The boundary between wellness and medical devices is becoming increasingly blurred. While some brands rush to market with unclear positioning and costly missteps, the most successful companies are taking a strategic approach—navigating regulations early, aligning product claims with market intent, and maximising commercial opportunity.
Positioning your product for success in a changing MedTech market
Our latest report helps product teams and business leaders understand the critical differences—and the growing overlap—between consumer wellness products and medical devices. Whether you’re looking to launch faster, scale confidently or reposition an existing product, this guide provides a clear framework for success.
What’s inside the report:
Wellness or medical device? The wrong label could cost you –From regulations to user trust, discover how the distinction shapes your product strategy.
Making the grey area work for you – The smartest brands are merging wellness and medical – see how they’re winning on both fronts without breaking the rules.
Launch strategy: routes to market demystified – See how costs, timelines and claims stack up – and what each route means for your commercial success.
Repositioning without the risk – Proven strategies for repositioning your product to boost trust, reach, and revenue.
Your five-point market readiness checklist – Practical guidance for aligning product features, claims, testing and go-to-market plans right from the start.
Don’t gamble on guesswork – Position your product with confidence
Health tech companies today face two strategic paths:
Reactive and high-risk – Rushing to market without regulatory clarity, leading to rework, compliance issues and missed opportunities.
Proactive and well-positioned – Making early, informed decisions that align claims, features and market needs while ensuring both regulatory compliance and strong commercial impact.
Where does your product stand?
Download the treading the line white paper here
Gain the clarity you need to confidently understand the difference between medical devices and wellness products and launch into the right market.
This report is essential reading for anyone developing consumer health products; whether that’s wearables, wellness apps, diagnostics or therapeutic devices. It combines regulatory insight with commercial strategy to help you avoid common pitfalls and seize the full market opportunity.
“Developing a medical device is complex and can be daunting. However, successful regulatory approval can drive greater commercial success and improve patient care.”
About 42 Technology
42 Technology (42T) helps businesses solve complex challenges and unlock new market opportunities through innovation and strategy. From global brands to emerging disruptors, we partner across consumer, MedTech and industrial sectors to turn sustainability ambition into measurable results.
With over 25 years of experience and a proven track record of commercialising innovation, we combine deep technical expertise with market insight to help forward-thinking businesses create what’s next.
Let us help you
We excel in deep innovation and technical breakthroughs, from early-stage exploration to end-to-end development and manufacturing.
