A new sweeping reform of the rules that govern the medical device sector in Europe represents one of the most disruptive changes to affect the industry in recent memory. The new EU Market Abuse Regulation (MAR) promises to disrupt Life Science and Medical Technology companies in several ways. This is not only throughout Europe, but with rippling effects throughout the the rest of the world. How has your MedTech or Medical Device company prepared for these changes?
What is EU MDR?
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry.
According to EY under these new rules, your MedTech or Medical Device company will have to:
- Provide substantially more clinical evidence to get products to market, or even to keep some products on the market
- Conduct deep portfolio audits to determine the new rules' impact on margins
- Relabel products and make data ready to be made publicly available
Where does the Gig Economy come into play?
MedTech companies are well-positioned to drive the future of health, but most cannot do it alone. They require a workforce of SMEs (Subject Matter Experts) and even skill sets that don't exist to fill in the developing job roles. Finding the expertise in technology and specialized digital health areas set to meet the changing market is a top priority for any company affected by these regulations.
Even if you're preparing for "legacy" EU MDR, the regulatory changes differ in several important ways from the legacy and current EU regulatory directives for medical devices and active implantable medical devices. The introduction of MedTech products will take this even further. As noted previously, changes in the regulation include expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies.
These changes will pose tremendous opportunities for specific gig workers and teams in both the US and Europe as the talent needs are extensive to ensure full compliance with the change. Through deep leadership alignment and strategy, an initiative-based workforce that harness the expertise of the gig worker has a strong market advantage to capture this trend. It's widely accepted that the new EU regulation for medical devices will have significant implications for the labeling operations of every manufacturer that is not only based in Europe but trades in Europe in any market.
Medical device needs associated with regulatory expertise have exponentially grown in that same time period. Medical device companies will need an executable global strategy based primarily on its new staffing goals. This is necessary to reach the level of immediate action and actions to get the necessary resource allocated.
There is an immediate greater focus and expansion of all services to address the current and future needs of not only the EU MDR, but all functionalities associated with the regulatory affairs, post-marketing surveillance, and product life-cycle enhancement. This means an increase of this niche workforce, and fast.
If you think ramping up to the necessary roles can be complicated, addressing issues that come with an influx of contingent workers will also need to be appropriately handled. Managing this new and larger contingent workforce while remaining compliant will be a new strain that many organizations may feel overwhelmed by.
Turning to Outsourcing
MedTech and Medical Device companies are starting to partner with Workforce Solutions companies, because in a time like this, expertise and ramping up their workforce is something they may become something bigger they can handle in-house.
In a Total Talent Solution, you can find the expertise you need by partnering with a company that already has a diverse pool of candidates to ramp up your staffing needs, and also help you manage all contingent labor management issues. This is including and not limited to payroll, compliance, managing suppliers, and reporting. If outsourcing all aspects doesn't seem feasible, most workforce solutions companies can come up with a solution specifically tailored to your needs. This can mean help with only parts of the process, and most importantly, it's all scalable. You can ramp up to help with immediate needs to be compliant and scaling back when you need to.
EUMDR and the Medical Device Directive is a transformational narrative in the Life Science Sector. Its specific effects are still being defined, but moreover, the precedence it has set for retrospective regulatory changes and the future classifications of MedTech products has created a new need for all types of non-employee models to address the seemly never-ending initiatives associated. By exploring a partnership with a workforce solution company, you may be able to meet those ever-changing needs with a custom-made contingent staffing and management solution so you can focus on the bigger things, like helping your customers get the medical devices as quickly as possible to save lives.