Perspectives From the Front Lines: Designing Automation Strategies for Medical Device Manufacturers
Invio Automation has decades of experience, delivering automation solutions into medical device and life sciences manufacturing environments.
Lessons learned and best practices from hundreds of engagements with our manufacturing customers.
The prevalence of the word “automation” in Fortune 500 earnings calls has increased six-fold in the last 10 years. Businesses in all industries are being challenged to do more with less, and they’ve generally been successful: earnings and revenue per employee among the Fortune 500 have increased every year for the last 10 years.
That said, the imperative to automate often gets stuck when hopscotching through an organization from CEO directive down to the factory floor. From “pilot purgatory” of McKinsey fame to glacial enterprise deployments, Invio Automation has a unique perspective based on engagement with hundreds of manufacturing customers to understand the automation deployment strategies that work and those that fail.
Medical device manufacturing is no stranger to automation, but within America’s 10,000 medical device manufacturing facilities are nearly 270,000 employees engaged in both menial and highly skilled fabrication, assembly, and quality assurance tasks. Small product size coupled with exacting precision often requires that employees have levels of dexterity and ocular endurance that further shrink the local labor pool. Components and sub-assemblies used in catheters, pacemakers, glucose monitoring devices, and injectable drug devices require skilled labor to complete their work using microscopes for the majority of their shift.
When formulating an automation strategy, a seemingly sensible approach is to focus on the activities that consume the most time for the most amount of people. Another strategy is to focus on the operations that drive the most rework, risk, and quality issues in the product. A third approach might optimize to fill key skill gaps based on increasingly poor labor availability.
The time and capital wasted, as well as the organizational skepticism that results from choosing the wrong automation strategy, can be disastrous to a company’s automation agenda. Invio Automation prioritizes automating the operations where they have delivered or witnessed solutions with a successful production track record.
Invio Automation prioritizes automating the operations where they have delivered or witnessed solutions with a successful production track record.
As a case study, Invio Automation’s Factory of the Future consulting team worked with a manufacturer of a wearable insulin management system that was tasked with launching a new product that would require nearly doubling the quantity of manufacturing personnel in their operation. The engagement started while the product was still in design and before validation requirements were conceived.
Partnering with an automation provider this early in the product lifecycle is underutilized but can translate into significantly faster time-to-market (TTM), lower manufacturing costs, and higher product quality. While the approach is well-known as Design for Automation (DFA), it’s rare for manufacturers to have the organizational design and processes developed to bring together all the functional stakeholders needed for success. This is where Invio Automation’s Factory of the Future team stepped in with a structured, workshop based approach to DFA.
The customer deliverables included a comprehensive manufacturing process that utilizes a standard chassis and pallet indexer that’s been used to produce millions of inhalers, PICC lines, injection pens & syringes, on-body pumps & sensors, cardiac implantables, needles, and breathing regulators. For the station designs, the Invio Automation design library was the source for solutions with a track record for die cutting, web handling, leak testing, thermal bonding, RF heat tip forming, bag sealing, induction heat catheter tipping, precision dispensing, and needle bending. As the volume grows, the customer can swap labor for robots with minimal redesign and effort.
“Essentially, we helped the business get from where they are today to where they want to be tomorrow. We supported their desire to have a phased automation plan that scaled as volume ramped up,” explains Jeff Chu, Director, Factory of the Future Services at Invio Automation. “We took their production forecast, prototype design, qualification requirements, and ROI model to develop an actionable automation strategy that leverages known technologies.”
FACTORY OF THE FUTURE CONSULTING DEEP DIVE
“Manufacturers face an increasingly complex automation marketplace with many options available to enhance workflows,” shares Chu. “But knowing what technology is ideal or feasible, as well as how to best implement and allocate resources, is often unclear and sometimes overwhelming. Plus, many manufacturing engineering teams are stretched thin or don’t have the in-house automation expertise required to properly define and assess their desired future state. This is where Factory of the Future consulting excels.”
“The aim is to serve as a collaborative partner,” he adds. “We work side-by-side with the customer’s engineering, product design, quality, and executive teams to develop these roadmaps for transforming their factories to meet their future vision and future goals.”
