At the 30,000 foot level, verification and validation testing of new medical technologies aims to answer two questions: did we make the right product and did we make the product right?

Design verification and validation is often completed through physical testing, but can also include other methods such as inspections, review of specifications, or analysis of materials.

 

Section 21 CFR 820.3 of the federal code defines design verification as “the process of confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is defined as “the process of establishing by objective evidence that product specifications conform with user needs and intended use(s).” 

 

The goal of verification is to ensure there is sufficient evidence that a new medical technology or device has met all engineering requirements (design inputs). Design validation ensures the product’s design output meets identified user needs. User needs can be validated in different ways including usability studies, short or long preclinical studies, and clinical trials. These typically evaluate the user’s interaction with the device, or its comprehensive functional performance.

For example:

A user need may state that the device must be portable. The validation test will confirm that a typical end user is capable of moving the product with them while doing certain daily activities.

A cardiac catheter may be required to detect electrical signals in the heart. A validation test may include recording electrical signals from a pig heart.

If an orthopedic device needs to stabilize a fracture, a validation test may be to implant the product in a pre-clinical model of a bone break and monitor displacement over time.

 A user need may indicate that a clinician must be able to dispense medication from a device. To validate the design, a usability study may demonstrate that a typical user can make selections from a touch screen in order to open a dispensing drawer.

The level of rigor for verification and validation testing including preclinical work varies significantly based on a technology’s regulatory classification. 

Our preclinical program director Evan Goldberg shared the following:

Preclinical work would enter verification and validation testing very early in the design and development process for a resorbable material, implant or FDA Class III device given the need to see how the device or technology performs in a chronic survival animal for a period of time. This is required to verify and validate engineering requirements and that the product meets clinical needs. 

Preclinical work would enter verification activities later in the design and development process for non-implantable products or technologies like surgical instruments that can [employ bench testing for a significant portion of verification and validation testing requirements]. Preclinical work later in the process assesses performance and human factors that can only be validated in a preclinical model, either cadaveric or in vivo.

Why GCMI for verification and validation testing

GCMI and our preclinical arm T3 Labs have successfully completed verification and validation testing for medical technology innovators from industry giants like Abbott and Boston Scientific to early and growth stage companies like ALung Technologies to physician innovators and engineers like Dr. Rebecca Levit, Professor Christopher Saldana and many others.

 

If you would like to take a deeper dive into our verification and validation testing capabilities for your new medical technology, product or device please use the contact form below. We will put you in touch with the member of the team most appropriate to address your needs.

Our Medical Device Design Services & Product Development Process

Project success is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. We follow a structured, phase-gated process that allows for a disciplined medical device design and product development approach. Our medical device design services and development process encourages an early focus on clear problem definition and de-risking a wide variety of potential solutions. By later phases, the funnel of medical device design options narrows significantly, converging on a final product that has been thoroughly shown to meet the customer needs and is ready for distribution.

Medical Device Innovation: A one-on-one with ATDC Lead Entrepreneur in Residence Frank Tighe and GCMI CEO Tiffany Wilson

Tiffany Wilson, GCMI CEO, and Frank Tighe, Lead Entrepreneur in Residence at ATDC, discussed the medical product development process for early stage innovators. Learn from their experiences by watching.

Feasibility

When an innovator has identified a medical problem, taking an efficient approach to identify the viability of potential solutions is key. Feasibility focuses on evaluating critical product elements early. 

At the completion of this phase, an innovator will have data-based support for the value in launching a full development program for the product including needed medical device design services.

Planning

In our experience, careful planning streamlines medical device design services needs and the product development process, lowering costs and providing greater market predictability. 

At the completion of this phase, the project team will have a clear vision for the path to generating the product. 

Design and Development

Iterations from medical device design services, refinement and evaluation allow for product evolution from the prototype stage to manufacturable assembly. 

At the completion of this phase, the project team will have the specifications and initial supporting test data for a functional product.

Verification

Thorough engineering evaluations of the product demonstrate whether the output of medical device design services and efforts have met all of the product requirements.

At the completion of this phase, a project team will have statistically significant evidence of the product’s functionality and safety.

Validation

Thorough system and user testing demonstrate whether the design has sufficiently addressed the customer’s clinical need.

At the completion of this phase, a project team will have documented evidence as to whether the product is usable and solves the stated clinical need.

Transfer to Production

In order to scale production to quantities needed for sale, manufacturing processes must be shown to repeatedly and reliably generate the commercialized product. For many medical products, regulatory approval must also be granted prior to market introduction.

At the completion of this phase, the product will be ready for routine production and sale.

