What are the leading companies in the medical device market doing differently?

Greenlight Guru conducted a survey of medical device industry professionals on product development, quality management and marketing. More than 500 quality, product development and management professionals were surveyed. The study has many interesting lessons, which we will try to summarise briefly:

How much revenue growth does the industry expect in 2022?

The vast majority of experts expect revenues to increase in 2022. 34% of respondents expected high revenue growth and 46% expected moderate revenue growth. Only 4% of respondents thought their revenue would decrease.

What drives growth?

The key trend is the growing demand for diagnostic solutions in non-clinical settings, i.e. solutions for "anytime, anywhere" healthcare. 26% of respondents use Bluetooth compatible, 25% use artificial intelligence/machine learning solutions and 19% use 3D printing technology in their products.

What are the key quality objectives for 2022?

The priorities of companies in the industry have changed significantly over the past year. Almost two thirds (63%) of managers say that accelerating product development will be the most important task in 2022. That's a 37% increase in just 12 months!

The other top priority is to obtain the necessary marketing approvals (certificates).

The survey also asked why the market leaders were able to stand out from the average. Which elements of the quality management system have been handled differently from other market players? Differences can be identified in the following three areas:

• Sharing quality data within the organisation.
  • Market leaders state that quality is a shared responsibility in their organisation (85%) - a best practice that can only be achieved if data is widely shared and easily accessible to all employees.
• Effective use of feedback mechanisms.
• High level of supplier relationship management.

• The vast majority of market leaders (79%) say that quality problems are always or often fed back into R&D activities, and 81% say that these problems are submitted for management review. Both are at least 50% higher than for non-market leaders. The introduction of feedback loops ensures that everyone, including top management, can make informed decisions about quality and product development, rather than reactive, short-term decisions. It is also critical to identify and report on key quality indicators that drive positive behaviour and support a strong quality culture.

• Market leaders are significantly more likely to say that their supplier management programmes are above average or excellent, and are more rigorous in screening and engaging suppliers. Market leaders also tend to take a more collaborative approach to managing supplier relationships, e.g. supporting clear communication and ensuring transparency of production status.

As can be seen from the above, a quality-centric approach and obtaining marketing approvals are the focus of market-leading manufacturers. In the EU, the first step for placing on the market is the registration of operators, which requires the designation of a responsible person (PRRC).