We are excited to be mentor at Stanford University's Health Hackathan. We will assess their technical feasibility and help provide guidance on product development.
image source: Human Factors and Medical Devices on FDA website by Walt Maclay Recently, I attended a fascinating panel discussion that explored the increasing importance of understanding human factors and user experience in the design and successful use of a medical device for home care or self-care. Medical devices like insulin pumps and home dialysis [...]
Wearable medical devices are biosensors attached to the human body to detect and monitor changes and capture biological / physiological data. These devices are usually non-invasive devices that function autonomously. Monitoring older adults and subjects with chronic conditions in the home and community are a growing focus of these applications. Common types of physiological functions [...]
by Walt Maclay At the 10x Medical Device Conference, which was held in San Diego the first week of May, I learned that major changes have been made in CE requirements for medical devices. After a long delay, the new rules were finally adopted in April of this year. The requirements are becoming more stringent, [...]
In a recent medical device project, we designed the control software and wrote the verification protocol for a class III heart pump. Our client submitted to the FDA and we are very happy to say that it was approved without any conditions or comments. It was quite unusual that the FDA had no comments on [...]
In CBInsight's article "Redefining The Future of Medicine: 72 Medical Device Startups Advancing Treatment And Prevention", they estimate medical device funding as $3.5B in 2016. It highlights and categorizes 72 private medical device companies. Their 9 business categories are: General Surgery - Companies developing advances to common surgical techniques as well as procedures such as suturing. Examples [...]
Voler Systems and V2Solutions recently partnered to develop the hardware, embedded software, mobile app and website for a home health product. It required a small battery-powered device to transmit data to a mobile phone and website. The biggest challenge in this project was the battery life: how to maximize the length of time between charges [...]
While the internet allows us to easily stay abreast of new developments in our industry, nothing beats face-to-face meetings for keeping one’s finger on the industry pulse, as well as establishing new and growing existing relationships via networking. We’ve created a roundup of 15 medical device and health tech meetups around Silicon Valley to make [...]