Quality

Adaptive Life Science caught up with Monir El Azzouzi on some of the latest developments in the Medical Device industry.To make the puzzle easier for us, Monir is helping us all on the MDR transition journey, so be sure to check out his website for the latest news, courses and insightful podcasts. You can find access to these free resources here; https://easymedicaldevice.com for the blog and https://podcast.easymedicaldevice.com to access the free podcasts.Monir has spent many successful years working for major players in the Medical Device industry, including Aesculap, Bausch & Lomb and Johnson & Johnson in quality and regulatory focused positions. I caught up with Monir to discuss some of the advances, and challenges with the MDR changes coming next year.The hot topic of the moment, the MDR deadline coming in May 2020 for Medical Device manufacturers and notified bodies… What is your opinion on the MDR and changes to the framework?We needed a new change in the regulations, as there hasn’t been one since 1993 except some amendments. The changes in software and artificial intelligence are not regulated under the MDD, and they will be under the MDR. This in itself shows us that we need the change. There have been a number of triggers over the years to suggest a change in the regulations, most notably the impact from the PIP breast implant scandal from 2009, which were sold with unapproved industrial-grade silicone gel.  Events like this accelerated the way the way in which the MDR was created and the new framework developed. It was rolled out quickly, and there was a lot of discussion and urgency. In short, we needed it, but the way it was delivered was not ideal. Now as manufacturers we have to deal with it and manage the transition. The fault is not only on the EU commission for how it was presented, it is also on device manufacturers who lack understanding and acceptance, and now try and ensure compliance too late in the process. We could have a bottleneck at the end, and a higher need for consultants to come in, fix problems and educate the stakeholders. The candidate market in the MDR space is dry and it could be a struggle to find the most qualified person to take on the challenge now.Could the MDR deadline be extended, due to the shortage in designated notified bodies, and lack of urgency from some manufacturers?I recently spoke with Erik Vollebregt from Axon Lawyers about this topic who said it is difficult for the EU commission to extend the deadline. We would basically need to start the process from scratch. There have been talks to use the strategy that is used for MDSAP (the single audit programme – USA, Canada, Brazil, Japan, Australia) If there are not enough notified bodies (NB’s) to complete the new certifications; currently at 5, 16 anticipated by EOY. Then perhaps there could be a procedure for showing an application for certification under MDR, even if it is not fully compliant by the deadline. The bottleneck that I mention is not only down to manufacturers certifying under the MDRs late; a lot of manufacturers are ready and waiting for their Notified body to be approved. Even then, some NB’s may still choose not to go through the MDR designation process, leaving manufacturers scrambling for a new Notified body that also has capacity to accept new customers. Before we had 80 notified bodies, then 70 and with the MDR we are still only at 5. 80 NBs to 5 is alarming. Who is having the biggest challenge? Smaller manufacturers or global players?Smaller manufacturers, if they are coming late to the game. It is a question of resources; the global companies should be well underway in their transition. Like small notified bodies, it is the smaller companies that could struggle the most. If you have not started the MDR transition, you are in denial!The British have a great saying, which helps in this scenario:Stop thinking it will be extended, that a miracle will happen, and start acting. It should also not be about surviving, it is about beating the competition – and your products will go to market quicker. It depends on whether the organisation is focused on sales or compliance, because although profit margins may be strong now, from May 2020 your products could be unsellable on the market. Think long term – that’s my advice.Is the designation too tough for a Notified body? Is that part of the problem?I think it’s appropriate and it harmonizes the standard across manufacturers. With the new requirements, there is a search to ensure that the Notified body chosen is trusted and impartial. Now with the MDR, the NB’s are heavily audited – so if they make the wrong call, they lose their certificate. Officially, there is also no longer a consultancy service from a Notified body under the MDR – they are just there to rate your performance and compliance.  It is tougher to be a Notified body under the new regulations, however for manufacturers you will now have an auditor who knows your devices (ie cardiovascular) so, approval is genuine without grey areas. You will have a genuine specialist monitoring your activities – this is good for customers too; having faith in the devices they use, and that they are properly regulated.There seems to be some concerns over the labelling requirements for the MDR transition – do you have any guidance on this for manufacturers?The UDI requirements could be a challenge – as this barcode must be on every device or packaging. The struggle can be if there is a large portfolio of products, not so much if there are a small number of specialist devices, so I imagine it is the larger manufacturers who would do well to hire a labelling specialist. This does not have to be a strategic person, but someone to execute the changes. At the beginning of the MDR transition, we said look at your whole portfolio, and get rid of waste. If you only sell 3 units per year of a particular device, is the investment in the MDR change worth it? No – it should be discontinued. EIFU (electronic instructions for use) and digitalization is making life easier, and the UDI is more of a space finding activity, nothing too technical!Consultancies vs In-house – What’s the best strategy?It really depends on the company. For big companies, I would always recommend having a consultant come in to understand the problem, fix it and leave. For smaller manufacturers, they could need a consultant due to lack of resources and headcount, but also, they will need a long-term conrtractor as regulatory compliance is a journey and has long term requirements. There also must be a PRRC (person responsible for regulatory compliance) – either a consultant, or in-house. Under the MDD, a sales rep could be the PRRC but now it must be a qualified person. My advice to smaller manufacturers would be to assess your level of need, portfolio of products and weigh up the balance on the cost of a highly qualified consultant, vs building an in-house team where all the value and understanding is retained in the business and team. ***Ready to explore a new career opportunity in the Medical Device industry?Please reach out to Rebecca Woodfield for a confidential discussion via LinkedIn or Rebecca.Woodfield@Adaptivelifescience.comAdaptive Business Group is a global Recruitment, Executive Search and M&A consultancy focused on interconnecting high-growth technology and service industries. Adaptive Life Science is a brand within the group and our sector-specific consultants source talent and M&A opportunities on behalf of Medical Device, Pharmaceutical, Biotech and Diagnostic’s companies who power the development of Life Sciences globally.

