The global market for Medical Device Outsourcing is projected to reach US$162.4 billion by the year 2027 trailing a CAGR of 8.4% over the analysis period 2020 through 2027.The pandemic has shaken the outsourcing Industry creating fissures that could mark the beginning of a Techtronic shift in outsourcing approaches. Near shoring which began growing in popularity even in the pre-pandemic period will now witness greater momentum. The growing backlash against globalization & the need to rethink supply chains and decouple from China will heighten the focus on near shoring. Near shoring will help side step the risk of heavy dependence on countries located far away from the manufacturer's country. Medical device manufacturers in the U.S in the coming years will cast a closer focus on Mexico, Costa Rica & other Latin American countries as against China.

Medical device outsourcing is an approach where a third party assumes responsibility of managing device development and manufacturing operations either in part or in entirety. Medical device outsourcing continues to grow in significance led by the increasing need for medical device companies to recalibrate their strategies to reduce costs, accelerate time-to-market and focus on their core competencies. Medical Device Outsourcing involves a third-party operating a part or entire client's technology assets. Outsourcing typically involves an agreement between the client company and the supplier or the external outsourcing service provider. As per the agreement terms, the supplier takes over the manufacturing means in the form of assets, workforce, and additional resources of the client company. Furthermore, the client company gets hold of the services provided by the supplier as per the contract terms. Medical device manufacturers (original equipment manufacturers or OEMs) sometimes hire a contract manufacturer to perform contract manufacturing services such as product prototype, production, injection molding, silicone compression molding, welding, assembly and packaging in a controlled environment, clean room and other auxiliary services such as metal machining. Medical device outsourcing can lower operational costs, increase business efficiency and boost productivity thus providing tangible, bottom line benefits to organizations.

Quality control is one of the most critical issues in the survival of medical device industry. Stipulated FDA regulations and a high competition in the market ensure that medical device companies confirm to the pre-determined quality standards. Fear of losing market share to the competitors keeps medical device companies on their toes in maintaining quality benchmarks. Outsourcing the manufacturing process will limit the challenges as well as potential liabilities concerns. Quality remains an important issue in considering whether to outsource medical device manufacturing processes. Outsourcing decision primarily depends on customer preference as well as the kind of medical device manufacturing undertaken.