Abstract

The growing need for businesses to optimize operations, reduce costs, and tap into specialized global expertise has made onsite-offshore transitions a critical aspect of modern business strategies.

However, transitioning work from onshore teams to offshore counterparts often presents challenges, such as communication gaps, cultural differences, time zone constraints, and project management complexities. This white paper proposes a comprehensive framework to facilitate seamless onsite-offshore transitions, ensuring operational continuity, efficiency, and effective collaboration across geographies. The proposed framework focuses on five key components:

  • Strategic Planning
  • Technology Integration
  • Cross-cultural Communication
  • Workflow Standardization
  • Performance Monitoring

It outlines best practices for setting clear objectives, defining roles and responsibilities, and using advanced tools to bridge communication gaps. Additionally, this paper highlights the fostering an inclusive culture and adopting agile methodologies to maintain flexibility and adaptability throughout the transition process.

By following this approach, organizations can minimize disruptions, optimize resource utilization, and cultivate a collaborative, high-performance work environment. Leveraging this framework allows organizations to achieve smooth transitions that align with strategic goals, ensuring long-term success in an increasingly globalised workforce model.

shutterstock_2528905445

Introduction

When a service provider or contractor works "onsite" it means they are physically present at the client’s office, factory, or premises to perform services or tasks. Terms often associated with onsite work include: onshore, in-situ, nearshore, client-site, on-premises, at-location.

Over the past two decades, the onsite-offshore work model has gained significant traction as organizations seek to balance operational efficiency with cost savings. This transition typically involves shifting specific business functions - such as IT, software development, customer support, and other back-office operations - from an onsite (in-house or domestic) workforce to offshore team located in another country.

Key drivers for this transition include:

Cost Efficiency

Reducing labour costs by leveraging talent pools in countries where wages are significantly lower than in domestic markets.

Access to a Global Talent Pool

Utilizing specialized skills and expertise from different geographic regions.

Scalability

Enabling organizations to scale up or down based on dynamic project requirements.

24/7 Operations

Exploiting time zone differences to ensure continuous productivity and workflow.

However, transitioning to an offshore work model also introduces significant challenges that must be addressed for operational success.

shutterstock_2149128815

Problem Definition: Challenges and Mitigation Strategies

While the benefits of offshoring are significant, organizations must proactively manage the challenges associated with transitioning from onsite to offshore model.

Challenges and Mitigation Strategies

Key Considerations in Transitioning to Offshore Work Model

1. Identifying Functions Suitable for Offshoring:

Not all functions are ideal for offshore operations. Organizations must conduct a detailed analysis of workflows to identify tasks that can be offshored without compromising quality, security, or customer experience.

Suitable functions typically include:

  • Software development and maintenance
  • IT infrastructure support
  • Data processing and analytics
  • Customer service and technical support
  • Back-office operations (e.g., HR, finance, and payroll processing)

2. Talent and Skill Matching:

The expert of the offshore team is critical to transition success. To ensure alignment between organizational requirements and the offshore workforce:

  • Identify and assess offshore vendors or setup direct offshore operations.
  • Prioritize relevant expertise, certifications, and industry experience.
  • Align skillsets with project needs, technical requirements, and business goals.

3. Process Standardization:

Standardized processes are essential for effective collaboration between onsite and offshore teams. This includes:

  • Documentation: Clearly document all workflows, processes, and responsibilities.
  • Automation: Use tools to automate repetitive tasks to minimize manual errors and inefficiencies.
  • Training and Upskilling: Train offshore teams on specific tools, workflows, and compliance requirements to accelerate the transition and mitigate risks.

4. Communication and Collaboration:

Maintaining seamless communication is one of the most significant challenges in onsite-offshore transitions. Best practices include:

  • Establishing clear communication channels of (e.g., Microsoft Teams, Zoom).
  • Scheduling regular meetings to synchronize progress, address challenges, and ensure alignment.
  • Encouraging cross-cultural understanding and to foster collaboration and a shared sense of purpose.
  • Setting clear expectations for response times and deliverables.

5. Governance and Security:

A robust governance model is essential to managing offshore relationships while ensuring quality, security, and compliance. Key governance considerations include:

  • Data Security and Compliance: Offshore teams must adhere to data protection laws, and undergo regular audits to ensure compliance.
  • Performance Metrics: Define clear Key Performance Indicators (KPIs) to monitor productivity, quality, and turnaround times.
  • Risk Management: Identify and mitigate risks such as data breaches, IP theft, or delivery delays.
  • Vendor Management: For third-party vendors, establish strong contractual agreements to safeguard sensitive assets and intellectual property.
shutterstock_2029236053

Establishing a Framework for Seamless Onsite-Offshore Transition

A successful onsite-offshore transition framework consists of several key components designed to address challenges and enable a smooth flow of workflow between teams.

