Always begin with the end in mind. I say this over and over in my presentations to underscore the importance of knowing the end goal before even starting the design process.
Let’s say you have an idea for an innovative dialysis device, and you want to find out what standards apply so you can begin your design of the prototype.
You are REALLY excited about the device and how it will positively impact patients’ lives. Not to mention the revenue stream it will bring to your company. And you.
You know you’re going to need product clearance and then a successful submission in order to get to commercialization, and you know that the regulatory requirements are constantly changing.
How constantly, you may ask?
Well, in 2016, the FDA published 35 new guidance documents. In 2017, they released another 30, and in 2018 it was along the lines of 60 guidance documents, for a grand total of 125 new guidance documents in three years.
It gets better.
You also have to consider the European harmonized standards that may apply if you want to go to market in both the US and the EU, as well as the ever-changing international regulations regarding the content of your clinical evaluation reports.
And, of course, #MDRisComing.
All this on top of already and still- applicable recognized consensus standards and requirements. ALL these documents could impact the design of your device, the content of your submission and your entire come-to-market plan before you even get started.
But you are a fearless and intrepid medical device entrepreneur. You won’t let all these convoluted regulations get in the way of your device.
Armed with lots of coffee, paper for the printer, several colors of highlighter and a VERY comfortable chair, you dive into the recognized consensus standards databases.
You know that you have follow 60601-1,60601-1-2, 60601-6, 60601-1-8, 60601-2-39 and 13867:2002+A1.
And that’s just to start with!
Upon review of those standards you see that that you have specific requirements for a medical device power supply.
Wait – a whole collection of standards related to whether a device has a power supply or not?
Oh, yes.
If that power supply is going to be used in an oxygen rich environment of greater than 23.5% oxygen, then you have risks that must be mitigated through the design of the power supply.
And there are different design requirements if your device has a detachable power cord versus a non-detachable power cord.
For example, the detachable cord must be protected against reversing polarity. If it’s non detachable then the terminal mains must not be accessible to the user and/or patient.
Only trained service personnel can perform installation, assembly, maintenance and repairs. There are requirements for circuit diagrams and for defining the specific tools for servicing the device.
Remember, you don’t really know anything about your device right now other than you have a cool idea. The ever-increasing pile of applicable regulations is threatening to topple over onto your device proposal, potentially squashing you and stifling innovation in the process.
Now imagine you’re already significantly down your device design path.
Maybe you have a working prototype, or at least full design diagrams and the beginnings of an intended use statement. The regulatory team has started outlining the clinical study protocols, maybe even creating the very first drafts of a submission strategy. You are making steady progress toward submission, and life is good.
But hold the phone – the marketing team just called, and they are saying they absolutely cannot sell this device unless it can be used for home use.
Effectively putting a huge hitch in your giddyap.
Back to the standards you go, only to find that because it’s now for home use, you have to include 60601-1-11, which is the collateral standard for home health care environments. You have to have 60601-2-49 for multifunction patient monitoring, and you have to follow the FDA guidance document for home use devices.
And ALL of those contain different and/or additional requirements than those you followed when you initially drafted your product design.
This is the reality of the global context of what it takes to bring your device to market.
All the design decisions you make SHOULD be significantly informed by standards. And if you DON’T allow your decisions to be informed by the standards, you could get to the end of your device design and development and have a prototype, and you won’t be able to pass any of the test criteria. ALWAYS begin with the end in mind. Develop your product design, intended use and submission strategy around the regulations, and you will be able to see straight to the goal.
And if the coffee pot is empty, the printer jammed, your highlighters have all run dry and you STILL don’t have a firm grasp of what you need to do, get your free copy of my Regulatory Pathway Assessment and let me help you find the way.
