What is a Medical Device Consultancy?
A Medical Device Consultancy is an organization with professionals having relevant experience in the domain to accelerate the development & manufacturing of Medical Devices. A professional working in a Medical Device Consultancy is an expert in technology, science, or evolving regulatory landscape of the country or world. The key responsibilities of Medical Device Consultancy are to connect big MedTech Companies with relevant certified professionals for manufacturing, regulation, designing, and more.
Medical Device Consultancies miss out on several aspects while evaluating a Medical Device Contract Manufacturer. Some key factors that need careful evaluation while picking up a Medical Device Contract Manufacturer are:
1.) Does the CMO (Contract Manufacturer) hold expertise for your project?
Compromising quality over cost is neither recommended nor beneficial. Explore the technical expertise that a project requires. Make sure the contract manufacturer has worked on similar projects in the domain. For instance, you have a client with an AI device for blood sample analysis ready for Go-To-Market. In such cases, while signing up with a CMO, it’s important that the manufacturer has worked on AI technology beforehand. This will help in getting a better Design for Manufacturing and the client can utilize their (CMOs) expertise to upgrade or improve device based on market feedback.
2.) Is CMO ready to assist you in ensuring market stability of your device?
Post Market launch the device is bound to experience certain feedback. A dependable Contract Manufacturer will help you in modifying the device as per the market feedback. Sustainable engineering services are necessary to make the product/device thrive in the market. In current industry dynamics, merely, Assembly and Scaling do not cover the scope of the Contract Manufacturer’s work. It’s expected that the contract manufacturer assists your client with post-market design enhancements. These changes make product a better market fit.
For instance, your client has a device for Wound Healing mainly for clinical use. Post-market release it receives numerous feedback in terms of usage and handling. It’s convenient and cost-efficient for your client if the Contract Manufacturer assists them with enhancements. This helps in attaining product/device stability faster.
3.) Does the CMO have Procurement Intelligence & Supply Chain Management skills?
Medical Device Supply Chain Networks, Procurement Planning & ERPs (SAP) are other important factors to evaluate. The contract manufacturer must have a strong network of vendors/suppliers to ensure deliveries even during uncertain times. A strong supply chain planning assures that your client will always have products for Go-To-Market, even when there are scarcities & massive fluctuations in the industry.
In times of COVID-19 supply chain disruptions many Medical Device Manufacturers faced immense difficulties in meeting the deadlines and coping with fluctuating market demand. Manufacturers with procurement intelligence and proper planning were ahead of others in meeting the growing demand of diversity of Medical Devices.
4.) What constitutes the BOM (Bill of Material) costing?
Pricing model is another important factor to evaluate. Eventually, your client is outsourcing manufacturing to reduce cost for Go-To-Market of the device. Make sure the processes involved, human resource, capabilities involved and everything is taken into account. The CMO must clearly state the resources utilized so that your client doesn’t have to pay overhead costs or experience any unnecessary delays.
5.) How robust is the Quality Management System?
The Quality Management System of contract manufacturer is the most important aspect to evaluate. Medical Devices as we know is a highly regulated segment. It’s crucial to evaluate quality management system to ensure that your medical devices are manufactured in compliance with Global regulatory norms. It’s also mandated that the Contract Manufacturer provides you relevant documentation (DHR, DMR and DHF) assistance for easier penetration into targeted geographies.
6.) What kind of client portfolio CMO caters to?
Visit the facility in person and evaluate capabilities of the manufacturer. Also, catch a glimpse of projects on which Medical Device contract manufacturing organization is working. Try connecting with some of their past clientele to get a reference about their services and timelines.
7.) What’s the level of transparency between CMO & OEM?
It’s necessary to evaluate accountability & communication transparency of the Contract Manufacturer. A certified Contract Manufacturer must communicate all the changes and modifications to the OEM on the first hand. Non-transparency or miscommunication can lead to overhead costs, controversies and delays.
Medical Device Consultancies are the bridge between Medical Device Contract Manufacturers & Medical Device Developers. Missing evaluation of even one of the factors can lead to overhead costs and excessive long timelines for Medical Device Developers.
Schedule a call with Johari Digital Healthcare to explore our globally approved & certified manufacturing services. With our Full Turn Key Manufacturing Services we’ve commercialized more than 145+ Medical Devices in diverse segments of Medical Devices.