Medical Device Product Development Lifecycle Support

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In today’s global medical device industry, a company’s ability to bring an innovative, cost-effective product to market quickly is dictated by how well they manage the processes that govern its design and development. But having the right resources in place or the time commitment and attention to detail required to navigate the complexities involved across each step of the medical device product development lifecycle is a challenge for many companies. Without the right expertise steering the ship, you run the risk of costly delays, missed milestones, funding complications, regulatory denials, and more.

At Sterling Medical Devices, we’ve been delivering medical device product development lifecycle support and design innovation—from concept to regulatory approval—for more than two decades. With deep expertise, a proven quality management system, and a comprehensive understanding of the complex requirements mandated by dozens of regulatory bodies worldwide, we can help you design and develop a quality product that meets all the required regulatory controls, so you can get your device to market faster and at a lower cost.

With Sterling’s medical device product development lifecycle services, you get advanced expertise and support to help your company bring its product concept to fruition. Our services span the complete medical device lifecycle phases:

• Feasibility: We start by making sure your device is viable, financially feasible, and meets the targeted users’ needs.  We do this by developing a rough idea of what the device will look like, what it’s intended to do, and how users are expected to use it. We also explore the current market space to confirm that users’ needs align to your intention for the product, define the regulatory pathways, examine possible predicate devices, and present this information to you to start the next phase of the design.

• Planning: Next, we provide you with all of the processes across the entire medical device product development lifecycle. We create plans that describe the design and development activities, schedule, standards we intend to follow, risk management processes, and usability processes. In essence, we partner with you to ensure you’re following the design controls put out by the FDA and other regulatory bodies to keep you on track through every phase of the medical device development lifecycle.

• Requirements: Here, we begin by writing the user, product, software, and hardware requirements. We also define the primary function of the device and determine what needs to be tested, how it will be tested, and what’s involved. We conduct formative user studies on an ongoing basis, where we talk to a broad spectrum of users—from patients and doctors to technicians—to obtain feedback on the concept as it relates to all functions of the device. From there, we refine the time, budgets and schedule as needed, and provide you the information on your path forward. 

• Design & Implementation: In the implementation phase, we transform the requirements into a documented structure as we design a clinically viable, pre-production device (mechanical, electrical, software, and integration). To do this, we partner with you to identify an optimum architecture for implementation of the system requirements, complete reviews of the design architecture to verify the quality of the design and implementation strategy, and update requirements specifications as necessary. We implement each hardware component and conduct ongoing design reviews of the design implementation and iterate the device prototype as needed to ensure the product meets requirements and adheres to regulatory controls. Finally, we engage with your manufacturer, arming them with the information they need to hit the ground running on production. If you don’t have a manufacturer lined up, we can facilitate that connection using our long-standing relationships across the industry.

• Testing: Though we perform testing throughout the entire medical device product development lifecycle to ensure the device design is headed in the right direction, once the production equivalent is developed, we conduct formal testing, which includes:
  • Verification: We test the device against design requirements to ensure the design outputs match the design inputs. This process typically includes testing of the software, hardware, and electrical components, as well as inspections and analysis of the various layers and sub-systems process.
  • 3rd Party Testing: Next, we engage a 3rd party test house to test the device to the applicable standards needed for the project.
  • Validation: Finally, we confirm that the users’ needs and intended uses for the device are met. This summative usability testing ensures that it functions as it is intended.
• Regulatory Submission: We submit your device to the appropriate regulatory authority, ensuring all required regulatory controls for safety and effectiveness are met.

Bring your idea to life with medical device product development lifecycle expertise from Sterling

Our medical device pros bring years of experience and an intrinsic understanding of the nuances involved in medical device product lifecycle development. We do it all, so you don’t have to. Plus, with experts guiding the process from the outset, you will enjoy a streamlined process at a lower cost with no hassle on your end.

For more information about our medical device product development lifecycle support services, contact us here.