regulations are likely not anywhere near to the top of your priority list. It does however make a lot of sense for you to be aware of Human Factors Engineering principles, values and the regulatory playing field.

I may be able to help you with at least creating awareness of what you should expect and possibly help you embed and plot some basic Human Factors Engineering activities on your roadmap. It should be a no brainer for you since early adaptation will help you design the first-time-right product, it will make your R&D phases more predictable and it will reduces the chance of costly, late design changes.

Having worked for a startup myself I do have a weakspot for entrepreneurs venturing out into the unknown on a noble mission. So don’t be shy to contact me, it can be a very light exercise to nudge you in the right usability direction.