Three things medtech firms need to do for 'true quality'

True Quality 2022 was a coming-together of some of the brightest leaders in medtech. Greenlight Guru, the hosts of the event, has identified some key lessons and sage advice from those who know it best. Here are three things True Quality 2022 speakers say medtech leaders need to be doing at their companies now.

Invest in medtech training for employees

The practice of continuous improvement is a cornerstone of quality management in the medical device world, and not without good cause. In this market, change is constant, as global regulations continue to evolve in response to the industry’s nonstop output of new technologies and ground-breaking healthcare solutions.

So, for medtech companies to stay in stride with the rest of the pack, leaders must apply the same lens of continuous improvement to their teams. For Greenlight Guru’s training and education manager Aaron Lucas, that means proactive training.

“Learning is usually reactive,” he said during his Greenlight Guru Academy Showcase presentation at True Quality 2022. “There’s a lack of resources out there. The market leaders who have all the resources are able to do the proactive training that we know is more successful. They're able to train their teams before there’s a problem.”

The numbers agree with Lucas, particularly regarding medtech market leaders prioritising education. According to Greenlight Guru’s State of Medical Device Industry Report, the most reported roadblock to commercialisation was inadequate training, especially among pre-market start-ups. Lucas explained that much of this is due to a combination of shifting regulations and a lack of available and up-to-date training resources for teams.

“A lot of times you have a training moment, but then a month later, what you needed to learn changes, and that opportunity to learn isn’t always still there,” he said. “As new changes happen, you need to be able to have the content to meet those changes.”

For medtech companies who do invest in in-house continuous training programs, findings from the 2022 State of Report demonstrate a major upside: nearly three in four of all medtech market leaders invest in in-house training programs covering the latest regulatory changes and requirements. These trained individuals were also much more likely to say they are “very knowledgeable” about industry compliance information.

“Education and training is vital for commercialisation, but it’s also about making better devices,” said Lucas. “Greenlight Guru Academy can help you go from single point, reactive training to continuous and proactive learning.”

Don’t give in to the fear of the unknown

Of all the four letter words, perhaps the most damaging one is fear. Even for leaders and executives, fear can lead to issues like uncertainty, self-doubt, indecisiveness, and poor prioritisation of business goals.

In the medtech industry, particularly, it can be a pervasive problem. Report data shows that a large share of medical device professionals don’t feel confident about achieving their business goals, as only 8% say they are “very well equipped” to meet objectives; conversely, 47% admit they are either “neutral” or “not well equipped.”

So, what’s causing these feelings of fear? For one, there’s a massive learning curve when it comes to regulatory knowledge, particularly for those without a long stretch of industry experience, as Kyle Rose, president of Rook Quality Systems, explained during his True Quality 2022 presentation.

“There is a big knowledge gap that often scares people working on this stuff,” said Rose. “This happens to everyone, but especially for those coming from a software or non-medical device background who are unfamiliar with FDA and device classes, it can be a big cause for worry.”

But fear can show up even for the most experienced of medtech company leaders. “That’s not due to some sort of weakness, it’s just biological,” says Kevin Bailey, founder and CEO of Dreamfuel.

“I work with leaders across all industries, and I can say firsthand that fear of failure or the unknown isn’t uncommon,” he said. “According to the National Science Foundation, an average person has about 12,000 to 60,000 thoughts per day. Of those, 80% are negative and 95% are repetitive thoughts. These repetitive negative thought patterns hold teams and individuals back from peak performance.”

To combat the negative thoughts, especially for those in growing companies, Bailey preaches an approach of mindset coaching. The key, he says, is to remember that fear is simply a feeling—not a premonition of current or future failure.

“You have to remember that you are not your emotions,” he said. “When you remember to breathe, reflect, and stay mindful, you can actually reframe your anxiety as excitement for the road ahead.”

Combat medtech recruiting woes with company culture

Whether you’re building a start-up from the ground up, managing the growth of a mid-sized company heading for an IPO, or at the helm of a major medical device enterprise, you rely on your teams for all that you do. So, it should come as little surprise that hiring the right talent in today’s medtech market is a major area of focus for leadership teams.

“The attraction and retention of talent is a big challenge,” said Mitch Lewandowski, head of quality for GRAIL, Inc. “How do we engage with employees and how do we bring people in? I think it’s going to continue to be a problem going forward.”

Solving the problem is becoming more and more about cultivating a good, positive company culture. However, that can take on many different forms, particularly in this post-pandemic world.

“COVID-19 opened up the doors and means we don’t have to recruit regionally,” said Lewandowski. “The flip side, though, is that they can also leave just as easily.”

One of the biggest driving factors of company culture is adjusting ecosystems and expectations to a collaborative remote or hybrid environment. Findings from the State of Medical Device Report showed that medtech industry leaders were more likely to offer “flextime” to employees. As a result, those companies’ employees tend to be more satisfied with their jobs, thus increasing retention and taking some pressure off hiring managers.

If you or your team are feeling pressures stemming from a lack of culture, shortages of talent, or the ever-shortening timelines of medical device development, the result could be a case of employee burnout.

“It’s so easy to fall into crunch culture,” said Justin Barad, founder and CEO of Osso VR. “If your employees feel like they’re burning out, it’s probably already too late. If you’re thirsty, you’re dehydrated.”

Overall, the focus of culture should always tie back to your people. Barad explained that doing so means ensuring they know their needs are taken very seriously. “We need to value free time and reward people for being creative and solving problems.”