Medical Devices /MedTech / Diagnostic startups often originate from an Idea to solve a
problem that founders usually have faced themselves from the medical or engineering perspective. However, many founders lack the understanding of a long road ahead for getting the product to market navigating complex regulatory requirements.
Artixio has been on the forefront in helping MedTech innovations and startups by providing guidance right from product development to commercialization using its past experience and wealth of knowledge. Artixio also offers grant to promising early stage innovations through its annual grant program.
Here is a high level summary of how startups can plan their product development and commercialization for new medtech innovations/ideas.
Understand the Regulatory Landscape:
Research: Familiarize yourself with the regulatory requirements specific to your target markets (e.g., FDA in the U.S., CE marking in the EU, and CDSCO in India).
Engage Experts: Work closely with regulatory consultants or experts to ensure compliance.
Product Classification and Risk Assessment:
Classify Your Device: Determine the classification of your medical device (Class I, II, or III) based on its intended use and risk level.
Risk Management: Develop a risk management plan (e.g., ISO 14971) to identify and mitigate potential risks associated with your device.
Quality Management System (QMS):
Implement QMS: Establish a robust QMS that complies with ISO 13485 standards.
Document Control: Maintain accurate records of design history, risk assessments, and changes.
Design Controls and Documentation:
Design Inputs and Outputs: Clearly define design inputs (user needs, specifications) and design outputs (product specifications, labeling).
Design History File (DHF): Compile all design-related documents in the DHF.
Clinical Data and Testing:
Clinical Evaluation: Conduct clinical evaluations to demonstrate safety and performance.
Testing: Perform necessary testing (biocompatibility, electrical safety, etc.) as per relevant standards.
Preparation for Regulatory Submissions:
510(k) Submission (U.S.): Prepare a 510(k) submission if applicable.
Technical File (EU): Compile a technical file for CE marking.
Dossier (India): Create a dossier for CDSCO registration.
Post-Market Surveillance and Vigilance:
Adverse Event Reporting: Establish procedures for reporting adverse events and incidents.
Post-Market Surveillance Plan: Monitor your device’s performance in the market.
Labeling and Packaging:
Labeling Requirements: Ensure your labeling complies with local regulations.
Unique Device Identification (UDI): Assign a UDI to your device.
Prepare for Inspections and Audits:
FDA Inspections: Be ready for FDA inspections (if applicable).
Notified Body Audits (EU): Prepare for audits by notified bodies.
Stay Updated and Network:
Industry Associations: Join relevant industry associations and attend conferences.
Collaborate: Network with other startups and learn from their experiences.
Remember that the regulatory pathway can be complex, but thorough planning, expert guidance, and adherence to quality standards will pave the way for successful medical device registration.
Join Artixio's Xchange forum to access the toolkits for areas outlined above and get answers to your queries for successful product development and launch.