Facilities: The Space and Tools Innovators Need for Medical Device Design and Development

GCMI has a 12,000 square foot medical device design and prototyping center where we help innovators, entrepreneurs and new-product teams bring their ideas from concept to reality. Within our space, we can go from a sketch to a design to a prototype quickly – sometimes in hours – allowing for faster iteration and speeding development.
Our Design and Development Facilities

Our Process Activities and Capabilities

  • Early Stage Product Strategy

    We call this “Phase 0.” During these early stages, we help guide products to the most efficient and effective pathway by using evidence-based decisions for product development.

  • Design History File Generation

    We have a staff that brings engineering skills, close attention to detail and a commitment to the development process. They have the insights to lead you down a more cost-efficient pathway to regulatory submission, manufacturing and commercialization.

  • Clinical Input and Review

    Our staff includes a Medical Affairs Liaison who provides and gathers initial voice of customer inputs at the earliest stages of a project, and adds guidance and perspective throughout the later stages.

  • Project Management

    Your success is our goal, so we treat your projects like our own. Our goal is to move through the development process in the right way. We guide our projects along a particular path because we know the risks.

  • Biomedical and Mechanical Engineering

    Our team is filled with biomedical and mechanical engineering talent, including professionals with biomedical and/or mechanical engineering degrees. We are well versed in the tools and methods to make a medical product.

Why Work with GCMI's Medical Device Design Services & Product Development Team?

Globally, medical product developers work in a highly regulated and uniquely constrained environment. The GCMI team works with you to realize your product while considering regulatory compliance, clinical practices, intellectual property, and healthcare economics. Our team contributes development expertise, clinical insights, medical device design skills, project management, and an ecosystem of experts to minimize risks and streamline the overall medical device design and development process.

Verification and validation testing resources

PRECLINICAL TESTING’S ROLE IN THE MEDICAL DEVICE DESIGN AND DEVELOPMENT PHASE

Where does preclinical testing enter the design and development phase of new medical technologies and devices? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg share deep dive insights.

 

“At the end of the day, some testing requirements in the design and development phase simply cannot be done ‘on the bench,’ Evan says. “In design input requirements and confirmation activities within the design and development phase, only cadaveric or small scale in-vivo testing can determine if a device provides appropriate grip or traction for the user, or if it works as intended in a beating heart or vessels with blood flow. Read on.

HOW DO YOU KNOW YOU ARE READY FOR PRECLINICAL WORK? INSIGHTS AND RECORDING FROM OUR LATEST WEBINAR.

How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question.

 

“How quickly can you get your feasibility study to look like your GLP study? When you’re doing any level of pre-GLP preclinical studies, you have to maximize the value of the information you are getting. You never want to go into verification and validation testing without knowing the answer to your questions.” Access the recording here.

HOW DOES OUR VERIFICATION AND VALIDATION PHASE OF MEDTECH DEVELOPMENT ‘TRANSLATE’ TO PRECLINICAL STUDIES?

Design validation ensures that you have made the “right” product – according to the customer’s needs. Design verification ensures that the team has made the product “right” – according to regulatory and engineering requirements.

How does verification and validation in the design and development process “translate” to preclinical?

Find the insights from GCMI / T3 Labs Preclinical Program Director Evan Goldberg tells us in this Q&A. Read more. 

WHAT IS VERIFICATION AND VALIDATION IN MEDICAL PRODUCT DEVELOPMENT?

At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this design output (product) and ensures that it meets all engineering requirements and user needs, respectively.

Have you made the right product? Have you made the product right? Read more about GCMI’s approach to medical device design verification and validation.

OUR PROCESS: WHAT IS THE DESIGN & DEVELOPMENT PHASE AT GCMI?

Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products.

Too many medtech development projects are unsuccessful because innovators discover major roadblocks too late in the process. Here are some of the top ways to give your medtech innovation a better chance for successful commercialization.

“Best Practices for Transitioning from Design to Assembly in Medical Device Manufacturing.” - A recent feature from Assembly Magazine

Designing for manufacturability is a critical task. The effort to develop a component manufacturing process and an assembly process is just as critical. Making these two paths overlap as much as possible allows a development team time to improve on manufacturing methods prior to any pilot builds.

IEEE Completes Standards Family Intended to Provide Safe and Secure Medical Device Interoperability

IEEE 11073-20701™-2018 defines an architecture that binds the participant and communication model to the Web services data transport model defined in previous IEEE 11073™ standards.

PISCATAWAY, NJ, 14 Feb. 2019 – IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Standards Association (IEEE SA), today announced the publishing and availability of IEEE 11073-20701-2018 – IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding.

Read more.

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