Hi ks629, I think you make a valid point but I see why using a different coating from the same supplier may be beneficial. Since the contract is already signed with that specific supplier, it's easier to change product selection within the company itself rather than seeking a new supplier. Now, it depends on why the primary source failed to be delivered on time. If the reason is something that has affected the entire supplier facility, such as an earthquake, it does not make sense to use a different coating from the same company. If the reason is just that a sub-supplier hasn't delivered their part on time or in good condition, then it makes sense to use a different coating from the same supplier that is readily available for procurement. It may be worth having a totally different backup supplier, even though it's more paperwork, in the case that the first supplier cannot meet requirements sufficiently.

I think that a good strategy could be to select a different coating from the same supplier as a short term solution to reduce sourcing risk while keeping the project on track and not causing any delays to the project by having to go through the process of selecting and qualifying a brand new supplier, and then plan on doing this work in the future as a follow up task to reduce the sourcing risk even more.

I guess my question to you all is how would selecting a different coating from the same supplier reduce sourcing risk? What is the major sourcing risk that is being reduced? Would it be acceptable if (in this case) Conmedics had a second qualified manufacturing site for HydroSurf? I see how it is easier than choosing a different supplier, but if it doesn't meet the goal of reducing the sourcing risk (inability to procure that component) what is the point?

I agree with srg36 only if the selection of a new supplier would hinder the progress of a project or manufacturing of devices. But I also agree with ks629 that sticking with the same supplier does not solve the issue. I believe this comes down to the amount of risk the team leader is willing to endure this decision because this does not meet the requirement...

In my opinion using the same supplier for two different products doesn’t fully satisfy the dual source requirement. While yes it does provide an alternative product in case the primary one isn't available for whatever reason, but the problem for me is that it isn't from a different supplier. There could be situations where the supplier is closed or has shut down, so your primary and secondary sources are both unavailable. If it were a different company then regardless of what is going with Company 1, Company 2 should be available. Using a secondary company does entail having them qualified for use with whatever process the company uses, such as signing a NDA or what not, but it should ensure a reliable second source.

In my opinion I believe that another coating from the same supplier does not satisfy the dual source requirement. From our second simulation we saw that companies will produce different results based on their testing and production methods. If you take another coating from the same supplier they can produce that coating the same way they did their first one but with minor changes to the components added. If there is a problem with the first coating there will be a greater chance there is a problem with the second coating because they are produced with the same methods. A second supplier though can verify that even with different production methods that results and product will be the same. A second supplier will mitigate and reduce risks but it may also incur more cost and time in finding this second supplier.

Agreed, I do not see much value from selecting an alternate source from the same company. I also do not see as much value in selecting a second source all the time for critical components. Other measures can also be looked into such as ensuring there is sufficient safety stock of a same component within your own inventory. Typically what I have seen is that companies will place large rounds of POs ahead of time to ensure there is backup product in case a supplier is not able to deliver at the time an order is placed with them due to severe circumstances. Qualifying a separate overall supplier that can manufacture almost exactly to spec of what you wanted in the beginning is a more efficient alternate method to ensure you will always have a reliable source of product rather than procuring another similar product from the same company.

According to different simulations we have done till now I have learned that its all about the working and proportion of the chemicals used to make a solution or coating. If the chemicals used in coating works as they are supposed to it doesn't if it is a different or same source. Since it does its work from all the reagents used to make the coating the issue of the toxicity or its structure that is important. This can be controlled by varying the concentrations of the reagents used or simply replacing it by same working, different properties defining chemical.

This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and then you need to assess the risk regarding the changes you've made. If you really thought about the risk involved in having a critical component and its back up sourced by the same supplier then you may start to think of all the things that can go wrong at the facility like smk45 mentioned, natural disasters and sub-supplier failures. You would have to base your management of these risks on their severity and frequency. Earthquakes, fires, tornados, and catastrophic disasters in general are very rare in occurrence but high in severity while sub-supplier failures are minor in severity and infrequent in occurrence. Just as Davos Neuro had to select at least two sources for a critical component based on their quality program, the supplier (if they are intelligently managing quality and risk) would ideally have alternative sourcing for their critical components, and noncritical components can be readily sourced. Thinking this way further reduces the risk in selecting a single supplier to source your critical component and its back up.

Unless I'm missing something here, according to the MiniSim, the AquaWhoa coating IS from another supplier: HyrdoSurf from Conmodic, AquaWhoa from AND. I agree here with the point made that much of the purpose of getting another supplier is to allow for redundancy in case of some incident, and that getting a secondary supply from the same company kind of defeats the purpose. Having a secondary supplier can also be done to alleviate fluctaions in demand by companies to suppliers (a products takes off and all of a sudden a supplier needs to supply 1000000 pieces of a component). That being said, having a redundant supply can actually hurt rather than help if not implemented properly. In a project that I am on, we are evaluating our products with regards to new requirements from the FDA about biocompatibility. One product in particular has a component that is sourced from two different places. This has lead to headaches as one of the suppliers creates and maintains the supplied component at a somewhat, biocompatible process/level, while the other one does not at all, which causes the whole product to be out of compliance. It would be much easier to work with one supplier to bring the product into spec, but having two creates even more work to be done.

I agree with ajm73. In the current mini-sim, the two products are made from 2 separate companies. There could be a point of view that favors having 2 sources from the same company, however. You would already know the work ethic and reliability of the company in question. If you already know the quality of work the company provides, it makes people less adverse to choosing the company. Also, when using a single company for multiple products, you tend to get deals on the pricing of the products. Finally, the products can be made in different facilities in case an environmental anomaly causes one of the facilities to no longer be able to produce a component.

I don’t think that using the same supplier but a different coating would satisfy the dual source requirement. Using a different coating might not be as useful and productive because each coating has a different set of properties. These properties dictate the behavior of the coating over time. They might last a different amount of years, be used for different types of devices, or simply are affected by different external factors. For example, a coating for a catheter definitely has different properties from a coating of a medical scissor. I believe that in order for the dual source requirement to be satisfied, the coating must be very similar to the one that was agreed upon. If the original company doesn’t have one that is similar, then the requirement can’t be satisfied.

If a second source is needed and does not meet the exact requirements of the product, an option is to revert back and modify the product requirements/specs so that the component from both sources meet the requirements. This of course requires more research from PD and must be justified/accepted by the stakeholders.

I completely agree with your point that using a supplier as a backup to itself doesn't make much sense. The point of having a dual source is to ensure complete independence assuming there are any problems with one of them. There a multitude of events which can occur that would mean suppliers can't fulfill their contracts. This includes natural disaster, work strikes, machinery fires, lack of resources and many others. This would lead to all product lines being affected in some way. This is why you must have entirely different vendors which can supply nearly the same exact product. They should be 100% interchangeable, different only in maybe price.