In today’s environment, medical device and pharmaceutical manufacturers are seeking alternate solutions to handle key functional areas such as Device Vigilance, Product Complaints and Medical Information.  Implementing and maintaining these programs internally carries significant time, cost and resource burdens.  With increased scrutiny by regulators, outsourcing provides a flexible solution with the ability to scale up or down quickly based on the needs of the business.  Furthermore, research performed by Grand View Research indicates that there will be a significant increase in outsourced activities by the year 2025.  Some of the benefits that companies can expect to see include:

 

  • Increased focus on core competencies
  • Improved processes and increases in efficiency
  • Ability to scale up / down quickly
  • Maintained control of oversight
  • Improvements in compliance
  • Leveraging of internal resources on other projects
  • Decrease in operational costs

Outsourcing Implementation Assessment and Strategy

Outsourcing key functional areas allows a company to focus on the core competencies of their business.  We can assist with evaluating if outsourcing is right for you by performing:

  • Evaluation of Existing Program – Review of the current state of the program to gain a better understanding by reviewing the following areas:
    • Management Hierarchy
    • Operational costs of existing program
    • Staffing
    • Systems
    • Operational Logistics
  • Strategic Planning Session – After review, RCA Subject Matter Experts (SMEs) will meet with key stakeholders to discuss our findings and strategize next steps.
  • Development and Structure of the Future State program

Upon completion of the assessment and strategy session, RCA will work with your team and the selected Partner to develop a communication model.  An area of key importance in a successful implementation is Collaboration, Commitment and Change Management.  We refer to these as the 3 Cs and we will work with your organization to address the points noted below.

 

Collaboration

  • Extensive collaboration is critical amongst the functional core team. All teams will be empowered and motivated to deliver success
  • Selection of the “right” leaders within the Client and Outsourcing Partner is critical in building strong team dynamics
  • Focus by Senior leadership on cultural and process change

Commitment

  • Key business Stakeholders are thoroughly engaged through the entire implementation
  • Transparency between teams builds mutual trust as well as appropriate and timely resolution
  • Open lines of communication to provide constructive feedback for continuous improvement

Change Management

  • Specific and timely communication is critical
  • Knowledge and focus on the long-term strategy and big picture must be the motivation of the leaders and SME’s to get through the challenges that will occur during implementation.

 

Since 2000, medical device, pharmaceutical and biologics manufacturers around the world have trusted Regulatory Compliance Associates® Inc. as their go-to consulting firm. Our team of over 500 industry experts offers the hindsight and advantage necessary to give you clear guidance from beginning to the end of the product life cycle. No matter what your unique industry needs, count on RCA® Inc. to develop an ideal consulting solution tailored to help you comply with industry regulations and meet your goals.

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