Manufacturing obstacles in IVD product development IVD manufacturers are looking to contract

 partners to provide guidance and relevant experience to overcome design and manufacturing challenges. With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more efficiently is mounting. To reduce costs and shorten product development cycles, some OEMs and start-up companies have been turning to contract instrument developers and manufacturers for their guidance and relevant experience to overcome common development challenges. As partners to major OEMs and start-ups, contract manufacturers can offer insights on the technical trends affecting the IVD sector and help develop solutions to meet the industry’s changing needs.

With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more efficiently is mounting. To reduce costs and shorten product development cycles, some OEMs and start-up companies have been turning to contract instrument developers and manufacturers for their guidance and relevant experience to overcome common development challenges. As partners to major OEMs and start-ups, contract manufacturers can offer insights on the technical trends affecting the IVD sector and help develop solutions to meet the industry's changing needs. 

 The changes in the IVD industry are being driven by increased laboratory test volumes and growing pressure to lower test turnaround times (TAT) with fewer skilled lab technicians. Any new product launches must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical user interfaces. This article will examine these trends, outline common obstacles associated with them, and discuss how working with contract partners can overcome product development challenges by showing examples of instruments that were introduced to the market with the help of a contract partner.


Rise in POC Technologies


Performing IVD tests at or near the location where patients receive care facilitates the medical decision-making process by eliminating delays caused when sending samples to laboratories. Faster test results may improve patient care in urgent situations, such as intensive care units or emergency rooms. POC technologies may also improve patient treatments and allow healthcare professionals to manage their patient's care while they are with them, without having to wait for lab results and meet with them later. These factors have been contributing to an annual growth rate of 7-10% in the U.S. professional POC market (not including patient self-testing), which currently accounts for about $3.6 billion of the overall IVD sector (see Figure 1).

The desire for faster test results is undeniable. However, in order for an IVD product to be a viable POC technology in the marketplace, it must meet a different set of definitive requirements than a laboratory IVD device. Most importantly, POC instruments must be simple to use since the end users are usually not trained lab technicians. Specific POC device features should include minimal maintenance requirements and on-board calibrations to ensure accurate test results, a user-friendly software interface, integration with laboratory and hospital information systems, and easy-to-use disposables that contain all the reagents for sample processing and testing. POC instrumentation should also have a small footprint and in some cases be portable since both hospital clinics and physician offices have limited space.

While such requirements may seem simple, they present IVD companies with a variety of design and manufacturing challenges. Most notably, a number of POC technologies require more complex disposable cartridges containing multiple reagents to process only one patient sample at a time, compared with simpler disposables in higher volume laboratory instruments. With this added complexity, product development teams must work together to ensure a smooth integration of the disposable cartridges with the instrument design and minimize costly redesigns. Working with a contract manufacturing partner that has experience in integrating disposable cartridge technologies with instrument design is one option to consider during the product development process.


Avoiding Too Much, Too Soon


Many OEMs and start-up IVD companies fall into the “too much, too soon” trap when developing their POC technologies. Such companies do not demonstrate the feasibility of the disposables, reagents, and assay processes prior to beginning to develop the hardware and software for the instrument with their contract partners. Even subtle changes in the disposable design can require major changes in the instrument's architecture, leading to increased development costs and schedule delays for design overhauls.

However, IVD companies can take certain steps to avoid such costly delays. Initially, the ability to meet assay performance requirements should be demonstrated at the macro level before scaling down to the micro level. In addition, cartridge development should be divided into smaller functions, followed by designing and testing those functions before combining them into an integrated disposable. This approach better defines the variables, how to control them, and how they are interrelated.

Furthermore, a systems approach is needed when designing POC technologies. Because disposable design and instrument design go hand-in-hand, having a contract manufacturing partner involved in the product development process can be helpful. Flexibility is enhanced when the disposable and instrument are developed together because tradeoffs can be weighed and the best cost-benefit decisions can be made. By working with a contract instrument designer and openly communicating any design changes in either the instrument or disposable, an IVD company can avoid schedule delays and redesigns.

Closely Considering Materials and Environment

Often when designing POC technologies, IVD companies fail to consider material compatibility requirements, the differences between prototype and production methods, and distribution logistics. All these factors affect the production and distribution of POC instruments. However, companies can address them by working with a contract instrument designer that has experience in such areas. 

Manufacturing obstacles in IVD product development