The questions you ask during interview play a key role in the impression you make on a prospective employer – choose wisely...Even at the most innovative companies, interviews can follow a predictable pattern. When the interviewer is comfortable that they’ve completed their assessment of you, a familiar question rolls around:“Do you have any questions for us?”What you choose to ask can have a greater impact than you might suspect.If you produce the same questions as everyone else (“What do you like most about your job?”, “What does your ideal candidate look like?”), you might learn some valuable information, but you can’t expect to be stand out for your innovation or make yourself memorable to the interviewer.If you ask something more thought-provoking, however, you can not only set yourself apart from the competition but take the conversation into unexplored territory which the interviewer has not talked about with other applicants.Your conversation becomes memorable, and you have a chance to score points not available to other candidates by discussing things they don’t discuss.Having a selection of insightful, business-focused questions ready can help you distinguish yourself from the crowd and create a unique exchange with the interviewer.Here are 6 examples and why they work:1. What short-term opportunities do you see for the team to improve results?Asking this shows that you’re focused on coming into the role to make an impact.You move away from typical interview generalities (candidate experience, desired skills etc.) to focus on tangible results and what actions can be taken to deliver better outcomes. At the end of the day, this is what the interviewer needs most on their team – no amount of experience or ability matters unless it’s applied to make a difference.Making the question about team rather than the individual role can also reassure the interviewer that you understand your function as being part of a wider collaborative effort.2. What’s the best investment the team has made?This question demonstrates an appreciation of budget and resources, understanding that team results are shaped by the resources at their disposition.Linking work outcomes to the investment and platform provided by the company reveals an ability to think about team performance from a more strategic angle, showing the interviewer that you have the capacity to think beyond the immediate confines of your personal role.It also gives the interviewer an opportunity to talk about positive aspects of the team you’ll be joining - if they are the hiring manager then they may well have been responsible for the investment they choose as their answer.3. How do you see the team in 3 years’ time?Asking questions with a time horizon creates confidence that you are thinking about your position in the long term, and expect to be part of that team after 3 years.The question implies a level of ambition, probing on opportunities that may be created as the team expands.It also invites the interviewer to talk about their own growth goals, and to share the plans they have for developing the group. You then have the opportunity to ensure that your interview performance and responses synch with these objectives.4. Are there trends you’re worried you’re not keeping pace with?This shows that you view your role in a commercial context, and don’t expect anything outside your job description to be someone else’s problem.Rather than be a passive member of the team, you are aware of threats and challenges in business and assume shared responsibility for overcoming these together with your manager and colleagues.Raising the issue of trends also takes the conversation into a wider reflection on industry news and developments, where you can have a chance to showcase your expertise and share your opinions of where things are headed.5. What will be the next big investment the team will make?Probing around future change to the team illustrates a potential to think big as well as small.In addition to joining the team to excel in your assigned function, you’re also interested in the roadmap for the team’s evolution.Are there any big changes coming up?What tools, infrastructure or additional talent would help the team’s performance move to the next level?You demonstrate a collaborative mindset, focus on team success and excitement for the future.6. What are you most proud of about the team?By inviting the interviewer to talk about what they’re proud of, you switch the conversation onto their own career and contribution, which inevitably generates a positive vibe in the discussion.Putting them and what they’re proud of in the spotlight helps show that you’re aware of your manager’s own career, and creates an opportunity for you to make clear that you will be an asset to their personal development and ambitions – joining the team to give, to support and not simply to follow instructions.***Ready to explore new digital marketing career opportunities?Adaptive Digital recruits across Europe and the USA for digital marketing and ecommerce professionals, filling roles with brands & agencies in more than 20 countries. To view Adaptive Digital’s full range of open jobs, click here.