The El Paso region has a history of excellence and expertise in manufacturing thanks to its binational location and partnership with Ciudad Juarez. While the region is a nexus for advanced manufacturing and a diversified manufacturing economy, it still lacks critical resources for product development and translational pathways. Medical products are highly regulated, have long development timelines, and require access to special skills, facilities, and equipment.
The MCA Innovation Center is lowering barriers for anyone within the ecosystem, from entrepreneurs, startups, and investors to manufacturers and suppliers, to collaborate and bring new and improved medical products to market. By investing in our region’s product development pipelines, the MCA hopes to keep manufacturing local and bring more critical supply chain elements closer to the product development lifecycle.
There are several product development models to choose from. However, the lifecycle from start to finish can be generalized in the following stages:
Stage 1: Ideation – the initial stage is focused on idea generation and answering early questions such as, What pain points does my product solve? Who are my customers?
Stage 2: Research –The idea or product must be validated through customer research and customer discovery.
Stage 3: Conceptualization– This includes estimating the project costs, human capital requirements, marketing plan, legal requirements, and overall business strategy. The information gathered at this can be used to create a pitch to stakeholders.
Stage 4: Prototyping – A physical representation of your product will be created such as a prototype (low or high fidelity) or a small volume manufacturing run. The time and scope of this stage can vary based on the product requirements and testing results.
Stage 5: Product rollout – Last is the launch of your minimum viable product (MVP), this is the culmination of all the previous research and prototypes. The MVP will have the minimum set of features that can be released to the market. New features or product iterations can be systematically rolled out to improve and fine-tune your product.
The types of certifications required will vary by product. For example, in the highly regulated medical device market, you will require several certifications and approvals for the product itself and the manufacturing process. This can include FDA approval of the device and a manufacturer that has obtained ISO 13485 certification. However, there are other types of certifications for other industries such as aerospace. Which has an AS9100 manufacturing certification and parts used on planes must be approved by the FAA.
Before getting your product certified it must be designed for manufacturing. This is critical when starting to engage with potential manufacturers. If your product is designed well and manufacturable, it will save time and money when working with your manufacturing partner(s).
Entrepreneurs and startups will introduce new, innovative products into the manufacturing ecosystem. Although investing time and resources into working with a startup can be risky, they can run out of funding, or their product fails. Success can lead to new capabilities the manufacturer can offer to new or existing clients.
Linking home-grown ideas to local manufacturers benefits the local community and industry by sustaining our local supply chain. A local supply chain will increase regional productivity and save money by eliminating the time and cost associated with shipping. Moreover, demonstrating a complete supply chain will attract other businesses to the region to take part in a growing local manufacturing cluster.
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2024 Medical Center of the Americas Foundation – Cardwell
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