Today we will draw the future of Medtech for 2019 by showing what will be poping-up or what is starting to become a trend.
I will do this description in 2 axes:
- Technology
- Regulation
Podcast Episode
On this episode, we will list all the trends on Medical Devices that will need to be followed. Don’t forget to subscribe to the podcast on your preferred platform.
Check show notes here.
Technology
Digital health and connected devices
As you may know we are using a lot of devices to make some prediction on our health data.
iWatch
FDA approved the algorithm used to predict heart disease as a Medical Device. This was kind of a revolution that a product used by consumers becomes a Medical Device. What was also surprising, is the fact that the time to get this approval was really short.
For those that know FDA, they are not really fast usually to release a new technology.
This can open the door for many other devices that can now follow the same path to be registered as a Medical Device.
Connected devices
There are also a lot of devices that are now using Bluetooth to connect with a mobile device. For example for diabetic type I, there are devices that can tell you what is your sugar level and display that directly on your mobile phone.
Some other devices are also able to communicate. For example, Bone Tag, which is tracking which implant you have on your body.
Big data
All the digital devices we are using are collecting a lot of data, and this can be gold for some companies. But to analyze all this we need some technologies.
This can help to determine if there are some specific disease on a population and define the right actions for the healthcare agents.
But those data can also be hacked and used for another purpose that the improvement of the health of the population. Cybersecurity is then a critical topic that the Healthcare Industry should eradicate.
FDA released guidance on cybersecurity that could be interesting for you to read.
Blockchain
To avoid hacking of some database that contains some information, a technology that was initially used with Cryptocurrency start to integrate the healthcare business.
The blockchain is a way to protect our data. Each transaction that we are creating on our database generates a block which is not stored on 1 server but on many.
With this technique, to hack the database, you should first locate all the different server that is used for your blockchain and hack them all at the same time which seems impossible. But we never know.
This can be promising and patients can maybe have more confidence to share their data with the authorized agents.
Artificial Intelligence
This is a word you heard since many years so I imagine you think it´s still not ready. But science is making big progress.
A publication issued on the European Radiology Experimental is showing that Artificial Intelligence is helping radiologist on the diagnosis by reading the images. AI can identify findings not detectable by the human eye. This also highlights the fact that this will not replace radiologists as there is still the importance of communication with the patient which is key for a better understanding.
3D Printing or Additive manufacturing
This is a topic I discussed on one of my blog article.
This is becoming a new way to manufacture medical devices. This opens more possibilities to design products with different shape.
We call it additive manufacturing as we are “adding” layers after layers to create the product. This is to be compared with the traditional manufacturing where we remove material (Milling) or we form the product (Injection molding).
Some manufacturer consider using 3D Printing for custom-made devices. But in the MDR 2017/745 regulation, when used as mass-production tool, this is not considered anymore as custom-made.
Another way to use 3D Printing, is bio-printing. Instead of using plastic or metal, we use cells or we call it Bio-ink in that case. We can create with that tubes or part of some organs.
Tele-health
The time spent in the hospital is reduced as there were many improvements on the surgery technics (Mini-invasive…). At the same time, the patients doesn´t want to stay at the hospital and prefer to get back home. So the usage of tele-health devices became really interesting to still continue to follow patients when they are recovering at home.
This looks also interesting for the healthcare system as it cost less in comparison to a patient staying in the hospital.
So you´ll hear more and more about devices that can communicate directly your health data to your doctor.
This technology is also interesting for patients that are living in some areas where there are no doctor. Imagine that you need to have a consultation and instead of driving some 100 miles away, you just connect a device that opens a discussion with a doctor. All the tools to perform a check are available. And the data are visible to your doctor. He can then tell you what to do. This is the future.
But similar topic with all what we said before, cyber security is also important in that case.
Regulation
Currently, we are in the middle of many transitions, so, the future for regulations is really rich. If there are many changes, it means that there are also some improvements to perform. This is known but this was also highlighted on many documentaries.
The first one was the Bleeding Edge on Netflix where the FDA system was criticized. And recently, it was the Implant Files that was specifically talking about the European directive.
Let´s review now which regulations are changing.
MDSAP
This is the Medical Device Single Audit Program. It is a program that combines the regulations of USA, Brazil, Australia, Japan and Canada. Since January 1st, 2019, Canada is requiring this certificate to all manufacturers that want to place Medical Devices on its market.
This program is helping to harmonize the regulation of many countries. If this is seen as a success, this can maybe motivate other countries to integrate it.
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ISO 13485:2016
This is the new released standard version of the Quality Management System for Medical Device companies. It was released in March 2016 with a transition period of 3 years. So companies should be compliant to it by March 2019. Read the FAQ for ISO 13485
This standard was updated to align with other countries requirements so it can integrate the MDSAP program. After this update there will be no differences between the FDA QSR 21 CFR part 820 and the ISO 13485:2016. Even FDA mentioned that they can decide to adopt ISO 13485.
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FDA new 510k Process
It was announced that FDA will update its 510k process. This is the most used process to register a Medical Device in the USA.
It´s also the process that was criticized on the Bleeding Edge documentary. So is there a link or was it planned.
The 510k process is requiring that an equivalent product to yours is already on the market to use it as a predicate. Read more on the article “4 Steps to Master Substantial Equivalence (510k process)”
As I mentioned, world is changing, so the regulators should also change the law to adapt. So this is a good news that FDA is starting this update.
Update of the ISO 14971
This is the standard for Risk Management of Medical Devices. Many meetings have been done to discuss about this standard but there is no official date for the release. But it´s targeted for 2019.
But as the ISO 13485:2016 is based on risk, it is really important for Medical Device manufacturers to look at the changes that could happen.
Brexit
On March 30th, 2019 the United Kingdom (UK) will exit from the European Union. But what will happen for the Medical Device manufacturers that are in the UK?
The MHRA which is the Competent Authority in the UK released information about that. Apparently, UK will accept CE marked Medical Devices as before the Brexit but for how long? [Guidance]
Recently, the first Notified Body accredited for MDR was announced and surprisingly, it´s the BSI which is a UK Notified Body. But as they anticipated the Brexit, they registered their place of business in the Netherlands.
So 2019, will be a critical year for UK in relation to the medical device industry.
EU MDR 2017/745 and EU IVDR 2017/746
We will talk about this update for the next few years so this is not only a 2019 topic. But 2019 is the year before it´s implementation.
So if you a re a Medical Device manufacturer that want to continue to sell its products in Europe, you need to understand this new regulation.
There are different transition periods. So this is critical for you to define the one related to your products. Read this article.
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And one of the important concept that can maybe help you is about “Placing on the market”.
If you are placing your products on the market before May 2020, those products can be sold until May 2025.
Learn more on the below video
New Medical Devices
The new Medical Device Regulation is now considering to include on its scope some products without any Medical Purpose.
Those products are listed on Annex XVI of the MDR. I described them on the blog post “What is a Medical Device?”.
I would be really interested to know the current situation of these companies. Do they even know that their products are now considered as Medical Devices in Europe? 2019 will tell us.
If you are not sure your product is a Medical Device, I created a video to help you with some examples.
Conclusion
2019 will be a critical year for the Medical Device industry. So the only way for Medical Device manufacturers to keep their business alive, is to learn about the new regulations.
Question
Thanks
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
