Do you have a medical device to launch?
Well I have good news for you and I have bad news for you.
Here is the bad news first:
Medical devices are not easy to launch and are masked with layers of regulations. There are several reasons for launching a new product into the market.
It may be due to a healthcare practitioner wanting life to be easier for them during a medical procedure which involves the innovation of a new device. It may be a completely new device that will save thousands of lives or improve the quality of lifestyle of those with health issues.
Whatever the case, there is benefit which will ultimately lead to patient safety. With this in mind the focus is to benefit others, and in doing so keeping patient and user risk at a minimum.
With reported incidents on the rise, authorities have tightened up regulations over the past few years, hoping that manufacturers will build quality in, while taking risk out (as far as possible) of a device.
So, what’s the good news?
Firstly, there are experts out there who are born out of necessity. Over years and years of being in the industry they have seen the good, the bad and the ugly.
Medical device experts can help hold your hand and make sure you get your product to market and explain the regulations bit for you. Medical device experts are almost lawyers these days, with the amount of legislation involved there is a tonne of legal language that can bore and scare you, and make you think – do I really want to do this?
So the take home point here is, if you have done your research and there is a market for your device, then yes you want to do this, but taking a slice of the global market can not only be profitable but also make you a philanthropist. However, trying to walk the journey alone can cost you heavily, so seek advice.
How to do it?
I call the following flowchart “Concept to Market” diagram, which I often put in front of start-ups, or those about to embark on developing a new Medical device.
There are several ways to plan, which is why I call it “an example” of what is required. At each end of phase, have a checklist and review you have completed what you set out to do.
The steps and stages are not set in stone; however they are a clear indication of the following –
Phase I – Initiation, Opportunity and Risk Analysis
- Plan the development of your device, remember to document this!
- Think about all the work that will be involved and admit that you will not be able to tread this path alone.
- Think about your funding strategies, which markets you want to enter – where? Why? and How? This is fundamental as each market has its own regulations and challenges. If you are developing a new product that no one has produced before , make sure you protect it by filing for IP (Intellectual Property) and patent your idea.
- Your market research is fundamental as it will lead to the following – are there equivalent devices on the market you can claim? Or do you need Clinical trials for your product? The difference between the two can make your venture feasible or unfeasible due to the high costs involved. Don’t forget to document this.
- Put in a QMS (Quality Management System). Your QMS is the foundation to your company, which once solid will provide a good base to build everything on. ISO 13485 is the standard that is adopted by most medical device companies and is internationally recognized, so get this in place. The QMS will incorporate your procedures, forms, templates of how you will lock down and control all activity in your company, therefore this must be taken very seriously.
Phase II - Formulation, Concept and Feasibility
- The Concept and feasibility stage in a way is critical as it will be the phase in which you have a working device that proves your idea
- Once you are convinced that your device has a market position, is viable and financially feasible, only then set the ball in motion. You will need funding for prototyping and trialling your device – however congratulations! If you have got to prototyping you have succeeded past Phase I, and your journey is beginning.
- Start thinking about risks and customer requirements early, at this stage you need to hear the voice of the customer and take feedback via surveys, competitor analysis, market research etc and adopt this into the design of your product. Oh, and don’t forget to document each step of the way!
- At Phase II you will be developing the concept and proving that it works, so you need to be prepared to go back over and over to revise the design as needed, and guess what – don’t forget to document the changes! Until you have reached design freeze, at this point you can put a stake in the ground and work with it.
Phase III - Design and Development – Verification & Validation
- Now your device is beginning to take shape, you have a prototype, you have done some trials but you haven’t really put the design through its paces, you are about to go into validation and verification of your device and prove that it will really withstand all the pressures of the real world. Make sure you know what your acceptance criteria are for each test. Think this through.
- A good way of doing this is by setting up a matrix, called a design trace matrix which will ensure you have not lost track of your customer requirements. You will need to translate this into engineering requirements i.e how will you actually make the customer requirement happen, what mode of testing to verify and validate, what processes do you need, what test equipment will you need? Have you started to think about a manufacturing and quality plan? Or will you outsource this?
- You should really get into your Risk management at this stage. Call out all the potential failures of what can go wrong due to bad design, poor process or bad manufacturing, user failures by foreseeable misuse. What measures will you put in place to control the harms from these failures? Are we looking at harms that can lead to death? Or are we looking at inconvenience to the user? Psychological harm? Be realistic and think this through. I cannot emphasis doing this thoroughly enough, as your device will not make it to market if the device is seen to be a risk to patient safety. Remember the bad news at the start of this article? The regulations are in place to increase patient safety and minimize risk.
- Ensure you know the regulatory requirements of the product and the regulatory requirements of the country/region you are about to sell in. The requirements in the US differ to those in Europe although there is very strong overlap, the submissions process is different. Your market research should have determined which region you wish to launch your product in first, so focus.
- If you had determined earlier that you needed Clinical trials for your product, you should begin your Clinical plan and use product for the trials from your design freeze through actual use in a clinical environment. Also look at what external approvals you will need, such as an Ethics Committee.
Phase IV - Final Validation and Product Launch Preparation
- We are well on our way now, you want to start thinking about marketing and branding now, Caution! - be careful what you put in your marketing literature, it must be backed by evidence. The number of times my toes curl when marketing experts make claims on products that have no justification can be frightening. My message is NO EVIDENCE = NO CLAIM.
- We should be gathering all our data now. All the Validation and Verification of our product should have passed! So we should be gathering all our evidence of testing - biocompatibility, electrical safety etc. etc. where applicable,
- Scale Up, nice…. If we are scaling up then we really are getting there. Wait…if we made a few successful products can we now replicate this in production?
- Perform all the stability testing, shipping trials, very often I see companies get to this stage to only realise they didn’t do all the testing, why? Because they didn’t know the regulatory requirements for the product, took shortcuts or didn’t see the real reason to do the test. Well the industry has put these tests in place for a reason; don’t just throw the baby out of the bath water.
- You should be completing your technical documentation now. Bringing together a file full of all the evidence required to put in front of a competent authority that will review/ audit your file for completeness against their expectations.
Phase V - Product Launch and Post Launch Assessment
- Do a final check of your technical documentation, you may need to make updates.
- Make sure you have plans in place for “Post Market”, you need a system to capture complaints, feedback and how will this information be treated? How will it loop back into your risk management system?
- Post Market - Will you need to update your design documentation, do you need to re-test? Do you need to get back in touch with the competent authorities to inform them of a significant change? Do you need to recall product from the market?
- OK, guess what? I think we could be ready now, your regulatory clearance, technical file review is done and if you got the auditor on a good day you are ready to launch your product. Once you have your license or certificate you can place your device on the market.
- If you are based outside the EU and you wish to sell product in Europe you will need an “Authorised Representative” who is appointed to represent your business in Europe.
Well congratulations! If you have made it through all the phases involved, you have received regulatory clearance and your device is now gaining sales, does the vigilance stop?
Not at all, now when you thought the journey ended, the journey has just begun.
Your device is in the market, in the hands of users so be ready for feedback, improvements and continuously reviewing your internal systems. Make sure you have a robust internal quality auditing system to review your records and ensure you are:
- Not cutting corners in production
- Following your QMS
- Making changes according to your change control system
- Following your feedback and complaints system
- Updating all necessary technical documentation as required
- Adequately resourced
- Continuously improving
Making a medical device can be both financially rewarding and solve complex day to day health problems. By no means should the process be rushed as the authorities will be watchful for vigilance, following regulations and complying with standards as necessary.
If you have followed the path indicated in figure 2.0 you will have a good chance of getting a product to market safely and successfully.