Our Services

The medical device industry is characterized by continuous improvement, providing innovative solutions that go beyond designing, developing, and introducing a medical device to the market.

With its diverse and deep experience within the medical device industry, 1MINDT consults on a broad spectrum of activities partnering with the client and its teams to develop practical solutions that can deliver tangible results. Of importance is development for sustainable business growth thereby supporting entrepreneurs with their startups or established medical device companies within the area of medical product, innovation, development, and technology.

When you’re moving from idea or concept to first in man, 1MINDT knows the way to get there. We offer medical device start-up/ companies, manufacturers an optimal path to market with expertise and tangible solutions, in the 3 key areas of the entire product development spectrum. In essence the key area’s:

1. Concept/Feasibility
   • Exploration of ideas to working concepts, showing the proof of concept (PoC). Or just fail fast as early failures drive innovation
   • Business evaluation
   • Constructing the idea allowing for Intellectual property (IP) protection filling, strategizing the IP portfolio
   • Early concept evaluation for design for manufacturing
2. Design Validation/Pre-clinical
   • Strategizing, IP portfolio, development, regulatory, biocompatibility, sterilization, etc ..
   • Phased development from concept phase to production
   • A critical independent review at the closure of each individual design phase, prior moving to the next phase
   • Design/production evaluation, verification, and validation
   • Pre-clinical evaluation management, planning, and reporting
   • Preparation for submissions to notified bodies or competent authorities
3. First into human, clinical
   • Site and KOL identification
   • Managing clinical studies
   • Obtaining market approval

1MINDT provides, on top of above mentioned support, guidance to start-ups in the medical care. Coaching or mentoring is focussed to understand the feasilibility of a concept. The aim is helping  starting businesses to find their feet in their business adventure.

A strong point of 1MINDT depth and breadth of medical care/device-focused expertise is our consulting practice, engagement with our clients ranging from a couple of hours sessions to onsite support.