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What is Medical Device Contract Manufacturing Service?
Contractual manufacturing of medical devices involves outsourcing the entire process, including production of the same, to specialized manufacturers. They are capable of R&D designing, developing, and producing medical devices on behalf of MedTech IT solutions and medical device companies. They handle all aspects related to the process such as sourcing raw material from suppliers, resource planning, medical device design and development, device assembly including joining, casting, molding, testing, packaging and regulatory compliance checks on a contractual basis. Medical device contract manufacturing companies assist these companies in leveraging their resources, technical expertise, software and other infrastructure so as to optimize time to market in a cost-effective and operationally efficient manner. Such manufacturing services are especially useful for smaller companies that do not possess the capacity, infrastructure or technical teams to conduct these operations themselves.
It has also become a trend amongst medical technology giants and OEMs to outsource the process, given the cost, resource, time-related benefits and reduction in manufacturing hassle. The global market for contractual manufacturing of medical devices was valued to be around USD $78.9 billion as of 2024 and is expected to reach approximately USD $149.4 billion by 2029, surging at a CAGR of 11.4%. This rapid transformation is majorly driven by the adaptation of Industry 4.0, including robotics, analytics, precision manufacturing, quality assurance, industrial automation, additive manufacturing such as 3D printing technology for the swift development of medical devices etc.
Growing market size of the medical device contract manufacturing industry
Factors to Choose Medical Device Outsource Manufacturing
It is of utmost importance for companies to choose carefully while outsourcing these procedures to contract manufacturing service providers because decisions related to such needs are underlined by several factors, some of which are given below:
Experience
It is a notable point to explore the years of experience, type of expertise, previous projects, experience in developing minimum viable product vs prototype that the contract manufacturers showcase. One can go through customer reviews and work portfolios of the manufacturers to make informed decisions. This helps in understanding the projects and industries they have been involved in that are relevant to the client. It also presents the scale of projects and types of clients handled, such as SMBs, tech giants, OEMs and others.
Innovation
Prior to association, one must check if the medical device outsource manufacturing providers offer product modernization and upgradation services. The team’s expertise and skills must be scrutinized thoroughly for the development of innovative products according to current requirements. Their capability for electronics manufacturing services, trends followed during development, and approaches to attain innovation must be considered.
Quality Control
Since the medical field involves thorough quality checks, businesses must make sure that the contract manufacturers they are involved with assure quality control during development or quick response manufacturing (QRM). They must assess their robustness and compliance through manufacturing records, device history records, inspection records, calibration processes, regulatory records, and testing data as and when available.
Communication
Swift responsiveness and communication are the keys to any successful product development and project accomplishment. Clients can analyze the routine strategy and daily operations of the manufacturers during the initial stages, which in turn indicates time for delivery. This can also be done by facility visitation alongside to-and-fro communication on quality engineering processes. The partnership tenure can be assessed through their explanations, project ownership, query-related response timeliness, communication methods and more.
Pricing
Since cost optimization is the need of the hour, medical device outsource manufacturing providers must adjust and present a pricing model that suits the clients. Alternative models may be developed as per the availability of resources, raw materials, level of customizations, global supply chain connections, technological advancements involved etc. A rough assessment of the quality of vendor connections across the globe, vendor-related costs, availability of components, the strategy of determining the costs of finished products, additional charges etc. must be done beforehand for clarification.
Supply Chain
Clients must analyze the global supply chain management processes of the contract manufacturer thoroughly. This helps in enhancing communication related to material and procurement costs that combine to make the total manufacturing costs and may also determine the timelines. They must compare and contrast material requirement planning costs with market pricing and quality control standards.
Sample workflow of medical device contract manufacturing
Tech Stack
Companies looking for experts in the medical device contract manufacturing industry must and should explore and evaluate their technical expertise as well as the verticals they have worked for. They should be able to fathom the business idea, company’s vision and provide solutions to the requirements in question by syncing their own experience and technical capabilities to avoid unnecessary losses.
