ACME Services
Translation to Commercialization Support
We are on a mission to revolutionize the landscape of cutting-edge microsystems based POC diagnostic technologies. Our specialized services advance the development, refinement, testing and commercialization of these technologies with the aim to accelerate the path to translation and clinical adoption. Over the past 5 years, ACME POCT has been a catalyst for success, supporting numerous emerging technology ventures in navigating the journey from technology development, through clinical validation, to FDA clearance and successful commercialization.
Our Framework
As member of the national Point-of-Care Technologies Research Network (POCTRN), ACME supports innovative ventures by using the HealthTech Innovation Cycle framework consisting of 10 innovation maturity levels across 4 domains: TECHNOLOGY, CLINICAL, REGULATORY, and MARKET/BUSINESS. This approach clearly defines deliverables and achievements at each level, which guide progress and manage risks through the development and commercialization process.
ACME POCT supports ventures in meeting technology maturity level requirements across the 4 domains through consulting and production services provided by expert resources within our center.
ACME POCT services are available to:
1. Recipients of our annual ACME POCT Translation to Clinical Impact Award
2. Any early-stage venture; we coordinate services through the Emory ADJUST Center, please use this intake form to request services.
Services Offered by ACME POCT
We offer a range of consulting, support, and production services that fall broadly into the 4 Innovation Cycle domains. We meet with each venture team to understand your needs to craft a scope of services that best fit your development objectives. Services can also be customized to meet your specific needs.
Watch to learn aobut our services and resources directly from the interdisciplinary ACME POCT team
In this video we share the services and expertise that ACME POCT provides to entrepreneurs, engineers, clinicians, and others interested in the invention, development, testing, and/or refinement of devices geared toward addressing unmet clinical needs within the areas of 1) Technology; 2) Clinical; 3) Regulatory; and 4) Market/Business.
TECHNOLOGY
Foremost, we are technology-focused center offering a wide range of design to manufacturing support:
Comprehensive technology assessment
Prototype design and fabrication support for microfluidics, sensors, and other devices
Materials characterization, imaging, and testing
3D printing and 3D bio-printing (for biomedical research and medical device prototypes)
Mobile app development
Usability and accessibility evaluations with actionable recommendations for device and Instructions for Use (IFU)
CLINICAL
We have access to leading physician experts across a wide range of clinical domains to help narrow your clinical use case or provide specific insight on clinical challenges you may be facing:
Clinical use case and needs assessment in partnership with clinical subject matter experts
Clinical usability assessment with potential end users (e.g. clinical lab or patients)
Laboratory validation with clinical samples
Clinical protocol development to facilitate pathway to market using regulatory guidance
Clinical validation pilot study (limited scope and size)
REGULATORY
ACME POCT Regulatory Consultants offer extensive experience in compliance, quality systems management, as well as strong relationships within FDA:
In-depth review current Regulatory strategy or plan
User requirements analysis
Reviewing, assembling, facilitating communication with FDA
Pre-submission meeting strategy and preparation
Planning studies designed to support regulatory submissions
Device classification
MARKET/BUSINESS
We provide some services in this domain:
High-level market and customer analysis
Introduction to local and national capital resources
SBIR and STTR application strategy