You want to design your progressive new technology or device and quickly get it into the hands of the clinicians and patients who need it, but MedTech research and development is complex and highly regulated. When and how to invest in initial clinical evidence? How to navigate regulatory requirements? Or when, where, and how to commercialize?  

When you need to incorporate diverse considerations from engineering, regulatory, market access and reimbursement, and clinical perspectives to form a unified strategy and do it right the first time, It Takes Avania.

Avania Clinical Solutions experts collaborating on medical technology development strategies to advance emerging tech from concept to market.

Hands-on Medical Technology Consulting

The team in Strategic Consulting and Product Development draws on extensive industry experience to provide strategic and operational expertise for emerging products through conception, design, and execution. Working closely with you, we develop a deep understanding of your unique challenges and then customize a strategy and operational plan to take your MedTech from idea to market.  

Whether we’re negotiating with a regulator on your behalf, assessing the most efficient method to demonstrate compliance of your product to standards, finessing the look and feel of your first generation device, or designing a study to bring you to market quickly and with high likelihood for approval, rest assured it will be completed accurately and efficiently — often before you even know it needs to be done. 

Customizable MedTech Compliance Services  

Offering hands-on, expert guidance through every stage of the product development process, Strategic Consulting and Product Development provides a wholistic and strategic approach to maximize the preclinical, regulatory, clinical, and commercial success of innovative medical device technologies. 

Our consultants will be involved early in your development process and will work backwards to make sure that product development is done with consideration to all standards and required testing, and that clinical evidence will meet regulator requirements, so that everything streamlines toward a successful regulatory submission and subsequent market authorization.  

Our integrated end-to-end platform ensures a partner that gives you the strategic guidance and clinical evidence necessary to achieve reimbursement once market authorization is obtained. 

Our advisors and subject matter experts will seamlessly guide you through the MedTech development life cycle, assessing your needs and designing a custom program that brings your goals within reach.   

  • Medical Affairs
    • Develop effective clinical protocols, emphasizing appropriate endpoint selection, eligibility criteria, statistical powering, and data collection requirements    
    • Conduct comprehensive country and protocol feasibility assessments to ensure efficient use of your time and resources  
  • Regulatory
    • Determine regulatory strategy for novel products in various jurisdictions 
    • Advise on sequencing of regulatory submissions and progressive indications for use 
    • Negotiate regulatory pathway, pre-clinical, and clinical testing requirements with regulators 
    • Draft and compile regulatory correspondence, including pre-submissions, applications to authorize clinical testing, and marketing applications   
    • Provide expert and responsive feedback to help address deficiencies noted from regulatory bodies 
    • Ensure smooth interactions with regulatory bodies across the globe 
  • R&D/Engineering
    • Define, develop, document, and deliver a pre-clinical strategy, encompassing all aspects of product validation and verification 
  • Engineering
    • Provide turnkey product development services including concept evaluation, design input development, detailed design, verification and validation testing, and transfer to manufacturing support  
    • Design and develop everything from tiny implantable and wearable devices to large installed capital equipment, software, and electronics  
    • Manage function, size, sterility, and biocompatibility requirements  
    • Ensure safe and effective function with IEC 62366 and FDA human factors and usability engineering guidance compliance  
  • Quality
    • Design and implement a compliant Quality Management System customized to fit your organizational size and structure  
    • Train your team on Quality Management System concepts and processes 
    • Perform internal audits, regulatory inspection preparation, and more

Responsive, expert, and hands-on medical technology consulting, project team leadership, and support to drive operational execution of trials ranging from pre-clinical to clinical FIH and pivotal.  

Proper field clinical management is essential for MedTech development, especially in first-in-human and early feasibility studies.  

With tertiary qualifications in healthcare, MedTech expertise, and years of experience across a wide range of therapeutic areas, our Field Clinical Specialist (FCS) team ensures compassionate patient care that leads to better patient and study outcomes. By ensuring that all surgical cases and follow-up visits are planned, managed, and executed with a high level of attention to detail, with quality data, and in accordance with regulatory requirements, our FCS team also contributes to a more comprehensive study view — actively mitigating risks before they occur.  

Our solutions include: 

  • Field clinical based support for all phases of pre- and post-market clinical studies 
  • Sponsor relationship​ management 
  • Driving recruitment initiatives 
  • Providing timely feedback on product performance 
  • Liaising with clinical trial sites, providing site personnel technical training and assistance throughout the study 
  • Site and sponsor training to optimize trial execution 
  • Managing logistics, including pre-case and post-case support 
  • Device accountability support and shipment coordination, both locally and internationally 
  • Storing, maintaining, and tracking investigational product (IP) for coordinated and timely shipment to activated sites  
  • Post procedure FCS reporting 
  • Virtual support (live streaming) when required 
  • Supporting patient follow-up visits 
  • Ensuring reported trial surgical data are accurate, complete, and verifiable from source documents  

Advance your MedTech product with the team who has what it takes. It takes specialized expertise. It takes global resources. It takes integrated solutions.
It Takes Avania.

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