Why is industrialization such a crucial step towards the successful manufacturing of your medical device?
Your engineering team has designed an innovative medical device and you now need to manufacture it on a mass scale. Are you confident you are going to have a smooth transition as you scale up to industrialization and production? What questions are critical when you reach the industrialization stage? Or even long before that stage? Eric Padoy, Industrialization Manager at Valtronic shares with you key factors that must be taken into consideration to confidently translate a design or prototype into a product that can be manufactured to meet the market volumes at a target production cost and at highest quality standards.
What exactly is Industrialization?
Industrialization consists of implementing optimized manufacturing processes for a product developed by Research and Development. The importance of this step to ensure seamless manufacturing and the possibility for quick ramp-ups cannot be overstated. So what is the best way to guarantee a seamless transition? Eric Padoy, Industrialization Manager at Valtronic Switzerland, insists on the importance of clear manufacturing instructions. Operators need to understand all manufacturing steps and all assembly operations must be as easy as possible to perform, including the ergonomic considerations. Clearly said, all assembly and manufacturing operations must be easily feasible to allow for repeatability, efficiency and quality.
Always consider Design for Manufacturing and Assembly (DFMA)
To guarantee this, Design for Manufacturing and Assembly (DFMA) should always be considered. Eric explains that “When designing a device, it is key to focus on the operators who are going to manufacture it. Are the manufacturing instructions clear enough? Do they allow for realistic and ergonomic assembly conditions? Is the flow optimized to guarantee quality, costs and deadlines?” DFMA, which combines two methodologies, i.e. Design for Manufacturing (DFM) and Design for Assembly (DFA) provides the foundation to meet all of these criteria. This is why it is so crucial to involve the right partner in a project right from the start if you do not have a Research and Development team in house. At Valtronic, the R&D team is using the DFMA methodology when starting a new project or reviewing the design of an existing device. Working in close collaboration with the industrialization and manufacturing team, our engineering team knows all manufacturing constraints and takes them into consideration when performing their design. This approach minimizes iterations and allows for faster time to manufacturing and time to market.
What happens in case of a production transfer, i.e. when Valtronic takes on a product designed by someone else?
When taking on a production transfer project, a contract manufacturer (CM) has to manufacture a product that was designed by someone else. In this case, Valtronic takes all necessary steps to guarantee a seamless transition. This generally involves sending a Valtronic team to the customer’s plant to fully understand their manufacturing steps and perform all operations together with their operators. The aim is to transfer all the customer’s knowledge to the Valtronic team. In other words, full involvement and collaboration with our customers are key to allow for a successful production transfer. Additionally, should some redesign be necessary to optimize manufacturing costs and cycle time, our Research and Development team have all the expertise and experience to assist our customers in optimizing the manufacturing of their products.
About Eric Padoy
Eric joined Valtronic in March 2018 as Industrialization Manager. With his 25 years of experience in implementing the manufacturing of medical devices for companies such as Medtronic, Compex, and Mentice, Eric has the ideal career profile for the industrialization of complex devices and is currently working on challenging portable home healthcare devices.