In Vitro Diagnostics, Design for Manufacturability: 3 Steps For Successful Transition

For medical engineering teams that are developing and designing in vitro diagnostic products, there are crucial steps in ensuring your products’ design for manufacturability elements are perfected for timely, efficient and compliant production and delivery.Engineer_Design-574376-edited.jpg

“Manufacturers that take manufacturability into account early and train cross-functional teams can reap rewards of condensed development cycles—which may mean even larger profit margins,” write Frank Pawlowski, KMC’s manager of technologies and solutions and Bill St. Onge, KMC’s director of manufacturing, in the September 2009 issue of Medical Device & Diagnostic Industry magazine.

To avoid critical mistakes, or pricey but crucial product redesigns late in the manufacturing process, there are 3 key steps. Diligence here improves your chances of developing a successful product and getting it to market on time.

  1. Know Your Users’ (And Everyone Else’s) Needs

When considering any type of IVD medical device design, the people’s perspective is important. It can mean the difference between a product that succeeds and one that fails. “Human factors and usability are now recognized as critical elements for successful medical product development,” write Spencer Lovette, senior program manager, Jerry Sevigny, Sr., principal systems engineers, and Jack Kessler, PhD., Sr., principal systems engineer, all of KMC Systems, in their white paper, “Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process: How Optimum Architecture Design Enhances the Product Development Process and Product Performance.”

How do you find this crucial human feedback? Early in the conceptual stage, conduct field research and concept preference in order to learn how users want to interact with the product, as well as hear feedback on how well the product works or will perform a desired function or test. Doing so early on can help “avoid the potential for costly major redesign iterations and schedule delays downstream. The risk of having poor market acceptance after an instrument launch is greatly reduced by engaging a representative sample of users and ‘listening’ to the voice of the customer,” write Lovette, Sevigny and Kessler.

Of course, you’ll need feedback from other parties, too, and these should also be collected and considered early on in the product development stage, note Palowski and St. Onge. “Companies must gather input about the desired features and intended functions of a device or instrument from all stakeholders, including marketing, regulatory, safety and technical design personnel…Further, medical original equipment manufacturers (OEMs) must make manufacturing a priority during the design process by involving production and quality control personnel as well as key vendors. Input from these parties can help avoid additional design revisions at later stages,” they write in Medical Device & Diagnostic Industry.

  1. Simulation Saves Money, Time and Effort

Just as it is important to consider all perspectives when working on an in vitro diagnostic device design, it’s also imperative to think through how the device will function most efficiently. Simulation modeling makes this possible, by helping to determine how to prioritize features such as operational performance, process technology, and other elements such as cost and complexity. It also can show where design challenges exist, and how to overcome them. Simulation prevents surprises and allows for different ways the device can process and control different situations.

“Simulation is performed by creating a computer-based model that describes the interaction between things (samples, reagents, and disposables), resources (sample and reagent racks, ovens, pipettors, transports, detectors) and activities (heating, washing, mixing, detecting) in a manner that mimics the interactions of a candidate system architecture,” write Lovette, Sevigny, and Kessler. “By running the simulation model, the designer measures parameters such as throughput or resource utilization, and observes interactions and conflicts that describe the performance of an instrument once it is built,” they write.

When considering IVD contract manufacturing, work with experts who are very familiar with simulation models for IVD diagnostic design. Greater familiarity helps the development process move quicker and can help reduce costs, write Lovette, Sevigny, and Kessler.

  1. Cheaper and Faster: How Off-the-Shelf Technologies Help IVD Products

You want to bring your IVD medical device design to the marketplace as quickly as possible—without compromising on safety, design or efficiency. The right IVD medical instrumentation manufacturer can help you do that. Using off-the-shelf (OTS) technologies “provide the benefits of reducing the cost of design as long as the feature sets meet the design requirements,” write Lovette, Sevigny and Kessler. Companies familiar with OTS solutions can help provide customers with “scalable, flexible modules for diagnostic instruments with different footprints and configurations across many chemistry processes and detection technologies.”

Longevity in the game helps refine and perfect OTS solutions. Some modules which have been integrated and verified in prior applications and devices over a long time, can include “all the major elements (positioning/motion control/robots/ drive and control electronics, control/data processing/GUI software, liquid handling, precision fluidic control and dispense) needed to construct a complete platform,” Lovette, Sevigny and Kessler write. In particular, they write, “the real value of utilizing the KMC off-the-shelf solutions is that these designs are proven and verified, not only reducing custom development costs but also the subsequent module test and integration costs as well.”

For more details about how KMC Systems can help bring your in vitro diagnostic product design to life through in vitro diagnostic manufacturing, click here or download the IVD white paper.


Topics: ivd product development, medical manufacturing