Your medtech device idea might be commercially viable, so when do you start thinking about quality management systems or the regulatory strategy? At the beginning. Today. Before you get too far down the track.
I cannot emphasise enough how important it is for a startup to have those frameworks in place as early as possible, so the team knows what to expect and when, that they are documenting everything in an orderly manner, that they are not working on assumptions, that they are engaging with their stakeholders early. This is notabout box-ticking; rather, by understanding quality processes and relevant regulatory requirements early and implementing them, you will benefit fromthem, by getting to market more efficiently with less iterations, a more fit-for-purpose design, less sunken money, and ultimately a better reputation andbetter market adoption.
Te Tītoki Mataora and the HealthTech Activator have put together an interactive workshop on 30 September for device startups where we will unpack the role of quality and regulatory planning, explain what needs to be considered and when, and help participants apply these concepts to real-world scenarios. This workshop will help you understand the concepts involved in regulatory requirements and quality management, explore the role they play in the successful commercialisation journey of a medical device and help you understand key considerations in implementing a quality management system and a regulatory strategy.
Startups often find themselves caught because they don’t know what they don’t know, a common scenario in New Zealand where we face few obstacles and theindustry is still growing. We are a very small market and what works here mightnot be sufficient in Australia, the US or the EU. Good market research andengagement with stakeholders early is key to success.
The development process between the idea and a market-ready commercial device is not a straight line. Let’s say you have an app to help people with their lifestyle, weight, diet, exercise. This type of product is likely considered a wellness device but by adding a claim around prediction of heart attacks it is suddenly considered a medical device and needs to go through all the regulatory hoops, and your journey to market access may change significantly. You must weigh the value of that add-on against the actual value your product delivers and understand the cost/benefit implications. In short, your lack of knowledge may cost you.
Start early and bring your stakeholders with you. Assumptions won’t makethe grade if you’re going to market; you need processes and checks and balances that hold you to account. Thinking you’ve identified the needs of your stakeholders– and that includes potential users – is not enough; you have to show you’ve donethe work and have validated your assumptions. In simple terms, the better your management and quality system, the more likely you are to get to market early andefficiently and succeed rather than fail.
As a startup, you must keep three elements on your roadmap at all times. Firstly, never assume, always ask; find out what you don’t know; talk to those who’ve already taken this journey. Secondly, start early. Thirdly, engage with your stakeholders.
If you are an early-stage innovator, researcher, pre-spinout group,or startup, this workshop featuring myself (Alimetry) and Natalia Lopez (Kitea Health) will help you understandthe critical role of quality and regulatory framework in a successful market launch. Register here.
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