Here are Four Crucial Design Factors to Consider.
The design and development of a new IVD device requires a diverse team of specialists to produce an instrument that is accurate, efficient, and cost-effective for IVD product development partners and end-users alike. In addition, every client will have unique specimen, quality control, and regulatory requirements for their device.
In today’s competitive marketplace, meeting these needs is increasingly complex. Here are four crucial design factors to consider when designing a high volume, low-cost point-of-care (POC) or over-the-counter (OTC) IVD device.
User Needs & Experience
Understanding what your client’s requirements are is fundamental to the design process. A device manufacturer must “read between the lines” and ask relevant questions to determine a client’s actual operating and QA/QC procedures to achieve their design concept, assure adherence to operational and/or regulatory protocols, and ideally, purchase (or repurchase) the instrumentation.
Device design must also take into consideration the long-term costs to the client. Many are already familiar with the corporate standard of clinical analyzer rental and ongoing purchase of consumables. For POC/OTC devices, however, it may ultimately be more cost-effective for the client to purchase the instrumentation outright, and then to select a maintenance schedule appropriate to their budget and test volume. The design of a user-friendly device that is modular, clearly labeled, and easily accessible to both client and maintenance personnel is expected nowadays in the industry. In addition, POC and OTC diagnostic designers should try to reduce instrument/reader costs as much as possible to mitigate barriers to entry.
Often overlooked, an excellent customer support system is integral to your client’s total experience. An overseas hotline that’s only open during limited hours does little to build customer confidence. Offering both telephone and online chat support is helpful to busy technicians and staff juggling other calls and patients. Prompt callback and on-site follow-up from dedicated repair personnel increase client confidence in your product’s reliability and your company’s ongoing commitment to its customer base. Supplying free shipping boxes, arranging for FedEx or UPS pickups, and postage reimbursement reduces the clinician’s bottom line and is helpful for small practices. Courtesy and reliability are your best advertisement!
Proven Expertise, From Concept to Market
Design for Manufacturing & Assembly
Manufacturing processes need to be taken into consideration early during the design process, as the fast/slow cycling of timed processing steps is critical to achieving high volume. It’s often advisable to onboard an automation expert during the conceptual and design phases. An expert can evaluate and incorporate efficient workflow functions and recommend additional features to expedite specimen handling and operational processes.
The human element must also be taken into consideration. This comprises everything from the UI display to the consideration of ergonomic and psychological factors in the physical design of the chassis, components, consumables, keyboards, and software. In addition, advances in digital design, materials, polymers, and software are constantly evolving and can often influence a client’s choice of a device company over its competitors.
Finally, your POC or OTC device design should include modular options to meet your clients’ varied needs. For instance, a larger practice might require several devices to be interfaced to its clinical database or EMR software. Alternatively, it may require peripheral devices (e.g., printers or barcode scanners). Modular components such as test cup hoppers, storage, and waste containers could streamline their workload. Offering flexibility in your instrument design will set you apart from the competition and ensure additional income over the life of the device.
Simplified, Accurate, and Precise Assays
Your product design should function accurately in any reasonable condition presented by its operating environment, especially when designing for a low-complexity application. Anticipating and mitigating against potential user error makes the product design robust. It is not possible to protect against all possible incorrect uses or misuses. However, you can mitigate many common sources of error by:
• Including CLIA-waiver recommendations in the Instructions for Use (IFU)
• Simplifying language and diagram complexity
• Decreasing the number and type of steps performed by the user
• Including clear and unambiguous labeling
• Clearly specifying the specific ranges of temperature, time, volumes, and concentrations (and any other variable that could influence performance)
Any POC/OTC device should be clinically validated from onboarding through the daily operation. Your clinical clients operate busy practices, and their testing staff are neither trained nor licensed for the kind of high-complexity testing available through a clinical laboratory. They need an accurate, reliable on-site testing device that is simple to operate and maintain.
Initial validation of the instrumentation with commercially available validation standards should be followed by consistent use of appropriate QC methods, materials, recommended shift protocols, and (preferably) internal tracking software that flags for accuracy and precision. QC failures should be confirmed early without delay, documented, investigated, and followed by re-calibration if necessary upon repeated failure of fresh QC materials. Seamlessly interfacing internal QC software with an external device database to alert clients of potential failures should be an integral part of your instrument design; offering an overnight replacement instrument service and a regular reagent delivery service will ease your clients’ workload and ensure continuous testing access for their patients. Lastly, industry-standard and/or federally required proficiency testing should be conducted regularly as specified by the governing regulatory agency in the client’s country of origin.
Complexity Means Cost
The final cost of an instrument design is dependent upon many direct and indirect factors. Various expenses impact the sale price of the instrument, including:
• Material type and availability
• Conversion process
• Assembly method
• Amortization
• Testing equipment
• Build and testing labor
• Delivery/shipping
• Partners and vendors
As much as possible, the instrument should be designed to eliminate excess material, size, and other components. The more assembly processes and contact points involved, the more there is a risk of a breakdown in the design chain resulting in increased costs for both the initial build and the client’s ongoing maintenance. Designing a cost-effective device that takes these factors into consideration decreases both production and operational costs—it’s a win-win for both you and your client!
Conclusion
Not every IVD product development partner is created equal. Each one varies in its design capabilities and approaches. Choosing the right company for your needs and budget is crucial for a timely and successful product build.
