D2 - Medical Device Design and Development

Guiding innovators through the medical device developmental

pathway: from concept to commercialization and cure.

At GCMI our experts and engineers partner with and guide innovators and product developers through a strategic plan to derisk their medical device in order to accelerate the commercialization pathway.

Why

Now more than ever, product developers and innovators are entering into a highly regulated and cost constrained environment. Identifying unmet clinical needs, and securing the guidance and resources needed to vet them and to foster proper development is a significant, though not insurmountable, challenge. That is where The Global Center For Medical Innovation (GCMI) steps in- creating a novel medical device is a complex process that requires a multidisciplinary team.

In the context of medical device development and for the sake of your design history file (DHF), that is provided to the FDA in the approval pathway, the way that a design is prototyped, verified and validated, and manufactured is very important.

Phase 0- Derisking your medical device from the start

One of the biggest challenges medical device developers and innovators face is enabling development of their technology in a multi-faceted process. It’s not as simple as, “I’ve made a prototype”, or “does the device work?” Project success is dependent upon careful planning and consideration across all functional dimensions – technological, clinical, commercial, legal, etc.. A concepts clinical need, development pathway, and technological feasibility are equally important. If you’d like to efficiently assess  the feasibility of your idea as a medical product, before significant costs are made, then a partner like GCMI is crucial.

Our Phase 0 process is key in understanding whether a technology is worth investing further.
Is there a market for the product? Will someone pay for it?
How will your device impact the outcome of care differently than the current standard of care?  
What is the product’s regulatory pathway?
Can you protect it? Who are your competitors?
What are the critical design elements of your idea?

Key aspects of this phase are

    • Development of a feasibility assessment strategy.
    • Identification of critical personnel and resources needed to realize success.
    • Development of enabling prototype devices to answer fundamental design questions, and identify critical to quality specifications.
    • Understanding and documenting the clinical need to design with end-users in mind.
    • Researching the concepts market and identifying competitive products.
    • Intellectual property survey and procurement.
    • Identification of the proposed devices regulatory pathway.

 

At the end of Phase 0, an innovator will better understand what makes their technology function, what makes their concept unique, and what they need to do in a methodical, objective, step-wise manner to get that product through successive “phase gates” into the hands of end-users and add value.

Phase 1 – Conceptualizing and Planning

We prepare a plan that identifies engineering requirements, materials, quality systems and evaluation criteria which overall streamlines the process while lowering development costs. In our experience, careful planning upfront with input from relevant experts results in shorter time to market and greater predictability. Phase 1 is when a team is assembled, a product specification takes initial shape, risks are investigated, and a plan is constructed on how to achieve technical/clinical/regulatory milestones.

Key aspects of this phase are

  • Project planning with the Design History File in mind
  • Risk documents
  • Technology and manufacturing specifications
  • Product requirements

Phase 2 – Design and Development

Once the plan is established, the actual designing and building process begins. GCMI’s prototyping capabilities allow the production of 3D models that reveal design issues and allow effective iteration processes. In this phase, a testing and verification plan is constructed that meets regulatory requirements and contract manufacturers are engaged to build pilot devices that are representative of the device that will eventually be distributed for commercial use.

Key aspects of this phase are

  • Design completion
    • Nailing down the mechanics of the device
    • Understanding the manufacturing process
    • Validating the design with users
  • Prototyping
  • Planning the regulatory pathway

Phase 3 – Verification

Consists of manufacturing devices for verification and validation testing. Data is collected and compiled into reports that can be used to support continuing engineering efforts and regulatory filings.

Key aspects of this phase are

  • Design verification
    • Stability studies
    • Design verification report with conclusions
    • Functional testing
  • Manufacturing transfer
  • Design transfer planning

Phase 4 – Validation

Validation testing requires the prototyped device or product to be evaluated by the targeted user. During this phase, we can begin both non-GLP and GLP preclinical studies with our partner, T3 Labs, and identify other necessary vendor resources leverage internal expertise in creating simulated use environments for training and testing devices.

Key aspects of this phase are

  • Execute regulatory filing
  • Development of commercialization literature
  • Both non GLP and GLP preclinical testing
  • Design validation tests

Phase 5 – Design Transfer

 

Scale-up manufacturing and distribution systems are put to use during this phase to create the final, commercialized device.

FACILITIES

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. With access to a 32,000 square foot medical product testing and training facility at GCMI’s T3 Labs, and medical product experts in GCMI’s MedTech Acclerator time and cost are saved and quality enhanced Within our spaces, we can go from a sketch to a design to a prototype quickly – sometimes in hours – allowing for faster iteration and speeding development.

GCMI’s core team of designers, engineers, and product developers, and leveraging our global ecosystem of cross-functional experts, we are focused on accelerating the product development and building the right team with specialized support needed on the path to commercialization.

IN HOUSE CAPABILITIES

Project Management
Device Development Strategy Creation/Council
Biomedical/Mechanical Engineering
Device Design
Additive Manufacturing
Elastomer Casting
Experimental Design
Instron/Mechanical Testing
Computer Aided Design (CAD)
CNC Manufacturing
Investigational Manufacturing
Device Assembly
Certified Class 10,000 Clean Room
Office Space for Medical Innovators
T3 Labs (Translational Testing and Training Laboratories, Inc.)