Medical Products Support Services (MPSS)

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Navigating the regulatory landscape can be daunting and frustrating for anybody involved in medical device research and development. MPSS was launched in May 2014, to assists Vanderbilt investigators with regulatory affairs related issues, and help bring innovative medical devices out of their laboratories and into the marketplace. MPSS provides individualized or large audience teaching and lectures in relation to medical device regulatory affairs.

MPSS can help determine if your product is regulated by the FDA and if so, how. This is very useful as FDA determination will affect the development pathway as well as the requirements for the type and amount of data to support safety and efficacy.

Please contact us and we will be happy to set up a meeting and provide guidance as per your need and product.

• Individualized consultation on your medical device
  • Device classification
  • Applicable regulations, guidance documents and standards
• Navigating the IRB and FDA process
  • Strategies and guidance for submissions
  • When to contact and interact with the IRB and the FDA
  • Support with the development of the clinical study protocol and consent form
  • Reporting
• Early product development regulatory guidance
  • Guidance for pre-clinical testing requirements
  • Guidance for benefit - risk assessment
  • Determination of need for Early Feasibility IDE
  • Risk assessment for SR / NSR guidance
• Informal communication and interaction with the FDA to get early input to regulatory strategies
  • Guidance for who to call and what to say
  • Facilitate and participate in meetings
• FDA pre-submission and IDE guidance and support
  • Guidance on when pre-submission is useful and what information will be needed.
  • Assist with addressing FDA responses and concerns on submissions
  • Assist with IDE submissions
  • Review draft submissions
  • Assist with understanding the IDE and documentation requirements
  • Assist with maintenance and reporting post-IDE approval
• Support for regulatory documentation
  • Provision and maintenance of Sponsor-Investigator Initiated Device Research Handbook
  • Provision of IDE templates and tools
  • Assist with device risk assessment and documentation
  • Guidance for using the Vanderbilt Quality Management System to meet FDA IDE requirements
• Take part in grants as consultants or co-investigators
  • Provide project regulatory assistance and guidance
  • Support investigators with grant submissions through review of drafts

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MPSS can assess the regulatory requirements for your product, whether the goal is a clinical study or bringing the product to the market. We also collaborate with the Vanderbilt IRB, to support investigators with their IRB submission documentation and help with resolving any questions or concerns. MPSS is available to assist with review of any investigational product.MPSS is also well connected with the FDA, with whom we interact to get advice and guidance whenever needed. If you planning a clinical study and it will require an Investigational Device Exemption (IDE) submission with the FDA, MPSS can help with the initial pre-submission as well as guiding you through the IDE submission process.

If you are planning a clinical study or in the future taking the device to the US market, it is always advised to have early interaction with the IRB and/or FDA, as applicable. Please reach out to MPSS and we can support you and facilitate these interactions!

• Individualized consultation on your submission documents
  • Navigating the IRB and FDA process for your product development
  • Informal communication and interaction with the FDA to get early input to regulatory strategies for your product
  • Assist in device risk assessments to support and guide IRB and FDA documentation and communication for your product
  • Provide guidance for pre-clinical data to support a clinical study application for your product
• FDA pre-submission and IDE submission guidance and support
  • Navigating the IRB and FDA process for your product development
  • Informal communication and interaction with the FDA to get early input to regulatory strategies for your product
  • Assist in device risk assessments to support and guide IRB and FDA documentation and communication for your product
  • Provide guidance for pre-clinical data to support a clinical study application for your product
• Guidance for using the Vanderbilt Quality Management System to meet FDA IDE requirements
• Assist in identifying resources relative to your medical product within and outside Vanderbilt

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MPSS staff have extensive medical product (pharmaceutical, medical device, and diagnostic) development and manufacturing experience. As such, we can provide various types of support in relation to product development, prototyping, testing, as well as identifying and interacting with contract manufacturers. If your product test data will be used for any kind of submission (clinical study or for marketing), your device must be documented according to FDA regulations, as well as having material and manufacturing traceability. For example, per the FDA, investigational devices must be designed and developed in accordance with Design Controls under the Quality System Regulation. MPSS can assist you with meeting these requirements.

