Oct 4
Tips for Better Medical Device Product Definition
The medical device product definition process can make or break a novel medical device. Our experts discussed the topic and offered tips in a recent medical device product definition roundtable. Their tips range from general guidelines to regulatory, reimbursement, lean startups, architecture, and hazard management.
Continue reading »
We recently asked our engineering and QA/RA leaders which new developments are likely to impact medical devices in the near- and long-term future.
The risk management approach
When you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to survive and it’s the start of a countdown to death. Most people only know of the most common treatments such as – chemotherapy, which uses drugs to kill cancer cells, radiation which is used to destroy cancer cells and damage cancer cell’s DNA to stop dividing and growing, and surgery which remove the cancer tissues. They imagine losing hair and being in the hospital for weeks or even, months. But what is cancer, really? Is there a cure? What’s the chance of survival?
Do you know the most overlooked step in creating a useful medical device?
When I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new products.
Co-op students answer FAQs and share their experiences
The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and learning. My new favorite tool to iterate is our laser cutting machine.
On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be of interest to medical device manufacturers. 
Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
Many organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past.