NeuMoDx™ Molecular and RND Group
Managing Complexity to Deliver a Best in Class Product
NeuMoDx™ Partnership with RND
When medical device companies look for a partner to develop complex medical device software, RND Group’s reputation for delivery and its collection of re-usable software products make it the go-to company for ensuring success. This particular case study describes one of the largest medical device software development projects RND Group has participated in since its founding in 1997. The resulting product has been recognized as a best-in-class solution for customers who need a molecular diagnostic instrument that provides efficiency, an easy-to-use interface, and a low cost per test performance.
Time and time again, RND Group clients report that their partnership with The RND Group helped keep their project’s software development on-schedule and within budget. The NeuMoDx™ team offers a similar report with their project. NeuMoDx™ is focused on simplifying complex technology for its customers and they appreciated the streamlined process delivered by RND Group.
About NeuMoDx™ Molecular
NeuMoDx™ Molecular was founded with the vision of creating a molecular diagnostic system that delivered high throughput testing capacity and a fast test result turn-around time, while simultaneously maximizing the “walk away time” for laboratory technicians using the device. These product goals, while concisely stated, required solving dozens of complex engineering challenges as this case study will illustrate.
NeuMoDx™ Molecular was started in 2012 by Jeff Williams and Sundu Brahmasandra in Ann Arbor, MI. The goal of the NeuMoDx System was to deliver the “simplicity of clinical chemistry analyzers to the world of real-time PCR based molecular diagnostics.” Other key features of the NeuMoDx instrument include the ability to perform “random access testing” i.e., the ability to simultaneously process different types of specimens and tests with maximum flexibility of test workflows. In addition, the system utilizes on-board reagents that are stable at ambient temperature and eliminates any special preparation steps for samples or reagents by the laboratory technician before loading samples and reagents into the instrument. Finally, samples and associated reagents and consumables can be loaded in a “continuous manner” without pausing the system at any time.
The NeuMoDx™ Solution
In 2021 there are two models of instrument available – the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems – supported by a single software application developed by RND Group. These instruments are being sold all over the world and are supporting rapid and high-volume testing of multiple assays across the marketplace.
In the U.S., the NeuMoDx GBS Assay has received 510k clearance and the NeuMoDx SARS-CoV2 Assay has received EUA authorization for testing using both NP Swab and Saliva Specimens. Several assays have received commercial approval via the CE-IVD Marking process, including Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus(HBV), Hepatitis C (HCV), Human Immunodeficiency Virus (HIV-1), Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), and GBS. The test menu is extremely broad and growing and spans qualitative and quantitative assays incorporating single and multiple targets in each assay.
There are other instruments on the market that perform the same types of tests as the NeuMoDx instrument. However, the NeuMoDx instrument delivers efficiencies the competition does not offer, including minimizing required operator interaction and producing results quickly, while still delivering a high throughput. An interesting analogy has been made about the NeuMoDx instrument and that is likening the instrument to a vending machine. A user (laboratory technician) can re-stock the instrument with various components – samples, reagents, cartridges, buffer solution – and then walk away for long periods of time, knowing that results for a variety of different tests will be delivered and available when the user comes back.
The execution by Jeff, Sundu, and the NeuMoDx team on the company and product vision have put NeuMoDx in a very favorable market position.
Software Partner Selection
The success of the NeuMoDx instruments is a result of many factors, with the software that drives the instrument being one of the most critical factors. The design requirements for sample-to-answer speed, random access and continuous loading, supporting multiple test workflows simultaneously with maximized walk away time are key differentiators in the marketplace and are all facilitated by the advanced software that has been developed for the instrument.
It is a reasonable to ask what software development companies are capable of developing such advanced software and developing the software under strict design controls as required by the FDA and EU IVDD regulatory organizations? The answer is that very few companies are capable of completing the job successfully. RND Group was able to deliver for NeuMoDx and the selection of RND Group for the job was never really in doubt for NeuMoDx’s founders.
“RND Group met or exceeded all of our expectations.”
Jeff and Sundu had some experience working on smaller projects previously with RND Group, with RND Group having developed the software requirements for the Handy Labs device. Despite familiarity and comfort with RND Group, give the scale and complexity of software development for the NeuMoDx systems, NeuMoDx performed exhaustive due diligence and investigated other software development companies before selecting RND Group as the sole provider of software development services. Several novel technologies were incorporated including a Hamilton STAR liquid handling system, use of a custom XPCR and Extraction Heater modules capable of asynchronous execution of nucleic acid extraction and real-time PCR, and integration of the instrument with external laboratory systems. NeuMoDx required that software development vendors, including RND Group, demonstrate that they were capable of managing and delivering a solution utilizing these new technologies.
