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:

• Microsystems and microfluidic engineering design and consulting   

• (Micro)fabrication flow development and support   

• Materials characterization, imaging and testing   

• 3D printing and 3D bio-printing for biomedical research and prototypes   

• Design and prototyping 

• Sensor integration engineering design and consulting 

   MANUFACTURING SUPPORT & CONSULTING
        We provide some services in this domain and will work to connect you with other resources to provide services we don't offer in-house. 

• Low volume (10’s to 100’s) manufacturing 

• Developing strategy towards Design for manufacturing (DFM) 

• Connections to higher volume contract manufacturers and initiation of pilot projects 

HUMAN FACTORS

Our human factors researchers can provide a series of usability and human factors evaluations and support, including iterative design feedback, usability/accessibility testing, formative evaluations, and pilot user studies. This can include feedback on quick reference instructions and/or instructions for use.  

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 assessment in partnership with clinical subject matter experts  

• Biorepository access (access to biological samples) 

• Laboratory-based analytical assessment with contrived panels and potential to do head-to-head comparisons with available assays  

• Lab validation with clinical samples 

• Clinical pilot evaluation studies 

• Clinical protocol development assistance 

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

DIGITAL HEALTH DEVELOPMENT

ACME POCT partners with the AppHatchery (https://www.apphatchery.org/) for Companion Mobile app development.  Services range from review of existing digital tools, architecture design and best practices, to full user experience design and software development.  A successful example project is the translation of an engineering scale software system (like matlab/python) to a mobile application for data collection and signal processing. 

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.