Our Design and Development Services

Project success for medical products depends on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. We follow a structured, phase-gated process that allows for a disciplined product development approach. Our process encourages an early focus on clear problem definition and de-risking a wide variety of potential solutions.

Our design and development capabilities address five elements critical to project success.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Early Stage Product Strategy

Description

  • Defining the technical, IP landscape, regulatory and marketing pathways for a medical device are critical when it comes to determining a product’s potential. Choosing the best track to solve a clinical problem can clarify commercialization options, minimizing time in the product life cycle and reducing development costs. What is the true clinical need? Are there competitive devices on the market to consider? Will a device that requires a clinical trial merit the development risk? What are the reimbursement considerations?

 

  • Creating a new medical device can be an overwhelming hurdle. Making a functioning, representative prototype of the device often requires specialized tools and materials. What would the device look like? Which clinical problems does it solve, and how does it work? Is there an outside-the-box design idea that could improve on the original concept?

 

  • In order to set a development project on a capital-efficient pathway, these questions must be addressed to “de-risk” the product and process.

 

Our Approach

  • We start with a big picture, honest look at a product’s goals and potential. As we dig deeper into the device strategy, we use our process to break the big picture into smaller pieces.

 

  • In the early stages, our goal is to guide products to the most efficient and effective pathway, using evidence-based decisions for product development. Our inputs come from a broad analysis, including the clinical market, the regulatory pathway, and competitive products. Integrating these inputs, we can then generate design ideas and functioning prototypes to support design decisions and intellectual property strategies.

Design History File Generation

Description

  • Once a device is ready to go from prototype to product, following a defined process and generating appropriate documentation is crucial. Regulatory bodies require specific documentation as evidence to determine the safety and efficacy of the product. These documents range from design input requirements to outputs like design specifications, manufacturing processes and risk analyses.

 

  • As we like to say, “If you don’t write it down, it didn’t happen.”

 

  • Internally, a design history file serves to document cross-functional team approval. This file also acts as a reference for future projects and iterations.

 

Our Approach

  • GCMI’s design and development team has significant experience following a rigorous product development process, generating a design history file along the way. We know the medical device development journey well, enough to choose good design strategies and foresee hidden landmines. Did you test your product performance early enough and often enough? Are you set up to pass your packaging test? What about final product performance?

 

  • We bring engineering skills, close attention to detail and a commitment to the development process. As a result, we increase the odds of a straighter, more cost-efficient pathway to regulatory submission, manufacturing and commercialization.

Clinical Input and Review

Description

  • In medical devices, clinical adoption is the end goal, and developers must focus energy on gathering clinical insights throughout a project. Is this new technology advancing clinical practice enough to interest a clinician? Will a new medical product perform as intended in the hands of the clinician? What patient limitations should be considered? Will the clinical representatives on a hospital value analysis committee go to bat for it?

 

  • Gathering objective clinical input on a device can often be a challenge. Medical product developers spend vast amounts of time and treasure trying to answer these questions through agreements with clinical advisors and consultants.

 

Our Approach

  • GCMI’s 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. Ready access to this input allows developers to focus the scope of their projects and unearth risks that must be addressed.

 

  • As a practicing urologist, Dr. Emily Blum brings first-hand experience and feedback to the development of medical products. She has training in general surgery and adult and pediatric urology. She recently completed the A. Barry Belman Fellowship in Pediatric Urology and the Joseph E Roberts Jr Fellowship in Surgical Innovations at Children’s National Medical Center in Washington, D.C. Prior to that, she completed her urology residency at William Beaumont Hospital in Royal Oak, MI.

 

  • With our location and networks in Atlanta, GCMI also has access to a sizeable pool of clinicians across a variety of fields including cardiovascular, orthopedic, pediatric, neurological and regenerative arenas. These resources are indispensable to developers evaluating their product for clinical use.

Project Management

Description

  • Medical device development requires a combination of vision, leadership, organization, communication, attention to detail and resilience. Someone has to abide by the project roadmaps and regulatory pathways, bring the team to consensus and divide responsibilities, juggle design options and testing data, and more. And when a wrench is thrown in even the best-laid plans, a project requires leadership to realign the team direction.

 

  • Absent a focused, well-planned program, innovators and product development teams will likely experience burn rates and risk levels higher than necessary.

 

Our Approach

  • 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 only advise cutting the corners that make sense, because we know the risks – inefficiencies, project derailment, etc. We expedite through project plans tailored for a balance of capital efficiency and the probability of product success.

 

  • When timelines or assumptions change, we recognize and acknowledge the changes and alert the customer. Our focus shifts to finding an alternate path, an alternate design strategy, an alternate supplier – whatever the project requires.

Biomedical and Mechanical Engineering

Description

  • Biomedical and mechanical engineering expertise is required across the entire product development process. From initial concept brainstorming to hands-on prototyping to design for manufacturing, engineering analysis and design skills are front and center. What design strategies will have the greatest chance for success? What materials should be used to make this device? How can we change a design for improved performance?

 

  • Even tasks like scoping the clinical need, performing a risk analysis, developing and executing tests with appropriate models, and developing design inputs require an engineer’s lens. That perspective allows the design and testing processes to move forward smoothly.

 

Our Approach

  • GCMI’s team is filled with biomedical and mechanical engineering talent. Our team includes professionals with biomedical and/or mechanical engineering degrees. We are well versed in the tools and methods to make a medical product. We are ready for a design challenge, a manufacturing challenge, or a testing challenge.

 

  • We staff our projects with the best internal skill sets for the job, and we engage external expertise from our ever-increasing ecosystem based on the project needs.

 

  • The result for our customers includes practical prototypes, data-based decisions and products that are designed with efficient manufacturing in mind.

The design and development team at GCMI facilitates medical product development.

 GCMI has a 12,000 square foot medical device design and protoyping 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