Have you made your medical device commercialization resolutions for 2023? We polled our quality, regulatory, project management, manufacturing, and engineering experts for their New Year resolutions. De-risking early, communicating often, testing, and managing pivots were top themes for 2023. Read their medical device commercialization resolutions below:
StarFish Medical YouTube subscribers grew 50% in 2022. What medical device commercialization videos were they watching?
Editor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one here. In this modern world, cyber security and data protection has become a familiar topic to us all. From agreeing to cookies on website, to data privacy agreements to […]
Managing medtech stakeholder expectations is an important element of medical device development success. Investors, Internal stakeholders, KOLs, Clinicians, Scientists and Engineers will all play a part in shaping and delivering a successful medical device. We asked key members of our team to share their best tips and lessons learned. Here are 8 tips to manage […]
Six BioManufacturing Trends to Watch in 2022 The COVID-19 pandemic shed a light on the strengths and shortcomings of the global biotech infrastructure in relation to pandemic readiness and general support of biotech innovation.
Personalized medicine approaches can transform the field of biomanufacturing through the use of additive manufacturing technologies. Successful implementation of such processes requires an interdisciplinary effort with engineers, biologists, and clinicians working together to achieve success developing regenerative medicine, microfluidic-based assays, or cell therapy applications.
Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public. Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted […]
This blog provides an overview of Medical Device Manufacturing Cleanrooms and draws upon our experience validating our Class 7 Cleanroom. A highly regulated environment, like that of a ISO 13485:2016 certified medical device manufacturer, requires assurance that critical processes can be performed within a controlled environment.
Keeping current with Health Canada’s medical device regulatory developments Over the course of the last year and a half, the number of accomplishments that Health Canada has achieved both in urgent response to the COVID-19 pandemic and towards priority projects is impressive. It has been said that timing is everything. While the operational pressures from […]
A Three-Pronged Strategy to Stay Ahead A medical device is a convergence point where various technologies and regulations come together to impact patient health. Within the diverse ecosystem of the medical device industry, there are fluctuations driven by new entrants, new technologies and new markets. These forces create market shifts and open up opportunities. KPMG […]
Key updates in ISO 15223-1:2021 Symbols are a universal language. When looking at smiley and sad faced emojis anyone from around the world can differentiate the meaning between the two. That is the power of symbols. In the right context symbols can convey a significant amount of information in a small amount of printed or […]
Ensuring new hires feel connected to the team and engaged in their position is critical. So much has changed since moving to remote work, including the onboarding process. Don’t be fooled; the initial weeks or months aren’t just when an organization assesses their new hire, it’s also for the new employee to determine if they […]