1. Governance and Leadership Alignment

  • Clear Vision and Objectives: Senior leadership must define the transition’s objectives, including performance metrics, cost-benefit expectations, and timelines.
  • Onsite-Offshore Governance Model: Establish a governance structure to clarify roles, responsibilities, decision-making processes, and escalation paths. Regular cross-functional leadership meetings ensure alignment and enable swift issue resolution.
  • Risk Management and Mitigation: Develop a risk management plan to proactively address potential challenges like delays, quality inconsistencies, or system integration issues.

2. Communication and Collaboration Protocols

  • Communication Plan: Develop a robust strategy to accommodate time zone differences, language barriers, and technology limitations. Use tools like Jira, Trello, Google Drive, and OneDrive for asynchronous collaboration.
  • Regular Touchpoints: Schedule daily or weekly stand-ups for progress tracking, updates, and alignment.
  • Cultural Sensitivity Training: Provide cross-cultural training to improve understanding, mutual respect, and communication effectiveness between teams.

3. Technological Integration

  • Unified Technology Stack: Use a shared set of tools for task management, communication, and collaboration to seamless operations.
  • Cloud-based Solutions: Adopt cloud platforms for real-time data access and improved collaboration. Tools like Slack, Microsoft Teams, and Zoom can help bridge communication gaps.
  • Security and Data Privacy: Implement data security protocols, that comply with international regulations to protect sensitive information.
shutterstock_2255961967

4. Talent Management and Knowledge Transfer

  • Skill Alignment and Onboarding: Develop a structured onboarding and knowledge transfer plan to ensure offshore teams understand the business processes, tools, and company culture.
  • Cross-Skilling and Continuous Development: Encourage continuous learning and cross-skilling to enhance workforce versatility and skill alignment with business needs.
  • Leadership Development: Identify high-potential offshore team members and invest in leadership programs to facilitate escalation management and smooth transitions.

5. Performance Monitoring and Feedback Loop

  • Key Performance Indicators and Service Level Agreements: Define clear KPIs and SLAs to measure productivity, quality, and turnaround times.
  • Continuous Improvement: Establish feedback mechanisms to gather insights, assess performance, and refine processes regularly, ensuring the framework adapts to evolving business requirements.
shutterstock_2446518931

Benefits of Offshoring

A successful transition from onsite to offshore work offers significant benefits including:

Cost Savings:

Offshore teams, particularly in regions like India, the Philippines, and Eastern Europe, provide skilled labor lower costs, reducing operational expenses without compromising quality.

Flexibility and Scalability

Organizations can scale teams up or down based on project demands, enhancing adaptability to market changes.

24/7 Productivity

Time zone differences enable continuous operations, speeding up project deliveries and improving customer support.

Access to a Global Talent Pool:

Companies gain access to specialized skills and expertise not readily available domestically, ensuring competitiveness.

Focus on Core Business Functions

Offshoring non-core functions (e.g., IT support, back-office tasks, or customer service) allows businesses to focus on strategic initiatives, driving growth and innovation.

Note: These benefits can only be achieved through meticulous planning, unambiguous communication, and effective governance.

Best practices for a Successful Onsite to Offshore Transition

Best practices for a Successful Onsite to Offshore Transition

Case Studies

Here are some examples of offshoring models, including captive centres managed by customers or suppliers, and scenarios where technology transfer constraints lead to sizable onsite teams.

1. Captive Centre Managed by Customer

  • Example: An Aero engine OEM set up its own captive centre in India to support global operations.
  • Use Case: Managing core Manufacturing platforms, ensuring regulatory compliance, and safeguarding sensitive customer data.
  • Benefits: Full control, regulatory alignment, and protection of proprietary technology.

2. Captive Centre Managed by Supplier (Hybrid Model)

Benefits_20of_20Establishing_20Captive_20Centers_20in_20India

Image Source: https://www.wisemonk.io/blogs/establish- captive-center-in-india-for-your-global- success

  • Example: Off highway company partners with Cyient Ltd to establish and manage a captive centre. The supplier manages operations, staffing, and infrastructure, while the client retains strategic oversight.
  • Use Case: Customer support and R&D functions where the client seeks control but lacks local expertise.
  • Benefits: Cost savings, operational efficiency and faster scalability without direct management.

3. Technology Transfer Requiring Sizable Onsite Teams

  • Example: An Aero tier-1 supplier outsources manufacturing / design / analysis support to Cyient Ltd. A large offshore team is initially relocated onsite to facilitate knowledge transfer.
  • Use Case: Complex domains like aerospace manufacturing and assembly at final assembly line, where initial knowledge transfer is critical.
  • Benefits: Smooth transition, faster learning curve and strong alignment with client expectations.
shutterstock_2157734987

4. Build-Operate-Transfer (BOT) Model

  • Example: A Healthcare company partners with a vendor to establish an offshore development centre. The vendor builds and operates the centre for a defined period before transferring the ownership to the client.
  • Use Case: Setting up operations in a new geography while reducing upfront risks and investments.
  • Benefits: Low-risk entry, local expertise and eventual full ownership by the client.

5. Project-Based Offshoring with Onsite Presence

  • Example: An Aero engine OEM outsources instruction migration projects to Cyient Ltd. Due to integration challenges with legacy systems, a significant portion of the offshore team works onsite for the project duration.
  • Use Case: Legacy modernization or integration projects requiring frequent client collaboration.
  • Benefits: Better communication, reduced delays and efficient knowledge transfer.