The MPSS team is available to meet and assist with any of your needs for guidance on product development, prototyping, cGMP and CMC manufacturing. Please contact us and we will be happy to meet and provide individualized support

• Medical Product Concept Consultation (pharmaceutical, medical device, or diagnostic)
  • What is the intended use and indications for use?
  • What documentation is needed for submissions?
  • What test data is needed for submissions?
  • How many/much products are needed and how will these be produced?
  • Guide the development process for evaluating new clinical indications for existing medical products
• Early product development regulatory guidance
  • Determination of need for an IDE/IND to achieve clinical data
  • Informal and formal communication with the FDA to get early input to development and testing strategies
  • FDA pre-submission guidance and support
• Manufacturing Guidance
  • Liaise with contract manufacturers and test labs to supply needed prototypes, products and services for research and development
  • Assist with manufacturing plans and related controls
  • ducation and training for product development, supply chain management and manufacturing controls, per FDA cGMP and CMC requirements
• Guidance for Documentation and Planning
  • Provide design control support to create needed Design History File documentation for the development of the medical product, including assistance with risk assessment, design inputs, design reviews etc.
  • Provide guidance for test strategies including pre-clinical and clinical data for safety and efficacy, as applicable
  • Support use of the Vanderbilt Quality Management System to generate needed product development documentation
  • Early product development planning and pathways
  • Assist with search of industry standards and methodologies for product development and manufacturing
  • Provide project assistance and guidance for medical product development and manufacturing
• Administrative Support
  • Effort support or administrative support on grants as consultants or co-investigators for planning and product development
  • Facilitate trans-institutional collaboration
  • Teaching and education in relation to product development and manufacturing

MPSS can help with strategies for bringing your medical product (pharmaceutical, medical device, or diagnostic) to the market. Through our close collaboration with the other teams at the Vanderbilt Center for Technology Transfer and Commercialization, we can guide you through the licensing pathway, as well as what steps to take to start a company based on your invention.

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• Consultation on bringing your pharmaceutical, medical device, or diagnostic product to market
  • Development of strategies for development, test data, FDA submissions, CMS reimbursement and other relevant topics
  • Evaluating FDA marketing submissions and related needs
  • Obtain early input on intended marketing submission through assisted informal FDA communication, such as selection of predicate device for 510(k) submission
• Guidance on FDA strategies for marketing pathways
  • Submissions include 510(k), De Novo, PMA, HDE, ND
• Support for grant development
  • Support investigators with review of planned grant submission
  • Provide statement of regulatory support
  • Take part in supporting grants as consultants or co-investigators
• Strengthen licensing agreements and new venture efforts through MPSS
  • Review of contract and CTTC invention disclosures for potential regulatory needs
  • Provision of FDA compliant documentation methods through use of the Vanderbilt Quality Management System to document product development needed for commercial distribution
  • Project assistance and guidance for translation of the medical product from Vanderbilt to the marketplace
• Guidance on FDA strategies for marketing pathways
  • Make connections for collaborative sites and investigators for your product or device
  • Identify industry standards for product development, and for manufacturing and distribution for your product
  • Provide assistance with external contract testing, prototyping, and manufacturing
• Support of new ventures based on Vanderbilt University medical product innovations

MPSS provides individual, small group and large audience training in various topics related to research, development, manufacture and commercialization of medical products. Please contact us for any training needs or opportunities for various talks and presentations. Below are a few examples of potential topics for education and talks:

• FDA Regulatory immersion
• Design Controls and Risk Assessment for your medical product
• Prototype builds and testing
• Commercialization of your Vanderbilt University innovation – going from academia to market
• Sponsor-Investigator roles and responsibilities
• IDE creation and submission
• Interacting and communicating with the FDA

Explore our curated collection of valuable resources designed to support individuals involved in the research and development of medical products. This comprehensive library provides essential guidance on navigating the complex world of medical device innovation, from understanding regulatory processes and pre-clinical testing requirements to exploring various submission pathways and software validation. Our aim is to equip you with the necessary tools, insights, and expert knowledge to advance your medical product ideas from concept to market successfully. Dive into these resources and leverage the wealth of information available to facilitate your journey through the medical product development landscape.

MPSS Presentations

• Click Here for Introduction to MPSS Programs and Services (Slides)

Investigator-Initiated Device Research

• Investigator Initiated Device Research Handbook (Secure Login Required)
• Human Research Protection Program
• Vanderbilt Institute for Clinical and Translational Research (VICTR)

FDA Links and Resources

• FDA Medical Device Home Page
• FDA Device Advice: Comprehensive Regulatory Assistance
• CDRH Learn based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts
• How to Study and Market Your Device, Device classification
• Early Feasibility Study Guidance
• CDRH Pre-submission Program- -prospective applicants of future premarket submissions may request feedback from the FDA through this program. Information about this resource maybe found in the FDA guidance Request for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.
• FDA Recognized Consensus Standards – use for guidance for pre-clinical testing requirements for various devices
• 510(k) Overview
• 510(k) Searchable Database
• 510(k) guidance
• De Novo guidance -- The de novo process provides a pathway
• Risk assessment for medical devices – use the international standard ISO 14971
• Benefit – Risk Assessment Guidance
• Software validation guidance
• Mobile Medical Apps Guidance
• Clinical Decision Support Software