Industry Perspectives

  1. An Intro To Tools And Methodologies To Improve Change Management

    This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.

  2. “We Are Only Diabetes”

    Medical device companies often face difficult choices regarding their products, from design tweaks and regulatory red tape to determining whether to solve needs in-house or outsource.One uniquely difficult decision, though, is whether to diversify — and how much — or to specialize.

  3. 2018 – Good For The Device Industry, Good For Patients, Good For FDA

    I recently assembled a forward-looking article for Life Science Leader magazine, blending feedback from seven medical device industry leaders, who discussed industry trends for 2018. Here, I share the full set of responses from Maureen L. Mulvihill, co-founder, owner, and CEO at Actuated Medical, Inc.

  4. Incorporating Accessibility Into Medical Device Design

    When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.

  5. 5 Things Medical Device Engineers Should Know About User Research

    When designing a medical device, nothing beats direct observation of, and feedback from, the people who will be using it. Ideally, this research is performed as a close partnership between the human factors (HF) researchers and the engineers who will be working on the device.

  6. India Looking To Local Solutions For Domestic Medtech Needs

    For most of the last century, innovation in the medical device ecosystem has emerged from rich countries: the United States, Japan, Europe, and Australia. But today, a thriving ecosystem has developed across India, driven in part by unique needs in India and in part by the cross-fertilization of ideas, education, and capital from American sources. In this article, we look at three startups that are addressing India’s unique problems today, but may eventually bring their solutions to a global audience.

  7. Serial Life Science Entrepreneur On The Road Less-Traveled

    Quick! You’ve just licensed disruptive technology from a university research institution. It holds the promise of improved treatment for a prominent disease around the globe; what do you do first?

  8. FDA Registration for CMOs – Still Crazy After All These Years

    Let’s face it: manufacturing in a regulated environment is more expensive than commercial manufacturing. With all due respect to the venerable prowess of medical device manufacturing professionals, even a lean, mean, 5S, Six Sigma, 8D machine cannot offset the cost created by a plethora of requirements, guidance documents, and standards.

  9. Skeletal Wonder From Down Under

    What a perfect day to talk about skeletons! What is a skeleton without a sternum and some ribs? A skeleton without a sternum and some ribs represents a person who may benefit from technologies by Melbourne, Australia-based medical device company Anatomics.

  10. What Does the Federal Risk Management Framework Mean for Medical Device Developers?

    Federal buyers make up an enormous and attractive market for medical device manufacturers. But tapping into this market can have unexpected pitfalls for medical device developers.