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 Emerging Technology and Product Development Strategy 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, Emerging Technology and Product Development Strategy 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.  

With tertiary qualifications in healthcare and MedTech expertise, our clinical management consultants and clinical field specialists ensure compassionate patient care that leads to better patient and study outcomes.  

Services include:  

  • Working closely with clinical trial sites, giving site personnel technical training and assistance throughout the study 
  • Providing timely feedback on product performance  
  • Supporting subject follow-up visits  

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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