Medical Devices
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers.
Common characteristics of the medical devices industry
The medical devices industry shares many common characteristics:
- Demand driven by advances in medical technology and science, and population demographics.
- Manufacturing methods and modes.
- Process - batch.
- Discrete - batch.
- Jobbing.
- Engineer-to-order.
- Make-to-order.
- Assemble-to-order.
- Make-to-stock.
- Forecasting.
- Product licensing and patenting.
- High level of specialization.
- Research intensive.
- Heavily regulated.
- Labor-intensive manufacturing for certain products.
- Patent disputes and litigation.
- Some subcontract manufacturing.
- Manufacturing intensive.
- Direct selling.
- Rep sales.
- Catalogue sales (on-line and paper based).
- Medical conference sponsorship.
- Marketing collaboration with other MD companies.
- Large receivables.
- High liability insurance costs.
- Prototyping and clinical trials.
- Service extensive global markets.
- Product insurance approvals.
- Large sales volumes.
- Product change control.
- Product traceability.
- Through-life support.
Medical devices industry challenges
The challenges the medical devices industry often faces are to:
- Sustain low-cost manufacturing efficiency for low technology products.
- Drive technological innovation for diagnostic and therapeutic devices and instrument.
- Minimise risk of technological obsolescence in a highly specialised product space.
- Reduce costs in a labour-intensive manufacturing environment.
- Prove cost-effectiveness to regulatory bodies.
- Control customer receivables and manage cash flow.
- Minimise risk of defects, product recalls and malpractice litigation.
- Improve electronic collaboration with customers and external partners in the supply chain, while ensuring data security.
- Provide customers visibility to orders, stock availability and account status.
- Keep pricing within regulatory body and insurer limits, while remaining profitable.
- Monitor and report on safety and health regulation compliance.
- Improve time-to-market and streamline business processes.
- Plan and manage distribution and goods in transit.
- Manage customer relationships.
- Manage the storage and retrieval of compliance documentation and certification.
- Manage and track warranties, warranty claims and returns.
- Integrate shop floor control and quality systems with business systems.
- Plan and manage capacity.
- Optimise inventory while meeting customer service level targets.
- Facilitate efficient Internet-based sales.
SYSPRO product modules can address these challenges
SYSPRO addresses these challenges with the following modules from its extensive enterprise resource planning suite. Suggested modules include:
- Engineering Change Control Module.
- Lot Traceability Module.
- Forecasting Module.
- Quotations Module.
- Product Configurator Module.
- Return Merchandise Authority Module.
- Bill of Materials Module.
- Requirements Planning Module.
- Work in Progress Module.
- Factory Documentation.
- SYSPRO Analytics Module.
- Quality Data Collection Module.
- Factory Scheduling System.
- Contact Management Module.
- SYSPRO Reporting Services Module.
- Landed Cost Tracking Module.
- Activity Based Costing Module.
