Don’t Let Your Supplier Write Your Material Specification

This seems obvious, doesn’t it?  After all, it's your specification so why would you let another interested party define something so critical to you and your organization. But you would be amazed to see how much it happens. At Boyd Biomedical our material sourcing team is often consulted by Procurement Managers, Engineers, and R&D heads that have found themselves painted into a corner without an alternate source or duplicity in their supply chain. And if you're reading this, then you know – it’s a big problem.   

Dual sourcing and the ability to innovate are dependent on material specifications that can be replicated or complemented with improvements that are built upon the baseline of a material specification. So how do you guarantee material performance, value, and stability without trapping your business in a supplier snag?

We know from our experience at Boyd Biomedical that the bill of materials for a product is typically derived from a long and iterative R&D process. That process eventually settles into a commercialized specification that has involved many trials and third party contributions. Within the advanced flexible materials market, we see new or improved processes being established at the same time as new or improved materials are. This happens with new product development as well as next generation revisions for existing products.

In the midst of the development work described here, we often find specifications get scribed from a limited selection of raw materials and suppliers - which are frequently already known by the product development team. The unfortunate consequence of this is that product specifications become trapped by the limits of these material specifications, or even worse they rely on a supplier's proprietary manufacturing technologies without even realizing it. Application engineer’s effectively allow their vendors to write their material specifications! What's worse, is that in most cases it isn't until a dual source is needed or a second generation product is developed that companies realize the predicament they are in. Some suppliers will even work hard to convince you to follow the characteristics of their materials – so as to assure their indispensability. Below are 5 tips for writing your own material specification and avoiding this trap. 

Form

Describe the format, size and tolerances required. Do you need a small roll of nonwoven, or a foam composite with both film and flexible foam, or an adhesive film? Are there any specific packaging or labeling requirements? Describe the physical attributes and color of the material. Is it soft and skin-toned or firm and crisp white? Does it have a smooth polished surface or is it a porous material? If you know what pore size or degree of calendaring is needed this is the place to quantify it.

Function

This one is obviously critical for so many reasons. What is the material purpose? The specification should be qualitative and measurable at the same time. Does it provide a barrier to moisture or provide fluid management or is the purpose to absorb and insulate other elements within the products overall? Is it a disposable medical device or an over-the-counter product? Describing how the material works and what failures arise when it’s out of spec or not present are important to understand and ensure that suppliers meet your needs. 

Composition

What type of polymer, fiber, or resin is required? How critical is the raw material formulation to the overall product? Sometimes, the monomers, additives, stabilizers, and catalysts used to manufacture polyolefin polymers, engineered resins, and fluorocarbons, are changed slightly within the tertiary supply chain. If the advanced flexible materials you are specifying require no variability and are regulated for trace migration limits, then formulation changes are a priority and should be noted. You need to define this level of detail and feel certain your supply chain can live up to it. At the same time – if you don’t require such control and are able to permit a wider range of furnishings without sacrificing the other conditions of your material specification - do so. There is enormous value in allowing range in your material specification when you can.

Compatibility

Advanced flexible materials used in medical device manufacturing and biotech manufacturing have a strict set of biocompatibility requirements and/or failure modes. When you are writing your own specification you should address how the product needs to react with other organic and inorganic materials. Things to think about could be related to material contact with skin or other living tissue, sterilization type or the possibility of contaminants and adverse reactions to bacteria, mold, chlorides, and/or trace metals.

Outstanding Characteristics

Companies describe their products with differentiation and unique characteristics all the time. So unless you’re making a me-too product you need to identify the raw material characteristics that are outstanding too. Many times we see a need to examine multiple steps in this category. Some items need to be cured while others carry specific life cycle phases or shelf-life expectancy. Find a measure of time or describe the process in which the specified material is required to hold its target criteria. This can relate to adhesion level and peel strength, color safety, fiber stability or packaging seals. Sometimes we see a material that blisters after being processed with another component and cured. Other times we see dielectrics that lose strength and integrity or a wound care dressing that dries out and declines in material efficacy. In advanced flexible materials markets, these are important characteristics to describe and target as attributes that are requirements of your material specification. 

Conclusion

It's your specification so make sure you write it. Material characteristics are usually dependent variables of one another but there is an unseen, independent variable that is a proprietary factor in the majority of advanced flexible materials - it's the process. Manufacturing technologies vary and just because one supplier's material is thick and uniform or thin and open doesn't mean that any other company's will be too. 

These are common issues we see which are worth considering when you sit down to write a material specification. Consider what your business needs from its supply chain and what you've determined the product requires from the materials specified in the BOM. These five categories can help to organize your thoughts. 

• Form 
• Function
• Composition
• Compatibility 
• Outstanding Characteristics