Newsletter V. 2022 Issue 3
September 2022 Newsletter – Integrating Two Worlds of Product Development
Newsletters
Newsletter V. 2022 Issue 2
September 2022 Newsletter – Integrating Two Worlds of Product Development
Newsletter V. 2022 Issue 1
March 2022 Newsletter – Back to Basics with Design Controls. Changes are coming to design control regulations. Advanced design controls
Newsletter V. 2021 Issue 3
December 2021 Newsletter – Digital Health – Big Updates from FDA
Newsletter V. 2021 Issue 2
September 2021 Newsletter – Digital Health and Medical Device Software Digital Health encompasses a broad range of products leveraging the latest software and communication technologies to improve patient health and increase the efficiency of healthcare systems. Some of the most innovative are software-only products (SaMD) utilizing sophisticated algorithms to analyze health data and aid clinicians …
Newsletter V. 2021 Issue 1
April 2021 Newsletter – Better Approach to Medical Device Development Let’s Get Back to Basics Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed to successfully develop an innovative …
Newsletter V. 2020 Issue 2
OCT 2020 Newsletter – Medical software challenges and new digital opportunities Some of the most promising innovations in healthcare technology today are based on software development and the digital health sector itself is a large and growing part of the industry (see below). Software enables many new opportunities in healthcare but also presents new challenges …
Newsletter V. 2020 Issue 1
The world as we know it is changing. Covid-19 has created huge disruptions and it’s harder than ever for teams to effectively communicate and develop new medical devices. Business collaboration and decision making are increasingly difficult. Fortunately plenty of organizations and companies are broadcasting new tools for collaboration. Maybe you’ve seen ads on LinkedIn for …
Newsletter V. 2019 Issue 4
Medical Device Startups Startups are the heart and blood of the medical device industry. They are driving innovation and making healthcare more effective and more personalized. Because of this, startups are well positioned for an emerging ecosystem of interconnected medical technology and services. Investors see the enormous opportunities in improving healthcare and developing technology and …
Newsletter V. 2019 Issue 3
Risk Management Risk management plays a central role in medical device development but many medical device professionals I’ve worked with over the years seem to have missed the forest for the trees. They are more focused on the details of risk management compliance than the central goal of product safety. This blog post summarizes the …