Resources to quick introduction to Medtech Industry

For beginners only!

I kind of find myself in a new journey of learning a specific industry with regulations perspective: Medical Device Industry. As an electronics engineer, I penetrate into all the essential details of medtech industry last month.

So, I decided to take a break and organize all my notes. I hope, this is starting point for a couple of more blog post. But as you already guess, I still don’t know anything in practice, so all my knowledge is coming from industry professionals via podcasts, courses and YouTube videos.

I kind of want to thank you for all the community for helping me to learn. So, let me list best of all for you.

Medical device training websites

First and foremost, education specific websites that generally has YouTube video or podcast channel as free sources and paid courses with certification. If you have money to spend, those are a great starting point.

Medical Device HQ

With their paid courses and YouTube channel, they are the first choice of mine. As their courses are not free and a bit expensive, they are well-designed with very helpful quizzes. I managed to finish their first and cheapest course and watched almost all videos from YouTube.

Volunteer Advertisement: If you are using YouTube not only for fun and time killing, but also to learn something, then I would suggest my favorite app to take notes: Snipo. They have rivals in YouTube note-taking, but if you have a notion account, you can’t find a better option for today (February 2024). And they support LinkedIn learning, Coursera, Udemy, ted, and Vimeo as well. You can even consider becoming a paid user if you need to transcript what video said in many languages.

Achieve XL

With Naveen Agarwal, they are also very active institute with lots of free contents.

Coursera

There are a couple of courses at Coursera. Some of them are free to access.

Companies with great blogs or white papers

Medcrypt

They are a startup from Y Combinator, founded in 2016. Based on their crunchbase profile, they got 34M$ investment. Best thing about their website is, they really publish a good white papers without collecting an email.

Orthogonal

They are a bit older company then the previous one, focused on Software as a Medical Device (SaMD). They have articles, white papers, podcast. I read a couple of articles and white papers.

Velentium

They also have great white papers. I found them over their director of product security, Christopher Gates. He has been very active on social media and attended lots of podcast episodes and YouTube videos with latest his broad knowledge on cybersecurity for hardware and medical industry.

Greenlight Guru

Quality and risk management as a service :) They focused ISO 13485 and ISO 14971 as a tool, and they seem far better option than excel. Another good thing about that company is, they are very productive to community with their blogs, white papers and e-books and podcasts.

Riscure

More cybersecurity company with lots of contribution to community and white papers.

RQM+

Another medtech service provider with good resources.

Battelle

Very interesting nonprofit from the USA. Let their website explain themselves:

As a nonprofit charitable trust, Battelle is committed to making a positive impact for the planet and its people. We do this through our daily work, but also in charitable giving, through corporate contributions and employee-driven initiatives.

They are working in various industry including medical. They are founded by Gordon Battelle in the 1920s. He seems another steel lord and philanthropist like Andrew Carnegie, a man who named Carnegie Mellon University. Anyway, battelle is an interesting rabbit hole worth deep dive.

Organizations & Forums

FDA ( U.S. Food & Drug Administration)

With their YouTube page and their website with countless guidelines, they are kind of primary source for information.

MDR ( Medical Device Regulation for EU)

As far as I understand, all of their documents and guidelines are free and open to the public.

MDCG (Medical Device Coordination Group) Working Groups

Another source of information from EU.

IMDRF (international medical device regulators forum)

With their different working groups, they are trying to create harmonized industry standards for the whole world.

Regulatory Affairs Professionals Society | RAPS

Another organization focused on regulatory professionals.

Device Talks

An open platform for communities with a lot of podcast show.

Other websites worth mentioning

Resources from Social Media channels

Substack Publications

  • Let’s talk Risk publication:

Let's Talk Risk!Mastering the art and science of risk management through conversations.By Naveen Agarwal, Ph.D.

  • Newly started publication that Naveer suggested:

IronLine’s SubstackTopics related to medical devices and IVDsBy IronLine Consulting LLC

Youtube channels

Podcast channels

ChatGPT’s

Yes. There are already a couple of subgpt expert. Here are all of them I can find today:

So, not that much for today. I see a compelling opportunity unfolding.


As a result, this blog post just became a guided list for medical device industry, if you are a complete beginner like me.