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 2 Read More »
Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation. Frequently, it’s because their company’s quality system, explicitly or
Software Testing Is Not Hardware Testing Read More »
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. 2020 Issue 1 Read More »
Writing and managing requirements for new product development is challenging and multi-faceted. Tips to help your team on the right path to good requirements.
Why Aren’t the Requirements Done? Read More »
The Two Mindsets of Successful Medical Device Development Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and lower manufacturing costs while still
Looking forward to presenting at MD&M with Roger Tang Read More »
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 4 Read More »
(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s work, a bad one hinders
How to set up a quality system for a medical startup Read More »
Aaron is excellent to work with and has been invaluable for the team’s success. His consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on to streamline technical or regulatory
Invaluable for the team’s success Read More »
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
Newsletter V. 2019 Issue 3 Read More »
Understanding all the details of risk analysis methods and compliance with the ISO 14971 risk management standard can be quite complicated but fundamentally, for development of a new medical device, risk management is about answering these seven key questions: What are all the possible things that could go wrong? What are we most worried about?
The Big Picture for Medical Device Risk Management Read More »
