10 Feb Contract Design Enables Innovation

Getting any design from concept to commercialization takes a lot of work, but medical devices are particularly difficult.  The added regulatory burden, risk management, and usability evaluations increase the effort required to successfully bring a medical device concept to market.  Sadly, this barrier to entry means that some great innovations will never see the light of day.  

Companies such as The Realtime Group bring their expertise in regulatory compliance, design, test, and submission to the table. We enable innovators to focus on what they do best: coming up with great new products to diagnose and treat people’s ailments and improve their quality of life.

Most design companies have designers who can work through technical challenges such as how to design a circuit, or a mechanical apparatus. In addition, companies that specialize in medical device development have a special mindset unique to the industry. This guides the staff to prepare for a successful submission by ensuring that work is performed, documented, and tested per compliant company processes.

This guides the staff to prepare for successful submission by ensuring that work is performed, documented, and tested per compliant company processes.

• Dedicated staff distill the latest regulations and standards into manageable requirements for  company processes and products.
• Regulatory experts review company processes for compliance improvement opportunities and provide a framework to jumpstart companies without existing processes.
• Product designers are familiar with and account for medical device-specific requirements in their designs.
• Testers produce and execute test protocols using good documentation practices.
• Developers produce design documentation formatted to streamline regulatory review.
• Test laboratory liaisons collect the documentation and work with Nationally Recognized Testing Laboratories (NRTLs) to shepherd products through compliance testing.

When deciding to enlist the help of a contract design firm, first consider what kind of help you need. The following questions can help you identify your needs.

• Do you know what tasks must be accomplished to get your product through verification, submission, and commercialization?
• Is your product ready to market right now?  If not, do you need help getting it there?
• Does your company have a regulatory department?  If not, a design firm with significant regulatory experience can help you avoid regulatory pitfalls.
• Does your company have ISO 13485-compliant processes in place? 
• How well-documented is your product? Do you need help determining what documentation to produce and/or help producing it?
• Do you need help verifying your product or preparing it for regulatory testing through a NRTL?

The Realtime Group is a contract design firm with twenty-one years of design experience specializing in regulated industries, including medical, aerospace, and defense.  Our staff has experience in almost every aspect of the medical device product lifecycle, from conception through post-market surveillance and product remediation. Give us a call at 972 985-9100, and let’s discuss how we can help you bring your innovation to market.