Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD.

Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfill obligations and achieve continuity that puts medical devices on the market.

 

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Some highlights of this episode include:

  • QE is a one-stop shop, like Amazon is for consumer products and Google is to ask questions about everything. However, QE specifically searches for healthcare, medical devices, pharma, and IVD products and service providers. 
  • QE is a platform invented but not influenced by QUINIQUE. Every notified body and registered consultants are listed. With QE, you can find, identify, select, and contact global suppliers.
  • To join and register for QE, book a membership package, choose a service provider type, and search by selecting relevant criteria. 
  • QE includes testing labs, distributors, suppliers, and requests. Otherwise, if you’re searching for results, you have to connect with multiple places and people.
  • Evaluating, monitoring, and selecting suppliers can be frustrating and time consuming. QE simplifies supplier management. 
  • Transparency is necessary to have fair competition and a clear supplier selection. Then, you no longer need to be dependent on a single supplier.

 

Links:

Bassil Akra on LinkedIn

‎Quality Engine

QUNIQUE Group

info@QUNIQUEgroup.com

European Commission

European Union Medical Device Regulation (EU MDR)

European Union In-Vitro Diagnostics Regulation (EU IVDR) 

Notified Bodies

TÜV SÜD

MedTech Europe

AdvaMed

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Bassil Akra:

“We are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way fulfilling their obligation and being able to achieve the target of market continuity and getting their device on the market.” 

“Every one of us is nowadays struggling to find things.”

“It is not the end list, this is the beginning. We’re going to extend this platform to get more transparency on the market.” 

“We have a large number of service providers who are unknown and they are available when we need them but we don’t know about them.” 

“Transparency is all what we need in life to have fair competition and a clear supplier selection.”


Transcript:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: On this episode of the Global Medical Device Podcast, I had the opportunity to chat with the Bassil Akra. Bassil's with QUNIQUE; you might recognize him. He used to be with TÜV SÜD, a Notified Body focusing on EU. What I like about Bassil is he has a real practical working knowledge of the EU MDR and IVDR, so a great resource from that perspective. And on this episode of the Global Medical Device Podcast, he shares this awesome solution called Quality Engine to help with supplier management. So whether you are a medical device company looking for suppliers and to help manage those suppliers and identify suppliers, this is a great resource. If you are a company who supplies products and services to the medical device industry, Quality Engine might be something of interest to you as well. So enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Excited today. Obviously, we've got a video component, so that's something we're rolling out on the Global Medical Device Podcast. So if you're listening to this an audio, be sure to go check the Greenlight Guru website where you can watch the full video of this as well so check that out. Joining me today is Bassil Akra. Bassil is the CEO with QUNIQUE. Bassil, welcome to the Global Medical Device Podcast.

Bassil Akra: Thank you, Jon, for inviting me here today to exchange with you about one of our platforms that we unrolled recently. But, I'm happy to take this opportunity to explain it to you and to your group and give them some insight on why we did this job and what is the add value of such a platform?

Jon Speer: Absolutely. And I guess before we dive too deep, I know you from EU MDR fame, I guess. I know you were... it seemed like you were on the road show going from stop to stop almost like you are a rockstar speaking about EU MDR as that was unfolding. And obviously, you're with the firm QUNIQUE today so before we dive too deep tell folks a little bit about your firm QUNIQUE and how you're helping companies.

Bassil Akra: Yeah. Thank you, Jon, for this. It's interesting to be named rockstar. I heard this multiple time because at regulatory field, we are not seen as rockstars. Typically, people will tell us we are really boring people and this is a really dry topic. But honestly, it became the last years when I started to focus on regulatory and quality is really enjoyable tasks to do. So in my previous life where before joining QUNIQUE, I was working for TÜV SÜD Product Service inaudible position starting years ago as a reviewer, auditor, moving to take the lead on a clinical team then being in multiple local and global position at TÜV SÜD up to member of the management board of the medical device sector for TÜV SÜD Product Service. And in that role I was representing Notified Bodies as well and multiple working group writing guidance documents and supporting also in meeting with European Commission and with the member States. And like you said, I have been in the past years helping on education on MDR, IVDR by doing the initial training that were done when the regulation was actually under discussion; it was not even officially published. Then I decided was the date of application, which was last year in 26th of May, 2020 before we had the surprise with COVID, I decided actually by date of application to stop my activity at the Notified Body to move to be an a consultancy, to help manufacturers understanding what the Notified Body expectations are. And COVID came, I didn't change my mind. I went to QUNIQUE and I'm happy that I'm here now on this side of the table where we are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way, fulfilling their obligation and being able to achieve the target of market continuity and getting that device on the market. But we also write documentation for manufacturer, help them communicate with Notified Bodies and so on.

