Selecting a Medical Device Supplier
Competition in the MedTech world is increasing every day, and in order to survive in this competitive industry, you need to rely on various service providers. When making a selection, the professionalism of service providers is a top priority for all organisations. As a medical device manufacturer, you must maintain a good relationship with your suppliers, as they are key for initiating your supply chain.
How do you select a supplier for Medical Companies?
- Step 1 – Creating a Statement of Work
A statement of work helps you to clarify and list your requirements. A robust supply chain channel starts with understanding the requirements of products/services. A well-crafted statement of work will help you to formalise your specifications and identify the expected level of quality. As an organisation, you need to involve your purchase department as they will help you to set benchmarks.
- Step 2 – Identify and Sort suppliers
Once you’ve defined your specific needs, identify who an ideal supplier would be. You select this based on a company’s capacities, service region, cost, legal status, customer portfolio etc. This process will help you to identify your needs and sort out the suppliers who don’t meet the criteria.
- Step 3 – Final Evaluation
Since you know who your ideal suppliers are, perform a precise evaluation based on the capacities of each service provider. Companies sometimes make a mistake by selecting the wrong service provider and losing out on market opportunities. Set up enhanced criteria and run the evaluation process.
Possible categories can include – different types of certificates obtained, reputation in the sector, regulatory conditions etc. Our experts believe that it is a question of identifying everything that could be problematic during a first-order to ensure that there are no unpleasant surprises. If your products are more specific, do not hesitate to use more demanding criteria in connection with the specified activity.
A process audit completed with a sample taking will allow you to see more clearly and finalise your choices. If you encounter issues when carrying out the audit, do not hesitate to implement stricter incoming controls.
Once you get your ideal supplier, arrange legal agreements and run down the selection process where you finally make a decision. Ensure a robust Supplier Quality Agreement (SQA) is agreed upon and in place, which clearly defines the expected deliverables and KPIs with respect to product quality.
After selecting the supplier, you should monitor their actions. Check if all the KPIs are met, and if there are any issues, you should raise non-conformance concern and rectify it with your supplier.
How to ‘manage’ your supplier?
Your suppliers can be monitored using various tools such as dashboards of indicators or process audits. Of course, it is not a case of monitoring ALL your suppliers, but as a minimum, you should monitor those who are “critical” to your business and to your supply chain i.e. those who could substantially impact the quality of the product.
- Indicators:
When we talk about indicators, we are referring to quality, deadlines, complaint management, returns management etc... These indicators need to be established by the service-receiving companies. There is no fixed formula for determining the indicators to help you monitor your suppliers. Indicators can change depending on the need and therefore, you may need to establish a new set of ratings. A lean approach will help you to stay dynamic and ahead of your competition.
- Audits:
Audits help you to check how the suppliers are fulfilling your requirements. You can use certain ISO standards to carry out strict audits in a structured format. Since the audit is used to check the entire production process, it starts from raw materials to delivery. Do keep a close eye on your suppliers’ ability to initiate or comply with the improvement process.
With advancing times, new digital tools have been created by different companies. This helps you to create a database of all your suppliers and keep track of their performance. As a manufacturer, it is your responsibility to ensure that all production elements are apt and comply with regulatory requirements. A thorough check with the suppliers will help you ensure that your product is being appropriately manufactured and delivered, meeting all regulatory requirements.
If you need any assistance with medical device regulatory affairs, then please feel free to connect with us
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Email us: mdd@mddltd.com
Med-Di-Dia strives to ensure that manufacturers overcome all challenges to their innovations, especially when we are your regulatory partners for devices, diagnostics and digital health.
