Class II and Class III Devices:
What it takes to get ahead
Less than 5% of medical device startups successfully bring a product to market.
Our goal is to make you part of this exclusive club. How?
Running out of cash is a big reason device startups fall short. That’s usually a result of underestimating product development time and cost. Or running into some unexpected design issues and having to start over.
Can we help you avoid these traps? Probably.
To begin with, you’ll be working with a team with the wide range of domain expertise.
In a nutshell, everything required to make a Class II and Class III device successful.
From ultra-low power hardware and software to biosignal acquisition and other advanced disciplines.
Learn about our areas of expertise:
But having this unique expertise is just the start.
We’ve designed our engagement model with your business success in mind.
This means no hourly billing that is hard to predict and control.
Simple. No surprises.
Instead, all of our projects are priced based on milestones achieved.
Which means that you can plan your budget with confidence.
So you can reach your product development milestones without running out of cash.
design for success
From napkin sketch to commercially-viable product, we take a holistic approach to product development, addressing all the required aspects for your device to be successful:
Technical
Ensuring the device can perform as required to deliver the intended clinical results
Usability
Ensuring the device can be operated in the intended clinical setting
Standards
Ensuring the design and development process is documented in compliance with ISO 13485:2016 and that the design meets the requirements imposed by relevant regulatory standards
Manufacturability
Ensuring manufacturing is feasible within your business case assumptions and identifying qualified suppliers and manufacturing partners
Financial
Optimizing device cost of goods sold (COGS)
“Nocturnal’s technical capabilities, collaborative process, and startup-friendly business model accelerated our ability to demonstrate our novel implantable technology in a preclinical setting.”
Joe Passman, Sr. Principal R&D Engineer, NXT Biomedical
