While we can assist customers at all steps of the product development and commercialization path, it is at the Concept/Consultation stage—the first stage of our Continuous Partner Involvement (CPI) process—that we provide the highest level of product differentiation and overall value. This is the idea stage where an OEM, an established third-party contract manufacturer or design house, or a start-up producer presents us with a new product concept. As part of this initial dialogue, we offer clients with non-disclosure agreements to protect any trade secrets or other confidential and proprietary information on their end so that they are comfortable providing us with the full disclosure and transparency we require to thoroughly understand their goals and assess the feasibility of their concept. More specifically, while we do not need to be privy to every technical detail of a more extensive system for which we are designing/manufacturing a specific component. All parties involved benefit when we have the most comprehensive understanding of said component’s function and any considerations regarding the potential mechanical, chemical, and electrical effects of that piece on other components within the more extensive system.
Full disclosure and transparency on the part of the client combined with our industry-leading expertise in medical product development, electronics, automotive, and other markets allow us to assess the project in terms of our ability to meet the customer’s needs. In this way, we can identify and address early on any potential design, regulatory, or production scale/pricing issues that might arise further down the project pipeline.
For example, at the inception of a project that finished product or component, such as a microfluidic cartridge, contains a passive component (in this case, a microfluidic chip), we can then select an appropriately passive adhesive to bond that component, thereby precluding the occurrence of outgassing or some other adverse chemical action or reaction that would have otherwise damaged the chip or compromised the integrity of fluid samples transported, mixed, separated, or otherwise processed in the device.
On the regulatory side, client disclosure and transparency at the onset of a project allow us to plan for any FDA compliance issues and related processes involved in bringing a product to market. For example, medical product design often consists of the use of FDA-monographed active ingredients.
For an optimal assessment of a client’s proof of concept, we also ask them questions regarding scale and costing expectations. What is the cost expectation target of the finished product be when it reaches the marketplace? What is a conservative estimation of the demand the finished product might see in its first year of commercial-level production? What would a more speculative and optimistic yet still plausible projection of first-year sales look like? These types of questions help us, and our customers determine the economic feasibility of product realization while keeping everyone’s expectations sensible, thereby opening the way for a dialogue concerning modification of the project’s goals and parameters if necessary.
After considering design, regulatory, production scale/pricing, materials, and downstream/finished product performance, we can determine if M&C Specialties’ engineering, rapid prototyping, manufacturing/converting, procurement, and logistical capabilities are a good fit for your project. From there, we take all the information gathered thus far and begin to produce initial sketches and mock-up samples for you to inspect before entering the formal Materials/Lab Testing and Design Explorations stages of the CPI process.