# Product Lifecycle * **Definition:** The comprehensive process that encompasses all stages of a medical device's life, from design and manufacturing to post-market surveillance and eventual disposal. * **Taxonomy:** CTO Topics / Product Lifecycle ## News * Selected news on the topic of **Product Lifecycle**, for healthcare technology leaders * 4.7K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 5/21/2025 | [**Basil Systems Raises $11.5 Million to Help Life Sciences Companies Make Smarter, Faster ...**](https://www.healthcareittoday.com/2025/05/21/basil-systems-raises-11-5-million-to-help-life-sciences-companies-make-smarter-faster-decisions-with-ai-driven-intelligence/) | [[Healthcare IT Today]] | | 5/15/2025 | [**Datavant to Acquire Real-World Evidence Platform Aetion**](https://hitconsultant.net/2025/05/16/datavant-to-acquire-real-world-evidence-platform-aetion/) | [[HIT Consultant]] | | 4/11/2025 | [**US Computer Vision in Healthcare Market worth US$11.53 billion by 2029 with 24.0AGR**](https://finance.yahoo.com/news/us-computer-vision-healthcare-market-141500545.html) | [[Yahoo Finance]] | | 4/7/2025 | [**Digital Thread Market is expected to generate a revenue of USD 1,589.2 Million by 2032 ...**](https://www.prnewswire.com/news-releases/digital-thread-market-is-expected-to-generate-a-revenue-of-usd-1-589-2-million-by-2032--globally-at-17-1-cagr-verified-market-research-302421933.html) | [[PR Newswire]] | | 1/22/2025 | [**ActiGraph Accelerates Clinical Trial Modernization With Transformational Acquisition Of ...**](https://www.clinicalleader.com/doc/actigraph-accelerates-clinical-trial-modernization-with-transformational-acquisition-of-biofourmis-life-science-business-0001) | [[Clinical Leader]] | | 1/22/2025 | [**ActiGraph Accelerates Clinical Trial Modernization With Transformational Acquisition Of ...**](http://www.clinicalleader.com/doc/actigraph-accelerates-clinical-trial-modernization-with-transformational-acquisition-of-biofourmis-life-science-business-0001) | [[Clinical Leader]] | | 1/21/2025 | [**Keysight Expands Chiplet Interconnect Standards Support in Chiplet PHY Designer 2025**](http://www.businesswire.com/news/home/20250121466743/en/Keysight-Expands-Chiplet-Interconnect-Standards-Support-in-Chiplet-PHY-Designer-2025/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 1/7/2025 | [**ActiGraph Accelerates Clinical Trial Modernization with Transformational Acquisition of Biofourmis Life Science Business**](https://www.prnewswire.com/news-releases/actigraph-accelerates-clinical-trial-modernization-with-transformational-acquisition-of-biofourmis-life-science-business-302344216.html) | [[PR Newswire]] | | 1/7/2025 | [**ActiGraph Accelerates Clinical Trial Modernization with Transformational Acquisition of ...**](https://finance.yahoo.com/news/actigraph-accelerates-clinical-trial-modernization-110000990.html) | [[Yahoo Finance]] | | 1/7/2025 | [**Revolutionizing Kidney Care: AccurKardia's AK+ Guard Earns FDA Breakthrough Device Designation**](https://www.mddionline.com/software/untitled) | [[MDDI]] | | 1/7/2025 | [**Bamboo Rose Acquires Verteego to Launch Retail's First AI-Fueled Decision Intelligence Platform**](https://www.prnewswire.com/news-releases/bamboo-rose-acquires-verteego-to-launch-retails-first-ai-fueled-decision-intelligence-platform-302343525.html) | [[PR Newswire]] | | 11/19/2024 | [**Lynx Software Technologies Sees Growing Demand for Timesys Vigiles™ as a ... - PR Newswire**](https://www.prnewswire.com/news-releases/lynx-software-technologies-sees-growing-demand-for-timesys-vigiles-as-a-leading-sbom-lifecycle-and-vulnerability-management-tool-for-edge-applications-302309349.html) | [[PR Newswire]] | | 11/11/2024 | [**Digital Twin Market to Grow by USD 114.1 Billion from 2024-2028, Driven by Industry 4.0 ...