Sydney, NSW (PRWEB) August 2, 2008
Roman Greifeneder, from Ventracor Australia, has given his expert thoughts on Supply Chain Management to Australia's Best Manufacturing. The publication is being distributed industry-wide late July 2008.
Ventracor is a global medical device company which produces an implantable blood pump, the VentrAssist® left ventricular assist device (LVAD). The company is dedicated to building partnerships with healthcare professionals to make the VentrAssist LVAD the standard-of-care worldwide.
Ventracor's product modules are manufactured with a combination of outsourced suppliers and in-house production. The Company strategy is to control all key manufacturing processes in-house where possible. Where commercially appropriate and where technically possible, processes that are not necessary for core competency are usually outsourced once initial teething problems have been resolved. "Even though these outsourced processes are less critical, they still require exhaustive systems for raw material, equipment and environmental controls to ensure product output and product realizations are always within design specifications and regulatory compliance," says Greifeneder. "This is exacerbated due to the critical life-support nature of the product. Supplier processes often require objective evidence to prove they are scaleable and fully validated to all applicable national and international standards and regulations to comply with Ventracor's global regulated market."
Suppliers play a crucial role in Ventracor's strategic goals. Wherever possible the company will outsource assemblies and components to conserve cash and capital. "It is not currently possible for Ventracor to produce all of its assemblies and components in-house. To do this would be prohibitive from a cost, competency and time to market perspective," explains Greifeneder. Based on these three factors the company leverages the experience of suitable suppliers to satisfy the three competing agendas.
Ongoing supplier rationalization, lead time reductions and cost reductions are an ongoing focus within Ventracor's supply chain, as production volumes increase, price reductions are made possible. Higher volumes also lead to higher yields as the supply chain gains more experience over multiple batches and larger production runs. "As our global market increases, the product volumes also increase placing downward pressure on our cost of goods sold (COGS)," states Greifeneder. "One role of the supply chain overall is to deliver continuing reductions in COGS (without quality compromise) concurrently while the internal processes are optimized to gain maximum efficiencies."
In Ventracor's case, supplier selection and management is paramount due to the critical nature of the product and the highly regulated environment the company operates within. To mitigate risks the current suppliers are managed via a combination of supplier assessments, supplier audits, supplier contractual agreements, detailed purchasing specifications, regular visits/conference calls, goods inwards testing and inspections.
New suppliers are selected based on a technical assessment and an assessment against all relevant quality regulations and standards. Further assessment is made as part of the product development process via first production builds, qualification runs and detailed verification and validation testing prior to ordering production grade parts. If both the technical and system level criteria are fulfilled, the supplier is then formally approved for use and carefully monitored inclusive of per batch feedback data.
When producing a Class III life-support medical device, the relationships with the key suppliers are critical from a conformance to specification perspective, from a cost standpoint, and from a regulatory view. "Careful management and controls are required to ensure the risks are minimized while satisfying the company's goals and corporate milestones, providing a challenging tightrope to walk," concludes Greifeneder.
Crystalaid are a key supplier to Ventracor and were involved in the editorial feature with Bean Media Group, publishers of Australia's Best. You can see their advertisement here.