Case Study

Vendor Systems Readiness

The Situation

Company: Large device vendor with device development and manufacturing arms, servicing Big Pharma

Issue: Experiencing negative feedback from a key client during the device development process. It is indicative of pain points experienced across client projects and could be costing them repeat business.

Project: Perform a systems readiness assessment and recommend solutions that will reduce partnership challenges and improve the company’s ability to be a preferred, turnkey vendor option

Challenges Expressed:

  • Vendor’s development and manufacturing entities work in silos
  • Pharma clients expressing frustration about limited testing services offered in-house and the need to contract additional vendors to complete testing
  • Misalignment between vendor and Pharma client documentation systems
  • Misalignment between vendor and Pharma client risk management processes

Impact:

  • Confusion at the client level and a resulting lack of trust that the client will get what they ultimately need from the vendor for product approval
  • Longer development timelines due to lost time coordinating between siloed vendors
  • Potential “holes” in regulatory documenation needed for approval submission
  • Client frustrations with limitations imposed by vendor
  • Overall strained customer relations
  • Potential loss of repeat business to competitors

Discovery:

  • While their clients leverage both the vendor’s development arm and clinical assembly arm, the vendor puts the onus of coordinating between the two entities on the client, instead of aligning and collaborating between the sister-companies. Additionally, there is misalignments between the two sites on fundamental process areas (i.e., how they trace risk from development into risk/inspections in manufacturing).
  • Vendor performs standard verification items but is highly resistant to other testing, forcing their clients to go out and find 3rd parties to do simple verification that the vendor could likely do much easier.
  • Vendor’s processes can sometimes be a “black box.” It’s not always clear to the client why they need certain inputs from clients or which outputs the clients will receive in turn.  
  • Vendor’s risk management process does not allow the client to take ownership of defining design verification sample sizes based on their own procedures/system level risks.
  • Vendor’s risk management process assumes their clients use a P1xP2 designation. If not, vendor force ranks everything to worst case which thereby has a downstream impact to the devices risk profile and verification strategy.

Solutions Implemented:

  • Created systems for Vendor to hold Pharma’s hand through the project transfer process and to align collaboration and processes across their sites.
  • It was determined that much of the testing desired by most clients was not outside the vendor’s scope, and a la carte service options were created to add on as a separate SOW when needed.
  • Created a map template for the necessary flow of deliverables from client to SHL and back to client. Suggested this map be incorporated into the SOW creation stage and allow for early consensus.
  • Created systems for adjusting design verification processes to client sample size needs that do not fall under Vendor’s own SOP.
  • Redesigned systems to plug into client’s risk management process.