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Medical Product Development Services
Turn your breakthrough medical innovation into a commercially viable product.
Fast, cost-effective, and reliable product development for groundbreaking high-tech medical innovations.
Let’s bring your next-generation medical device to life.
You have a vision for a high-tech medical device that will transform patient outcomes; we have the unique medical device development expertise and in-house capabilities to take your idea from concept to market—fast and cost-efficiently.
We’re proud to support healthcare innovators throughout the entire product life cycle and forge long-term strategic partnerships with the minds behind tomorrow’s transformational medical technology.
Chris Bass
InventoRR MD, CEO
“It has been great working with Sonele. Their team has been extremely responsive and helpful in working with us to design AbClo into the great product it is today.”
A better partner for developing your product
Lower costs
Reduce your production costs thanks to our end-to-end approach that streamlines product development and manufacturing.
Faster time to market
Ensure your product reaches patients and healthcare professionals faster due to our proven experience, advanced manufacturing capabilities, and specialized tools.
DFM-focused process
By prioritizing Design for Manufacturability (DFM) from the outset, we minimize the need for redesigns.
Long-term partnership
We’re here to support you beyond the first few units of your product, acting as your long-term manufacturing partner.
How we transform your medical concept into a market-ready solution
01
R&D + Proof of Concept
De-risk early-stage development with expert feasibility studies, technology validation, and innovative solutions.
- Our medical product developers help you identify technical challenges early, reducing costly rework later in the process.
- We provide data-driven insights to refine product concepts before you commit to full-scale development.
02
Medical Device Prototyping
Accelerate design iteration and validation through high-fidelity functional prototypes.
- We enable real-world testing of form, function, and performance before finalizing the design.
- We provide quick-turnaround prototypes for stakeholder feedback and investor presentations.
03
Electrical & Mechanical Engineering
Optimize mechanical design and electrical systems for reliability, manufacturability, and performance.
- Our engineering team ensures seamless integration of components, reducing potential failures in production.
- Our designs are optimized for scalability, efficiency, and cost-effectiveness.
04
Software & Firmware Development
Ensure seamless device operation, data processing, and connectivity with embedded software and firmware.
- We provide custom real-time software solutions tailored for medical devices, ensuring precision control and regulatory compliance.
- We integrate wireless connectivity, AI-driven diagnostics, and cloud-based data solutions where needed.
05
Industrial Design
Design ergonomic, user-friendly, and aesthetically refined devices optimized for clinical and patient use.
- Our medical device designers focus on human factors engineering to enhance ease of use and safety.
- We ensure every medical device design meets market expectations and usability standards, improving adoption rates.
06
Regulatory Support
Reduce regulatory roadblocks and streamline your path to market approval.
- We can offer assistance in choosing the correct testing protocols to meet the required regulatory approvals (i.e. FDA, Health Canada, CE Mark).
- We provide detailed design history files, process validation reports, risk assessments, and testing documentation to facilitate your regulatory submissions.
- We maintain rigorous quality and traceability standards throughout development and production to ensure compliance with regulatory (i.e. FDA, Health Canada, CE Marking) requirements.
07
Manufacturing
Manufacture your medical device product under the same roof to reduce risks and costs, speed up time to market, and ensure product quality, safety and compliance.
Frequently asked questions
At Sonele, we approach every client’s needs individually. To get a better understanding of the potential costs associated with your medical product development, we encourage you to reach out for a personalized quote. Our expert team is ready to provide you with detailed information and support to guide your project from conception through to market.
It depends on many factors, including the complexity of the device, regulatory requirements, and manufacturing considerations. However, the entire process typically takes 2-7+ years, with Class I (low-risk, exempt from 510(k)) projects taking closer to 2+ years and Class III (PMA, high risk, implantables, novel devices requiring clinical trials) projects taking closer to 5-7+ years.
Sonele operates under a certified ISO 13485 Quality Management System (QMS) for medical device development and contract manufacturing.
Sonele has experience developing ultrasound imaging systems and probes, surgical devices, diagnostic tools, therapeutic systems, medical software and health IT.
Contact Us
Ready to push the boundaries of medical technology?
The future of healthcare innovation starts here.
Fill out the form, and we will contact you within 3-5 days to start the process of bringing your breakthrough technology to life.
