With guidance from the Johner Institute, med-tech startups can navigate complex regulations early and bring innovative products to market safely.
As a young computer scientist, Anne Arndt recalls working at a medical device company in Germany, where she was expected to handle all regulatory compliance alone, with minimal budget. There was little appreciation for the huge task at hand, as well as the risks of developing products that might later turn out to be non-compliant.
Now, as part of the Johner Institute, Arndt helps med-tech businesses avoid these exact issues. While med-tech companies use technology to tackle health problems, they are often constrained by laws that vary from country to country.
“There is so much complexity in the regulatory environment, and many manufacturers lack the knowledge to bring a medical device to market. We support manufacturers to comply with laws and standards in a timely manner.”
Arndt stresses that compliance considerations should be built into the development stage, not after.
“A startup in New Zealand might be developing its device, but if they lack an understanding of legislative requirements, they may miss critical steps to ensure market readiness—whether in New Zealand or overseas."
Understanding compliance early prevents costly rework later, Arndt says, which can save significant time and money.
Many med-techs have international ambitions, making it essential to consider overseas requirements well before expanding globally. The Johner Institute helps med-tech companies develop products that meet regulatory standards in target markets, providing peace of mind.
“Different regions may classify a device in unique ways," Arndt explains. "People tend to understand the legislation, but they don’t always fully grasp its implications.”
In New Zealand, med-tech innovation often falls under laws established in 1981. These are likely to be updated soon to align with international standards, so startups developing products today should consider how regulations might change to future-proof themselves.
The Johner Institute partners with manufacturers to monitor regulatory updates, helping companies stay ahead.
Arndt highlights that many companies lack awareness of regulatory compliance’s importance.
“The challenge is to make it easy for device manufacturers to place devices on the market, while ensuring patient safety and easing governmental concerns about new technology.
“We shouldn’t stifle innovators’ creativity but rather guide them. It’s essential to have someone outside the company who can say, ‘That’s great, but let’s make sure it’s safe."
Find out more on the Johner Institute.
