Outsourcing Medical Electronics Manufacturing
Outsourcing in the field of medical electronics manufacturing has become a strategic consideration for many companies. This practice involves contracting external partners to handle the production of medical devices.
The decision to outsource can be influenced by many factors, including cost considerations, the desire to focus on core competencies, access to specialized manufacturing skills, and the need for a flexible and scalable production model. Outsourcing offers companies the opportunity to streamline operations, enhance efficiency, and navigate the complex landscape of regulatory compliance, ultimately can contribute to the development and delivery of innovative medical technologies.
Let’s understand a few factors that influence the decision-making process for outsourcing the manufacturing of medical devices:
Manufacturing Capabilities
To find the appropriate partner, it is imperative to ascertain whether the intent is to outsource specific components or materials, such as a printed circuit board (PCB), or more comprehensive Electronic Manufacturing Services (EMS). A contract manufacturer such as Vexos can do both, offering both Custom Material Solutions (CMS), and more comprehensive tasks, including engineering, assembly, testing, box build, and the delivery of a fully finished product with final packaging—ready for customer receipt.
Quality Standards and Regulatory Compliance
The FDA Quality System Regulations (QSR) serve as a national benchmark for the quality management systems of medical companies. Vexos facilities are ISO 13485 certified and have established FDA-compliant quality and regulatory management structures for processes such as product recall, traceability, record retention, and risk management, aligning with the standards set by Medical OEMs.
Global Supply Chain Visibility
The significance of global supply chain visibility has grown as manufacturing processes have extended to offshore locations. Managing products through their entire product lifecycle is crucial to our customers’ success. By utilizing proprietary analytical tools, Vexos can provide assistance from inception of a product through field service requirements and manage the lifecycle of critical components of the BOM.
Time-to-Market Improvement
Time-to-market significantly influences the bottom line as medical product lifecycles shorten. Medical Contract Manufacturers like Vexos enable Medical OEMs to swiftly introduce products, manage demand effectively, and scale up quickly to meet market requirements. With manufacturing facilities spread across the globe in 6 locations, Vexos offers OEMs quick product introduction for a critical competitive edge.
Enhancing Efficiency and Flexibility
Medical OEMs gain efficiency, responsiveness, advanced production technology, and increased capacity through Contract Manufacturers. Outsourcing allows Medical OEMs to focus on core competencies, enhance market flexibility, and transition from fixed to variable costs. Contract manufacturers such as Vexos offers additional value-added services such as Design for Manufacturability (DFM), Design for Testing (DFT), Design for Assembly (DFA), Design for Excellence (DFX), Prototyping, and New Product Introduction (NPI).
Localized Manufacturing for Global Markets
The demand for large medical systems in emerging countries drives the need for localized manufacturing. Manufacturing medical equipment in the same market where it is sold makes practical sense, considering the weight and shipping costs. Contract Manufacturers with operations in low-cost manufacturing regions like Mexico and China provide an advantage, with Medical OEMs benefiting from a favorable tax and tariff structure when equipment is both built and sourced in the target market. With 6 manufacturing facilities and presence in strategic locations – Ohio, LaGrange, USA; Vancouver, Washington, USA; Toronto, Ontario, Canada; Juarez, Mexico; Dongguan, China; Ho Chi Minh City, Vietnam, Vexos offers a unique competitive advantage to its customers.
Emerging Opportunities and Challenges in the Medical Manufacturing Sector
The medical manufacturing sector is witnessing a surge in demand for certain types of medical equipment, due to rising rates of some chronic diseases and a relative increase in DALY, (disability-adjusted life years). There is a growth in demand for a wide range of devices, particularly those used for IoT-based remote health monitoring, and home healthcare assistance devices. Devices used in various medical settings for diagnosis, monitoring, treatment, and management of patient care such as pulse oximeters, hearing aids, ventilators, x-ray machines, ECG, MRI, CT scanners are also seeing an increased demand. With the flexibility and efficiency of a Contract Manufacturer, OEMs can more easily bring new products to market to respond to ever-changing medical equipment needs.