As an operational and manufacturing consulting service, the Factory of the Future (FotF) team supports customers in developing automation strategies, investment road maps, and transformation plans – not just concepting, prioritization, and scope definition of individual projects. Deliverables from a consulting engagement will look different for each company. For some, it may include multiple engineering concepts and simulations to identify the optimal approach. For others, it can deliver a roadmap for new product introduction that optimizes different levels of automation at the ideal phase of commercialization and volume.
“For every project, we deliver a tactical, implementable plan for the customer’s engineering and executive teams. This includes Current State Evaluation Results, Future State System Specifications, Business Case and ROI Calculations, Plant Transformation Roadmap with Investment Summary, and other deliverables as needed,” says Chu.
Example deliverables from a consulting engagement have multiple uses, including internal budgeting and approval, ongoing operational planning, and supplier specifications.
“Today’s manufacturing professionals are often tasked with choosing among dozens of competing technologies and an unbiased understanding of the pros and cons is often rare. This lack of clarity can lead to frustration or even immobilization,” says Charlie Shortridge, Sales Engineering Manager with Invio Automation. “The goal is to deliver cogent project identification, prioritization, and expectations. Our FotF team works together with planners and engineers to workshop, conceptualize, simulate, and ultimately create the factory our customers need to achieve their company’s goals.”
FotF consulting has proven valuable for customers across a range of product complexities in many industries, including Class I to Class III medical devices. It has enabled successful production scaling and automation planning for Continuous Glucose Monitors (CGMs) and insulin delivery wearables, In Vitro Diagnostic (IVD) products, and even implantable health critical devices.
“This is where the collaborative effort comes in,” says Chu. “Manufacturers are experts in their products and in the nuances of their operations, while we bring expertise in technology, automation, manufacturing process development, and material flow optimization.”
FotF engagements can also be highly specific and tackle a process-specific pain point such as leak testing. A manufacturer of a single-use device that collects urine and other fluids needed technical consulting to upgrade an existing process from single-device, individual testing to a fully automated, 32-channel leak testing system. The engagement was a sprint that concluded with a 3D concept, testing documentation, hardware recommendations, fixed pricing, and an ROI calculation consistent with the methodology supplied by the customer.
A CASE IN POINT: MATERIAL FLOW FOCUS
A North American manufacturer was familiar with automation but needed help improving the overall material flows within their facility. Specifically, their current assembly line was a conveyor-based, linear flow line that had served them well for years, but as product variants proliferated, there was a need to start from scratch. The customer engaged Invio Automation to help evaluate a kitting strategy, the use of autonomous mobile robots (AMRs), automated packaging systems, and vision systems for in-process and finished goods verification.
“The customer was highly proficient in their use of automation, but struggled to increase throughput to meet growing demand,” says Chu. “Invio’s team diagnosed their linear, conveyor-based system as the critical constraint. While this system had been successful for many years, by challenging the existing paradigm, we fundamentally changed the way their factory was laid out. This ultimately unlocked previous limitations and captured unrealized revenue.”
“We began our assessment by whiteboarding and drawing out different ideas, collectively trying to reimagine the ideal system design. What key pieces of technology would enable this solution?” Chu continues. “In these workshops, we extract a lot of information about what the customer has previously explored and seek to align on the right degree of automation for their future state. To be successful, the solution must be owned, operated, and maintained by the customer. We make sure to set them up for sustainable success.”
Post-workshop, Invio created a 3D concept and FlexSim simulation of the proposed factory, as well as an actionable plan to implement. These tools create a compelling vision of what each customer’s factory of the future looks like. It also allows them to iterate quickly on proposed concepts, identify potential project pitfalls early, and solicit customer insights that would be difficult to identify from written specifications alone.
The Factory of the Future consulting team uses a value stream map to inform project ideas and run simulations to validate hypotheses. Invio has the broader capability to deliver these solutions, from design through installation.
The cadence of a typical consulting engagement.
THE BENEFITS
“The goal of our consulting efforts is to pull forward 3-5% of a project’s total cost, in hopes that by collaboratively conducting key engineering activities very early on, we can de-risk overall scope and cost for major projects,” Chu explains. “What Invio Automation offers is a structured process that greatly reduces the unknowns and potential risk factors inherent in transformational projects.”
“Working together with automation-specific domain expertise can make all the difference,” says Shortridge. “The FotF team has the knowledge to assess project risk and potential impact, and then evaluate and engineer systems for a successful return on investment. They’re well-versed in what certain technologies can and cannot do, as well as how different solutions have been successfully used elsewhere.”
