The medical device design services and product development team at GCMI facilitates medical product development through all phases – from initial concept generation through transfer to production manufacturing. We guide and execute along a strategic pathway, focusing on both product excellence and regulatory compliance. Our team works with a variety of innovators: individual physicians, researchers and engineers, start-up companies and publicly traded industry leaders.

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.

When an innovator has identified a medical problem, taking an efficient approach to identify the viability of potential solutions is key. Our Phase 0 focuses on evaluating critical product elements early, with limited cost and effort.

Key Questions:

  • What is the clinical need or problem to be solved?
  • How will the product’s critical features address clinical need?
  • What is the product’s regulatory pathway?
  • Can the innovator’s intellectual property be protected?
  • Is there a market for the product? Who are the competitors?

At the completion of Phase 0, 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.

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

Key Questions:

  • What are the product requirements and key risks?
  • What design tasks are needed?
  • What are the considerations for manufacturing and testing the product?
  • How long will the project take and at what cost?
  • Who is the project team, and what external resources are needed?

At the completion of Phase 1, the project team will have a clear vision for the path to generating the product.

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

Key Questions:

  • What does the product look like, and how does it work?
  • What materials are in the product and how is it manufactured?
  • Have all product risks been addressed?

At the completion of Phase 2, the project team will have the specifications and initial supporting test data for a functional product.

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

Key Questions:

  • Has the product met acceptance criteria for each functional requirement?
  • Is the product safe to use?

At the completion of Phase 3, a project team will have statistically significant evidence of the product’s functionality and safety.

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

Key Questions:

  • Is the product effective at meeting the user’s needs?
  • Can users reasonably perform the tasks required to operate the product?

At the completion of Phase 4, a project team will have documented evidence as to whether the product is usable and solves the stated clinical need.

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.

Key Questions:

  • Is the product effective at meeting the user’s needs?
  • Are all critical manufacturing processes producing assemblies that meet design specifications?
  • Is the manufacturer prepared for product traceability, distribution and marketing?
  • Have regulatory entities approved the product?

At the completion of Phase 5, the product will be ready for routine production and sale.

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 development process.

Featured Medical Device Design Services & Product Development Content

Medical Design & Outsourcing: FDA issues FAQ on 3D-printed equipment against coronavirus

Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. Read.


GCMI, in partnership with Children’s Healthcare of Atlanta and the Georgia Tech Pediatric Technology Center, has completed our first design files for those wishing to prototype Face Shields for healthcare providers, the first in what we hope will be a series of designs for badly needed PPE items.

Engaging a flexible third party medical product development firm to help you tackle an inflexible process

“GCMI is unique in that we were able to choose the services that we needed precisely at the time we needed them. The way GCMI engages with their customers is unlike any other firm.” – Lou Malice, nFant CEO

5 Things to Invest in Before Prototyping New Medical Devices

It’s crucial to maintain a capital efficient, yet flexible, process for medical device design services and product development process in order to have the greatest likelihood of arriving at your intended destination in the least amount of time.

“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.

4 Key Compliance Issues for Medical Device Companies

From our colleagues at Greenlight Guru:

“The goal for most creators of new medical devices is to be able to get them to market as quickly as possible, right? So, what commonly puts roadblocks in the way?

Compliance issues. What are the common issues and what happens with these non-compliances?”

Greenlight Guru founder and VP of QA/QR shares his insights. We thank Greenlight Guru for including GCMI on its “Ulimate List of Medical Device Incubators and Accelerators”.

Shifting indications can accelerate a medical devices’ original intention

“We would be quite naive about what’s next if not for GCMI. It’s a bootcamp on medical technology commercialization for academic researchers.” – Darren Roblyer, Ph.D., Boston University

Recent Medical Device Design News