Scaling Service Operations Without Compromising Quality or Profitability

For medical device original equipment manufacturers (OEMs), exceptional service delivery is not an afterthought, it is mission critical. Effective service ensures uptime, patient safety, and regulatory compliance while directly impacting revenue and customer satisfaction. However, scaling service operations presents challenges: how do you grow efficiently while maintaining quality, controlling costs, and staying compliant?

This guide explores proven strategies to:

Optimize workforce management through a hybrid service model.
Minimize downtime and service costs while maintaining operational efficiency.
Ensure compliance and service excellence to mitigate risk and enhance brand reputation.

By implementing these best practices, OEMs can scale their service operations while enhancing profitability and maintaining the highest industry standards.

Leveraging a Hybrid Workforce Model for Scalability and Flexibility

A hybrid workforce model combines full-time employees (W2) with assistance from an integrated service provider (ISP). The ISP provides a fractionally allocated workforce that can strategically augment the OEM's service operations while enhancing the efficiency and quality of service.

Key Benefits of an ISP Model:

Cost Efficiency: Engaging ISPs for specialized tasks (i.e. Scheduled vs. Reactive services or Legacy vs. New Product Introductions) or peak periods to reduce overhead associated with full-time staff.
Expanded Coverage: OEMs can easily adjust workforce size to cover regional gaps in response to market demands without long-term commitments or geographic constraints.
Access to Specialized Skills: Integrated Service Providers have access to a diverse range of highly trained technicians who bring skills learned from performing a variety of repairs on many different types of equipment.
• Regulatory Compliance: A strong ISP partner ensures ISO adherence, proper training, and process compliance.

Implementation Best Practices:

Define Roles Clearly: The OEM must determine which services they want to keep in-house and which they will delegate to the ISP. This division can be done by geography, task type field service (scheduled vs. reactive events), depot repairs, customer care services (Level 1, Level 2), or possibly warehousing and logistics capabilities.
Ensure Compliance: An ISP with extensive regulatory experience can guarantee that all applicable laws, regulations and processes are being observed.
Maintain Quality Standards: The ideal partner will have a robust ISO-governed quality management system (QMS). Their QMS will ensure that everything from training to documentation will be executed according to the OEM’s standards. Documentation must be transparent, auditable, and processes replicated with uniformity across the entire operation.
Standardize Training Protocols: Use a "train-the-trainer" model to maintain consistency across internal teams and ISP technicians.

Quick Win:Design a pilot program testing the capabilities of prospective partners to ensure that their procedures and quality standards align with the proposed project. Establish KPIs to track during the pilot program to determine its success.

Reducing Downtime and Service Costs

Downtime translates directly into lost revenue and dissatisfied customers. By adopting predictive maintenance models and streamlined logistics, OEMs can optimize response times and reduce service-related expenses.

Best Practices for Cost-Efficient, High-Quality Service:

Predictive Maintenance: Utilize data analytics to anticipate and address issues before they lead to equipment failure. Work with a partner who can leverage your own service management system to ensure data is being logged and shared. This will ensure you work with real time data sets to plan your service schedules.
Optimize Workforce Deployment: Route optimization software and hybrid workforce models improve first-time fix rates and reduce travel costs. Expanding your workforce with a hybrid partner can also lead to a much more efficient deployment of technicians. Utilizing a depot repair center can also save on travel and other costs for routine maintenance.
Inventory Management: Warehousing and logistics are essential for minimizing downtime, as time spent in transit and lost to inefficiencies can increase turnaround time and decrease customer satisfaction. The correct partner can establish stocking hubs to ensure quick part-availability and lower shipping expenses or business continuity during off hours.

Quick Win: Assess your top 10 causes of downtime and identify one bottleneck that can be improved immediately with a workflow or process change. Identify one cause of downtime that can be fixed with an additional service software. Identify one cause of downtime that can be fixed with an engineering change in product management processes. Looking for the latest advances in Field Service to help get you there? Check us out at Field Service Medical 2025!

Ensuring Regulatory Compliance and Service Excellence

As service operations grow, so do regulatory obligations. For example, ISO 13485 and FDA 21 CFR Part 820 require a structured approach for maintaining compliance. Large enterprises must prioritize regulatory compliance to protect their brand and ensure market access. Startups should treat compliance as a growth enabler, allowing them to scale efficiently, gain credibility, and reduce long-term operational risks.

Best Pracitices:

Stay Informed: Regularly update your knowledge of relevant laws and regulations affecting medical devices. If you run into any issues requiring a Field Corrective Action (FCA), an ISP can help you remediate the situation quickly and cost-effectively.
Implement Robust Training Programs: Regular training and education are necessary to ensure all team members are fully equipped to perform any necessary service. A master training approach (train the trainer), where the OEM enables the ISP to train its own workers according to their guidelines, can help extend the reach of hybrid teams while freeing the OEM to concentrate on other tasks.
Conduct Regular Audits: Perform internal audits to identify and rectify compliance gaps proactively. Another benefit of an ISO-registered partner is that their standards require regular audits for registration to be maintained. These audits are focused on quality system compliance and process improvement. OEM partners greatly benefit from this extra scrutiny and transparency ensuring compliant quality mechanisms are in place with the ISP.

Quick Win: Perform a compliance gap analysis on your service operations and ensure your quality policy is up-to-date and easily accessible for all team members, including partners. Hold your partners accountable to your standards with regular check-ins and create a framework to share data and documentation. The FDA has intensified its focus on inadequate or missing standard operating procedures (SOPs) in 2024, issuing multiple warning letters, and will continue scrutinizing this compliance gap in 2025—ensure your procedures are documented, enforced, and regularly updated to avoid costly violations.

Conclusion

Scaling your service operations successfully hinges on strategic workforce management, proactive maintenance practices, and unwavering adherence to compliance standards. By embracing a hybrid workforce model, implementing measures to reduce downtime, and prioritizing regulatory compliance, your organization can achieve growth that is both sustainable, flexible to market conditions, and profitable.

Quest International is here to be your integrated service partner, helping you achieve your goals efficiently and cost-effectively. By partnering with Quest International, OEMs gain access to:

A flexible fractionally allocated workforce to scale field and depot services while meeting critical Service Level Agreements.
A proven ISO-certified partner, with multiple ISO quality system registrations (ISO 9001:2015, ISO 13484:2016, ISO 14001:2015, and ISO 27001:2022), as well as ANSI/ESD S20.20-2021 registration for ESD safety.
End-to-end service solutions, from field support to warehousing and logistics.

We can assist with the entire service cycle, from field service to depot repair or customer care solutions to warehousing and logistics. Contact us today to explore how we can support your long-term service strategy.

For more insights on optimizing your service operations, explore our other articles on Quest International's QView Blog.