UK Life Science consulting firm Maetrics, is sharing the results of its findings from a survey of UK medical device companies. The report of the work, performed by MindMetre Research Ltd, offers an insight into how 50 companies view the short term future, at least from the perspective of their Compliance and Quality Management functions.
Full-service life sciences consulting firm, Maetrics is a leader in the life science consulting field, a position it clearly wants to cement with the commissioning of this new report. The study, conducted by leading business analyst MindMetre, surveyed more than 50 compliance and quality management professionals from four life sciences sectors, of which just over half were medical device companies, with participants from both large corporations and small to medium enterprises (SMEs). The intention was to determine the industry outlook, examine growth drivers and provide insight into planning and buying behaviours, and interesting reading it makes too.
If you’re in the game, you could probably predict much of the feedback, the nutshell version concluding:
- Emerging markets are key to growth as the more established markets present barriers such as price-restraint and increasing regulation. That said, compliance issues are also problematic in those emerging territories too (just ask anyone who’s tried to gain approval in South Korea or who faces the newly toughened regime in China). Notably the report also points to 43% of respondents 43% expressed concern about finding qualified staff for their emerging market forays.
- 58% of medical device firms say the introduction of Unique Device Identifiers (UDIs) will be one of the major challenges for 2015, especially for IT.
- Product launches (48%) and new Medical Device Regulations (45%) also pose significant hurdles.
- Across all UK healthcare and life science firms, respondents reveal lack of investment in compliance as businesses say they lack resources (68%), time (67%) and budget (65%).
- The medical device industry in the United Kingdom has been hit hard with spending cuts by the National Health Service and decreasing prices due in part to order pooling. Also distressing to this sector is stricter EU regulation: 61% of businesses responding to the Maetrics study cited unannounced inspections by notified bodies as a principal challenge for 2015.
- 61% report difficulties with implementing regulations to their specific environment.
- 60% say that regulations are hard to interpret and change often.
“This is a historic and exciting time for the industry,” said Peter Rose (pictured), managing director at Maetrics. “Emerging market expansion offers an appealing solution for businesses that are feeling under pressure in mature markets, but ensuring compliance with different regulations is going to be tough.”
“Having a strong quality and compliance team, whether internally or externally through a consulting partner, is more important now than ever before,” Rose continued.
“It’s clear that the key to fully leveraging the opportunities in emerging markets is confidence in interpreting and implementing regulations.”
Down to the nitty gritty, we rather like this report and will be returning to its findings in this week’s “View from the Med” editorial which will be posted tomorrow.
Source: Maetrics Ltd.