**](https://finance.yahoo.com/news/digital-twin-market-grow-usd-185900017.html) | [[Yahoo Finance]] | | 11/1/2024 | [**Recent Developments in Pharmaceutical Validation**](https://www.pharmexec.com/view/recent-developments-in-pharmaceutical-validation?utm_source=www.pharmexec.com&utm_medium=relatedContent) | [[PharmExec]] | | 11/1/2024 | [**Recent Developments in Pharmaceutical Validation**](https://www.pharmexec.com/view/recent-developments-in-pharmaceutical-validation) | [[PharmExec]] | | 10/16/2024 | [**All Whitepapers**](https://www.pharmexec.com/whitepapers) | [[PharmExec]] | | 10/2/2024 | [**18 of the Top 20 Medtech Companies Partner with Veeva MedTech to Get Devices ... - PR Newswire**](https://www.prnewswire.com/news-releases/18-of-the-top-20-medtech-companies-partner-with-veeva-medtech-to-get-devices-and-diagnostics-to-patients-faster-302265339.html) | [[PR Newswire]] | | 9/26/2024 | [**Why Product Market Fit Won't Cut It: Healthcare AI Demands Governance First - Medium**](https://medium.com/@news_52674/why-product-market-fit-wont-cut-it-healthcare-ai-demands-governance-first-722bac323faf) | [[Medium]] | | 9/11/2024 | [**Oracle Helps Customers Build Smart and Responsive Supply Chains - PR Newswire**](https://www.prnewswire.com/news-releases/oracle-helps-customers-build-smart-and-responsive-supply-chains-302244536.html) | [[PR Newswire]] | | 8/26/2024 | [**Navigating next-generation product lifecycle management solutions to advance business outcomes and drive revenue**](https://www.fastcompany.com/91178299/navigating-next-generation-product-lifecycle-management-solutions-to-advance-business-outcomes-and-drive-revenue) | [[Fast Company]] | | 8/16/2024 | [**Cloud Based Product Lifecycle Management Market Report Presents an Inside Look at ... - WhaTech**](https://www.whatech.com/og/markets-research/it/867926-cloud-based-product-lifecycle-management-market-opportunities-and-strategies-2024-2033-growth-analysis-outlook-overview.html) | whatech.com | | 8/9/2024 | [**Medical Device Engineering Market worth $20.1 billion by 2029 driven by Technological ...**](https://finance.yahoo.com/news/medical-device-engineering-market-worth-143000381.html) | [[Yahoo Finance]] | | 7/22/2024 | [**Enhanced Data Management Boosts Market CAGR to USD 2220.9 Billion by 2031 - Yahoo Finance**](https://finance.yahoo.com/news/cloud-computing-market-enhanced-data-141500985.html) | [[Yahoo Finance]] | | 7/11/2024 | [**AFL Celebrates Grand Opening of its Poland Manufacturing Facility**](http://www.businesswire.com/news/home/20240711658851/en/AFL-Celebrates-Grand-Opening-of-its-Poland-Manufacturing-Facility/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 7/9/2024 | [**Aitomatic's SemiKong uses AI to reshape chipmaking processes**](https://venturebeat.com/ai/aitomatics-semikong-uses-ai-to-reshape-chipmaking-processes/) | [[VentureBeat]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **ProductLife Group (PLG)**: A global leader in regulatory and compliance consulting for life sciences, enhancing capabilities through acquisitions. - **Vantage ALM**: Formerly Sterling PLM, now focuses on Application Lifecycle Management solutions for engineering companies. - **FDA**: Regulatory body emphasizing a total product lifecycle (TPLC) approach for AI-enabled medical devices. - **SAP**: Provides integrated PLM solutions that enhance operational efficiency. - **Koch Industries**: A major player in the cloud-based PLM market, focusing on innovative solutions. - **LabVantage Solutions**: A provider of laboratory information management systems (LIMS) that integrates with SAP Product Lifecycle Management to streamline operations. - **Accenture**: Consulting firm involved in PLM implementations and digital transformations. - **Technical Product Manager**: A mid-level leader responsible for the design, build, and management of healthcare technology solutions. - **Oracle**: Offers cloud-based PLM solutions with a focus on supply chain and manufacturing. - **ELIQUENT Life Sciences**: A regulatory consulting firm that provides comprehensive solutions throughout the product lifecycle, focusing on pharmacovigilance and risk management. - **Veeva Systems**: Provides Development and Commercial Clouds to enhance efficiency across the product lifecycle for medtech companies. - **Original Equipment Manufacturers (OEMs)**: Companies that design and manufacture products that are sold under another company's brand. - **Siemens**: A key competitor in the PLM space, providing advanced technology solutions. - **Ontogen Medtech**: A company expanding its operations into contract manufacturing services for medical devices, in-vitro diagnostics, and health hard-tech industries. - **TransDigm Group Inc**: A leading aerospace components manufacturer focusing on proprietary products that allow for premium pricing and higher margins. - **RegASK**: A company providing AI-driven regulatory intelligence solutions to streamline compliance across the product lifecycle. - **SAI MedPartners**: A strategic services provider for biopharma clients, enhancing support from drug discovery to market launch. - **MIDI**: A medical device consulting firm expanding into Toronto to enhance its capabilities in product development and commercialization. ### Partnerships and Collaborations - **Workhorse Group and Siemens**: Adopted Siemens Xcelerator portfolio for cloud-based Product Lifecycle Management to enhance efficiency in developing zero-emission vehicles. - **Field Medical and FDA**: Field Medical's technology is part of the FDA's Total Product Lifecycle Advisory Program to facilitate rapid development. - **ProductLife Group and Halloran Consulting Group**: Acquisition to expand regulatory and compliance consulting capabilities in the life sciences sector. - **LabVantage and Henkel**: Collaborating to integrate LabVantage LIMS and SAP PLM into Henkel's R&D platform to enhance digitalization. - **Siemens and NVIDIA**: Partnering to enhance product lifecycle management through AI and data integration. - **LabVantage Solutions and Henkel AG**: Partnered to integrate LabVantage LIMS and SAP PLM into Henkel's R&D platform, enhancing digitalization and streamlining operations. - **Atom Therapeutics and China Medical System Holdings**: Collaboration for the commercialization of lingdolinurad, focusing on product lifecycle management. - **MDIC and CDRH**: Collaboration aimed at enhancing patient-centric initiatives and improving healthcare quality throughout the product lifecycle. - **CobbleStone Software and Legal Tech Talent Network**: Partnered to provide training and staffing services, enhancing contract lifecycle management. - **Akkodis and Salesforce, Microsoft, Siemens**: Formed partnerships to deliver tailored sustainability solutions across industries. - **Veeva Systems and Smith+Nephew**: Collaboration to utilize Veeva's unified clinical solution to simplify clinical operations and accelerate trial timelines. - **ActiGraph and Biofourmis**: Acquisition aimed at creating a unified digital health ecosystem for clinical research and development. - **Pluristyx and Humacyte**: License agreement for using Pluristyx's iPSC line to manufacture insulin-producing cells. - **Commonwealth Center for Advanced Manufacturing and QVI**: Partnership to improve efficiency and quality in manufacturing through advanced metrology. - **Arcadia and CareJourney**: The acquisition strengthens Arcadia's partnerships with major healthcare brands, expanding its customer portfolio. - **NSF and RegASK**: Collaborating to enhance regulatory workflow orchestration through AI-driven solutions. - **Tata Elxsi and DENSO Robotics Europe**: Collaborated to establish a Robotics and Automation Innovation Lab aimed at advancing healthcare automation. - **Ultromics and Janssen Biotech**: Collaboration to develop EchoGo¬Æ Amyloidosis, an AI-based software for cardiac amyloidosis detection. ### Innovations, Trends, and Initiatives - **Total Product Lifecycle (TPLC)**: A framework discussed by the FDA for managing the lifecycle of medical devices, particularly those utilizing generative AI. - **Total Product Lifecycle (TPLC) Approach**: FDA's guidance emphasizes ongoing evaluation of AI-enabled devices for safety and effectiveness. - **Cloud-Based PLM Solutions**: The growing adoption of cloud-based services in product lifecycle management, enhancing efficiency and reducing time to market. - **Total Product Lifecycle Approach**: Advocated by Dr. Srivastava for continuous evaluation and international cooperation in AI healthcare applications. - **OpsHub Digital Thread**: New capabilities for enhancing traceability throughout the product lifecycle by integrating PLM, ALM, and DevOps tools. - **Digital Transformation in PLM**: Adoption of Industry 4.0 principles, including real-time data analytics and predictive maintenance. - **Agile Methodology in MedTech**: Adapting Agile practices to enhance product development efficiency despite regulatory constraints. - **Cloud-Based PLM Growth**: The market is projected to grow significantly, driven by the shift from on-premise to cloud solutions. - **Contract