6. Global Delivery Model

  • Example: An enterprise outsources SAP implementation to a supplier using a global delivery model. Core development happens offshore, while a portion of the team works onsite for stakeholder alignment and real-time troubleshooting.
  • Use Case: ERP implementations, multi- geography rollouts or IT infrastructure transformations.
  • Benefits: Cost optimization, 24/7 productivity, and proximity to clients during critical phases.

These examples illustrate different offshoring models tailored to specific business needs, technology constraints, and operational strategies. Cyient Ltd. has successfully developed a sustainable offshore ecosystem by aligning with organizational goals and prioritizing:

  • Clear governance structures,
  • Effective communication protocols,
  • Integration of advanced technologies,
  • Efficient talent management, and
  • A culture of continuous feedback and improvement.

This holistic approach enables Cyient to deliver seamless onsite-offshore transitions that drive efficiency, scalability, and long- term success for global businesses.

shutterstock_2194651727

Conclusion

The United States Food and Drug Administration (FDA) plays a vital role in safeguarding public health through its regulatory oversight of various products. Key functions include product approval, inspections, enforcement actions, public health education, research, and emergency response. Drug approval pathways, such as 505(b)(2), ANDA, and standard approval processes, are essential for bringing new medications to market. Achieving market clearance in the United States requires careful planning, strict adherence to regulatory requirements, and active engagement with regulatory authorities. Although FDA approval fees are high, they contribute to expediting the drug approval process. Nonetheless, challenges in submitting IND/NDA applications to the FDA persist, including regulatory compliance, data requirements, communication, timelines, resource allocation, and acceptance of foreign clinical studies. Overcoming these challenges requires meticulous planning and close collaboration between sponsors and regulatory authorities.

Conclusion

The transition from onsite to offshore work model offers substantial advantages including cost efficiency, access to global talent pool, and improved productivity. However, to fully harness these benefits, organizations must adopt a well-structured approach that prioritizes clear communication, robust governance frameworks, effective talent management, and a sustained focus on quality and performance.

By following the best practices outlined in this white paper and proactively addressing potential challenges, organizations can establish a seamless, efficient, and sustainable offshore model. This approach not only complements onsite operations but also drives long- term engagement, scalability, and business growth.

shutterstock_2262270303

About the Author

Prashant Kamble[57]

Prashant Kamble
Senior Project Planner, Cyient Ltd.
Bachelor of Engineering (Mech)
Email: Prashant.Kamble@cyient.com

Mr. Prashant Kamble brings over 23 years of rich experience in steering high-impact projects across industries such as Aerospace, Automotive, and Medical Healthcare. He has successfully partnered with leading global OEMs and Tier 1 companies, including Pratt & Whitney Canada, Airbus (CT Ingenierie France), Medtronic (USA), and GKN (UK), to deliver complex and prestigious projects.

A recognized expert in his field, Mr. Kamble is celebrated for driving innovation, optimizing processes, and delivering consistent, high-value outcomes aligned with strategic business objectives. His expertise spans:

  • Manufacturing and Assembly Process Planning: Standard Operating instructions (SOI) / Work Instructions / Methods.
  • Quality and Process Excellence: Mastery in Supplier Quality, FAI, APQP, PPAP, Engineering Change Management, Value Engineering, and PLM.
  • Leadership and Program Management: Skilled in program execution, fostering client relationships, and leading cross-functional teams.

With a proven track record of managing complex, multi-disciplinary projects, Mr. Kamble’s leadership and ability to foster collaboration position him as a vital contributor to driving organizational growth and operational excellence.

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

FDA's Review Process and Timeline for De Novo Submission Request

    • Acceptance review (21 CFR 860.230)

      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:

      • The De Novo request has been accepted for substantive review;
      • The De Novo request has not been accepted for review (i.e., considered RTA) and the requester has 180 calendar days to fully address the RTA notification; or
      • The De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.
shutterstock_1967621848
    • Substantive review

      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—

      • Include the requester's name;
      • Identify the De Novo number;
      • Include the requester's name;
      • Identify the submission as a response to the Additional Information letter;
      • Identify the date of the FDA's request for additional information; and
      • Provide the requested information in an organized manner.

      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.

shutterstock_2256748249

 

CyARC—Accelerated Regulatory Platform

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.

shutterstock_1932149360

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

Conclusion

The De Novo submission pathway offers an important regulatory mechanism for launching novel medical devices in the United States market. By understanding the key components of De Novo submission, strategic considerations, and post-market obligations, medical device manufacturers can navigate the regulatory pathway effectively and obtain market clearance for innovative technologies that address unmet clinical needs and improve patient care. While most medical device companies face challenges in their De Novo submissions, collaboration, resource allocation, and strategic planning are essential for achieving successful market entry through the De Novo pathway.

About the Author


Abhishek Kumar-2

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.

 

shutterstock_1485212855