Medical Device & Pharma
Solutions & Expertise
Driving Performance Excellence for Medical Device and Pharmaceutical Companies
Medical Device and Pharmaceutical companies operate in a unique regulatory environment and with very specific device class certifications. Implementation Engineers partners with companies in this space to work within the regulatory environment in order to meet growth and cost improvement objectives. As new devices and drugs are brought to market, manufacturing and supporting processes that meet strict guidelines must be brought online and executed flawlessly. We work with companies to meet Certified Good Manufacturing Practices (CGMP), FDA requirements and ISO requirements. Additionally, some manufacturers are moving from batch to continuous production in order to reduce waste, while also leveraging traditional improvement and quality methods that have been deployed throughout industry.
Implementation Engineers partners with Medical Device & Pharmaceutical companies across the organization to implement critical solutions, such as:
- Manufacturing start-ups and ramps that effectively and safely produce new products and devices. Like other industries, speed to market and reaching production is compressing; a company’s ability to ramp up operations and processes has a direct link to program profitability. Implementation Engineers partners with companies nearing this ramp up phase to execute plans effectively and on time.
- Visual management systems including KPI identification, data visualization, management structure and creating necessary behaviors to support a high-performance organization. These systems enable day-to-day variance management and process control and support ongoing continuous improvement.
Dynamic Solutions Address Industry Challenges
Implementation Engineers partners with companies to address complex business challenges and transform your Performance Excellence capability into a competitive advantage. Some of the industry challenges we solve include:
- High Performance Management Systems
- Rapid growth execution
- Lean facility layout
- Scrap Reduction
- Mold optimization
- Santiziation cycle time reduction