Shipbuilders face mounting pressure to deliver projects on time, within budget, and to specification. Traditional project planning and execution cannot adequately address challenges posed by complex ship designs and economic uncertainties. Innovations such as the Digital Thread Approach and Shipyard 4.0, aim to integrate key systems across the shipyard, reduce production costs and maintain quality, enabling shipbuilders to meet evolving market demands.
The Digital Thread Approach revolutionizes ship construction, by integrating key systems into a unified ecosystem. Each system enhances the Shipyard 4.0 ecosystem:
Integrating these systems enables seamless collaboration, aligning design, engineering, production, and logistics functions for a cohesive workflow.
Integrated Product Development Environment (IPDE) represents a transformative approach in shipbuilding, driving efficiency and collaboration across the entire project lifecycle. By seamlessly integrating critical systems such as PLM, ERP, and MES, IPDE establishes a cohesive digital ecosystem. Below are the key components and their contributions:
This comprehensive IPDE solution will not only streamline operations but also act as a catalyst for future ship designs, driving global adoption of digitalization in shipyards. By leveraging these integrations, shipyards can significantly improve project outcomes, reduce re- engineering, enhance collaboration, and achieve sustainable growth in a competitive market.
Fig1. IPDE Solution.
The implementation of this digital monitoring system marked a significant step toward the adoption of Shipyard 4.0 principles in Indian shipyards. By leveraging advanced integration and analytics, Cyient enabled these shipyards to improve operational efficiency, meet project deadlines, and enhance overall productivity.
Mohit holds a Doctorate Program Degree in “Digitalization in Defense”. As a Subject Matter Expert (SME) in marine and shipyards, he focuses on designing and optimizing business processes to enhance customer experience, boost profitability, and maintain a competitive edge using latest technologies and platforms.
Upon receipt of a De Novo request, the FDA will conduct an acceptance review. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. If any of the acceptance elements are not included, a justification has to be provided for the omission.
To aid in the acceptance review, it is recommended to submit an Acceptance Checklist as per the guidance document with the De Novo request that identifies the location of supporting information for each checklist element.
The De Novo request will not be accepted and will receive a Refuse to Accept (RTA) designation if one or more of the elements noted as RTA items in the Acceptance Checklist are not present and no explanation is provided for the omission(s). However, during the RTA review, the FDA staff has the discretion to determine whether the missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted.
Within 15 calendar days of the Document Control Center receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following:
Once the De Novo request is accepted for substantive review, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm that the device is eligible for De Novo classification.
During the substantive review of a De Novo request, the FDA may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information.
If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. If an Additional Information letter is sent, then the De Novo request will be placed on hold. The requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.
Note: The response must be sent to the DCC within 180 calendar days of the date of the Additional Information letter. No extensions beyond 180 days are granted. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the letter, the request will be considered withdrawn and deleted from the FDA's review system. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device.
The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the DCC of the appropriate center. The response should—
The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to decide about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request.
Cyient offers a one-stop solution, CyARC–Accelerated Regulatory Platform, for helping medical device companies to ensure regulatory compliance. Empowered by Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all the functions who have the required skillsets and expertise to support medical device companies throughout the life-cycle of their medical devices.
Abhishek Kumar is an SME in Medical Device Regulatory Affairs, Quality Assurance, and Clinical Affairs with over 13 years of experience. He has led the EU MDR-2017/745 sustenance program, identifying business opportunities for sales teams, and managed the engagement program for a US-based medical device company. He has supported the gap assessment, remediation, and submission of 45+ Technical Documentations as per EU MDR, and created 40+ CERs for Class I, II, and III medical devices according to MEDDEV 2.7.1 Rev-4. Additionally, Abhishek has developed proposals for global markets, including Europe, US, ASEAN, China, Taiwan, and Japan, and prepared and implemented regulatory plans for NPD in 90+ countries by analyzing feasibility, defining requirements, and coordinating cross-functional teams.
