In the midst of a global pandemic, the role of commercial field teams evolved right before our eyes. Digital sales aids and tele-detailing are now mandatory sales tactics in a virtual Provider-Rep engagement. Now that field teams are starting to settle into “the new normal,” manufacturers are turning their attention to the next phase: make […]
The New Roaring 20s: How Outsourced Commercialization is the Revolution We Need. To effectively commercialize a product, traditional service silos stand in the way of true healthcare transformation. Do disparate service providers look at the life cycle in the same way you do? There is a real need for a market access strategy that converts […]
What kind of clinical data is required for FDA clearance of a Digital Medicine? It depends. Digital therapeutics and digital medicines that are subject to FDA regulation are considered medical devices. The amount of clinical data required by FDA generally depends on risk. Many moderate risk (class II) medical devices seeking 510(k) clearance are required […]
I often meet with Digital Health or Pharmaceutical clients to discuss their commercialization journey, and they ask me the same question. What specifically triggers FDA regulation of a digital medicine? Some of these products require FDA clearance and some do not. Regulatory oversight of digital medicines depends primarily on intended use, which is generally captured […]
Launching a product is a serious undertaking, requiring a seamless approach to building a commercialisation strategy that includes all the variables needed to maximise the investment across the product’s lifecycle. Nowhere is this more true than the world’s largest market, the United States (US). We know that a successful product launch is critical to maximising […]
Q. How do you successfully commercialize a new product in the new era of “patient-as-consumer” and “outcomes-based healthcare”? A. You design and deliver an engaging, high-touch patient experience. In this 30 minute webinar, Tom Doyle explains how manufacturers historically relied on a one-size-fits-all HUB model that utilized benchmark data from products in similar therapeutic classes […]
[Webinar: 23 Minutes] With over 20 years experience on the clinical research arena, Mike Ryan shares the importance of patient engagement from the clinical trial all the way across the drug development continuum. He highlights that although some patients might not qualify for the clinical trial, they should continue to be relevant as future clients/patients […]
The “Great Gatsby Era” was an exciting time of new prosperity, infinite creativity and dramatic social change. Long-standing social norms and traditions gave way to the “mass culture” and consumerism that modernized American society. “What will they think of next?” was a popular expression that defined the era. On the 100-year anniversary of this revolutionary […]
Commercial Strategies for a Successful Product Launch. With the launch of new blockbuster drugs becoming less frequent, there is increased scrutiny on the importance and success of clinical trials, mandatory to determining the safety and efficacy of a developing product. The road to commercialization is daunting – the process of bringing a product to market […]
The promise of digital health – from wearables to mobile health apps – could revolutionize healthcare by improving adherence, reducing costs, and making treatments more personalized. Mike Ryan shares insight on the opportunity to set a commercialization standard in the digital therapeutics market that meets customer need, works with regulators and payors, and defines how […]
