Business Details
Expert Product Design & Development Services
Established by a seasoned professional with over three decades of experience in technology-driven product development, our company specialises in transforming innovative concepts into tangible solutions. Since completing my MSc in mechanical engineering and applied physics in 1987, I have led projects across medical devices, sensor technology, and IoT, supported by a network of experts. Our ISO13485-certified quality management system ensures rigorous compliance for medical device development, while our agile, distributed teams leverage PRINCE2 methodologies adapted to project-specific needs.We prioritise collaboration through digital tools like Teams and Zoom, enabling seamless remote work with clients globally. Our track record includes partnerships with startups, SMEs, and larger organisations, delivering cost-effective prototypes and scalable solutions in fields ranging from diagnostics to environmental monitoring.
Services
Product Design
Medical Device Development
Sensor Technology
IoT Solutions
Regulatory Compliance
Highlights and features
- ISO13485-certified quality management for medical device development
- Virtual teams with expertise in mechanics, electronics, and embedded software
- Adapted PRINCE2 project management for flexible, risk-aware delivery
- Proven success in medical diagnostics, environmental sensors, and IoT
- Collaboration tools enable seamless remote teamwork globally
Associations and certifications
- ISO13485
What people say
Cost-effective functional prototype
Experienced virtual team
Reduced unit costs
Agile and flexible approach
Regulatory compliance expertise
Services
Product Design
Transforming concepts into market-ready products through mechanical, electronic, and software integration. Our ISO13485-certified processes ensure compliance for medical devices and sensor-based solutions. Clients benefit from agile development cycles and cost-effective scaling.
Medical Device Development
Full lifecycle support for diagnostic and therapeutic devices, including regulatory submissions. Expertise spans human factors, embedded systems, and manufacturing transfer. Projects include molecular diagnostics and patient monitoring solutions.
Sensor Technology
Designing precision sensors for environmental, security, and industrial applications. Capabilities include optical, fluidic, and data analytics integration. Delivered solutions for gas detection and real-time monitoring systems.
Virtual Project Management
Coordinating distributed experts using PRINCE2 methodologies adapted for flexibility. Tools like Teams and Slack enable collaboration across time zones, ensuring timely delivery without compromising quality standards.
Regulatory Compliance
Navigating ISO13485, CE marking, and FDA requirements for medical devices. Documentation support ensures audit-ready submissions, reducing time-to-market through early compliance integration in development cycles.
People
Marc
Founder
MSc in mechanical engineering (1987), marketing degree, and 30+ years in tech product development. Led projects from LED printheads to medical diagnostics, previously at Team Consulting and Bax Innovation.
Lawrence Archard
Electronics Engineer
Specialises in embedded systems and medical devices. 10+ years collaborating on projects including consumer electronics and diagnostic tools. Former TTP consultant with expertise in hardware-software integration.
Rachel Jones
Human Factors
PhD in Computer Science with 20+ years in UX design. Advises on user-centred design for healthcare and telecoms sectors. Design Council associate and Nottingham Trent University visiting professor.
Jed Place
Regulatory Affairs
PhD in Surface Physics with 25+ years in medical device compliance. Guided three product generations through EU and US regulatory pathways, ensuring quality systems and market approval.
Questions
What industries do you specialise in?
We focus on medical devices, sensor technology, and IoT solutions, with experience in environmental monitoring, diagnostics, and industrial equipment.
Are you ISO13485 certified?
Yes, our quality management system is ISO13485:2016 certified, specifically designed for medical device design and manufacturing.
How do you manage remote projects?
We use PRINCE2 methodologies adapted for flexibility, supported by collaboration tools like Teams, Zoom, and Slack for real-time coordination.
Can you help with regulatory submissions?
Yes, we prepare documentation for CE marking, FDA approval, and ISO13485 compliance, ensuring audit-ready medical device files.
What regions do you serve?
Primarily the UK and Europe, with remote collaboration enabling global project support across time zones.
