Our Services

Great ideas shouldn’t just sit around in a lab somewhere, or stay locked in an inventor’s mind.

We offer medical device development services at every stage of the product development lifecycle. Our cross functional engineers have regulatory and clinical insight, bringing awareness to current industry requirements. This improves their risk assessment skills, ultimately accelerating medical device development of concepts to clinical use in the safest manner possible. Similarly, our cross functional regulatory and clinical staff have front end engineering development experience that helps them identify efficiencies, and avoid pitfalls, thereby accelerating product development.

When you need a team with broad experience and knowledge who really wants to get your medical product idea to the market where it can help patients, we are ready to collaborate.

Contact us to learn more and to discuss what we can do to help guide your project through the medical device product lifecycle.

Product Development Lifecycle

Concept Generation
I.P. Development & Prototypes
Feasibility
Design V+V Design Control
Regulatory Filings
Clinical
Approval / Post-Market Activities

Design

Design

Concept development starts with a good idea, ideally directed toward an unmet clinical need. In making the leap from an idea to initial concept, we can begin to use engineering know how to develop the optimal medical device. Decisions and progress at this point can have a lasting impact on the future success of the medical device.

Design
Prototyping

Prototyping

An important step in the development process is the fabrication of a prototype that both looks and functions like the final device. The prototype communicates the idea and builds confidence with key stakeholders and investors. A well-made and well-conceived prototype can help bolster intellectual property filings, or enable completion of the “killer experiment” for future seed- or bridge-round funding. Computational modelling can also help inform this phase of development and optimize prototyping activities.

Prototyping
Design History File

Design History File

Creating appropriate and regulated documentation of your device during development can be an overwhelming experience. There are several commercial software systems available to help manage your design history file (DHF) or alternatively, you can create a system designed for your needs. Regardless, developing a relationship with a partner that has managed creation of design controls through best practices is prudent. A good starting point is to review the regulations of 21 CFR Title 820.30.

Design History File
Regulatory Submission

Regulatory Submission

Preparing a regulatory submission for the FDA is a critical step in the cascade of events that lead to product approval. We can work with you to develop your strategy and prepare the submission, as well as assist in or leading interactions with the FDA.

Regulatory Submission
Clinical Trials

Clinical Trials

With our extensive experience conducting clinical trials, we can help you design and complete studies that collect the right data, in a cost-effective way. Wherever possible, we recommend designing streamlined studies that generate only the data necessary to achieve your goals. We understand the unique demands of clinical trials and have dealt with nearly every challenge imaginable. When conducting a clinical study, we actively monitor not just the data, but study site performance and compliance with applicable regulatory requirements in order to identify emerging trends. We work with study site investigators and staff to find workable solutions to issues and address them in a timely manner.

Clinical Trials
Regulatory Approval

Regulatory Approval

We can help you with final marketing approvals and postapproval support. At every stage, we use fundamental science and data to show how your product meets regulatory requirements. Postapproval clinical studies are often required as a condition of approval of a PMA. We have experience designing postapproval studies for devices used across many clinical applications.

Regulatory Approval
Technical Patent Support

Technical Patent Support

Development and protection of an idea go hand in hand. Generally, we are a fee for services firm and will assign developments or additional embodiments of your idea to you.

Technical Patent Support
Regulatory Strategy

Regulatory Strategy

We can help you find your regulatory path through the development process and beyond. When you partner with us for support with regulatory submissions, we listen to your needs to help you determine your regulatory path to approval.

Regulatory Strategy
Process Validation Testing

Process Validation Testing

When the concept is ready for validation testing, you need a method validation to help you through this pivotal phase of development. We maintain a robust validation procedure that has been audited by multiple third parties over the 16 years of holding our ISO/IEC 17025:2017 accreditation. We can deliver the testing for our clients or a validated method depending on the need or request.

Process Validation Testing
Surveillance

Surveillance

Postapproval clinical studies are often required as a condition of approval of a PMA. We have experience designing postapproval studies for devices used across many clinical applications.

Surveillance
Design Iteration

Design Iteration

Medical device engineering is an iterative process. As we learn more we are able to add those learnings back into our process and hopefully limit the number of design iterations. Regardless, our clients have found it beneficial to work with a partner that has a proven design process including an understanding on how to iterate.

Design Iteration
EFS Device Assembly

EFS Device Assembly

Our team understands the challenges unique to producing devices for pre-clinical and early clinical experience. We can work with your early proof of concept prototype and build it under an efficient quality system to be evaluated. Some of our experience includes, but is not limited to, assembly for permanent implants, delivery systems, and single use devices.

EFS Device Assembly
Computational Modeling & Simulation

Computational Modeling & Simulation

Our experts can provide an optimum solution for medical device development using computational modeling and simulation (CM&S), also known as computer aided engineering (CAE). We use general linear/nonlinear mechanics and fully coupled engineering physics to design and optimize device design, evaluate the performance of devices (e.g., virtual testing such as fatigue life evaluation and RF heating related to MRI), and optimize design considering manufacturability (design for manufacturing) before physical prototyping. By leveraging CM&S early in the product life cycle, we can significantly shorten the time and cost of product development.

Computational Modeling & Simulation
Medical Device Testing

Medical Device Testing

Every medical device needs to be tested to assess its safety and effectiveness. We listen to your needs while considering the clinical, scientific, regulatory and engineering perspectives before work begins. Our experience helps you determine what tests are needed to properly evaluate your device. We have a portfolio with over 250 accredited tests and are actively validating new testing methodologies. We maintain accreditation to ISO/IEC 17025:2017.

Medical Device Testing
Boundary Condition Development

Boundary Condition Development

Design inputs are an important part of medical device development. The inputs define all of the criteria and requirements of your medical device. Our experts have robust experience working with physicians, writing and reviewing peer reviewed literate and ultimately defining the limits of a device in terms of clinical significance. This can be a model development project, a physiologic loading condition project or a combination of the both. Regardless, knowing the boundaries on design are an important part of medical device development.

Boundary Condition Development

Concept Generation
- Design
- Technical Patent Support
I.P. Development & Prototypes
- Prototyping
- Technical Patent Support
- Design Iteration
- Computational Modeling & Simulation
- Medical Device Testing
- Boundary Condition Development
Feasibility
- Prototyping
- Regulatory Strategy
- Design Iteration
- Computational Modeling & Simulation
- Medical Device Testing
- Boundary Condition Development
Design V+V Design Control
- Design History File
- Computational Modeling & Simulation
- Medical Device Testing
- Boundary Condition Development
Regulatory Filings
- Regulatory Submission
- Process Validation Testing
- EFS Device Assembly
Clinical
- Clinical Trials
- Process Validation Testing
Approval / Post-Market Activities
- Regulatory Approval
- Surveillance

OUR COMMITTMENT

We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.76/5 points (10).