Combating the challenges of medical device development
In what ways is medical device development similar to other product development?
If you are in a product development role, you will be very aware of the sorts of challenges you face, including:
The Rational Solution for Systems and Software Engineering has been produced to help companies to meet these challenges. In this post, I am going to briefly discuss the solution for medical device development that is being built as an extension.
In what ways is it different?
The most obvious difference between the medical device world and the general world of product development is the highly regulated environment in which medical devices are developed, sold and used. From its earliest days on, the industry has been used to working within strict compliance frameworks. This has a number of implications that you need to consider carefully. Some of the challenges specific to this industry include:
What do you need to worry about?
Are you planning to sell a device in just one country or internationally? Even if you are only selling in one country, you might need to take into account regulations in places where you (or sub-contractors) manufacture. For example, the United States Food and Drug Administration (FDA) regulations apply to medical devices or parts of medical devices sold or made in the USA.
So you almost certainly need to consider multiple sets of regulatory requirements. This gets trickier because there are not just different regulations, they are often based on different philosophies. National regulations, such as those from the FDA, are typically based on outcomes, not on prescribing specific activities. However, many international standards, such as ISO or IEC, do prescribe ways of working. You need to find a balance. And that's not all, many national bodies are moving towards the use of international standards. All this adds to the complexity of ensuring that you are compliant with applicable regulations.
As if all that was not enough to give you a headache, remember that failure to comply with these regulations can have severe consequences, including large fines, closure and even jail for responsible executives.
In practice, this all means that the people responsible for processes in medical device companies have to be aware of multiple standards, but if they do their jobs well it will not significantly affect developers.
How can we help?
We have recognized the issues for medical device developers and in response have created the Rational solution for medical device development. This provides support for all the key activities of development (requirements, modeling, verification, validation and testing, configuration and collaboration management) through an integrated tool set and practices. It is made up of these elements:
The practices that we deliver provide a basis for your own content. Many people look for “best practices” in industry areas. There isn’t really a single set of "best practices" for medical device development. Essentially, best practice in engineering consists of delivering what is wanted within necessary constraints, including time, resources, regulation, etc. You could state that it comes down to the same advice as given to presenters, which we can re-phrase as "say what you are going to do, do it, and then show that you have done it". To support you, we have identified some common themes as being important for medical devices. These include:
The solution allows you to access context-specific, tailorable content at any point. For example, if you are writing requirements in DOORS, you can find out what practices are recommended in your organization for writing, where requirements fit into your life-cycle, how these practices are implemented in DOORS and, if you need it, higher-level guidance on topics like traceability.
Solution brief: Improve processes, manage IEC 61508 and IEC 62304 standards, develop quality products
Webcast: IEC 62304 for medical device software development: Steps to compliance
Webcast: Developing medical devices with safety, reliability, and security in mind
Webcast: Agile development of medical devices
Webcast: Achieving medical device software compliance under IEC 62304
About the Author
Dr. Keith Collyer is an expert in Requirements and Systems Engineering. He trained as an electronic engineer, later moving into software development. His interest in the “people” aspects led him into project management, quality assurance and processes, never losing sight of the need to develop systems that meet real needs. Much of his career has concentrated on helping organizations large and small to introduce requirements management. The key aspects of this are ensuring that the client understands the needs for and benefits from requirements management, clarifying and defining with the client the processes involved, including the necessary information and inte