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.