In December I had the opportunity to present at the 2016 BIOMEDevice conference as part of the Embedded Systems Conference (ESC) in San Jose. Because of my experience with medical devices and cloud-based software development and many years as a systems and embedded software engineer, the topic chosen was how to address common errors in Cloud-connected medical device systems development.
In today’s medical device industry, it is becoming essential to select product development partners that have ISO 13485 certification. In fact, more and more medical device manufacturers are requiring their suppliers to be ISO 13485 certified.
It is hard to avoid uncertainty in product development. Those that are seasoned in bringing products to market know that risk is an inevitable part of the development process. Project risks are lurking around every corner during product development. But don’t let that scare you.
For medical device developers outsourcing can be an effective solution to increase innovation, reduce risk and get to market quicker. Choosing the right development partner can be tricky when many make the same claims and seem to be equally qualified.
I was recently listening to a discussion about the difference between technology development and product development and why it’s so important to clearly understand. Lots of people fail to recognize the distinction and it costs them a lot of R&D dollars. Here’s one simple way to think about it.
In a recent work session the question of how to control scope creep in product development came up. It was an interesting discussion and I was struck by how the causes could be described in a pretty simple way. That’s not to say controlling scope creep is simple, but knowing the source may be a place to start. Here are three to be aware of:
In the competitive landscape of medical devices and the advantages to being first to the market, many are tempted to move into product development at a rapid pace. Moving into product development quickly is full of risks, particularly in the medical technology space where development is heavily regulated and process driven. There are five elements of product development that you must thoroughly understand prior to entering formal medical device development to reduce risk. Missteps here will certainly cost you time and money and might even doom your product altogether.
The past decade has brought a renewed interest in product development that reimagines the convergence of hardware and software technologies with the cloud. The ability to miniaturize and integrate sensors into ‘smart’ devices that connect to the cloud has unleashed a wave of product innovation. This revolution has transformed how we use technology, and is not limited to smartphones and wearables, but has found valuable application in medical, life sciences, health, sports, transportation and at home.
As we meet new clients one of the questions that’s frequently asked is “Why are you better than the design arm of a contract manufacturer, or an ODM (Original Design Manufacturer)?” Other than a few unique situations, our experience shows that it is always better to go with a design firm that does not have an exclusive manufacturing relationship ove