PLM for Life Sciences and Healthcare
For transforming regulatory complexities into your competitive advantage.
Accelerate product development and streamline operations through tailored PLM (product lifecycle management) solutions. By integrating patient-specific insights, embedding quality and compliance at every stage, and supporting collaboration across the value chain, we empower life sciences companies to deliver personalized, high-quality products to market faster.
We help life sciences companies achieve high-quality, personalized products by enabling a predictive and adaptive approach to development and manufacturing.
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Regulatory compliance
Regulatory compliance in the life sciences industry is critical to ensure patient safety and product efficacy. Organizations need integrated solutions that provide traceability, collaboration, and automation to meet evolving regulatory requirements across global markets.
Quality management
Quality management in life sciences is crucial for ensuring patient safety, regulatory compliance, and product efficacy. It involves navigating complex, ever-evolving standards set by agencies like FDA and EMA. Companies must implement robust systems to manage CAPAs, complaints, non-conformances, and audits while maintaining operational efficiency. The challenge lies in embedding quality throughout the product lifecycle, from design to manufacturing, while adapting to regulatory changes and managing global quality operations.
3DEXPERIENCE is used to centralize quality management processes and automate workflows to meet GMP and ISO standards. Maintain data on a digital platform to capture and share quality standards across sites, and enable virtual testing to reformulate products while managing regulations efficiently.
Integrate quality management to document, track, and address quality issues centrally. Automate data collection, analysis, and reporting to streamline quality assurance, and provide a unified view of all captured data to effectively resolve quality concerns.
Streamline quality management by providing a single source of truth for product data and quality documentation. Facilitate efficient document control, change management, and compliance tracking. Automate quality processes while reducing errors and ensuring adherence to standard operating procedures.
Clinical trials
Clinical trials face strict regulatory compliance demands to ensure participant safety, data integrity, and adherence to frameworks like FDA, EMA, and ICH-GCP. Challenges include managing complex documentation, maintaining audit trails, ensuring informed consent, and meeting diversity requirements (e.g., FDA’s Diversity Action Plans). Non-compliance risks delays, fines, or trial termination.
Automate study design, track compliance with test specifications, and centralize data to meet FDA/EMA requirements. Standardize data collection across sites, automate QC (quality control), and implement traceable reporting. Use dashboards to flag deviations early, ensuring alignment with stability testing protocols and reducing citation risks.
Approval processes
Approval processes in life sciences involve navigating complex regulatory landscapes to obtain market authorization. Challenges include managing voluminous documentation, ensuring data integrity, and adhering to diverse regional requirements (e.g., FDA, EMA, PMDA). Companies must demonstrate product safety, efficacy, and quality through comprehensive submissions. The process is time-consuming and resource-intensive, with evolving standards like the EU MDR increasing complexity. Efficient management of regulatory submissions, change control, and post-market surveillance is crucial for timely approvals and maintaining compliance throughout the product lifecycle.
Support the process of regulatory submission by providing advanced analytics and reporting capabilities. Aggregate and analyze data from multiple sources, generating comprehensive reports for regulatory bodies. Use statistical tools to support data integrity verification, improving the success rate of approvals and enabling continuous compliance monitoring.
Integrate product development with regulatory compliance, enabling real-time tracking of design changes against regulatory requirements. Support digital continuity from design to submission, facilitating faster response to regulatory queries. Enhanced data management capabilities ensure traceability and compliance with evolving standards like EU MDR.
Product development
Life sciences product designers focus on creating user-friendly devices that meet clinical needs while ensuring regulatory compliance. Effective design solutions empower teams to innovate rapidly while reducing prototyping costs and time-to-market.
Personalization
Balancing user-friendliness with regulatory compliance, addressing diverse user needs (including those with impairments), and conducting tests in realistic environments can pose numerous complex challenges for product development teams. Companies must navigate complex standards (e.g., IEC 62366-1, FDA guidelines) while managing costs and timelines. Remote testing, particularly for home-use devices, presents additional hurdles. Effective testing requires multidisciplinary collaboration and consideration of factors like physical ergonomics, cognitive load, and potential use errors to ensure safe, efficient device operation.
Virtual testing capabilities enable companies to simulate user interactions with devices, considering ergonomic factors and potential use errors. This approach reduces physical prototype needs, accelerates iterative design, and allows for testing across diverse user profiles and environments, addressing key challenges in ergonomics and usability testing.
A platform for collaboration between design, engineering, and usability teams is crucial when addressing multifaceted ergonomic challenges. Data management capabilities support comprehensive documentation of usability studies, providing solid groundwork for regulatory compliance. And virtual prototyping tools enable early-stage ergonomic assessments, reducing costly late-stage design changes.