Jon Speer: Yeah. And I think you have a special vantage point of being so knowledgeable about EU MDR and specifically the way Notified Bodies function and operate. I think that's an asset that I'm sure your clients benefit from on an everyday basis. So, I'm super excited to learn more about your Quality Engine. I know you and I have had a brief opportunity to chat a little bit about it, but obviously today I'm going to learn just as much as everyone else in the audience today. What is this Quality Engine opportunity that is offered by QUNIQUE?

Bassil Akra: So we decided based on our experience, every one of us is nowadays struggling to find things. If you need consumer product, you go to Amazon. You find everything that you would need. If you need other, let's say, if you are looking for travel, you want to do a vacation, you go to booking. com and you find actually your trip. You can book it. But, if you are looking for medical device service provider, you start searching, you start searching around. Even if you are looking for a Notified Body, you want to find it out you can go to Nando's European Commission website, and then you have to search through PDF and all of these things. So, if you want to have a testing lab, if you have some connection, then you are in good shape. If you don't have connection, you have to ask some friends. You need to go to some events to see who is delivering such services. So we thought it would make sense to have something similar to what we know from a consumer product portfolio point of view, that we have something for the healthcare system, not just for medical devices, for IVDs, for also pharma to ensure that that is everything in one single place. And this is where the idea of Quality Engine came from. So, it is a platform which was invented by QUNIQUE, but it is not actually influenced by QUNIQUE. It's independent service from QUNIQUE, which is a platform enabling everyone to have visibility on what they are offering. So every consultant can be listed on that platform. Every Notified Body. The idea is like to create one single page where you go on the website and you find actually the service providers that you are looking for. All service provider must be actually registered. So they are interested to be listed on this website. So you have an authorized representative who wants to gain more visibility. They go to... he would go to Quality Engine, register his company enter all the information needed. And if you have then a customer who is looking for an authorized representative, he will be able to search for free on the website and find the ones who registered themselves. So they have one single place where they can see actually the service providers that they are looking for. And they are able to also compare between those service provider and have the visibility who's offering which services in which market and get much more details at one single place. The idea is here to have better transparency to identify the relevant service provider. Today if you look to your supplier management, they have their supplier list and they do not change it because they don't need to change it unless there is a problem. But when the problem happened and you are looking for a supplier and then you start searching. But, if you have one place where you can review which suppliers are possible for you, the supplier which are available in the different jurisdictions, then you have a better opportunity to identify ones and to start talking to the different ones and select off of them and you are not limited in your approach.

Jon Speer: Yeah. So if I... You don't mind if I chime in.

Bassil Akra: Please go ahead.

Jon Speer: I think this is important. So, if you're a med device company, it doesn't matter if you're a startup or you've been in business for many, many years, managing suppliers is super important and to Bassil's point, once you've vetted and you've got this nice approved supplier list, everything is good. Until it's not. And when it's not, excuse the expression, but it could be a shit storm because now you're trying to find somebody that maybe you had a supplier that no longer is meeting your quality criteria on a particular material or whatever the case may be. Or you had a sterilization validation failure and this has happened a couple of times. Now you've got to find somebody else. So where do you go to find that? Google, you can search there, but your results are questionable at best. And so my understanding is what you're trying to do is curate and organize people or companies who are providing products and services to healthcare med device, IVD, pharma and organize information by different categories and topics so that I, as person who might be in need of supplier, I can go there as a one- stop shop, so to speak, to see who's there, who's registered, are they the type of supplier that meets my needs.

