Of all the important elements of medical device new product development (NPD), project planning and management gets the least attention and is the most poorly performed. Full stop.
We expend tremendous product development effort to deliver patient safety, product performance, and physician ergonomics. We design for cost, manufacturability, and reliability. We agonize over the wording and acceptance criteria of every requirement. Our drawings are exquisitely toleranced. No spec is left unverified or unvalidated. Instruments and fixtures are IQ’d, OQ’d and PQ’d. Manufacturing processes are thoroughly validated. We justly take pride in these achievements. One medtech engineer told me that he sleeps better at night knowing his risk analysis was well-done.
Yet when it comes to planning a project, our attention wanders. We put in some effort, get frustrated by the complexity and ambiguity of the project tasks and dependencies, and call it “good enough.” We don’t put nearly the effort into planning that we put into FMEA’s or inspection instructions. We write something up, get it signed, and a couple of weeks later, project plans lie quietly buried and already outdated in a design history file. Most of the time, we don’t know how to make the plan any better, even if we wanted to.
Sound familiar? Software companies have shown us that there is a better way.
I’m not going out on much of a limb when I say that, as an industry, medical device companies are not particularly strong in project management. A tool (like Microsoft Project) is not a management technique. Program management offices abound in larger companies, but rarely do you find a systematic approach to defining the activities of project management. The Critical Chain approach has advantages over a traditional Gantt chart, but at the end, it’s still only a tool. We’re really stuck in last century thinking.
The New England medical device startup community is an amazing innovation ecosystem, producing great products and great companies over several decades. New startups are the lifeblood of that ecosystem, so I’ve been tracking first-time venture financing of medical device companies in New England since 2005.
I’m way overdue for an update. You’ll find my 2014 Q4 New England Venture Funded Medical Device Startup List linked below.
At Fractyl we’re building an amazing team – the best I’ve ever worked with. Our team is super smart, highly productive, and absolutely dedicated to our mission. We see the big picture but we aren’t afraid to sweat the details. We also know how to have fun.
Great teams start with great recruiting. Recruiting best practices are important, but not enough. Read on to learn how we’ve built best team in medical devices.
I’ve been writing about physician owned distributorships (PODs) for a while. See my previous posts here and here. Whether or not there is improper behavior, physician owned distributorships create the appearance of impropriety and give the medical device industry a bad name.
Earlier in September, the Justice Department finally took action against a physician owned distributorship. It took time for the Office of the Inspector General (OIG) to build its case against PODs generally (see the OIG activities here), and against this distributorship in particular. My guess is that the Justice Department will try to use this case to set a precedent, so the Continue reading →
While you might be sick of Amazon telling you that customers who bought product X also often bought product Y, Amazon knows what sells more products. I’ve used the same technique in medical device markets. Last year I wrote about medical device market segmentation using procedure data – finding prospects for your procedure X based on customers who perform procedure Y. Why target interventional cardiology as a whole, or so-called “early adopter interventional cardiologists,” or community hospitals versus academic medical centers, when you can specifically target sub-segments based on actual device use, e.g. IVUS users, chronic total occlusion specialists, or high volume stenters?
In 2014, big data powers marketing in consumer and tech, and it’s coming to medical device marketing and sales. Applied well, big data can focus sales efforts on the likeliest adopters, identify prospects that you never knew existed, and uncover market segments with unique product needs. If you don’t already know the power of big-data-driven marketing in the consumer world, read the recent (chilling) US Federal Trade Commission report on data brokers.
Medical device customers are consumers too. Here’s how I used big data at Candela in 2009 to re-imagine our marketing and sales approach.