G.RAU Inc. Our Expertise

Innovative Expertise

From concept to approval, we bring decades of expertise to the medical device industry.

Nitinol and Advanced Biomedical Alloys

Material Selection

Material selection is a pivotal step in medical device development, with direct effects on safety and overall device effectiveness. Decisions around biomedical specialty alloys must be based on a thorough technical knowledge of their intrinsic properties and applications.

The selection of the wrong material – or the delay in material selection – can result in redesigns and delays in product realization.

Our team offers deep expertise in biomedical materials such as Nitinol, cobalt chromium, stainless steel, magnesium, and titanium alloys. Our extensive knowledge can help you define the optimal material for your device at the right stage of the design cycle.

Partnered with our laboratory services, such as tensile, radial force, corrosion, and fatigue, our team can provide you discrete data to help you find answers about your material-related questions.

Fatigue

Fatigue and Fracture Mechanics

Fatigue and fracture mechanics are key considerations for any implantable medical device, with critical influences on durability, efficacy, and patient safety. A comprehensive understanding of fatigue behavior and fracture resistance is essential to design devices that perform under cyclic loading and harsh physiological environments.

Inadequate considerations and evaluations of fatigue and the risk of fracture can compromise device performance, delay regulatory approval, and potentially impact patient safety.

Our team brings extensive expertise in fatigue and fracture mechanics, specializing in the evaluation of specialty biomedical alloys such as Nitinol, cobalt chromium, stainless steel, magnesium, and titanium alloys. With a deep understanding of these complexities, we provide guidance from early-stage design to design verification, to help ensure your device performs as intended under real-world conditions.

Partner with us to help streamline development, mitigate risk, and meet regulatory expectations with confidence. Our actionable recommendations can guide you to design devices that excel in durability, safety, and performance—all in an effort to help you bring your product to market faster.

From early design to validation, we provide actionable insights to help ensure your device performs under real-world conditions. Partner with us to minimize risks and bring your product to market with confidence

In parallel with our fatigue laboratory services , as well as our microscopy and metallography inspections, our team can support critical fatigue-related inquiries.

Manufacturing Process

Process Optimization

Manufacturing processes significantly impact the quality, scalability, and consistency of medical devices. Thorough control of these processes ensure reliable performance throughout the product lifecycle.

When shortcuts are taken – or unnecessary steps are incorporated – the manufacturing process can suffer from inadequate controls that lead to quality issues, delays, and increased costs.

Partnered with our laboratory services, our advanced expertise delivers process evaluations and improvements tailored to your manufacturing goals to ensure consistent product performance through the intended lifecycle of the device.

Our team offers extensive expertise in manufacturing and process optimization, specializing in advanced techniques for working with biomedical materials such as Nitinol, cobalt chromium, stainless steel, magnesium, and titanium alloys. From prototyping to full-scale production, we optimize processes to enhance quality and reduce time-to-market. Partner with us to guide you to efficient, reliable manufacturing solutions.

Our laboratory services can help evaluate your manufacturing processes, including HAZ analyses and microstructure evaluations, as well as surface sciences.

Regulatory Strategy

Define Your Strategy

Regulatory strategy for non-clinical testing is a critical component of medical device development due to its direct impact on clinical trial initiation, product approval, and long-term success.

Without a focused strategy, companies risk delays, regulatory pushback, or unforeseen challenges that negatively impact timelines and to bring their product to the market. A clear and well-defined regulatory approach will simplify the navigation process of these complex requirements.

We help ensure that your regulatory strategy is not only streamlined but also robust to fulfill both U.S. and international requirements. We provide technical justifications, as well as scientific rationales – that align with regulatory expectations – to help you avoid unnecessary setbacks.

We can guide you through the intricate steps of the regulatory process from early-stage planning to submission preparation. Partner with us to create a comprehensive, well-informed strategy that brings your product to market efficiently.

Meet our team of experts to help navigate your regulatory strategy.

Root Cause Analyses

Identify and Resolve

Unanticipated results from in vitro benchtop tests, animal studies, or clinical trials require immediate identification of the underlying issues to maintain design progress.

Delays in resolving root causes can slow down the design cycle, and lead to setbacks in the process development and approvals – yet the solution may be simpler than expected.

Our team offers support in root cause analyses to help medical device companies tackle complex problems. From initial investigations to actionable solutions, we provide clear recommendations to address issues, minimize delays, and help support the success of your product. Partner with us to navigate challenges and keep your development on track.

Learn how we can help evaluate the unanticipated results with our laboratory services to support your root cause analyses.

Boundary Conditions

Define Your Limits

Boundary conditions determine how well medical devices will perform under real-world clinical environments. It is essential to understand human biomechanics, anatomy, and disease-specific factors to ensure device reliability and patient safety.

Misinterpretation of boundary conditions can lead to design inefficiencies, reduced performance, failed device verifications, and risk to patient safety.

With knowledge and technical experience in biomechanical deformations, physiology, anatomy for various disease states, our team provides insights into the in vivo environment, to allow for optimized device design and non-clinical testing.

Our technical experts can assist your team to determine operational boundaries, biomechanical and material responses, and overall device design recommendations. Partner with us to refine device parameters and align performance with clinical demands.

View our laboratory services for material fatigue evaluations and corrosion evaluations.

Corrosion and Biocompatibility

Surface Science Expertise

Corrosion resistance and biocompatibility are essential to ensure patient safety and the performance of implantable devices. The understanding of corrosion mechanisms such as pitting, galvanic, and metal ion release is vital for long-term device functionality.

When corrosion and biocompatibility considerations are not addressed, challenges include reduced device lifespan, adverse biological reactions, and regulatory hurdles.

With expertise in specialty biomedical alloys, we offer insights into material processing, passivation practices, and clinical evaluations to help ensure your device is resistant and safe.

From material selection to benchtop testing and clinical alignment, our team delivers actionable insights to reduce risks and advance your device with confidence. Partner with us to address these corrosion and biocompatibility challenges and advance your device with confidence.

Explore our laboratory services to learn more about our surface science evaluations.

Tailored Workshops

Laboratory Expertise

Our Expertise

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