Hiring for experts in software as a medical device
The ever-increasing digitisation of the world and interconnectedness has created many new opportunities and challenges, especially in the digital health sector. Software as a Medical Device (SaMD) is improving the way we approach the healthcare system by aiding clinicians to be able to make quicker and more informed decisions for providing patients with treatment options and diagnosis. SaMD can be updated and modified with reactive ease to reflect the latest advances in medical technology, providing clinicians with the most up-to-date help at their fingertips. But the ease with which SaMD can be updated presents challenges for regulators in keeping these medical devices safe and controlled, whilst also treading a fine line in not negatively impacting on the massive innovation and growth that this sector is experiencing and is expected to continue to experience. To succeed, Software as a Medical Device companies should be on the lookout for passionate regulatory affairs professionals who can navigate the fine line between innovation and safety.
What is software as a medical device?
Software as a Medical Device (SaMD) is a type of standalone medical device that directly serves a function impacting patient treatment, this differentiates it from Software in a Medical Device (SiMD) which is software that assists the functioning of a medical device. This is clarified by the FDA in that SaMD is ‘designed to carry out one or more medical purposes’. A key feature of Software as a Medical Device is that it requires no hardware, which removes many of the barriers in being able to update the technology industry-wide efficiently. It can take the form of software or mobile applications that can help to detect, cure, and manage the entire treatment process of diseases and medical conditions.
Another key feature is that SaMD can utlilise big data and is capable of constantly collecting it through a myriad of sources to allow clinicians to offer the most sophisticated treatment management options. Likewise, SaMD has a clear benefit in being able to gauge user feedback in real time as it is available across multiple devices. This combination of being able to constantly source information and feedback leads to quicker production and innovation, which in turn positively reflects on improved health outcomes and treatment options. SaMD is also closely linked with AI/machine learning and AIaMD, and the development and application of this technology to medical device innovation presents a further fuzzy area for regulators to effectively monitor, as the rate at which medical technology and innovation advances can continue to increase at an exponential rate, leaving regulators playing catch up.
In this rapidly-developing industry, it is crucial that your organisation is making the right decisions when hiring a SaMD regulatory professional that is able to keep up with the pace of change. Elemed’s dedicated network of motivated SaMD professionals could be just the resource you need to ensure you are staying compliant as regulations evolve.
What are the regulations for software as a medical device?
In order for a product to access the European market, a prospective SaMD product must comply with all of the relevant regulations outlined in the Medical Devices Regulation (MDR) (EU) 2017/745, which includes complying with health, safety and environment legislation, and having a mandatory CE certification. For the UK market, the relevant regulations are outlined in the UK Medical Devices Regulations (UK MDR) 2002. The FDA has also developed clear guidelines regarding SaMD products’ interfaces needing to support clinical vocabulary, and that manufacturers need to outline the possible negative implications of their device.
The complexity of regulating SaMD in a balanced manner has been addressed by the International Medical Device Regulators Forum (IMDRF), which acts on a voluntary basis to help coordinate regulation aimed at SaMD. One way they have attempted to address this is through the establishment of the Software as a Medical Device Working Group in 2013 that has produced a framework defining the level of risk that a particular SaMD product has in relation to being able to accurately treat patients. The actions of the IMDRF has helped to close the gap in addressing the public health risks of SaMD with that of existing regulations that are not always adequate at keeping up with the unique risks posed by digital health technology, the sheer amount of patient/consumer data that SaMD capitalises on, and the rate of innovation and change.
To help mitigate this risk, your organisation should be on the lookout for exemplary SaMD professionals that can expertly navigate the changing regulations, and have the right specialist knowledge to fit your specific requirements. They can be a real challenge to find, which is why it is worth investing in securing the right SaMD professional.
Key things to look for when hiring a software as a medical device regulatory affairs specialist
We asked our CEO Elena Kyria for her expert opinion on hiring SaMD professionals: “Regulatory/Quality experts with specialist knowledge of Software as a medical device and IEC 62304 is a high growth area for Elemed. The demand for this specialist experience will only continue to increase as we see technology companies move into healthcare and disrupt the status quo.”
The importance of an agile mindset
The importance of an agile mindset cannot be understated when looking for a software as a medical device regulatory affairs specialist. Given that SaMD is by its nature agile technology, finding a professional that similarly embodies an agile mindset can help strike a perfect balance for your organisation.
What is an agile mindset? It is essentially a state of mind that involves staying extremely flexible through a commitment to collaboration and continuous learning. Having a workforce of people with agile mindsets can allow an organisation to flow seamlessly from one challenge to the next without becoming bogged down and left behind by the latest best practices. This is especially important in keeping up with the fast-moving world that is the Software as a Medical Device industry.
An agile culture allows for an organisation or team to achieve strong results through having a cohesive understanding of ‘why’ being agile is important, which in turn fosters continuous collaboration and a support structure where everyone is striving to self-improve, optimise their work, and reflect on mistakes. Therefore, having an agile mindset mimics the fluidity and innovative qualities of SaMD, and being able to work in sync with how SaMD devices are developed can lead to exemplary SaMD regulatory professionals.
Agile vs Waterfall approach
Agile management is about being as flexible and adaptive as possible. In contrast, the ‘waterfall’ approach places emphasis on pre-planning and having fully defined goals prior to commencing on a project. Planning and design becomes easier when a framework has been agreed upfront, and the project can flow forward much like a cascading waterfall. The waterfall approach is commonly used in medical device companies in product iteration, and both the agile and waterfall approaches have their differing strengths.
Finding a SaMD regulatory professional that can fluidly work in both of these approaches could be a game changer for your organisation’s regulatory prowess and project work. Elemed can do the hard work for you in finding these difficult to find SaMD experts that can allow you to navigate the entire product lifecycle with ease.
Finding great regulatory affairs professionals for SaMD
It can be difficult to find great regulatory affairs professionals for SaMD – at Elemed we use our extensive network of industry-leading contacts to ensure that you can find a candidate who meets the exact profile that you are looking for. In the rapidly-changing world of SaMD and the challenges of smoothly regulating it, a specialist recruitment agency with an established network of SaMD regulatory specialists looking for new opportunities could be just the answer you are looking for! Get in touch with our team today to discuss your hiring requirements. For extremely urgent and flexible hiring needs, a contract SaMD hire might be your best option. Get in touch with Elemed Interim to speak to an expert and find out more.