I know we have not gotten into any regulatory stuff for Europe yet, and we generally do not cover that in this class. (It is covered in Advanced Medical Device Development at NJIT.) However, take a quick Google search for "EU Medical Device Regulation" (EU MDR) and read some introductory material on that. A page or two ought to get you relatively up to speed enough to answer this:
With all of the chaos in the EU due to the MDR coming into play right now, and Brexit on top of all that, what effects do you foresee on Project Management, i.e. the ability to manage, pay for, and schedule projects?
Spiral Medical Development
www.spiralmeddev.com
Joseph Philips defines project management in his PMP Project Management Professional Stud Guide as “the practice of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria at the specified time.” The primary challenge of project management is to achieve all the project goals within the given constraints. Given the new EU MDR, I would believe that Project management for these medical device companies would not only have a problem with meeting current deadlines but updating previous protocols that the MDR demands in order to remain complacent. This new regulation would be cost and time defective considering their new products not only have to follow the EU MDR, but legacy products would also need to follow this protocol, which means if companies were compliant to the previous regulation, the new regulations would issue a lot more changes, bringing on the need to focus more on either developing a legacy product, or create a life cycle approach to device regulation. However, there are some positives to this new regulation which allows for significantly better traceability of all medical devices sold in the EU region due to the mandate for Unique Device Identification (UDI) which will help with clinical investigations, product registration, and post-market surveillance, including a access to the latest data on medical devices for sale in Europe. Provided that the regulation was published in May 2017, medical device companies had ample of time and opportunity to maintain/update complacency to the new regulation.
The implementation of the new EU MDR will pose a challenge for medical device manufacturers who sell in the European Union since, on top of any existing projects, they now must invest time, money and resources into ensuring their devices are compliant with this new standard. A survey conducted by RAPS (Regulatory Affairs Professionals Society) and KPMG revealed that only 27% of medical device manufacturers are confident they will fully comply with the MDR by the time it goes into effect this May (Source: https://www.raps.org/news-and-articles/news-articles/2019/9/27-will-be-compliant-survey-highlights-lack-of-r). Efficient project management within these organizations is key in order to meet this deadline, especially for organizations with many different EU marketed products under their belt, as there will be multiple projects going on simultaneously.
Additionally, the MDR defines a broader scope of medical devices compared to the MDD, and as a result there are several categories of products which fall under the regulation of the MDR which were not covered by the MDD. These include medical software, cleaning products intended to disinfect medical devices, or even cosmetic products such as colored non-prescription contact lenses. Companies that manufacture such products may have to adhere to medical device regulations for the first time, which can be challenging considering the more stringent requirements in the medical device industry compared to other industries. Hiring project management personnel with a background in the medical device industry could benefit these companies greatly since they are experienced with these requirements.
These new regulations, combined with the now almost certainty of Brexit, put medical device companies, and especially project managers into a unique and challenging scenario. EU MDR has introduced a whole array of changes to the existing laws, with the three major changes being in increasing the strictness of the tracking requirements, increases in safety requirements, and a broadening of what is considered a medical device. All of these will have large effects on all medical devices used in the EU. All old devices have until May 26, 2020, to come into compliance, which means a great deal more information must be submitted to the European government in order to make these devices compliant again. For new devices, this means that more data must be collected and turned over before a device can be released in the EU. This means a great deal more responsibility for project managers in charge of devices being released in the EU. they must now factor in the increased time that it will take to get all the information together for regulatory approval, and they also must be more diligent with the devices as what used to not be considered a medical device may not be considered one. I expected the UK will follow EU MDR even after Brexit occurs, but this would still require that a device now needs multiple submissions to be accepted in the UK. All in all, I think these changes to the Medical Device landscape will create a great deal more work for project managers that they must deal with.
Despite that EU MDR puts medical device companies in a difficult situation to quickly comply, I agree there are positives to the new regulations. With concepts like UDI that will allow better traceability and effectiveness of the products in the long run, and covering online sales to better provide for services from a distance, MDR as a whole is a positive change for the future of medical device regulations on a global scale.
Because MDR has to be fully implemented by May 26, 2020, many companies shipping to Europe are going to be on the grind to make sure their current products are in compliance with MDR. Project managers are going to have some difficulties making sure the company is on track with their current trajectories regarding their products moving forward, which means that better collaboration with different internal departments to make sure testing, data collection, etc. are all fulfilled by MDR. Costs will increase because devices have to be tested again, which means more materials and instruments have to be used; scheduling for potential future projects will have to be on hold for a while because the main priority is to make sure that current products on the market are following regulation; and manuals and other paperwork have to be updated for current products. I think with Brexit occuring that the UK will have to also follow EU MDR eventually, and their companies will have the same issues as other global companies.
Expanding more on Josh's point on various companies having issues with meeting the timelines and deadlines issued by the EU MDR, the rushed deadlines that multiple company executives are calling to delay can lead to many more issues. The regulation is set to take effect on May 2020 but for some classes of medical devices, this is too early so they are allowed a longer transitional period until 2024 to adhere to the industry's regulation standards. Without this extension, many departments that deal with supply chain and labeling would run into a lot of issues as they have to convert their whole system to a new set of regulations.
As well as issues with the new EU MDR, the issue of Britain's secession from the European Union has caused a ripple effect on all companies whose subsidiaries are located in Britain. While working in Ethicon as a Supply Chain Data management co-op, this information was brought to my attention as I was working on a project that provided my manager with constant metrics of various products that were being completed in plants located in Britain specifically as those needed to be monitored with utmost prudence. Plants in Britain from various companies have to transfer their labeling and product development departments to different locations located within the European Union so that they can continue to have relations with the rest of the European Union.
I have seen first hand the toll issues like Brexit and the new EU MDR has taken on Project managers as it has become harder to manage their employees who are struggling to complete daily tasks when their main focus is on finishing tasks related to these problematic issues. This causes a cascading effect where even the products itself become somewhat faulty and it causes a patient safety issue. This is why multiple executives are calling for delays in the process as there needs to be more time to complete the regulatory framework. Serge Bernasconi, MedTech CEO, said in a letter, "[W]ithout immediate action by the European Commission, the new regulatory system will not be ready on time to ensure continued access of patients and healthcare systems to life-saving and life-transforming devices. This set of circumstances will profoundly disrupt medical technology's internal market ... putting patient safety, healthcare services, and EU healthcare environment in major disarray." However, there are others who say that constant delays can cause the market to become unattractive to investors as well so they are pushing for the commission to finalize their decision and implement the new regulations.
I believe that all of these changes will have a great impact on the 3ed world countries other than EU, where there the cheapest Medical device get picked over the others even if its known of it bad reputation. How is that connected to the topic?, will more restrict rules means getting more people to work in new or preexisting projects to meet deadlines or suspend some projects to work on the highest end Products, therefor small company with "Cheapest quality and price" which used to have CE marks, now need to worker harder than before to stay in the markets, which will lead to there cost to be much higher than before.In addition, the competition between the companies for expanding there market shares will increase.
I agree with my colleagues that this new rules will be time and cost defective,but since one of the points of having different Programs and projects is to sense the change before it happened, as it written in PMBOK Guide, 6th edition "Project Managers expect change and implement processes to keep change managed and controlled". PM who are ready, will take this as an opportunity to keep there Brand Name on the top, that have its benefits in marketing and expansion.
