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How a system-based modular approach minimizes risk and accelerates SaMD go-to-market​

27 Jul 2023

In the field of healthcare systems compliance, the difference between 99% and 100% is a chasm.  ​ 

“Software defect.” “False upstream alarms.” “Firmware error.” “Login error.” “Software bug.” “Sensor failure.” “Cybersecurity vulnerability.” The FDA list of software-related recalls is sobering reading. We see the story behind each event – the teams that worked overtime designing and building a new device, quality assurance professionals checking each and every vulnerability, last-minute adjustments, the elation of a seemingly successful release… And all the while a tiny flaw lay hidden from sight, with the power to derail everything compromising safety and exposing liabilities. ​

As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It’s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let’s dive in. ​

Compliance and agility by design​

There’s a common fear that safety and compliance slow down go to market. A justified concern? Yes and no. Of course, extra steps take extra time. That’s why, wherever possible, we work to engrain safety and compliance considerations into every process. For example, a remote patient monitoring system that records patient data needs to do many things, some are basic functions; others cross over into the “safety” category. Safety and compliance are mandatory and are integrated into the development process. Pharma and MedTech companies will speed development and improve quality if they adopt two changes: agile processes combined with modularity by design. To see how modularity adds value, let’s look closer at the challenges SaMD teams face.​

Challenges of connected systems ​

With today’s more connected and complex systems, the boundaries of what constitutes “Software as a Medical Device” are often blurred. For example, when the system is distributed, with parts of an application running on a wearable, mobile phone, or in the cloud, and  a combination of medical and non-medical functions, is the whole system SaMD? How do we manage a combination of safety and non-safety, administrative and other functions that all need to work together to fulfill a medical purpose? If the system is developed as monolithic, this increases effort to get regulatory approval and places additional compliance effort to modify, improve or add functions after the system has received initial market authorization. What’s the solution?​

The benefits of modularization for connected health ​

A pragmatic approach to accelerate SaMD development, manage safety and regulatory complexity, and maintain flexibility, is modularization. We segregate SaMD products by function and by risk category (high, medium and low risk). This makes it possible to apply the appropriate level of risk control and testing measures in each case. Using pre-built, ready-to-use SaMD modules developed under certified processes and qualified tools, assures reliable, fast and compliant software. ​

Modularization reduces regulatory complexity and – together with agile development models – speeds up the time to market, while providing the flexibility we need to continuously adapt functions. Most critically, it reduces risk. The “hidden flaw” we talked about earlier – in a modular system there’s no place to hide, and agile development makes it possible to and correct flaws early in the development cycles.​

Reducing risk and regulatory complexity​

We believe that risk is best managed when technical and regulatory responsibility go hand-in-hand. The closer a development team is to the consequences of success or failure – the more skin they have in the game – the more we count on them to scrupulously manage risk. We’d been working in the SaMD field from the start, at the intersection of software, life sciences and regulatory, so taking regulatory responsibility for our work was a natural step. How to manage regulatory compliance is an important question for every innovator – a far-reaching question with many dimensions. For us, most crucial is the link between technical and regulatory responsibility.​
​You can find more about our offer and our Legal Manufacturer capabilities on our webpage, and we’re also available to consult on any aspect of risk and compliance.

When your innovations hit the market, dozens of factors affect their success. Avoidable mistakes should not be one of them. Let’s make your products flawless.  

Meet our experts

Andrew Koubatis

ER&D Pre-Sales Director