As part of the vendor selection process RND Group shared its extensive experience in Hamilton integration and highlighted that it is one of primary software development partners that Hamilton recommends to its OEM customers like NeuMoDx. Regarding integration of custom XPCR and Extraction modules, RND Group was able to point to similar hardware integrations it had performed – both with a Hamilton instrument and with other custom-developed instruments. And, for laboratory system integration, RND Group has a pre-built, reusable Laboratory Information Systems (LIS) software module that has been successfully used by several RND Group customers to integrate with laboratory systems.
Software Project Overview
As software projects for RND Group go, development of the NeuMoDx software was a large effort. From initial requirements definition to release of the first commercial version it took 48 calendar months with an RND Group team of 8-10 people.
As part of the vendor selection process RND Group shared its extensive experience in Hamilton integration and highlighted that it is one of primary software development partners that Hamilton recommends to its OEM customers like NeuMoDx. Regarding integration of custom XPCR and Extraction modules, RND Group was able to point to similar hardware integrations it had performed – both with a Hamilton instrument and with other custom-developed instruments. And, for laboratory system integration, RND Group has a pre-built, reusable Laboratory Information Systems (LIS) software module that has been successfully used by several RND Group customers to integrate with laboratory systems.
The project budget is managed per-quarter, based on the features that NeuMoDx and RND Group mutually agree will be included in the release. Sundu Brahmasandra remarked about the budgeting and release cycle by saying “I think RND Group’s ability to forecast costs and deliver on-schedule is much better than they industry standard. As a customer, of course I would like all features delivered immediately and at as low a cost as possible. RND Group’s open communication about release timing and costs helps me manage expectations of my stakeholders effectively.”
Challenges and Solutions
“We only seriously considered one software vendor for our project. RND Group’s reputation and results speak for themselves.”
As described earlier, the NeuMoDx’s system design incorporates several features that position it as the best molecular diagnostic instrument for customers who are looking for a combination of speed, ease of use, throughput, and low cost per test all enables using ambient condition stable reagents. Implementation of these features presented numerous technical challenges that RND Group had to address, including:
Up to 288 samples can be loaded at a time, with multiple types of tests represented across the samples, and with the ability to access samples in any specific order.
Facilitating random access and supporting multiple types of assays was achieved through breaking down the PCR process into operation steps – liquid handling operations, Lysis, nucleic acid extraction, and reagent mixing – and scheduling those operations on the available hardware. The available hardware consists of 8 Hamilton ADPs (air displacement pipettors), 4 PCR Modules with 12 lanes each, 2 heater modules with 48 wells each, and 2 sets of bulk reagent fluids.
With the exception of ADPs, any single hardware component can be taken out of service at any time while the system is using that component and the system will automatically adjust and continue working.
The same software runs on 2 different platforms, the N288 and N96, where N96 has roughly half the hardware of the N288.
Based on the software architecture and design established by RND Group, the N96 was able to be supported with minimal change to the software and was functional within one month after the instrument hardware was complete.
Support for Laboratory Developed Tests (LDTs) that run concurrently with FDA and CE Mark approved tests and integration with Laboratory Information Systems (LIS) for test order download and results upload.
RND Group designed the software to isolate the result calculation and reporting for each assay, ensuring LDT, CEIVD, and FDA cleared assays can safely and reliably be performed simultaneously on the same instrument.
RND Group leveraged its existing LIS interface module to create of a variety of configurable LIS workflows to address NeuMoDx’s need to operate in a variety of customer lab environments.
How did RND Group deliver software that solved the numerous technical challenges and met stringent requirements for FDA and CE Mark software? There was a lot of hard work and long hours, for sure, but the following qualities allowed RND Group to deliver successfully for NeuMoDx:
1. Regulated (FDA, CE) software development experience
RND Group has released over 50 FDA-approved medical devices to the market. We have our own quality system and know exactly the deliverables and content required for regulated software submission.
2. Software engineering experience
Software architecture and use of engineering principles are key when building an application as large and complex as the NeuMoDx application.
3. Software verification experience
Our Verification Engineers are true engineers with high levels of skill and expertise in building testing tools, creating test cases, and testing the software in ways that end users will use it.
4. Management and leadership experience
Managing the internal RND team daily and managing the external customer relationship requires a unique combination of technical and business/customer focus skills, and these skills are required of all RND Group project leads.
5. Consistent customer involvement
Regular communication and agile delivery of software releases were key to ensure both NeuMoDx and RND Group were aligned on features, schedule, and cost and that neither party was “surprised” by expectations or delivery.
“I take great pride in the fact that The RND team successfully delivers the best of class features that NeuMoDx expects.”
Final Thoughts
As expansive as the development has been to date and the NeuMoDx software offers a whole host of customer and workflow friendly feature, NeuMoDx and RND Group are continuing to work together as a collective team to produce new software releases containing a multitude of additional features enabling new workflows and analysis methods. This continuous improvement is aimed at assisting NeuMoDx as it moves towards a marketing leading position. Both companies can look back fondly on their partnership that is now 7 years old. But, more importantly, the partnership continues with RND Group working side by side with NeuMoDx to achieve and expanding on the vision of Jeff and Sundu.