Bassil Akra: Yeah. And this is a starting point actually, because you mentioned something which is a very essential for us. We thought at the beginning, we will have the suppliers listed there who are interested. So we get them on it first. We have long- term plans with Quality Engine where you're going to have also the ability to rate your supplier, which enable you then long- term to start looking on who is delivering which kind of services. What are the feedback of their customers? We are working also on adding much more organization within Quality Engine. So you will find also association in the future. Today, for example, if you look to medical device and you ask you're going to go to AdvaMed. In Europe, MedTech Europe. But who is the one who you can contact if you have a question? Who to reach to? And those association would be listed there. Also societies. Now we have a lot of opportunities to get key contributors on Quality Engine, but it is not the end list. This is the beginning and we are going to expand this platform to get more transparency on the market. And taking an example of a CRO today if you are searching for a CRO, you have big names that you may use, but there is a lot of other service provider there that you may be selecting them based on your location, based on let's say your budget, your company mentality. You don't want to work with a big player historically. You want to have the first experience. You have then the visibility and you can decide which one you want to play with, which one you want to work with. And you have the ability to get first a decision based on a full overview which you don't have at this moment, because nowadays, when you are selecting an organization, you just have, like you said, you go to Google and the one who going to show up on the first page that might be for you relevant, but then you call them and they tell you we don't have time for you at this moment because we are full. And then you're like, okay, I'm lost. How to find another one. So this gives you an opportunity to have the visibility needed.

Jon Speer: Yeah, I think it's... What I'm hearing you say is it's the first stop, not the last stop. But to your point, today without a tool like Quality Engine, maybe you get lucky on your Google search. Maybe you're able to post a comment on LinkedIn. Maybe you're able to reach out to your network. But this is just a really smart plan and a really smart service that you're offering. And, to me, I think one of the things that resonates with me a lot is especially with respect to like the new concept or the new regulation regarding economic operators in the EU, I think this is super important as well.

Bassil Akra: Yeah. When you open LinkedIn or you open other social media at this moment you see I'm searching for a distributor. I want to have translation services. I'm searching for an importer in Europe, or I'm searching for an importer in the US or other jurisdictions. And people are missing this place where you can be listed. So, my recommendation to every organization, if you want to get the transparency, we need to have one single place. This was actually... The whole idea was created based on our experience. Because today if you want to have something and you ask yourself who can be my customer or my partner or my service provider, you keep Googling. You try to Google it to find it out. You will not find it always. You may find it if you are looking for a chair or you are looking for like a boiler, but if you are looking for biocompatibility testing lab, then you get just one name. If you are looking for a sterilization service provider, you will find one, two names. But we have a large number of service providers who are unknown, and they are available when we need them, but we don't know about them. So we want to get this visibility and not just for the European market. It's on the global level, because with this platform the intention is to have global overview about what are the service providers who can support in each field, including also suppliers of softwares, of materials and so on, which enable us in the future to have a better selection process.

Jon Speer: Absolutely. I dig it. I love it. I'm a fan. Bassil, I wish I would have thought of something like this. So to you and your colleagues at QUNIQUE, congratulations, I think is a really great idea. What else would you like to share about the program that you think is important for the audience?

Bassil Akra: So, the most important thing is like every company who would be looking for registering, you can have... For the one who are searching this platform, it will be a free registration because everyone can search the platform. It's like a Google search. Then you can have an ability to search it and to search for your service providers. For the ones who wants to be listed on that platform, all what you need to do is to select which membership is relevant for you to which let's say a level you would like to get access to, which kind of information. And then you can inaudible yourself, and you can test the system at this moment because we are offering a membership for three months for free, where you can test it and you can get yourself listed, sees it as a possibility of getting more transparency. We are at the starting point. And I see it actually like you, Jon. I see it as a vision. My big hope is one day is that we have everything in one single place. What I like in platforms and consumer products, whenever you want to have a new TV you can search these platform you find. Whenever you want to have something to eat today, you can find rating for all restaurants at once. But, whenever you want to have a test lab, you just have to connect some of your people to see what is their experience. And we want to have like a visibility in the fields which is the most important field. And we should learn out of COVID- 19 how much time we spend to understand who can help us testing patient masks. And this would allow us to have like one place to find all the best labs, all the facilities as well.