Advanced 3D modeling and human simulation capabilities allow designers to evaluate ergonomic factors early in the development process. Support the creation of virtual user personas, including those with physical limitations, enabling comprehensive usability assessments. Integration with other tools on the 3DEXPERIENCE platform allows for rapid design iterations based on usability feedback
Miniaturization
The requirement for smaller, yet more functional, devices presents significant challenges in design, manufacturing, and performance. Key issues include heat dissipation in densely packed components, maintaining signal integrity at high speeds, and ensuring electromagnetic compatibility. Manufacturing complexity increases, requiring precision techniques and advanced materials. Designers must balance size reduction with functionality, power efficiency, and reliability. The trend towards miniaturization affects various industries, from medical devices to consumer electronics, driving the need for innovative solutions in design and production.
Advanced 3D modeling capabilities enable precise design of miniaturized components and systems. Virtual prototyping tools allow engineers to optimize designs for size reduction while maintaining functionality. Support the integration of thermal management solutions and electromagnetic compatibility analysis to address key challenges in miniaturization.
Simulation tools help address thermal management and signal integrity issues in miniaturized designs. Enable virtual testing of heat dissipation strategies and electromagnetic interference, reducing the need for physical prototypes. Multiphysics capabilities allow designers to optimize component placement and material selection for compact, high-performance products.
Support collaboration between multidisciplinary teams when addressing complex miniaturization challenges. Integrate design, simulation, and manufacturing processes, enabling rapid iterations and optimizations. Data management capabilities support traceability and version control, essential for managing intricate miniaturized designs.
Biocompatibility
The process of selecting materials that interact safely with biological systems while meeting functional requirements can present several complex challenges. Key hurdles include rigorous testing (cytotoxicity, sensitization), balancing material properties with design needs, and navigating evolving ISO/FDA standards. Time and cost pressures arise from lengthy testing protocols, while design changes risk invalidating previous assessments. Material incompatibility can lead to device rejection or recalls, demanding precise selection and validation processes.
Accelerate material selection by predicting biocompatibility through molecular modeling, reducing trial-and-error testing. Integrate ISO 10993 test data templates to streamline compliance documentation.
Validate material interactions virtually using cytotoxicity and tissue response models, dramatically reducing time spent in physical testing cycles. Identify thermal/mechanical stress points affecting biocompatibility.
Enable concurrent design of device geometry and material integration, ensuring manufacturability aligns with biocompatibility constraints, and support rapid prototyping iterations for complex implantables.
Data privacy
With the rise of connected medical devices and electronic health records (EHRs), cybersecurity has become a critical challenge in life sciences. Organizations require strict governance frameworks to ensure secure data exchange across healthcare systems without compromising privacy or operational efficiency.
Connected medical devices
Connected medical devices pose several critical data privacy challenges, from protecting sensitive PHI (patient health information) to ensuring HIPAA/GDPR compliance and securing data transmission. Vulnerabilities in wireless protocols and third-party integrations risk unauthorized access, while legacy devices often lack modern security features. Rising cyberattacks, like ransomware targeting device controls, threaten patient safety and organizational trust.
Ensure HIPAA-compliant data governance by centralizing PHI management across device lifecycles. Automate access controls, track consent documentation, and maintain audit trails for regulatory reporting, mitigating risks of unauthorized data sharing.
Integrate end-to-end encryption and role-based access for connected devices. Provide real-time monitoring of data flows to detect vulnerabilities, while ensuring secure PHI handling across a collaborative environment for design, testing, and deployment phases.
EHRs (electronic health records)
Handling EHRs presents critical data privacy challenges, including safeguarding sensitive patient information from breaches, unauthorized access, and cyberattacks. Compliance with regulations like HIPAA and GDPR requires robust encryption, access controls, and audit trails. Vulnerabilities arise from insecure data sharing, legacy systems, and third-party integrations. Ensuring data integrity while enabling clinical workflows demands secure storage, transmission, and de-identification techniques. Recent threats include ransomware attacks and accidental leaks via analytics tools, necessitating solutions that balance usability with stringent privacy protections.
Ensure HIPAA-compliant EHR management by centralizing access controls, automating audit trails, and maintaining version control. Secure sensitive data across the lifecycle, preventing unauthorized access while streamlining compliance reporting.
Integrate end-to-end encryption and role-based access for EHRs, enabling secure collaboration across teams. Real-time monitoring detects vulnerabilities, while AI-driven analytics support data integrity without compromising privacy.
Manufacturing processes
Life sciences manufacturing processes must meet rigorous standards for safety and efficacy through techniques like process validation and advanced sterilization methods. Digital tools that simulate manufacturing scenarios and validate processes are essential for optimizing production while adhering to strict industry regulations.
Process validation
Process validation in life sciences presents several challenges related to the complexity of system integrations, evolving regulatory standards (FDA, EMA), and maintaining data integrity across increasingly automated workflows. Manufacturers must identify CQA (critical quality attributes) and CPP (critical process parameters) while managing variability in raw materials and scaling from clinical to commercial production. Emerging therapies (e.g., gene/cell) lack historical data, demanding novel validation approaches, and analytical limitations, coupled with stringent documentation requirements, further complicate compliance.
