Translation to Commercialization Support

We are on a mission to revolutionize the landscape of cutting-edge microsystems based point-of-care 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.

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.

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

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.