In 2020, market demands and operational challenges brought on by the global health crisis shook the foundation of the medical device industry. Many companies had to quickly adapt their operations to simply survive, while other companies found themselves in a unique position to thrive. What strategies, tactics, and technologies enabled some organizations to outperform their peers?
 
To understand how companies weathered the pandemic and approached key challenges like risk management and process improvement, Greenlight Guru recently conducted a benchmark survey of more than 300 professionals in the medical device industry. The results, compiled in the 2021 State of Medical Device Quality Management and Product Development Report, offer a detailed look into how top companies performed well despite 2020’s disruptions and how they’re maintaining quality through 2021.
 
How COVID-19 Affected the Medical Device Industry
In general, the pandemic severely disrupted medical device companies’ supply chains and revenue projections. Some did experience spikes in demand for their products, but most companies faced steep challenges like much of the business world did.
 
Smaller organizations with less excess capital were particularly vulnerable during this time: 63 percent of survey respondents said the pandemic negatively affected funding, and 59 percent said it negatively impacted time to market. Slower times to market led to decreased revenue-generating opportunities; combined with difficulties raising capital elsewhere, 39 percent of respondents said their companies faced serious challenges to their financial viability.
 
While 2020 painted a dark picture, 2021 is looking brighter. Of those surveyed, 79 percent said they expected modest or strong revenue growth, while only 5 percent believed revenue would shrink. Companies have already turned their attention toward this year to recapture some of the opportunities COVID-19 took away.
 
Signals from Market Leaders
The bullish view on 2021 revenue may seem surprising, but it reflects a confidence in the market and a commitment to quality that supports successful companies’ operations. In fact, organizations rated “highly competitive” relative to their market peers were four times more likely to forecast strong revenue growth in 2021.
 
While highly competitive companies could be expected to outperform others, their confidence comes in large part from their investment in quality management and in fostering a quality culture. For example, 40 percent of high performers document design controls in a traceability matrix during concept and feasibility—as compared to 8 percent of lower-performing peers. Their early commitment to risk management persists throughout the product lifecycle, with one-half of top performers fully integrating risk management into their QMS. And these companies are twice as likely to leverage traceability for change impact analysis as well.
 
These responses point toward top performers’ shared view that quality is not a “checkbox” activity but rather a strategic asset. To them, quality is both a tactical advantage and a mindset to influence best-in-class medical device development and improvement. High-performing companies use quality management to break down silos between departments, and their culture enables leaders to activate quality like the strategic asset it is.
 
4 Ingredients for True Quality Outcomes in 2021
To take advantage of quality as an asset like a high-performing organization, companies need to invest in a quality culture. Part of the solution is adopting technology like medical device quality management system (MDQMS) software and a shared vision from leadership that champions quality as a core value. Building up quality as a strategic asset, however, requires focusing on four other key areas as well.
 
Market strength: Companies that see quality as an asset are twice as likely to say their companies are “very competitive” relative to their peers. They also performed better than peers throughout 2020 in terms of funding and time to market.
 
Efficiency: High performers encourage efficiency in every aspect of their operations. For example, quality companies are 1.6 times more likely to be able to show closed-loop traceability than companies not prioritizing quality. Top performers can update their traceability matrix in four hours or less.
 
Risk management: Companies that are focused on quality understand the importance of integrating risk management throughout the product life cycle: 57 percent of top performers say they integrate risk versus 34 percent of those who do not prioritize quality. The benefits of integrating risk management don’t often manifest early, but when it matters—like during product recalls or company audits—having an integrated risk management system makes a significant difference in producing a True Quality medical device.
 
Strategic point of view: Quality-focused companies use their QMS to greater advantage. They’re twice as likely to believe their QMS data is reliable and to use it in making business decisions. They understand quality doesn’t stop at compliance but instead contributes to overall company success.
 
While 2020 certainly challenged how the medical device industry operates, it also demonstrated how companies using quality as a strategic asset can weather difficulties and set themselves up for success in 2021 and beyond. Companies wanting to reach high-performer status in the marketplace should consider prioritizing the development of a quality culture in the year ahead.
 

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Jon Speer is the founder at Greenlight Guru a medical device quality management MDQMS software and a medical device guru with over 22 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.