By Harsh Thakkar
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In December 2022, Karandeep Singh Badwal appeared as a guest on the Life Sciences 360 podcast hosted by Harsh Thakkar.
Karandeep is the Founder of QRA Medical and helps companies with appropriate licensing, marketing, and legal compliance of medical devices. On the show, Karandeep shared how he came into the med-tech industry, trends in the med-tech industry, and tips for medical device companies to keep up with regulatory changes.
Below are the highlights of his Q&A with the podcast host:
Q- What changes have you seen in the med-tech industry from when you started your career and where it is today?
Yes, certainly. The European Union Medical Device Regulation (EU MDR) is the elephant in the room; let's face it. Anyone who talks about the medical device industry is talking about the EU MDR, and I advocate it. There needed to be a change, and many companies had plenty of warnings.
The EU MDR began to be enforced around 2017, and if companies are not ready for it, that is their fault. The EU MDR did not come out of anywhere, and it was necessary because there were many companies that did not have proper technical files or risk management procedures, which meant that there were many unsafe devices on the market. I believe that the EU MDR has helped to eliminate those companies that were not doing things correctly.
Therefore, I am going to be an advocate here. Many people in the industry may disagree with me, but I think the EU MDR was a much-needed change.
Q- What do you think companies can do to be prepared for any regulatory, business, or technical changes that are coming up in their company or the industry in general?
Many companies need to work on determining their product first and foremost. So, whenever I take on a new client, I always ask: what is your intended use statement? What I mean by that is, who is your intended patient population? What are your intended claims? What markets do you want to target? Is it the UK, the EU, the USA, etc.? And, of course, number four is what clinical data you have. Many companies need to realize that this is the mistake I've seen them make; they need to know their product.
Once you have that figured out, you can work backward from there. So, first of all, figure out your product, what claims you want to make, and what markets you want to go towards. It's surprising how many companies I speak to need to know the answer to these questions.
Q- What do you think would help them get to those answers? What would you recommend they do to get to that stage of maturity?
Find a similar device on the market and see what claims they are making; this will give you a rough idea of what claims will get you onto the market.
Especially if you are going into the US, you have two different routes: the 510 K and the De Novo. The 510 K route means you have substantial equivalence, so something is already on the market with similar claims to yours. This means you can use them as a predicate device, telling the FDA, "Look, there is already a device on the market with similar claims. We are claiming something similar."
The other route with the FDA is the De Novo, which means there is nothing similar on the market. Therefore, research to see if something is similar to what you want to claim, and work backward from there.
Q- Any interesting projects you recently worked on with any clients?
Yes, quite recently, I have been working on what is known as a combination product, which is a drug-device combination, and I find that fascinating.
My university background was in pharmaceuticals, but I have never worked in pharmaceuticals to this day. It just so happened that the first job I had after university was in medical devices, which is the area I went into. So, it was very interesting for me to return to my early student career and see what pharmaceutical devices are like.
A combination device is very strange because you have the pharmaceutical and medical device sides. So, I am working on the medical device side, and they have pharmaceutical experts there. It is very interesting to see how these two industries integrate with each other. There are a lot of similarities between them.
Q- What are some of the trends you are seeing today in the industry or something that you see coming up in the next three or five years?
For me, the software is what people think of traditional medical devices such as pacemakers, defibrillators, stents, etc. Over the past couple of years, I have been getting into the software side of the industry, and it feels as though that is where the industry is moving. Artificial intelligence, machine learning, etc., seem to be the industry's direction.
Last week, I was in the US and attended RSNA, a radiology event with a special section dedicated to artificial intelligence. So, for those young people out there who are looking to get into medical devices and are wondering which area to work on, I would recommend artificial intelligence and machine learning. That seems to be where the future is in medical devices.
Q- So you are currently doing consulting under QRA medical; how did you get into starting that?
In 2018, I started my own company. I used to work full-time, but I would only recommend this to some. I was unsure if I wanted to go into consulting, as it completely differs from full-time work. There are no pension schemes, backup plans, or support for finding clients, administrative work, finance, or accounting.
In 2020, as the consulting work increased, I worked 70 to 80 hours a week. And it was at that point that I decided that I'm going to go into full-time consulting. So I only recommend this for some, but if you are unsure that you want to go into consulting, keep your full-time job. Don't give that up. Try consulting part-time, maybe just a few hours a week, to give a bit of a taster.
And if you decide that you enjoy consulting, you can decide that you want to go full-time into it. I don't recommend leaving your full-time job, jumping into consulting, and deciding it's not for you. And then going. I recommend keeping a full-time job, maybe doing something part-time, and then working out whether it's the best decision for you.
Q- If you had, let's say, had all the power to define how consulting should work, what would you change?
Consulting is all about customer service. You need to go above and beyond. And number two, when it comes to consulting, is that we need to deliver much more than you think you need to.
As a consultant, I explain to people that I sometimes work up to midnight. Some days I'm up at 4:00 AM if I'm working with a US client. And I think that's the key. When you are a consultant, it's not like a regular nine-to-five job, where you finish at five o'clock, shut the computer off, and walk away.
When you are a consultant and my phone beeps, I get an email or something like that, you have to answer that immediately, and that's what comes with consulting, and that's a little bit, that's kind of what the downside of consulting is. You have to be immediately available at all times. And I feel the bad consultants out there are not doing that.
They're treating it as if it were a regular nine-to-five job, but the whole purpose of consulting is that you're someone who needs to be available 24/7. That's really what consulting is.
Q- What advice do you have for professionals coming into the industry, whether it's about creating their brand on LinkedIn or, just in general, the mindset they need to have if they're starting their careers?
Remove your limiting beliefs. I've come across so many young people in the industry and said, oh, I've just come out of university. I will never be a manager. I will never be this. Immediately, you're setting yourself up for failure. Just remove that negative connotation immediately.
So what I say to them is that even if you're not confident in making your own content on LinkedIn, another form of engagement on LinkedIn is engaging with other people's posts. So even if you don't want to make your videos or you don't want to make your own. You can start engaging with other people's posts. You don't even have to make video content. You can start making posts and images, and LinkedIn is a beautiful tool for that.
I've often said to students when people say, look, Karandeep, I've finished X, Y, and Z degrees, I don't know what to do. I say you know what? Go on to LinkedIn. Find people who have done similar degrees and see what they're doing two years from now, five years, 10 years, 20 years. And don't be afraid to contact people. And the fact is, I've had students message me and say, oh, Karandeep, I'm sorry if I'm offending you. If I've contacted you. I'm like, guys, don't be offended. I'm happy to help you.
There are so many great people in the life science industry that if you reach out to them for help, they will happily help you. And if you reach out to somebody, what's the absolute worst they can do? Just ignore you. Are you any worse off?
So that's what I will say to the young people out. Go out there and contact people you think can help you. And the absolute worst they can do is ignore you. And if you keep contacting people, eventually, you'll come across someone willing to help you because that's what the life science industry is about.
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