Jon Speer: Yeah, I totally agree. I mean, just to your point, I chuckled a little bit because I had some experience from the past where I did a Google search or what have you looking for, I think it was packaging provider if memory serves. And the first few results I contacted these people and we're this tiny little startup and our initial volume was in the tens of units, maybe hundreds of units, at least starting out. And these packaging providers, they wouldn't give us the time of day because we weren't going to meet their minimum order quantities and that sort of thing. So, it was a nightmare trying to figure out who, what kind of packaging providers would be a good fit for the type of company, the shape and size of company and stage of company that we were in at that point in time. So I think it sounds like this is a really great opportunity to help, not only the person searching for that, but companies, i. e. for example, like the packaging company or the test firm or the quality management system software providers being able to use this as a means to help promote what they're doing and what types of companies are a good fit for their products and services and that sort of thing. So it's a two- way street.

Bassil Akra: Yeah. And I was talking with some Notified Bodies even in Europe with regard to that. And some of them, they were like, oh, we deliver also testing service. I was like, but no one knows about that. They have them, but they never have that transparency. So, a Notified Body is not just a Notified Body it's also testing inaudible in a lot of cases and they do not put the visibility on that. So their customers go and search for a testing lab whereas they can deliver testing and nobody know about that. So, I think it's an opportunity for a lot of organization to share transparency on their system and enable a better oversight on what they are delivering. I think this is all what I wanted to share in a quick overview on Quality Engine with short wording. So, it is a place where we're going to get transparency in the healthcare system. You will have like your service provider from now in the future in one single place. And my goal is for every service provider in this field to just test the system, make yourself visible, and you will see that it will be an add value for both sides.

Jon Speer: Yeah. The overall, and thank you for giving a little bit more insight on the Quality Engine, but this is a hot topic that has been a hot topic probably since I've been an industry, which is going on over 22 years now, supplier management. Companies struggle with this and it doesn't matter if you're a startup or you're a large company. Evaluating suppliers, monitoring suppliers, the whole supplier selection process, this is super time consuming and can be very frustrating. So this sounds like a really great service to help companies shore up their overall supplier management practices. I appreciate you going into some depth and detail.

Bassil Akra: Yeah. So, I think it's like at the end, whenever we have also a full overview about suppliers, the supplier management team will have a better ability to deal with their daily work in a better way. And also your negotiation as a manufacturer, or also as a supplier will be much better because you understand your market and you understand also alternatives which are available in a better way because transparency is all what we need in life to have a fair competition and a clear supplier selection. And you are not any more dependent on one single supplier. You have that ability to have this overview. And this is also an ability for small suppliers to play the game and to support in places where others would not be willing to support, like you mentioned, with your example of not finding a packaging service provider.

Jon Speer: Absolutely. Terrific. Bassil, anything else to offer or any other tips, pointers to offer either med device companies or IVD companies, or maybe suppliers to those before we wrap today's session up today?

Bassil Akra: I think on what I can say, have a look to this website. Check it out to see what is actually inside it. If you have also recommendation, get in contact with us. And if you are preparing for, you are searching for consultant service and you want to be supported on MDR, IVR independently from Quality Engine, you can reach out to us and we are happy to support you and help you towards getting your devices in compliance the new obligation in Europe.

Jon Speer: Absolutely. And folks, also want to remind you that Greenlight Guru, we're here to help you as well. As you probably know by now we have the only medical device Quality Management System software platform in the market today. We've designed it specifically for the medical device industry. Yeah. It works for IVD companies as well. And it's been designed by actual med device professionals. So, I would encourage you to go to www. greenlight. guru to learn more about the Greenlight Guru products and services. We'd be happy to have a conversation with you, learn a little bit more about your needs to see if there might be some opportunity to help. We work pretty closely with folks like Bassil Akra and the team at QUNIQUE, as well as other resources within the industry as well. So, it's an ecosystem; I think it's really important for us to stay really well connected and we're trying to improve the quality of life. So, if there's somebody that I know that I can connect you with that's going to help you advance your product and technology, that's what we're going to do. And it's just the way the world should work to be quite honest, in my humble opinion. So, thank you as always for being loyal listeners of the Global Medical Device Podcast. Continue to spread the word. As you've noticed, we've added some video to the element now so be on the lookout for future episodes. And until next time, you've been listening to the Global Medical Device Podcast.

 


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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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