Compliance
The contract manufacturer should be familiar with regulatory submissions such as 510(k) and Conformité Européenne (CE) mark. They should provide regulatory check services such as product identification, classification, labeling instructions for use, design history file and dossier, risk assessment, testing etc. This helps in evaluating accountability in terms of support services offered.
Sustainability
It is an added advantage if the medical device contract manufacturing providers showcase sustainable engineering services such as support for design repair, return, and product feature improvisation down the line, reduction in costs, obsolete part management, maintenance, post market launch compliances such as Restriction of Hazardous Substances (RoHS), Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Waste from Electrical and Electronic Equipment (WEEE) etc.
Benefits of Medical Device Contract Manufacturing
Given below are some of the advantages of choosing contract manufacturing services for medical devices:
1. Supply Chain: Given contract manufacturers have an established network of vendors and suppliers; they can easily source components, procure raw materials for development and final product delivery, thus saving time to market. They can handle the supply chain management and vendor relations in place of OEMs and businesses looking for such development.
2. Cost Savings: Clients can save on huge amounts of capital expenditure in terms of expertise, capabilities, infrastructure, resources, labor, experience, design, development, prototyping, diagnostic and therapeutic equipment etc. to which they have limited access.
3. Quality Control: Through medical device outsource manufacturing, safety and performance are assured via rigorous quality control, testing procedures and established system set up. Contract manufacturers also offer services for packaging and sterilization of medical devices. This is especially crucial for products that are used in sterile environments like operation theaters etc.
4. Record Keeping: Contract manufacturers are accountable for maintaining development and material-related notes and records. They assure from time to time that the devices meet regulatory standards such as Quality Management Systems (QMS), ISO 13485, Medical Device Single Audit Program (MDSAP) etc. set by the European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA).
5. Core Focus: Clients can utilize their time and engage resources in core competencies and more productive or creative activities such as marketing, product innovation, branding, global outreach, market penetration, sales etc.
6. Scalability: Medical SMBs and mid-sized medical device companies can leverage large infrastructure and a number of resources to scale up production as per increasing demand without expending on new facilities.
7. Tech Advancements: Most of the companies under the medical device contract manufacturing industry are equipped with latest technologies such as computer vision and AI-based solutions for quality control, device production, Generative AI-based regulatory compliance updates and more.
Opt KritiKal as Your Trusted Manufacturing Partner
In this blog, we discussed the various benefits of hiring manufacturing partners on a contractual basis, such as easy market penetration and hassle-free regulatory approvals across the medical device contract manufacturing industry. Not only do these companies bring high-quality medical products to the market but also meet stringent regulatory requirements while easing their clients’ involvement in manufacturing process through operational efficiency and safety. It is a noteworthy point that the robustness and reliability of medical devices are directly proportional to the strength of quality assurance standards maintained by them.
KritiKal offers state-of-the-art medical embedded systems design, development and manufacturing services. We conduct in-depth value analysis as well as provide printed circuit board design and manufacturing, assembly, box build assembly and surface mount technology-powered solutions. Apart from precision machining and seamless system integration, we also cater to our clients with long-term partnerships for assistance in efficient supply chain management, production journeys, Gen AI-based compliances and regulatory updates. In addition to these, we also showcase extensive capabilities in quality assurance through computer vision-enabled packaging, labeling inspection, regulatory guidance and consulting support for swift market entry. Please get in touch with us at sales@kritikalsolutions.com to know more about our solutions and realize your manufacturing requirements.
Manoj Kumar works as a Software Developer at KritiKal Solutions. He has a versatile skill set spanning crafting, installing, testing, and maintaining robust software of various platforms, languages, and embedded systems. He is proficiently skilled in JavaScript, TypeScript, ES6, Node.js, Vue.js, VUEX, Pinia, Next.js, Nuxt.js, React.js, Vite Redux, Webpack/Babel, Angular, NgRx, Flutter, Java, Kotlin, Python and more. With his ability to stay abreast the latest developments in tools and procedures, he ensures that the delivered projects remain at the forefront of the industry