Design & Engineering

Critical System Design Techniques for Safety, Reliability, and Compliance

These steps include the following:

Fault Tree Analysis
Failure Mode Effects Analysis
Risk Analysis

Systems Engineering

Systems engineering plays a huge role in medical device development and includes various steps, like documenting product requirements and design, identifying risks, and finding solutions to any problems that arise during the development process. Simply put, systems engineering tackles the development process as a whole and encompasses operations, performance, support, and testing. Taking a systems-engineering approach to medical device development is, therefore, a holistic approach that makes the entire development process more efficient and risk-free.

Medical Device Design Engineering Services

The medical engineering consultants at Outer Reef Technologies are highly trained professionals with years of expertise in medical device development and manufacturing. Our medical device experts in mechanical engineering, electrical engineering, systems engineering, design engineering, and more ensure that your experience with us is not only streamlined but also results in the best possible product.

Our medical device design engineering services ensure the conception of well-thought-out and tested designs that hold up when the product is produced. Because the final product’s functionality depends on the design, our team of in-house experts works around the clock to create unique designs that fit our clients’ exact needs. Whether you require individual components, surgical equipment, or entire devices, the team at Outer Reef Technologies can be of service.

Specification Development

Specification development takes place after the research and discovery phase and consists of formulating specifications for the medical device being designed. These specifications include electrical and mechanical to software requirements and cover areas like functionality and safety. This early stage is especially important since caution here can help avoid costly modifications later. Hiring medical device experts experienced in medical product development is integral to ensuring the success of the project. Failing to do so can result in loss of both time and money.

Embedded Systems

Because developing embedded systems is such a complicated and time-consuming process, it necessitates hiring Medical Engineering Consultants who are not only competent but also experienced in all aspects of the project. This includes design, simulation, verification, and validation. The process is also risky, which makes this even more important – with Outer Reef Technologies, you will not have to worry. Our integrated embedded systems development solutions are established and can be relied on.

Electromechanical Systems

Mechanical and electromechanical systems are a large part of medical device manufacturing. Complicated electromechanical systems and assemblies are used in all sorts of medical devices, including those used in treatment centers, clinics, and hospitals. Extensive experience is required for proper development and the various steps within, including prototyping, assembling, and testing the devices. To expertise, the process also requires an influx of cash.

Outer Reef Technologies not only provides you with the best minds in the industry but also aims to do so at a reasonable price. Additionally, because we’re ISO 13485 compliant, you’ll never have to worry about quality control.

Fault Tree Analysis

Fault Tree Analysis (FTA) uses a top-down perspective when evaluating medical devices. It uses “and” and “or” logic gates to evaluate safety and can detect sequences that can result in system hazards. Our medical device experts use FTA to identify and rectify any design weaknesses.

Failure Mode Effects Analysis

Failure Mode Effects Analysis (FMEA) uses a bottom-up perspective to evaluate medical devices and is extremely thorough since it takes every element into consideration. In addition to helping detect and eliminate product failure modes, it also reduces costs and improves product reliability.

Risk Analysis

Outer Reef Technologies complies with ISO standards, and uses FTA and FMEA to identify hazards such mechanical hazards, electric shocks, and chemical poisoning and provide risk mitigation strategies.

Hire Outer Reef Technologies for Product Design, Engineering, & Development

Medical device design and manufacturing is no simple task – that’s why you need medical device experts and the best team possible to do the job well and make getting approvals from the relevant authorities as simple as possible. Outer Reef Technologies has years of experience in medical product development and has dealt with everything from surgical equipment to robotics. Our CEO and founder, Jonathan Azevedo, has been in the industry since 2009 and helped develop the first orthopedic robotic platform.

If you’re interested in working with us, learn more about us here or simply contact us here – we look forward to hearing from you and starting the medical product development journey together.

Product Examples

Robotics and Automation

Our main focus and core competency is developing robotic platforms from the ground up. We are proud partners with ABB and handle all of their medical applications.

Motor Controllers

No matter your motor controller needs, we have the solution. Our team can develop hardware and firmware for your sensored or sensorless BLDC motor.

Surgical Navigation/Motion Capture

We develop high accuracy and precision navigation systems for the medical and gaming industries. Our systems incorporate IMU, optics, and/or mechanical tracking options.

Surgical Suites

After working decades with the top surgeons, we have brought many Class III medical devices and suites to the industry from concept through clinical trials and 510k submission.

Imaging and Optics

Our team has extensive knowlege and experience developing and manufactiring optical devices ranging from LED fiber optics to rigid and flexible scopes.

High Precision Encoders

As nearly all of our products require the highest level of accuracy and precision, in a small form factor, we typically design our own encoder solution to meet the clients requirements.

Virtual and Augmented Reality

We have partnered with some of the top companies in the world to develop world class virtual and augmented reality devices. Our specialty is in sensor calibration, system integartion and verifcation.

Industrial Product and Packaging Design

Our design team utilizes SolidWorks to design and develop all of the products mechanical components. We utilize FEA and 3D printing to ensure our designs meet all requirements, prior to manufacturing.

Software and Application Development

These day there are apps integrated into nearly every product. We can support desktop, mobile and standalone apps, including apps which are required to integrate with the cloud and/or remote devices.