A Brief Overview of Improvements in R&D efficiency

Continuous process improvements, the use of good modern development methods, standardization and the implementation of the right software tools are the keys

• to increase efficiency, 
• to establish clarity, to achieve mutual understanding, to avoid misinterpretation,
• to manage distributed teams and
• to achieve a robust organization which can react to disruption fast.

And sometimes process improvements are just mandatory to be allowed to act in certified industries. Continuous improvements not just of products, but of the whole product development process must become part of the mind-set of each development engineer.

Below a brief and definitely incomplete lists of my activities in this context:

Process Improvements

• Introduction of a global stage gate development process together and in alignment with other groups of the company; creation of all related documents, checklists and a unambiguous glossary, 
• Introduction of a global product change management process as front end to many local engineering change processes for a strict design control at all internal and external manufacturing sites
• Enhancement of development process, change management and the general product and project documentation to the requirements of various medical device directives (FDA510k, IEC 60601-1/2, MD 93/42/EWG and CFDA (China)). In 2009 we achieved certification for medical device development for the first time.
• Introduction of a general risk management according MD  93/42/EWG (ISO 14971) and machine directive MRL 2006/42/EG (ISO 12100)
• Implementation of a systematic and legal conformal patent system
• Definition of systematic innovation (evaluation) process
• Establishment and strict implementation of a continuous improvement process; Creation of a vital improvement culture; utilization of methods like Kaizen Blitz, Gemba Walk and others
• Introduction of a stage gate process for product documentation (operation manuals, service manuals, validation documentation (IQ,OQ,PQ)

modern development methods and standardization

• Introduction of system-, design- and process- FMEA as standard methods in development projects
• Utilization of several development methods: QFD, TRIZ, 3P, value analysis
• Use of general management methods like strategy deployment and balanced scorecard
• Implementation of standard work in complete R&D
  * daily stand up meetings
  * visual boards for all groups and for big projects 
  * standardized A3-report templates for all project proposals and project status reports
  * use of 5S in the laboratory and for some extend in the office area
• Creation of unambiguous test procedures for all verification tests
• Creation of a detailed design guideline
• Standardization and modularization of products documentation to increase reuse of text fragments
• Definition of preferred part list, replace of suboptimal standard parts by customized "standard" parts

Implementation of software tools

• Implementation of SolidWorks as standard 3D-CAD program; step by step replacement of all other CAD tools; establishment of in-house training; support of other sites for implementation by consulting and training; step by step switching big parts of the organization to SolidWorks
• Implementation of a product data management system (SolidWorks EPDM); global use at all sites for archiving active and passive documents according requirements of several directives; enabling global collaboration. According SolidWorks we had one of the most sophisticated and biggest installations: >500 active user, > 15 sites; > 1,5 million documents, > 30 self created program extension
• Controlled digitalization of > 1 million paper documents
• Integration of global product change management process in SolidWorks EPDM which allows to manage the complex and distributed structure of the global business and the storage of all change related documents in one system without redundancy

Robust Systems - our services for process improvements, modern methods and standardization