Category: Medical Devices

The Ask:

A global medical device company, a Top 100 ASX performer, launched a new product range which was well received in the market with indications of good sales potential. However, manufacturing output simply could not meet the demand and customers were becoming increasingly frustrated at not receiving their orders on time

Challenges:

• The product range consisted of 2 main products which, with 4 colour variants (and 2 more to be launched), yield 20 SKUs and 120 accessories
• The output level was supposed to be 1400 units per month with aspirations to raise output levels to 3000 units per month over 6 months
• Throughput levels and yields were lower than target but were expected to rise with production experience (the actual output was 300 units per month)
• There were quality, quantity and timeliness problems with deliveries of bought-in components
• The high failure rates of incoming components and assemblies consumed valuable trained resource to rework failures and therefore, reduced capacity
• The operation was labour intensive with 30 people employed on 8hr shifts plus overtime and around 10 on afternoon shifts
• There is no automation, each piece is hand-built under microscopes
• The average lead time to produce one unit was in excess of 45 days

The Approach:

Changes were implemented within the company’s framework of:

• Internal organisation structure
• Regulatory and compliance requirements
• Incoming Inspection and GMPs
• Document control and SOP processes

The Ask:

A global medical devices company under consent decree for 2 years across two sites

Findings:

• FDA Audit in 2013 (21 483s were issued)
• Quintiles audit in 2015 (91 Findings were issued)
• Also included in the scope were Dekra & TGA findings

Summary: 112 Major Findings, 408 Minor Findings. All business areas Impacted

Challenges:

• The organisation had engaged with a number of contractors, structure was fragmented and not yielding results
• The systemic issues which had led to many of the findings were directly preventing the organisation from addressing the findings effectively
• The organisation had been living with these findings for the past four years – motivation was low and successful remediation seemed unlikely to many
• Resources across the organisation were heavily loaded with day to day operations

The Approach:

• 9 Program teams (2 Design teams) developed based on the 15 Subparts – 21 CFR 820

Success Enabling Systems Leaned:

• CAPA system
• Complaints Management System
• Change Control System
• Nonconformances
• NVA steps removed processes refined

The Ask:

A global medical devices company wanted to embark on the implementation of the EU MDR.

Scale:

• 250+ Technical Files
• Seven global locations

Challenges:

• Very little internal experience in large scale programme management
• The organisation did not have the experience to bring a global programme of this scale through the required phases and into execution
• ‘No internal’ toolkit to address a programme of this scale
• To move a program of this scale required a distinct set of tools that were standardised, scalable and transparent
• How to measure & track progress over the programme lifecycle? (4 Years)
• Overloaded Internal Staff: How can we make this management as hands-free as possible?

The Approach:

The Ask:

A global medical device company enjoying increasing market share was suffering an increase in high-value inventory because of QA test release lead-times.  The average time for final test/release was 8.6 days which meant that orders were held in the warehouse awaiting release.

Challenges:

• Testing lead-times were long (days) and getting longer
• The number of samples being sent for testing was increasing
• The backlog of samples awaiting testing was growing bigger
• Current staffing levels could not cope with the volume of tests
• Investigation procedures were complex
• It took a long time to obtain results from the different tests and compile the report
• Highly educated, experienced laboratory technicians were difficult to find
• Recruitment and training lead times were long (months)
• There was limited laboratory workspace for additional staff and test equipment

The Approach: