Medical Device Development
Everything you need for your healthcare and medical device development
From concept through manufacturing and FDA approval, we’ve got you covered
Medical device development and the FDA certification process requires high standards of testing, process and documentation that often goes above and beyond the needs of standard product development.
Kickr’s in-house medical device team and biomedical engineers can help you navigate the unique challenges of medical device development, documentation, prototyping and production.
Our QMS Management Services can help you quickly spool up your Quality Management System for your product and company. We are here to fully support your medical device development with thorough and thoughtful engineering, process and quality systems.
Our turn-key medical device services include design control, risk management, and prototyping through contract manufacturing.
Throughout the development process, we work directly with you to realize every important aspect of your device, including:
- Determining the technical specifications of your device
- Feasibility studies
- Engineering & design for usability
- Selecting and optimizing the appropriate materials
- Building, integrating, and testing software solutions
- Prototyping and testing your design
- Packaging design including labeling requirements
- Design Controls and Quality Assurance Processes, ISO 13485 and 21 CFR
- Compliant Quality Management System and QMS management
- Documentation for FDA approval, 510(k) submission support and certification for Class I through Class III devices
Smart Syringe
This conceptual medical device helped doctors provide more accurate dosing for patients, ultimately saving time and preventing potential errors or oversights.
Kickr Design developed the internal electronics, user interface (UI) and external housing. We then built the prototype for user testing.
What are the most important considerations for medical device development?
Unlike consumer product development, your medical device specifications are not just a spreadsheet of product performance. When developing a medical device, your product specifications are deeply integrated into your medical claims, risk analysis, and testing regimen. Therefore, extra care must be put in at the beginning of the development process to ensure we minimize the testing and documentation effort while maximizing the device’s marketability. Even a simple change from a manual pump to a microprocessor-controlled pump can drastically affect the costs and test requirements. Careful consideration of specifications with a strong knowledge of Medical Device Regulation is critical in your development partner.
There are thousands of pages of regulation surrounding the development of medical devices. Often, we see clients with other firms dive right into the engineering of a product even before understanding the regulatory pathway and strategy for their product. Will your product require pre-clinical animal testing? Are there other predicate devices that can help define the regulatory pathway? How were they tested? Does your product need to go through sterilization testing? Drop Testing? What are your Labeling and shipping considerations? These are all questions that can be answered with an initial FDA regulatory analysis that Kickr Design’s regulatory experts can provide as a first step in our process.
ISO 13485 and 21 CFR define specific protocols and requirements for design controls and your quality management system within which your product development, testing and risk analysis must be completed. Skipping steps and missing signoffs or insufficient risk analysis can mean your product may not be approved by the FDA upon submission, or even worse, cause injury or harm to a patient. Kickr Design not only has our own internal quality management system that is ISO 13485 compliant but also has the experience to assist you in developing and maintaining your QMS, DHF (Design History File) and other mandatory aspects of medical device development.
Medical Innovations we’ve been part of
Let’s bring your project to life!
Interested in developing or getting FDA approval of a medical device?
Our team of engineers is here to help. We offer free consultations and estimates.
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