Manufacturing Expansion**: Ontogen Medtech's new manufacturing division aims to meet the growing demand for high-quality medical devices throughout the product lifecycle. - **Digital Twins**: The trend of using digital twins to replace physical prototypes, improving sustainability and reducing costs in product design. - **Digital Twin Technology**: Rapidly expanding in healthcare for real-time data analysis and product lifecycle management, focusing on cost reduction and improved patient care. - **Integration of IoT and AI**: PLM systems are leveraging IoT and AI to enhance collaboration and reduce time-to-market. - **Vertical Integration in Supply Chain**: Improves speed-to-market, cost efficiencies, and quality assurance in medical device manufacturing. - **AI in Product Development**: The integration of AI technologies to enhance product development processes and improve patient support programs. - **User Experience in Healthtech**: A shift towards prioritizing user experience in product design, emphasizing the importance of engagement and feedback. - **Low-Code Platforms**: Baracoda's BConnect platform accelerates the development of AI-driven smart devices, enhancing product lifecycle efficiency. - **Regulatory IT Systems by MHRA**: Introduction of SafetyConnect and RegulatoryConnect to improve communication and responsiveness in the product lifecycle. - **Sustainability Initiatives**: Akkodis focuses on reducing lifecycle emissions and improving resource efficiency in healthcare. - **AI in Medical Devices**: Utilization of AI technologies to improve medical device design and development processes. ### Challenges and Concerns - **Legacy System Stagnation**: Traditional PLM systems struggle to keep pace with technological advancements, necessitating modernization. - **Complexity in Product Development**: Many healthtech companies struggle to translate innovative technology into user-friendly experiences, leading to overengineering. - **Market Readiness**: The challenge of ensuring faster market readiness for new products while maintaining compliance with regulatory standards. - **Market Pressures**: Companies face competitive pressures and regulatory challenges while trying to innovate and maintain market position. - **Out-of-Specifications (OOS) Issues**: Challenges in maintaining product specifications can arise from human error and supply chain complexities. - **Regulatory Compliance**: The complexity of regulatory processes and the need for compliance in the pharmaceutical and medtech industries, particularly in pharmacovigilance. - **Collaboration Complexity**: The need for clear communication and shared responsibilities among stakeholders in managing risks associated with new technologies. - **Regulatory Approval Delays**: Slow regulatory processes can hinder patient access to life-saving treatments. - **High Costs**: The medical device engineering market faces challenges related to high costs and the need for specialized engineering services. - **Investment Barriers**: High costs and regulatory standards present challenges in the medical device engineering market. - **Data Management for AI**: Manufacturers must ensure datasets are representative and manage data proactively for AI-enabled devices. - **Regulatory Challenges**: Adaptive AI systems pose unique regulatory challenges as they evolve with new data, requiring a focus on functional use. - **Investment and Funding Gaps**: Healthcare organizations face challenges in securing private capital for innovation amidst a competitive landscape. - **Healthcare IT Upgrades**: Organizations face challenges in upgrading to new systems while managing budget constraints and existing environments. - **Cybersecurity in Medical Devices**: New FDA provisions require a software bill of materials (SBOM) to enhance cybersecurity compliance. - **Patient Safety with AI**: The FDA warns against unmonitored AI systems, advocating for continuous monitoring post-deployment. - **Data Security and Privacy**: Increasing importance in the context of cloud-based solutions and digital twin technologies, particularly in healthcare. - **Data Security**: Concerns regarding data security and cybersecurity in the adoption of cloud-based solutions and digital transformation. ## Related Topics [[Product Development]]