Medical Device Engineering Services

Engineering with clinical and regulatory insight.

Navigating the product development path from idea to approved medical device is an exciting journey. The medical device development community can all agree that the ultimate  goal is to put the best device in a physician's hands, so they can treat patients.  We all want to improve a patient's medical treatment; this is both satisfying to our engineers and engrained in our culture. The experience of the MED engineers can help you move your project from one phase to the next, bringing your idea closer to its realization. We’ve learned along the way, the better work you complete on the front end, the greater likelihood of success in later stages of development. We use  first principles of engineering to help move devices through the medical device development process, with the end goal of commercialization in view.

We collaborate with our clients wherever they are in the medical device development process.  Our engineering team has history and experience with upfront feasibility R&D including acceptance criteria development and material level testing, formal verification and validation testing that is needed for global regulatory submissions, and post-market competitor evaluations for claims. Our 13 year history of ISO 17025 accreditation has given us assurance that our efficient and well thought out reports will help you demonstrate how your medical device meets quality and safety standards. Our test reports are accepted by regulatory authorities globally.

We have medical device testing and engineering experience including design controls and validations, testing to support regulatory deficiency question responses, clinical case support and physician training on proper delivery of a wide range of devices. Some areas in which we have experience testing devices include:

• Orthopedics
• Biologics
• Women’s health
• Vascular stents, grafts, wires and other accessories
• IVC filters
• Heart valves
• Urology
• Endoscopy
• Vascular and endovascular grafts

Some of the services we provide

CLINICALLY RELEVANT ACCEPTANCE CRITERIA AND BOUNDARY CONDITION DEVELOPMENT

Defining robust clinically relevant acceptance criteria and boundary conditions can be a significant hurdle in the medical device development process. The clinical environment can be complex and highly variable. We have developed the acceptance criteria and clinical conditions for hundreds of devices in a wide range of clinical environments. Our efforts have helped produce medical devices that successfully stand up to their intended use and the requirements for regulatory approval.

TEST METHOD DEVELOPMENT

Many tests needed to develop a medical device are not currently prescribed in testing standards. In the absence of standardized test methods, it is up to the medical device developer to define and develop the testing methodology that will appropriately challenge the device. We have a robust history of test method development and validation. In fact, many of the tests that we have developed through the years eventually made their way into testing standards and guides. We are actively involved in ASTM and ISO standards and chair several of these efforts. We can help you identify an appropriate test standard or develop a new methodology. For a complete listing of our validated methods you can click here.

Accreditations

  • ISO 17025 Accredited Methods
PHYSIOLOGIC MODEL DEVELOPMENT

Anatomic modeling plays an important role in understanding human anatomy and disease and ultimately how your device performs in worst-case patient populations. Each person is unique, and so are the diseases and disease states that result in morphologic changes within the body. Developing a physiologic model for a diverse patient population to be used for design verification testing is a significant challenge. We can create physiological models that mimic the clinical environment by leveraging cadaveric models, experience of physicians, as well as other sources. These inputs combined with our experience have helped us create clinically relevant models and their associated justifications to evaluate device safety for many customers.

RISK ANALYSIS, RISK MANAGEMENT AND DESIGN CONTROL ENGINEERING

Device requirement generation is a useful and necessary step in the development process. We have experience with risk analysis, creation of user needs, design control file creation, process validation, clinical evaluations and many other activities as identified in ISO 14971 that are required to produce a safe medical device. We can help at any stage you are in with the development of your medical device.

Accreditations

  • ISO 13485 Certification
COMPUTATIONAL MODELING AND SIMULATION

Our highly experienced computational modeling and simulation team can support product development activities as well as regulatory approvals. We can perform finite element analysis, computational fluid dynamics and RF heating simulation related to MRI on a wide range of devices. We are active in research and publication with the ultimate goal of reducing the burden of the medical device approval process.

For more detailed information, please contact:

Justin Metcalf
Director of Engineering Services
Justin Renfrow
Contracts Director