We’ve talked before about the benefits of contract manufacturing and some important things to think about before you venture into the CM world. Here are a few more tips to help you decide which contract manufacturer will be the best fit for your needs.
Here at SafePath®, when we get an inquiry from a potential CM client about ourservices, we start by asking them a few standard questions. This helps us get a sense of the scope of their project and a sense of their business.
First, the basics. What kind of product are you looking to manufacture? What technology is the product based on? Who owns the intellectual property rights to the product and the associated technologies, and from where do you source your raw materials?
Then we get into regulations. What do you intend your product to be used for, and where do you intend to sell it? Which government agency (or agencies) regulates your product?
Next, we talk numbers. How much of the product do you need, and what is your ramp-up period for production? We fully understand that forecasts are not set in stone, but it’s important for us to get a sense of your predicted volumes.
Finally, we talk about what exactly you need from your CM. Is your product fully developed, or will you need help running studies or making adjustments to the product? Where are you on your regulatory path, and will you need help navigating the regulatory and licensing process?
Contract manufacturing is a relationship, and like any relationship, sometimes two parties will just not be the right fit. We believe that any good contract manufacturer should be open and transparent about this so that both parties can decide whether the relationship would be mutually beneficial. Here are a few “red flags” to look for when talking to a potential contract manufacturer. While these aren’t necessarily deal-breakers, you should consider them before signing a contract with a CM.
- Your areas of expertise don’t overlap. If a CM has no experiencing making your type of product, it could be risky to do business with them, at least for that particular project. This is especially true if you don’t have a final, well-defined design for your product because they may not have the necessary expertise to help you finish it.
- They don’t have the right regulatory licenses and certifications that your product needs. This is particularly crucial for medical device manufacturing and medical diagnostic test manufacturing. For example, SafePath® is a USDA Licensed Biologics Manufacturer, while our sister company, IVD Research, is FDA registered, follows cGMP (current Good Manufacturing Practices) guidelines, and is ISO 13485 certified.
- Your predicted production volumes don’t match up to the CM’s capabilities or business model. Your expected volumes might be higher than what a CM can realistically handle; this will often be the case with smaller CM firms. Alternatively, your volumes might be too low for a larger firm to want to bother taking on; in addition, using a larger firm to produce a small batch could result in your product getting lost in the shuffle and turn you into a small fish in a big pond. Make sure that the CM you work with can handle your production volume efficiently while giving your product the time and attention it deserves.
- The CM is great – but their location isn’t. Some companies may want to work with a local CM to ensure a more personalized relationship. Others may prefer a CM that is located in some other strategic region; for example, close to their target customer base so that finished products can be more easily shipped out. Sometimes it can even come down to the simple issue of time zones – you may not want to have to get up early or stay in the office late to have a conference call with a company three time zones away.
- The CM doesn’t have a strong quality system already in place. You need to make sure that any CM you work with has a proven, reliable quality system. The two big things to look for in a quality system are traceability and a strong advisory notice and change notice system. These will help ensure that your CM can efficiently and accurately track all raw materials, sub-assemblies, and finished goods. Their quality system should also include a way to provide you with regular reports so you remain fully up-to-date on the status of your project. SafePath® and IVD Research both follow ISO 13485 quality system guidelines (IVD is ISO 13485certified).
- Your vision and/or business models are too different. Here at SafePath®, we think of our contract manufacturing clients as partners. We want to build a personal relationship to create innovative products WITH you, not just FOR you. These personal relationships are where we really excel. This kind of partnership may be just what you’re looking for in a CM! On the other hand, you may not be looking for this type of partnership – and that’s fine, too. Plenty of CM firms want to maintain the traditional client-manufacturer relationship. It all depends on what you are looking for and what model best fits your company’s, and your product’s, needs.
Entering into a contract manufacturing relationship can give your business a big boost. But just like with any business decision, a lot of factors go into a successful CM relationship. Use these tips to guide your CM search, and you’ll be more likely to find a firm you can work with for a long time to come!