Quality is big business in the medical device and pharmaceutical industries. These are two of the most highly regulated of all businesses: everything is tightly controlled, from product quality, process controls, licencing and approval of importers, distributors, etc.
This level of control is manna for the project manager: nothing is left to chance! But how are these controls reflected in PMO? Is the same level of control to be seen in the project and portfolio space, as on the manufacturing floor or in the warehouse?
This might not always be the case. Some stages of a product or project lifecycle might not be within the control of the PMO: if there is a dependency on an external supplier or a Notified Body, then project schedules can be harder to predict, and harder to control.
An Engineering Solution
So how is it possible to bring better control? The most effective way to do this is through an old-fashioned feedback loop. Project Management best practice tells us that Lessons Learned is one of the most powerful tools in the PMO toolbox. By setting the right measurement points, the project manager can harvest very valuable data to gain insights and improve current and future planning cycles.
This has never been more valuable than right now. Every medical device sold in Europe must be re-registered to meet the new European MDR regulations that have recently come into effect. This places a massive overhead on medical device companies to submit registrations, and on Notified Bodies to approve them. How long will they take? What level of resource will be needed to meet the demand? Is this mammoth task possible within the available time?
These are questions that can be answered through careful measurement and analysis, resulting in better-informed estimates and planning. By collecting valuable data across hundreds (or in some cases, thousands!) of medical devices, it is possible to gain insights and recognise patterns. Aside from the highly-skilled regulatory experts managing the registration of MDR products, the medical device industry is also depending on skilled data analysts and PMOs to help plan and prioritize this work. This means that delays and other risks can be identified early, and managed to avoid disruption to product supply.
Aspira has very highly skilled PMO professionals well suited to this work. We have Project and Portfolio Managers working with our clients in the Medical Device industry to ensure they can meet the demands of MDR regulations, within the tight timeframes available. Contact us today for a consultation