STAGE 1
Product Development
Visualize your medical device from every angle with linear and 3D modeling, and simulate real-life behavior to assess critical testing points. Design right the first time with product development solutions, including SOLIDWORKS, SIMULIA, CATIA, and more.
- Design next-gen biological, chemical, and materials at the atomic and molecular levels.
- Engineer your products using powerful 2D and 3D computer-aided design.
- Assess medical device performance and reliability with realistic 3D prototypes.
- Evaluate and predict your product's behavior in multiple real-life scenarios through a model-based approach.
- Bring products to market faster using virtual twin technology as decision support and evidence for in silico clinical trials.
STAGE 2
Validation & Verification
Ensure your medical devices meet design requirements and patient needs with validation and verification solutions.
- Accelerate the process of evaluating materials and product safety.
- Reduce the validation effort for testing medical device functionality.
- Verify your compliance with industrial regulations quickly.
- Facilitate cross-disciplinary collaboration and solve underlying design issues early.
STAGE 3
Clinical Studies
Fast-track your medical devices with Medidata, the only eClinical solution that helps you run your trials, engage with patients, sites, and sponsors, and leverage the latest clinical research data.
- Smooth the patient recruitment and study experience before, during, and after clinical studies with unmatched patient centricity.
- Simplify and improve clinical data quality with a unified clinical data management solution.
- Design patient-centric studies with AI intelligence and synthetic control arms.
- Transform clinical operations workflows for a shorter study timeline.
STAGE 4
Quality & Regulatory
Activate a Total Quality Management (TQM) program to comply with ever-changing regulations to get and maintain market approval, manage risk, and meet patient safety demands.
- Move beyond compliance to full traceability across a unified digital thread.
- Continually innovate across your value network in a Product Lifecycle Management (PLM) collaboration environment.
- Effectively capture customer product usage and risks for post-market surveillance.
- Confidently navigate international, regional, and national standards from IEC, ISO, and WHO to FDA, EU MDR, UKCA, and more.
STAGE 5
Manufacturing & Supply Chain
Sustainably accelerate your operations to minimize deviations and waste with a virtual twin of your plant assets, supply chain, and production processes.
- Digitally model your ideal-state production process to create as-built products to match as-designed products.
- Virtually commission, validate and optimize production lines, workflows, and employee ergonomics.
- Achieve next-gen supply chain resiliency with a fully connected supply chain network.
- Proactively monitor plant equipment maintenance for maximum uptime.
STAGE 6
Commercialization
Assess how your medical device performs in the real world and adapt your products as your patient experiences evolve.
- Market products using rich, interactive 3D content experiences.
- Personalize surgical planning with seamless collaboration between device manufacturers, surgeons, and other HCPs.
- Monitor post-market activities to track and reduce the number of adverse events and product recalls.
- Link real-world data (RWD) with clinical trial data (CTD) for effective safety tracking.
-(1)-1-min.jpg?width=1200&length=1200&name=Breaking-Barriers--in-Medical-Device--Development--The--Convergence-of-Data-and--Regulatory-Compliance-(MAR-23)-(1)-1-min.jpg)
