Updated: Sep 6
Are you a medical device manufacturer and source components for manufacturing your products abroad?
Then you already know about the risks of international procurement – from compliance with regulatory requirements, quality problems, exchange rate fluctuations, higher transport risks and delivery times to language barriers and cultural differences.
Since supplier management requires a lot of work, outsourcing some tasks to specialists can make sense, especially for SMEs with limited resources.
In addition to the generally known procurement risks, in MedTech, we also must ensure that suppliers have a well-functioning Quality Management System (QMS) and ideally comply with the specifications of ISO 13485 and the requirements of MDR 2017/745.
Especially when working with new suppliers, their QMS should be verified through a supplier audit.
Because unfortunately, some suppliers turn out to be charlatans who have acquired their ISO certificate on the black market (yes, this does happen) and, in practice, do not have anything like a good QMS.
For medical device manufacturers with limited resources, supplier selection, audits or supplier development represent significant efforts.
Outsourcing these tasks to external partners can reduce the workload enormously and increase efficiency.
Outsourcing Your Supplier Management in MedTech – Your New Competitive Advantage?
You are a buyer and now you think: "That's my job, we don't outsource it!".
Don't worry – when we talk about outsourcing, we're not talking about dissolving the entire purchasing department, just taking the pressure off it.
When working with a trading partner like SIFo, you benefit from a well-developed network of qualified suppliers and favorable conditions – even as a small company that cannot (yet) call off large quantities.
Here are the Top 7 benefits of working with a trading partner in your Supplier Management in MedTech:
1. Your risk is minimized in many ways.
Trading partners who have established relationships with suppliers have usually already conducted audits themselves and know the capabilities and weaknesses of the suppliers. As a result, you mitigate the risk of working with a supplier who may not be able to meet your requirements.
2. You can devote yourself entirely to your core competencies.
Trading partners can handle audits and other aspects of the supply chain for you, allowing you to focus on your core competencies – the design and production of innovative medical devices.
3. You comply with all mandatory regulations.
A vital issue in MedTech. MDR 2017/745 requires not only documents from you but also from your suppliers. That is why a supplier audit is essential – it ensures that practical workflows function correctly and all necessary documents are in place. If you do not have the capacity to do these audits on your own, hiring an external quality expert who is experienced and has the necessary knowledge certainly makes sense.
*PS: For those who conduct audits and want to be sure to comply with all MDR requirements, here is our 10-point checklist for supplier compliance according to MDR 2017/745.
4. You gain access to a broader range of suppliers and products.
External partners with a wide range of suppliers will find it easier to quickly identify the right supplier for you. You may gain access to products that are difficult to source directly.
5. You can better respond to fluctuations in demand.
By sourcing products from multiple suppliers, trading partners can help you respond quickly to changes in demand or shifts in the market. Relying on only one supplier or geographic region can be risky. Having multiple suppliers for a material gives you more flexibility in case your demand suddenly increases or a supplier can't deliver the quantity you need.
6. You benefit from the knowledge of experts and thus gain efficiency.
Consultants specializing in MedTech who have the necessary knowledge and experience in procurement and regulatory requirement can support you, as a manufacturer, make more informed decisions and ensure a smooth supply chain.
7. You save costs due to established business relationships.
Trading partners can often negotiate better prices and conditions with suppliers than a single manufacturer. In our case, some of our customers have saved up to 70% of costs by using our network.
Conclusion: Supplier Management in MedTech
Our experience shows that outsourcing supplier selection, audits, or further supplier development have been associated with increased efficiency and long-term cost savings for our previous clients.
Your purchasing and quality department will be significantly relieved, and you will benefit from existing structures and resources.
Convince yourself and let us find out in a personal conversation which advantages arise for your situation. Contact us at firstname.lastname@example.org.
PS: If you want to learn more about Quality- and Supplier Management in MedTech, check out our free learning resources at our SIFo Medical YouTube channel.