1. A lot of regulatory demands

Regulations are often a driving factor in the medtech industry. Typically, before a project even begins, there needs to be a plan in place that clearly demonstrates how a device or piece of software will be developed. Once the product development is underway, any changes from the original design need to be carefully documented and every change to the way the product works has to be traceable. However, all this documentation has a purpose. In case of an audit, it should be easy to trace back every step of the project to show that the finished product is indeed as it’s supposed to
be and that it is safe to use. As much as this ensures the compliance and safety of the project, it also creates some challenges from the project management perspective. Additional to the resources needed to carry out the project, extra resources are needed to document it. A few past projects in which we used the agile methodology have been about point-of-care IT, where we worked on developing software that connects medical devices to the medical record systems. From experience, ensuring good documentation of an agile project is possible as long as we as the executing organisation have the right expertise, in the form of the ISO 13485 certification and adherence to other standards such as IEC 62304, together with the right experience, in terms of skilled employees.

2. Resistance to change within the organisation

Some medtech companies are experiencing varying degrees of resistance to change, especially when an agile methodology is introduced. There is often fear of increased risk in a project. The main detractors of the agile methodology tend to be the regulatory and the quality departments of the company. However, agile development of medical devices is possible – in fact, some regulations encourage iterative development. Medtech companies where the regulatory and quality departments work in a solution-oriented way can realise the benefits of agile and still comply with
the regulations. Together with the previous point, this brings us to the final, and perhaps the biggest, challenge faced by medtech companies.

3. Getting products to the market fast enough

Medtech companies are not only competing with each other. They also are indirectly compared to consumer electronics companies. It all starts with expectations. Updates to consumer electronics are being pushed to market quicker and quicker, which raises the expectations consumers have of all electronics. In the end, medtech companies have problems with getting products fast enough to market. Solving this challenge is not easy. On one hand, the medtech companies are feeling the pressure of delivering on the expectations, but on the other, they have to make sure that the
products are safe and compliant with the regulations.

News from ERNI

In our newsroom, you find all our articles, blogs and series entries in one place.

  • 22.11.2023.

    Recognising trends: An insight into regression analysis

    Data plays a very important role in every area of a company. When it comes to data, a distinction is made primarily between operational data and dispositive data. Operational data play an important role, especially in day-to-day business. However, they are not nearly as relevant as dispositive data. This is because these data are collected over a longer period of time and provide an initial insight into the history or the past.

  • 08.11.2023.

    Why do we need digital transformation for medical devices?

    For hospitals, it is not up for discussion as to whether they want to digitalise. The increasing age of the population in western countries and the progressive shortage of medical professionals mean that without digitalisation, the healthcare system will not be able to provide the quality that patients want in the future.

  • 25.10.2023.

    Mastering the challenges of mobile app testing: Strategies for efficient quality assurance

    Discover the unique challenges faced in testing mobile applications and learn how to overcome them effectively. From selecting suitable devices and operating systems to leveraging cloud-based test platforms, test automation and emulators, this article provides seven essential strategies for optimising your mobile app testing process.

  • 11.10.2023.

    Incorporating classical requirements engineering methods in agile software development for a laboratory automation system

    Traditional agile methodologies can sometimes struggle to accommodate the complexity and regulatory requirements of laboratory automation systems, leading to misalignment with stakeholder needs, scope creep, and potential delays. The lack of comprehensive requirements documentation can result in ambiguous expectations and hinder effective communication among cross-functional teams.

  • 27.09.2023.

    Unveiling the power of data: Part III – Navigating challenges and harnessing insights in data-driven projects

    Transforming an idea into a successful machine learning (ML)-based product involves navigating various challenges. In this final part of our series, we delve into two crucial aspects: ensuring 24/7 operation of the product and prioritising user experience (UX).

  • 13.09.2023.

    Exploring Language Models: An overview of LLMs and their practical implementation

    Generative AI models have recently amazed with unprecedented outputs, such as hyper-realistic images, diverse music, coherent texts, and synthetic videos, sparking excitement. Despite this progress, addressing ethical and societal concerns is crucial for responsible and beneficial utilization, guarding against issues like misinformation and manipulation in this AI-powered creative era.

  • 01.09.2023.

    Peter Zuber becomes the new Managing Director of ERNI Switzerland

    ERNI is setting an agenda for growth and innovation with the appointment of Peter Zuber as Managing Director of the Swiss business unit. With his previous experience and expertise, he will further expand the positioning of ERNI Switzerland, as a leading consulting firm for software development and digital innovation.

  • data230.08.2023.

    Unveiling the power of data: Part II – Navigating challenges and harnessing insights in data-driven projects

    The second article from the series on data-driven projects, explores common challenges that arise during their execution. To illustrate these concepts, we will focus on one of ERNI’s latest project called GeoML. This second article focuses on the second part of the GeoML project: Idea2Proof.