08 5月 Developing a Scalable Automation Strategy
A key challenge when developing new medical single use products is optimizing automation strategy as volumes grow. Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery systems and medical device systems, routinely helps its customers commercialize new products by providing a scalable solution designed to significantly increase capacity and reduce labor cost as volumes grow.
In new product development, Forefront Medical’s team uses a standardized process in which customer requirements are assessed and a Design Development Plan (DDP) is created. A customer specification is then developed and market inputs are collected. Once the customer specification is approved, 3D CAD models are developed and analyzed. Design reviews which include functional analysis and risk evaluation are completed. After a customer’s team approves the design, prototyping and verification began.
Forefront’s team also analyses manufacturing and assembly automation options during this DDP phase, since the ability of the product to meet its volume price target is heavily dependent on the manufacturing and automation strategy meeting cycle times and minimizing labor when production volumes are achieved. While manufacturing processes such as molding, extrusion or metal fabrication and any concomitant tooling are defined by the product design, the automation process can evolve over time as volumes increase.
Forefront’s team utilizes a standard DDP for automation. The team evaluates the product, its projected volumes, the fixed costs associated with an automated line and the anticipated length of the project to determine if the benefits provided by automation will outweigh the costs. When product volumes are difficult to forecast, the team will often start the program with more manual assembly volumes, often for the first year. Once volumes become consistent, the team begins the automated production line design process.
Typically, automation strategy for single-use medical products can take one of two forms. An index system uses a conveyor to move product under assembly from station-to-station and is often a good choice for medium volume production. A continuous flow line with robotics is often the best choice for high volume production.
Once the basic line configuration concept is decided upon, the team looks at the material delivery system, jigs and fixtures, and stations. A preliminary design is developed and modeled using computer simulation. The team reviews the simulation for improvements to cycle time and once the final design is approved by the customer equipment is put on order. The final step is line validation. As a rule of thumb the goal in determining whether or not an automation strategy is warranted is that the cost savings of automation should pay back the cost of the line in a single year.
While each line is designed to customer requirements, there are some standard elements common tomost automated lines. The first element is the material delivery system. This is typically comprised of vibration bowls or a feeder system that delivers the first parts to be assembled to the first station. Depending on the product’s cosmetic requirements, vibration bowls may need to be surface treated to minimize the potential for scratching the parts. The first station is set up with jigs and fixtures to property position parts for subsequent assembly operations. When robot arms are used, this positioning must be very precise. Vision systems are used to verify correct placement in the jig and/or fixtures and correct assembly at the end of the line. A central conveyor moves product between stations. Typically, the first few stations are simply assembling parts. If adhesive is being used to join parts, a UV cure station is near the end of the line. A fluorescing agent may be added to the UV adhesive to make it easy to detect whether or not it is applied correctly. A packaging station is present at the end of the line using film and Tyvek to seal the product in final packaging.
Much of the “labor” eventually done by robots can be done by actual production operators until volumes reach a point where the cost of robotics is less than actual labor cost. Once the basic line concept is designed and computer simulated, determining the breakeven point is fairly easy. The advantage of selecting a contract manufacturer capable of providing a scalable solution that implements automation as consistent volumes are achieved includes:
• Reduced non-recurring tooling costs early in the product’s lifecycle
• The ability to shift from labor to automation at the precise point when production volumes can pay back the investment in a reasonable time period
• The elimination of the learning curve that can occur when separate contract manufacturers are used for each phase of the product lifecycle.
Carefully analyzing a contract manufacturer’s track record in scalable automation solutions is the best way to determine if they are capable of supporting the project’s requirements.
About Forefront Medical Technology
Forefront Medical Technology is a global medical device contract manufacturer with five locations. Singapore is Forefront’s headquarters, as well as home to our Design Engineering Center and specialty manufacturing. JiangSu and Xiamen, China, are additional manufacturing locations and are also China FDA Registered. Shanghai, China, Farmington, CT USA are regional Business Development offices which assure our technical sales teams are close to our customers for local, responsive assistance.
We have developed extensive capabilities with laryngeal mask airways, diagnostic devices, drug delivery systems, enteral feeding catheters, infusion sets, wire reinforced tubes, optically clear components, patient monitoring devices and other specialty products. Each of our locations has state of the art manufacturing capabilities that include class 100K clean rooms for extrusion and injection molding, complimented by class 10K clean rooms for assembly and packaging. Forefront Medical’s integrated technical approach provides customers the total manufacturing solution and global supply chain. Our facilities are TUV ISO 13485:2016, ISO 9001 and FDA Registered. Forefront is a wholly owned subsidiary of VicPlas International Ltd, who is listed on the SGX Main Board, Singapore stock exchange.