Updated: Apr 28, 2021
Japanese companies are famous for taking their time in the initial phase of product development - pondering over every nook and cranny and considering DFX (Design for Manufacturing, Cost, Robustness, etc.) before actually starting the development process. As a consequence, products are more often than not launched on time and budget, and spark joy (to borrow from Mari Kondo) with a well thought out design and low failure rate.
There is something to be learned from this, and companies that don’t spend enough time upfront to properly define what the product should do, what the user needs, and technical specifications, often suffer the consequences - scope creep, unsurmountable technical issues, negative value chain effects, and ultimately delivering to market a product that is not what the customer wanted in the first place.
When it comes to development in the medical device industry, the stakes of “jumping into it” are much higher and riskier - due to the simple fact that there are so many non-intuitive requirements that have to be followed. As an example, some years ago I was working with a contract developer that wasn't aware that fire-retardant material had to be used in a certain part of the device due to requirements “clearly stated in the IEC 60601-1 Subclause 11.2.1" Not knowing this, cost many weeks of rework, scrapped material, and tens of thousands of Euros. In any given project, chances are that issues like these arise - delay product launch and decrease the value of the product as well as profit margin.
A medical device development project should be initiated with proper emphasis on specifying the project properly. Relevant stakeholders (internal and external) should jointly define the intended purpose (who uses it, on whom, where, and for what indication), user needs, and this is then translated to possible technical solutions. These decisions then define the class of the device (active vs non-active, invasive vs non-invasive, etc). This input then forms the framework for what specific regulations to use. At this stage a rough timeline, resource needed and budget can be made - and very importantly, make iterations/changes if necessary.
Defining up front the scope and specifications of a development project with qualified stakeholders is crucial to deliver a great product to market on time and cost. If you are interested in learning more, please learn about our SQR1 workshop here.