After attending the Medtech Monday event held in Irvine this week, it became very apparent that the thought of managing the regulatory or quality requirements of your product was a scary one for the novice. This had me thinking of key learnings that I’ve found valuable in product development, and thought I’d share a few…
Firstly, from a book I read years ago from Dr Stephen Covey, “Begin with the end in mind!”. What do I mean by that within the Regulatory space? Never forget that either you, or a potential merger company, intend taking this product to market. To get there requires regulatory approvals, so positioning for regulatory approval and reimbursement must be a fundamental and integral part of product design.
Getting to the end of a journey always requires a map. Do get some expert advice around what the regulatory pathway looks like for your product. This is a relatively inexpensive exercise which will outline the process, timeline and potential costs for entering a specific market. You need to be clear and specific on which market(s) you are looking to enter. For example, are you looking to launch in the USA? If so, the information you receive should include the specifics around the class, including the relevant FDA regulation code, length of time it’ll take to gain approval, and most importantly, what does the cost look like?
Secondly – I hear over and over when dealing with auditors: “If it’s not written down it didn’t happen”. Regulators want to see written evidence of compliance and that means formal document sets. Most start-up developers work through concepts and ideas of your product. It can be an iterative and messy process. But it’s important to keep as good a history as possible. These early records provide a kick start to the formal production of Technical File documentation. On a number of occasions, we’ve had organisations come to us who have no records from their initial development phase. This results in working backwards to then development these key documents from scratch – with all the associated extra time and pain. Begin with the end in mind and you will be better prepared to get into the formal design phase.
So what do you actually need? At a minimum, manufacturers must assemble three sets of files.
- Design History File (DHF): This document is one of the first steps you should be considering through the products development. This document consists of all key documents that you’ve developed while creating your product.
- Device Master Record (DMR): Especially looks at the manufacturing requirements and steps to develop the product at a point in time.
- Summary Technical File, or STED: This document is a collection of technical documents which include the devices intended use, risk management files, testing and clinical evidence and the various manufacturing processes. This document also identifies how your product meets the specific regulatory requirements, including standards used etc.
These file sets all overlap so it’s important to get the structure right. Want to learn more? Take a deeper dive by viewing the recording of our recent webinar – “Building a Technical File”.
Thirdly: Will it work in the real world? Regulators do like to see lots of laboratory testing, but these days, all regulators also want to see some sort of evidence that the device works in the real world – that means Clinical Evidence. This area is a challenge for all: from small start-up companies through to multinationals. What clinical data are required? Do I need a complete clinical trial? What trial design to use? Most of these questions won’t need answering from the beginning, but clinical evidence for many devices is based on review of literature, consideration of risk assessments and of preclinical testing and comparisons to predicate devices. Which brings us back to beginning with the end in mind. AS you do all that early work, build your technical data set, and most importantly, start to use prototypes: always have an eye to developing hard evidence that this new device will work in the clinic. Again, not having the discipline to maintain good records from the beginning can result in backward steps, and lost time.
Regulators the world over have been tightening their requirements and expectations for Clinical Evidence. We will be looking at the current expectations in major international markets in our February Webinar. Do I really need that Clinical Trial? A Global Approach to Clinical Evidence.
So the takeaway is – Don’t Panic, but do be strategic and plan early. A small investment now into getting that roadmap, and instilling a culture of writing things down and keeping orderly records will save you a lot of pain and cost along the way.
If you’d like to discuss any of the above on how you can be better prepared for your regulatory requirements, email us at firstname.lastname@example.org, meet with us at the upcoming Asia Pacific Medical Device Summit or drop a line to our CEO Grant Bennett who is attending MD&M West – Driving Innovation: Getting Innovative Products through FDA next month. Let’s Talk!