Lean Quality Solutions for Medical Device & Pharmaceutical Companies

Synergis, a sister company of BioTeknica, offers comprehensive lean quality solutions.

Lean quality is a set of principles used to achieve improvements in productivity, quality, and lead-time by eliminating waste.  The term lean, first used in the late 1980s, described Toyota’s approach to conducting business.  It is not just an approach to cost reduction or one particular business tactic, but how organizations think and act in a manner that creates more customer value.  Lean thinking is the optimization of how products flow across technologies, assets, departments, and ultimately to customers.

Medical device, diagnostics, biologics, and pharmaceutical companies are beginning to implement lean quality system methodologies that BioTeknica and sister company Synergis have employed for more than 25 years. BioTeknica focuses on providing lean quality system solutions to achieve Quality-Cost-Delivery-Morale (QCDM) outputs in your processes, methods, and practices.

We partner with your team and employ a best practices model, customized to your specific needs and the capabilities of your team.  We serve as consultants, coaches, mentors, and Senseis to assist in the development of expert practitioners within your organization.

Lean methodologies include solutions for:

  • new product development

  • manufacturing/production

  • supply chain

  • business processes

  • quality processes

  • customer services

  • support services

Our approach consists of focusing on globally demonstrated Lean Quality Methodologies. For example:

  • standardization of processes
  • mistake-proofing processes
  • elimination of waste
  • other methodologies that lead to operational excellence

Our approach not only implements these types of processes, methods and tools to manufacturing, supply chain, and operational areas, but also in areas that have traditionally only had a focus on compliance, such as complaint handling, design controls, and CAPA processes.

We work closely with client teams, providing the “knowledge, capacity and capability” to expand their value, satisfaction and morale, focusing on Quality by leveraging our experience on standardization and best practices.

Finally, we ensure that the gains are sustained by deploying our “Sustainability Process,” consisting of the triad:

  • standardization of best practices
  • education and training
  • systematic process to ensure consistent compliance