When I first released my book I had 600 contacts and participated in 1 group. Now with 2,800 contacts and 9 groups, I thought I would remind all that this great resource is available on Amazon ..read more

The Story Mentoring and coaching product managers are two of the most rewarding things I do. Recently during a session with several mentees, one of the product managers seemed down. When I asked what they were feeling, the emotions flowed out. He was overwhelmed by the sure volume of Work that he was facing. In addition, there had been recent layoffs at his company, so he wasn’t feeling very secure. Those two conditions combined produced anxiety that he had been battling for months. So, unfortunately, he was slightly depressed. He was new to product management and hadn’t felt this way before ..read more

Context Over the last year, I have conducted several New Business Development activities (acquisitions and funding). In pursuing favorable decisions on both fronts, I have been what my son calls ‘Ghosted.’ In the past, my generation called it being ‘Blown Off.’ Reflection The phenomena caused me to pause and ask why someone would ghost another professional trying to pursue a mutually beneficial goal. Is it that difficult to say no thank you? What is the downside of admitting that you don’t want to pursue the relationship, the deal, or the investment? I am exploring the potential motives and t ..read more

Prelude I have had several discussions with companies recently that are wanting to enter new markets. We start the discussion, and they want to talk about regulatory requirements and pricing. Both topics are critical to entering a new market; these two topics and about 50 more are all critical to first, choosing the next right market, and secondly, developing a winning strategy and creating a tactical plan to make it happen. Entering a new market will likely consume significant resources. Therefore, it is worth taking the right amount of time to determine if you will succeed. In my 40+ years ..read more

Prelude In recent weeks, I have had discussions with three potential clients about their shot-gun approach to launching their new technology platforms. My advice was the same for each of them, FOCUS is power. Pick the right channel, or product, or therapy to go after, and then apply all your assets to entering that market segment. The return question, ‘how do I know which is the ‘right product, channel, or segment?’    Set-up  A fourth potential client had it all figured out and was just looking for confirmation and a bit of help in doing it. He wanted to start with segmenting ..read more

Set up In a coaching session that I held yesterday with a Sr. Product Manager we were preparing for his first-ever new product launch when, it occurred to me that in all the blog posts and in my book, INSIGHTS: 33 Lesson Learned in Medical Device Marketing[1] I have never really explained that a new product launch is not a single event. The launch never really ends. It is made up of events that track the product life cycle. So, it might serve us better to think of them as a series of Launch Campaigns. Across the life cycle, your device will be exposed to different target customers, geogra ..read more

Prelude With the creation of the STeP process the FDA finally, after 45-years, signals that they are proactively trying to fill the implied mandate from Congress to protect the US population by ensuring that safety is proactively promoted in the medical device space. Set-up  Safety has always been a prime motivator for change within the human population.  When I think about the motivators for physicians to change their purchasing (use) behaviors I reflect on a model that we have all seen before,  Maslow’s hierarchy of needs.  Modifying Maslow’s labels for the five levels to ..read more

Prelude Before we look at the title question let me declare some personal bias. Because of what I have seen over the last 40 years, I am now and have always been an advocate for patient safety. I believe in regulatory control over the medical device industry, so I have never cut regulatory corners. I must admit that there were times when I used those regulations to my advantage. I am not a regulatory compliance professional. Set-up  Live case presentations at major medical conferences can provide a huge momentum surge for a new product or technique if all goes well.  If things don ..read more

Prelude The core focus of the EU MDRs is Postmarket surveillance [PMS], with the recent guidance document, TIR 20416:2020 reinforces this quite clearly[1]. The goals of PMS are: Monitoring medical device safety and performance Meeting regulatory requirements Contributing to lifecycle management To achieve these goals the guidance document wants manufacturers to: Actively and systematically gather data Record and analyze relevant data Focus on quality, safety, and performance Engage in PMS data gathering and, more importantly, analysis as a lifecycle activity Us ..read more

Set up I have been approached recently by several start-up companies to assist in launching their New Medical Devices. All of them have worked incredibly hard on developing their technology. Brilliant scientists, physicians, and inventors, they genuinely have done great work, some spending more than five years on getting ready for their launch. More often than not, they are not prepared, for a variety of reasons, but at the core is that they didn’t have anyone with a Marketing Mindset performing the upstream marketing role. But are they ready for their launch? Have you put the building blocks ..read more