The COVID-19 pandemic kick-started the supply chain disruptions, especially critical chips shortage, along with its long-reaching effects not only in auto, consumer electronics, but also in life-saving medical devices and systems. Almost immediately, Original Equipment Manufacturers (OEMs), especially bioelectronics that are classified as FDA (Food and Drug Administration) class III, started experiencing a high demand for equipment, major disruptions to raw materials and components supply, and talent shortages.
More and more med-tech companies are turning to CDMOs (contract development and manufacturing organization) to seek help for keeping/maintaining the balance between reducing costs and maintaining quality in turbulent times. That's why it's important to understand what a CDMO is and what benefits they can offer to your business.
In this blog post, we'll explore the definition of a CDMO, as well as discuss some of the key benefits that you will gain from medical product outsourcing. So, whether you're looking for innovative technology solutions, world-class technical service quality, or simply want to stay ahead of the curve, read on!
CDMO is an outsourcing contract established between the pharmaceutical industry or a medical device company and an external service provider. End-to-end CDMOs can manage and simplify the complexities of the supply chain, and streamline the overall process of moving a med-tech innovation from concept to market. Choosing a right CDMO partner like COFORCE Medical can meet your needs at every step of your product journey and beyond.
CMO vs. CDMO
First thing first, there is a huge difference between the terms of "CMO" and "CDMO".
1. While CMO refers to "contract manufacturing organization" who is mainly focusing on medical device manufacturing, CDMOs are more like strategic partners with expertise in medical device design and development and market areas
that medical device OEMs are now actively seeking.
2. If you look out for the medical device outsourcing history, it's easy to find out that OEMs have changed their strategies from "only outsourcing partial processes" to "seeking a reliable partnership with CDMOs that have capabilities and resources needed for their products."
3. CDMOs like COFORCE Medical can provide OEM clients with targeted solutions vary from the proof of concept, design & development, to the final mass production. Facing the limited access to needed resources and inevitably increasing capital investments in in-house R&D, OEMs are eager to partner with the "right" outsourcing provider throughout their product life cycle.
The need for a CDMO in the current medical device market scenario
The role of CDMOs has continued to grow strong based on their cost-effectiveness - they provide values that cannot be directly matched by any other players like traditional CMOs. As medical device OEMs strive to bridge competency gaps and innovate products, CDMOs offer a comprehensive perspective on product development and manufacturing. In addition, their mastery of processing techniques and novel materials allows OEMs to bring down costs without compromising their high-quality standards.
Medical device OEMs’ biggest challenge is “Uncertainty”. From COVID-19 pandemic to the Russia-Ukraine war, med-tech companies are struggling with supply chain disruption and stock shortage. Unlike other electronics manufacturers, the tricky part for medical device is that
If a component is in shortage, you cannot simply replace it with something similar without the regulatory board’s approval.
Being Asia’s pioneer CDMO and a few targeting complex active implants, COFORCE Medical has the expertise and infrastructure to support a wide range of medical device launches, cradling from early development throughout the journey to commercialization. We also have the ability to provide a high level of technical service via our integrated med-tech supply chain in Taiwan to ensure your product compliance with regulatory requirements.
* Scale your medical device production cost-effectively
Medical product development is becoming increasingly complex and expensive, which lays tremendous weights on OEMs while finding ways to scale their production cost-effectively. By partnering with COFORCE Medical, you can access our large pool of high-quality techniques and components supplied from Taiwan to fulfill your device needs. COFORCE Medical can help you fast track R&D activities of your medical device; our effective and affordable solutions will be your solid support. Furthermore,
Your precious time and resources are spared to be invested in your business model or clinical trial preparation.
* Speed up time to market for your medical devices
Medical products, especially FDA Class III devices, are often designed more complex than others; and on top of that, they require careful risk assessment for approval. Our reliable outsourcing service will help to reduce development time, minimize potential risks and move your product to market faster – key factors in winning over authorities, wary patients or insurers. Quality is of utmost importance. COFORCE Medical's pre-clinical verification and validation program guarantees that your medical product meets strict standards such as ISO 13485 before going into production. The right CDMO for OEMs should have a strong team like ours, consists of experts, engineers, RA/QA specialists and project managers, who collectively can help you avoid detours and accelerate your time to market.
* Benefit from the expertise and resources of external professionals
Medical device industry has its unique challenges, including technical, regulatory and more. Having a reliable CDMO on your side is incredibly beneficial, particularly when many companies in the med-tech sector are suffering from talent shortage. COFORCE Medical’s med-tech experts are here to help you take advantage in the market to achieve a competitive edge. They are dedicated into making things easier for you to bridge potential competency gaps effortlessly -
Expensive in-house R&D and the challenge in acquiring talents will no longer be your concern.
We can provide insights from design & development to manufacturing, which could lead your products to success. Our objective is to bring your med-tech innovation to life.
Q1. What to look for in choosing an outsourcing partner?
When you are choosing a CDMO partner for your medical device, the fundamental key is to make sure that the CDMO services include all the capabilities and resources that align with your needs. It is also important to ask about their access to resources, their team members' experience with the general medical device industry, and their expertise in the market segment that your company operates in.
Q2. How can the right CDMO help you deal with the supply chain shortage?
Medical device OEMs should consider partnering with a CDMO that has expertise in their product fields and can provide aligned technical capabilities. COFORCE Medical is one such CDMO that is committed to providing tailored, full-service solutions to our clients under any circumstances.
Q3. Who is COFORCE Medical?
Together, we are your collective force.
COFORCE Medical Inc. is your right fit outsourcing partner providing innovation with existing product expertise in implantable bioelectronics. Being Asia’s leading medical device outsourcer, we bring all the components & services you need under one umbrella, offering fast access for you to Asian technology centerpieces.
Q4. What kind of services can COFORCE Medical provide?
Whether you are a cutting-edge start-up, medical scientist, or leading industry manufacturer. COFORCE Medical offers End-to-End Outsourcing Solutions catering to your needs at every step of your medical device journey include but not limited to
Partner with us, COFORCE Medical will be your collective force. Backed up by a self-integrated supply chain in Taiwan, we can together lead your product to success. Contact us today to know more about our services and every possibility for your medical device.
COFORCE Medical Inc.
Address 31F,-11,No. 99,Sec. 1,Xintai 5th Rd., Xizhi Dist., New Taipei City,
Taiwan 221416
Tel. +886 (2) 2697-1065 ext:132
E-mail [email protected]
Website https://www.coforcemed.com/
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