Manual Processes and Scalability: How to Navigate from Small-Batch to High-Volume Production
Many medtech manufacturing processes are still performed manually for a variety of reasons. Assembling intricate products, such as an implantable cardiac device or wearable drug delivery device, requires a level of dexterity that, until recently, robots couldn’t deliver. Visual inspection is a critical part of quality control, but earlier machine vision technology couldn’t compete with the human eye. Implementing high-precision automation can also be cost prohibitive, especially at the beginning of a product lifecycle. During process development and early production, the cost of automation that meets the requirements can’t be justified.
While manual processes offer some advantages, such as the flexibility to switch easily between products or make other minor adjustments, they don’t scale up efficiently. Increasing output means adding employees and running more shifts. Factors like high scrap rates, which were understandable early in a commercialization effort, become increasingly costly and unacceptable.
Automated systems, on the other hand, can reliably deliver higher quality products. For example, precision assembly with injection molded components is a process that requires a high degree of precision and consistency. While many manufacturers have invested in automation to improve throughput and quality, they often see inconsistent results. This relates to foundation principles that support automation systems that are both accurate and precise.
Q&A with an Automation Specialist
Charlie Shortridge Sales Engineering Manager
While the benefits of automation are clear, deciding exactly to move forward is more challenging and usually requires more expertise than many companies have in-house. As the head of Invio’s Automation Solutions division, Charlie Shortridge has managed hundreds of successful projects. His application expertise includes diagnostic and drug delivery devices, infusion pumps, inhalers, injection pens and syringes, just to name a few. We caught up with him recently to talk about how manufacturers can make this process as successful (and painless) as possible.
What are the most common mistakes companies make when considering automation?
CS: Trying to identify solutions too early. Manufacturers rarely spend enough time identifying and prioritizing automation opportunities. It’s important to create metrics that provide reliable data to determine how successful a delivered automation system is. Simulation and testing for proof of concepting are often underutilized as well. Without these efforts, companies commonly utilize non-optimal technology, automate flawed processes, and incur delays and changes to projects once kicked off. The result is often a system with unanticipated secondary issues, such as new quality defects, maintainability, and sustainability.
When a company makes the decision to invest the time and capital to modernize operations, it’s understandable that they want to see an ROI as quickly as possible. Part of my job is helping stakeholders across the organization understand the value of analyzing current capabilities, defining project scope, exploring scenarios, and building scalability into their larger commercialization plan.
What is the single piece of advice you would give any manufacturer?
CS: Bring in an automation partner as early as possible! The saying “a dollar spent in planning saves ten in execution” definitely applies here. While manufacturers are experts in their products and processes, they can almost always benefit from working closely with an automation specialist. Specialists can present realistic options and clarify tradeoffs to manufacturing stakeholders, allowing them to make informed decisions.
What challenges do manufacturers face that make scaling automation particularly difficult?
CS: Most manufacturers are forced to use different partners at different stages in a product’s lifecycle. Any time a new partner is introduced, they are likely to run into the same issues with the product, process, or equipment nuances that the previous automation supplier had figured out. This is often the case because it can be difficult to get large automation companies interested in smaller projects, and smaller automation suppliers may not be able to handle the larger projects as the automation scales in size and complexity. Invio acts as a good partner by actively looking to be involved in every stage of that lifecycle so that we bring knowledge continuity of a customer’s product, process, and strategy to each project.
How should companies evaluate a potential automation partner?
CS: The ideal partner has expertise with a broad range of technologies and industries – you want an automation partner to bring experience to the table that your company does not have. An ideal partner should also be proactive, not just responding to requests but understanding the goals and issues to be addressed with automation and recommending different ways that they can be achieved. Companies should utilize automation specialists to analyze the cost-benefit tradeoffs of different concepts and levels of automation so they can make the best choice of those options based on accurate, up-to-date information. They have real-world implantation experience across a variety of industries and vertical-specific experience with process validation and other FDA regulations.
Invio has developed a methodology that allows us to deliver more value at every stage of automation. (See chart below.) By helping with a customer’s less-automated system now, we can better support scaling efforts years from now. That way, when the processes are validated, it doesn’t lock a customer into something that limits manufacturing systems and operations when they are trying to produce vastly higher quantities.
