In this blog, we have discussed medical device contract manufacturing service. Additionally, we have highlighted why new medical device companies or startups should opt for this service. Furthermore, we have tried to answer some common FAQs.
Contract manufacturing is a service in which one company forms an agreement with another to create products on behalf of the parent company. Basically, it is the process of outsourcing at a manufacturing scale. It is similar to the way companies outsource employees. By opting for contract manufacturing services, companies can easily launch their products in the market without having to worry about production.
What is medical device contract manufacturing?
Medical device contract manufacturing is a service where a manufacturing firm specializes in producing medical devices for other businesses. The medical device company that owns the idea (sole proprietorship) outsources manufacturing to a medical device contract manufacturer. The medical device will be manufactured according to the specifications sent by the original company in compliance with ISO:13485 requirement and FDA guidelines. The contract manufacturing service includes the creation of prototypes; manufacturing the entire product, a single part, or a larger product; large-scale production; and assembly of a wide range of medical devices. Moreover, the purpose of outsourcing can be cost optimization, regulatory compliance, device upgrade, or upscaling of production. Additionally, the reason for choosing medical device contract manufacturing can be for focusing resources on product research and development. While, the contract manufacturer will handle the entire manufacturing process as well as ensure regulatory compliance.
What is covered in the medical device contract manufacturing scope?
The following are usually covered under the medical device contract manufacturing service scope:
- Medical device manufacturing
- Device assembly
- Testing and process validation
- Quality assurance
- Regulatory assistance
- Packaging for shipment
What are the types of contract manufacturing services provided?
There are mainly three types of contract manufacturing services provided:
- Make to stock (MTS)
- Make to assemble (MTA)
- Make to order (MTO)
Do medical device contract manufacturers assist with prototype development for medical devices?
Medical device contract manufacturers may assist with prototype development for medical devices. They help the parent company with medical device design development, material selection, and the creation of functional prototypes. By availing this service, medical device manufacturers can ensure the device prototypes are developed efficiently and adhere to necessary regulatory standards. Furthermore, companies can test and refine their products prior to mass production.
6 advantages of medical device contract manufacturing
- Medical device manufacturing experience and technological expertise: Medical device contract manufacturers have extensive expertise in medical device manufacturing. They work with various companies on multiple medical device manufacturing projects that enriches their experience in the domain. Moreover, they have manufacturing experience and technological expertise across various segments of medical device production. Furthermore, they can help you choose the right materials, machinery, and technology for your product. Hence, medical device companies can utilise the experience and expertise of contract manufacturers.
- Cost-effective medical device production: By using medical device contract manufacturing service, medical device companies can save funds required for establishing a manufacturing facility, maintaining staff, and procurement of raw materials. Costs can be optimised at various levels. Capital cost, resource cost, and machinery cost saving can be done. Moreover, the funds saved can be used for marketing, branding, R&D, and other important purposes.
- Regulatory support: Medical device contract manufacturers work with multiple clients. Hence, the they have a knowledge of the regulatory requirements and expectations. They can guide medical device companies on regulatory requirements and industry quality benchmark. Thus, they can help new medical device startups align their products with industry standards.
- Time to market launch is reduced: New medical device companies face various hurdles, such as regulatory compliance and production-related issues, when launching their product in the market. Thus, it is vital to choose a regulatory compliant contract manufacturer with rich experience in the medical device industry. Preferably, opt for an ISO:13485 certified medical device contract manufacturer.
- Improved market access: Medical device contract manufacturers usually have considerable networks in the market and an understanding of the market trends. Medical device companies can utilise the contract manufacturer’s network to increase their product’s reach in the market.
- Easy production scaling: By opting for medical device contract manufacturing service, companies can easily scale up or down their production. Companies will not have to worry about altering their medical device manufacturing infrastructure or operational protocols while changing their production scale.
Are there any regulations governing contract manufacturing service?
Medical device contract manufacturing is also stringently governed by regulations. For instance, in US, Food and Drug Administration (FDA) has formulated guidelines for contract manufacturing services for medical devices. The aim is to ensure safety, quality, and effectiveness of the devices, even though their manufacturing is being outsourced. Furthermore, medical device contract manufacturers should be complaint with ISO 13485 guidelines for medical device quality management system.
Pharmadocx Consultants: Your trusted medical device regulatory partner
When opting for a medical device contract manufacturing partnership, it is vital to check whether the manufacturer will be best fit for your product. Moreover, the manufacturer should be willing to adapt to your requirements and be ready to respond to all the queries. Launching and establishing a medical device business can be overwhelming. It is mandatory to comply with all the regulatory guidelines for medical devices to legally launch your product in the market. However, navigating the regulatory guidelines is cumbersome. Additionally, securing the license can be a lengthy and time-consuming process. Fret not! We at Pharmadocx Consultants will provide all the regulatory support you will need to launch your medical device.
Our team will help you prepare all necessary documents, such as device master files, plant master files, SOPs, essential principle checklists, and risk management dossiers. Additionally, we will help you secure the necessary licenses in a seamless manner. Having more than 27 years of experience in the industry, we are one of the premier medical device regulatory consultants. Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you have a smooth regulatory journey. Let us deal with the regulatory headaches while you focus on establishing your business.
FAQs
What is a medical device contract manufacturing company?
A medical device contract manufacturing company is a firm that undertakes the medical device productions process for another company that possesses the rights to the design and technology of the device.
Why should medical device startups opt for a medical device contract manufacturing service?
New medical device startups usually lack experience in various medical device production aspects, such as regulatory, operational, infrastructural, and machinery requirements. Moreover, they will also not have sufficient funds to establish a medical device manufacturing facility. By opting for a contract manufacturing service, medical device startups can ensure effective medical device manufacturing. Furthermore, they will get guidance on regulatory requirements. Additionally, they can utilise the medical device market networking of the contract manufacturer for their own benefit.
How can medical device contract manufacturers provide regulatory assistance?
Medical device contract manufacturers work with multiple medical device companies. Hence, they have an understanding of the regulatory guidelines as well as the requirements that may be applicable for your device. Thus, they can provide guidance and regulatory assistance. Moreover, a contract manufacturer with a regulatory compliant manufacturing facility will ensure your devices are being produced per regulatory guidelines. Hence, you will be able to launch your device in the market with less number of regulatory hurdles.
What is the expected growth rate of the contract manufacturing market?
The global medical device contract manufacturing market is expected to reach approximately USD 113.3 billion by 2026 at a compound annual growth rate (CAGR) of 11.5%. Hence, the market has a promising future with huge potential.
