Every product development process in the medical device industry is unique due to factors such as function, use, performance, and cost objectives. In some cases devices function stand-alone, while others are complementary to the primary device, impacting the way the development process unfolds. Broadly speaking, devices may be generally categorized as reusable or single-use. When it comes to the process and economics of development, there are pros and cons to each type. One of the primary challenges to developing single-use devices is meeting pricing targets, as material and labor costs must be minimized in the final product. Costs and margins need to be continuously evaluated and remain at the forefront of the developer’s mind.
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With single-use disposable devices, it is critical to meet pricing targets. Disposable products are attractive to medical professionals for a variety of reasons, but they understand they are paying for a single-use and are not willing to exceed a certain price point. This sets a viable cost ceiling to products which compresses margins, adding complexity to the development process. In order to combat this challenge, a successful product development partner will minimize the materials and labor required to manufacture a product, limit disposable elements of a product, and provide a cost optimized design. The design team must consider these factors early in the development process in order to achieve the client’s targeted acquisition price.
Maintaining Low Material Costs
Three primary cost factors have to be considered when designing optical devices for manufacturing: material, labor, and margin (including yield). With disposable products in particular, the materials should be limited to keep costs low. Material costs can also be managed through procurement strategies, such as annual buying options and blanket purchasing. This is why it is important to project quantities for years two, three, and four in order to properly account for economies of scale. Early on the costs will generally be higher with low volumes and standard labor costs, but are expected to be reduced as time goes on.
The Need for Skilled Labor AND Automation
Labor is often the most costly element of production and therefore needs to be closely analyzed when working to achieve the low price points required for disposable products. It is key to develop an early manufacturing strategy and mitigate the amount of labor applied to a product. While complete automation can greatly reduce labor cost, it often requires a very large initial investment (dependent on the complexity of the product). For this reason, it is usually not part of the initial process, but should be considered for future implementation. Utilizing a qualified skilled workforce is an essential part of the product launch process. A platform needs to be built upon year after year. Year one could be highly labor intensive, but year five could consist of complete automation, which needs to be planned for in the early stages of a development program.
The Lighthouse Advantage
Lighthouse Imaging has an extensive training program. The assembly processes are extremely precise, requiring strong manual dexterity and specialty skills. They invest time in training their associates and continuously evaluate their skillsets to ensure quality manufacturing for their partners. The Lighthouse process includes several steps that result in a clean price point. The phases include design verification, specification confirmation, and then product validation. At the end Lighthouse clearly understands the pricing and is engaging in manufacturing contracts while ensuring their client’s comfort with the plan.
Lighthouse sets themselves apart with their all-encompassing view of the process. From day one, they are designing a product for manufacturing. They are very experienced on the manufacturing side, spending time on the floor so they can produce a solid product and meet cost targets. Lighthouse sees the process from conception to manufacturing and beyond. With their partners, they work diligently to generate revenue from manufacturing and sales. They consider every angle as they drive through the design process and deliver products at the speed of light.
Lighthouse Imaging is a holistic, systems focused organization with expertise in visual imaging and medical optical devices. Understanding a system as a whole allows them to design and manufacture products with superior performance, quality, and value. Through this fundamental approach, and combining Product Development with Contract Manufacturing under one roof, they can deliver products at the Speed of Lighthouse.
The key to a successful long-term partnership with a client is based on four critical elements: technology, timeline, budget, and performance. In addition, the compatibility of the two teams is important to ensure maximum collaboration and cohesiveness. Using clear and thorough communication, Lighthouse strives for their client to receive maximum value from the partnership.