Deep knowledge and know-how when you need it

Business Process / Product Rollout, Healthcare

The General Manager, a major supplier of hospital infusion devices needed to build out a new revenue-generating business unit for implementing technology-based infusion devices at hospital sites. He needed a very short time-to-market for this highly competitive product.

Previous deployment had taken many weeks (with varying degrees of chaos). The client requested our assistance in creating a precise, cost efficient, repeatable process for rolling out these complicated devices.

We provided the client with an Interim Director / Process Specialist solution.

Over the next year, we built the process playbook that integrated the hospitals and medical organization’s teams. Using our process, the client was able to successfully deploy more than 50 hospital implementations while reducing the time-to-market to 8-12 weeks per site.

Global Supplier Quality Compliance, Healthcare

We worked with the Director of Supplier Quality in the Global Compliance group for a multibillion dollar medical device manufacturing firm. The group needed to remediate supplier issues that were identified by the FDA and internal audits.

There were over 1,900 gaps identified in the supplier management database that needed to be closed and over 159 suppliers requiring audits. The company also needed to implement new corporate supplier quality procedures. The problem was identified when the FDA issued a Consent Decree which barred the company from selling its devices and even prohibited them from developing a new, upgraded products.

The client needed specialized consulting leadership to help him identify and close all gaps, identify any additional potential issues, and develop a remediation plan.

We provided a 5-person team consisting of a Program Manager and 4 Supplier Quality Specialists that developed a plan to close all existing issues in five months. The team also identified six additional compliance gaps and presented a plan to close them.

The immediate benefit to the client was the closure of 1,908 gaps in the quality system and 159 successful audits. Within this timeframe, we also successfully created and launched the company’s first Receiving Inspection Process to protect patients from potentially bad products.

The project turnaround was extremely successful. Originally, it was Number One on the CEO’s critically list. At completion, it was nominated for Project Of The Year Award along with 12 other projects, and received the Second Place Award.