Virtual process validation using multiphysics simulation helps to identify optimal CPPs and CQAs without physical trials. Predictive modeling reduces reliance on scarce materials (e.g., viral vectors) and accelerates scale-up validation for novel therapies.
Ensure data integrity with centralized analytics for process parameter tracking. Automate compliance documentation (ICH Q7/FDA) and identify deviations in real time, ensuring alignment with evolving regulatory requirements.
Integrate design, simulation, and validation workflows, enabling cross-functional collaboration. Support CPV (continuous process verification) through real-time monitoring and AI-driven insights to maintain quality during production scaling.
Sterilization techniques
Validating sterilization effectiveness for complex device geometries, maintaining consistency across batches, and adapting to evolving regulatory standards (e.g., EPA’s ethylene oxide restrictions) are all significant challenges for life science companies. Heat- or chemical-sensitive materials risk degradation during sterilization, while methods like liquid chemical sterilants struggle with biofilm penetration and post-processing contamination. Ensuring biological indicator accuracy and automating workflows to reduce human intervention are critical for compliance and patient safety.
Multiphysics simulations optimize sterilization parameters (e.g., heat distribution, chemical exposure) for complex devices, reducing physical trials. Validate novel methods (e.g., gas plasma) while predicting material compatibility issues, and ensure efficacy without compromising product integrity.
Automate sterilization workflows to minimize human intervention in aseptic processes. Standardize equipment loading configurations and monitor environmental factors (humidity/temperature) to ensure batch consistency and compliance with FDA/EMA guidelines.
Streamline sterilization validation with centralized data analytics for biological indicator performance tracking. Automate documentation for regulatory submissions (e.g., ISO 10993) and identify deviations in real time, accelerating scale-up for viral vector therapies.
Supply chain management
Supply chain management in life sciences involves sourcing high-quality raw materials, conducting supplier audits, and maintaining traceability while ensuring regulatory compliance. Life sciences companies need tools that integrate supplier collaboration, inventory optimization, and real-time monitoring for seamless operations.
Inventory control
Companies in the Life Sciences sector face significant challenges with JIT production and demand forecasting in supply chain management. These include balancing inventory levels to avoid shortages or surpluses, managing product perishability, and responding to volatile demand fluctuations. The complexity of global supply chains, material shortages, and regulatory requirements further complicate forecasting. Additionally, the need for rapid production and delivery of vital medicines must be balanced against the risk of waste and high costs associated with overproduction. Accurate demand prediction is crucial but challenging due to changing healthcare needs and market events.
Centralize demand forecasts and JIT workflows, automating compliance documentation (FDA 21 CFR Part 11) while tracking supplier performance. Real-time analytics adjust production schedules based on market shifts, reducing stockouts significantly.
Virtual modeling and simulation of production processes helps optimize efficiency and reduce costs for JIT manufacturing.
Engineering services
Advanced analysis solutions to optimize product performance and efficiency, aiding in streamlining JIT production processes and improving forecast accuracy.
Sourcing of raw materials
Life sciences companies face stringent traceability requirements to track materials from raw suppliers to finished products, ensuring compliance with FDA 21 CFR Part 11 and EU MDR. Complex global supply chains, manual data entry errors, and opaque tier-2/3 supplier practices create compliance risks. Supplier audits are resource-intensive, with challenges in verifying adherence to quality standards (e.g., ISO 13485) and detecting counterfeit materials. Regulatory shifts like DSCSA serialization demand real-time visibility, while geopolitical disruptions necessitate agile supplier risk assessments.
Centralize supplier data and automate audit documentation, ensuring real-time visibility into material origins and compliance status. Creating and maintaining a digital thread enables effective tracking of components across tiers, flagging deviations from quality standards and streamlining FDA/EU audit preparation.
Digital twin technology maps supplier workflows and can be used to simulate risk factors. Automate tiered supplier scorecards and integrate IoT data for real-time traceability, reducing counterfeit risks in raw material sourcing.
Secure B2B collaboration with suppliers via centralized data exchange. Validate supplier certifications and automate audit checklists, while ensuring immutable records for serialization compliance.
Sustainability
Sustainability is becoming a key focus for life sciences companies aiming to reduce environmental impact across the product lifecycle. Companies need digital tools to track sustainability metrics, optimize energy usage, and implement circular economy principles effectively.
Let's solve your challenges, together
This page lists some of the most common challenges in the Life sciences industry. If all of this sounds a lot like your business, don’t worry, you’re not alone!
How do we know? We’ve worked with hundreds of businesses across Life sciences industries, and we’ve solved all of these challenges before. We’d love to work together with you to implement a solution that set you up for success.
Essential software for life science companies
For end-to-end PLM (product lifecycle management) and collaborative innovation.
For effective management and collaboration in science-driven industries focused on developing new materials and medicines.
For robust product data management, business analytics, and decision support.
For streamlining interaction between businesses, suppliers, manufacturers, and partners.
For codeless customization of 3DEXPERIENCE user interfaces.
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