One of the fastest-growing sectors within the broader pharmaceutical market is that of global medical devices. Known in the industry as ‘MedTech’, it is a market expected to be USD 613 billion by 2025. Barbara Peralta at Amplexor explains that as the value of the market increases, so does the volume and complexity of the associated regulated information that needs to be managed.
Extract:
‘Managing Regulatory Requirements as the MedTech Sectors Sees Unprecedented Growth’
Amplexor’s Barbara Peralta on how and why MedTech manufacturers must adopt a more joined-up and better co-ordinated means of refining technical content in order to manage increasing regulatory requirements.
One of the fastest growing sectors within the broader pharmaceutical market is that of global medical devices. Known in the industry as ‘MedTech’, it is a market expected to be USD 613 billion by 2025. As the value of the market increases, so does the volume and complexity of the associated regulated information that needs to be managed.
In May 2021, the EU Medical Device Regulation (MDR) came into force across EU member states, and the equivalent In Vitro Diagnostic Regulation (IVDR) will follow in May 2022. It is a similar story of increased regulatory requirements in the rest of the world. Other regions are heading in a similar direction to the EU, with health authorities keen to make devices more traceable and enforce more consistent monitoring of device safety, prior to products entering the market and once they are in use.
This all means that organisations must define and implement a clear and robust content strategy to meet global requirements and to reap their own business benefits from them. Manufacturers will need to decide how they will optimise processes, manage resources and fill any gaps in their current skill sets.
Although regulatory compliance can feel onerous, increased information and process rigour can positively affect any MedTech business.
Removing content siloes
Organisations in many industries commonly store content across repositories. This siloed approach also exists in MedTech, which exacerbates this by adopting a relatively ‘loose’ approach to change management. This includes amending labelling, quality, and marketing content in a siloed manner rather than scheduling the updates centrally.
To stay on the right side of the new regulations, to maintain the highest level of patient safety, and to take advantage of economies of scale, manufacturers need to adopt a more joined-up and co-ordinated means of refining technical content. This should involve looping market feedback back into product lifecycle and labelling management and a holistic and systematic approach to planning and scheduling content updates.
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