Ask most medical device marketers about market segmentation, and you’ll get an earful about physician specialty (and subspecialty), hospital/facility size or type (academic, ASC, for profit, large system, etc), or adopter type (early adopters, followers, and skeptics). Unfortunately, these approaches rarely help companies identify customer groups that are differentially addressable – i.e. best served by different products or services, different price points, and/or different marketing channels and sales techniques.
Medical device firms can do much, much more to understand and better serve their markets. Even back in the 1980’s much more could be done. Let me explain how I approached market segmentation twenty-something years ago.
Technically creative product designs stoke engineering pride. Most medical device engineers are happiest when flexing their technical muscle – developing elegant mechanisms, designing clever electrical circuits, and writing creative code. Technical muscle grows stronger with every new product developed.
Strong technical muscle alone doesn’t make a medical device engineer a star. A great attitude is necessary too, but still not sufficient. Star medical device engineers also develop several other muscles needed to bring great products to market. One critical strength is the ability to develop great engineering specifications and tests.
More than two million drug-eluting stents were sold worldwide in 2011, of which 87% were manufactured from just five product designs [source]. The success or failure of product development is ultimately measured by financial outcomes. Each of us hopes our large investments in product development will be returned many times over by the sale of millions of profitable manufactured units.
A great product design is thus the set of instructions that enables scalable, salable, profitable production.
Lean manufacturing, now common in the medical device industry, originated in the automotive industry. Companies that truly embrace lean practices dramatically reduce costs and inventory levels while improving product product quality.
Stage-gate and requirements-driven product development, pervasive due to FDA’s QSR, has roots in PRTM’s PACE process and Robert Cooper’s Winning at New Products. A well-designed product development process shortens new product development timelines and improves the likelihood of product success.
Medical device companies reap tremendous benefits from borrowing the best practices of other industries. Unfortunately, most of us spend our whole careers in medical devices with limited knowledge of other industry practices. Meanwhile, as Marc Andreesen wrote last summer, “Software is eating the world.”
It’s not just the dramatic decline in the costs of memory, processing and communications that is fueling the software revolution. Key to software success is a radically new approach to product development best summarized in Eric Ries’ fantastic book, The Lean Startup and Kent Beck’s classic Extreme Programming Explained.
While I don’t expect scalpels to be replaced with software anytime soon, we in medical devices can learn a lot from Lean Startup software practices. Today’s topic: test-driven development (TDD).
Look around the parking lots of medical device companies, and you’ll find that most engineers drive Japanese cars. Even those who drive something else acknowledge the manufacturing prowess of Toyota, Honda, Nissan, Subaru and Mazda. When it comes to cars, we all know that manufacturing matters. Look inside the buildings of medical device companies though, and it’s often a different story. Most product development engineers have little understanding of the discipline of medical device manufacturing, other than a required familiarity with good manufacturing practices. It’s the rare medical device product developer who understands single-piece flow, 7 wastes, line-balancing, cell-based manufacturing, theory of constraints, poka-yoke, kanban design, kaizen events, six sigma, zero defects and the many other buzzwords/elements of lean manufacturing. It’s a real problem.
The best development engineers know that manufacturing matters, and engineers who “get” manufacturing create significantly better product designs and significantly more value. No great medical device designs make it to the end customer without being manufactured. I could even argue that medical device product development is all about manufacturing. Here’s what I mean.
Developing new products to improve patient care is the best part of being in the medical device industry. Who can argue with that?
You’ll find the most exciting devices being developed in venture-funded start-ups – a structure that provides the single-minded, do-or-die focus needed for success, along with the risk capital needed to fuel the work. Here in New England, we have a great medical device start-up ecosystem, with dozens of companies working to solve significant medical problems with great new devices.
Each quarter, the MoneyTree Survey lists virtually all venture financings in the US. The 2011 Q1 numbers just came out. Reviewing the data, I thought it would be a good time to look back at the New England medical device companies started in the past several years.
Medical imaging systems have been talking to PACS systems for years, saving costs and improving care. I’m always impressed that my children’s doctors can access current and historical x-rays and MRI’s at the drop of a hat. Integration of devices with PACS enables medical images to be captured, backed up, transmitted, analyzed, and reviewed in other care sites and at other times. The age of the standalone medical imaging system is long gone.
Other medical devices are beginning to follow suit, interfacing with electronic medical records (EMRs) and hospital inventory management systems. Networked devices are on the way, and the age of the standalone medical device is heading to a close.
The era of networked medical brings challenges and opportunities. Are you ready?
Medical device product development is justifiably hard. Innovative devices push technical and clinical boundaries. Before being used for patient care, new devices must undergo rigorous analysis and testing. It takes months or years to bring new medical devices from concept to reality. So it’s a big milestone when the last signatures finally authorize product release, and the first units ship to the first customers. Time to celebrate? Not so fast.
Your first customers decide if you should celebrate. Initial shipments are just steps towards the ultimate objective – satisfying unmet customer needs and building a great business. How well have you really done? A couple of weeks ago I wrote about the need for metrics to be customer-facing. Here are a few suggestions for quick-and-dirty customer-facing metrics to help you assess your product launch.
Broadly defined, platform technologies are families of IP that enable multiple distinct clinical applications for distinct patient populations. MicroCHIPS and Seventh Sense are great examples.
Because platforms address multiple market opportunities, the revenue potential of a company with a platform technology can be several times that of a single application company. Does that mean platform technologies are easier to fund?
Pitching platform technologies to VC’s can be challenging. First, cool new technologies need lots of explanation. Second, presenting multiple market opportunities takes lots of time. One of my most popular posts has been “Medical Device VC Funding: Slide Deck – Part 1,” which covers a company developing a single medical device product to address a single unmet need. How should companies with platform technologies present to VC’s?
Most trade disputes between medical device companies involve intellectual property (IP). While the conflict between LightLab and Volcano is relatively small compared to others in the medical device industry (e.g. check out last year’s $1.7B battle between Boston Scientific and J&J), the lessons to be learned are large.
Briefly, Volcano is developing a competing product to LightLab’s OCT system, and accelerated their program by purchasing LightLab’s laser supplier Axsun. The dispute involves allegations of patent infringement, unauthorized disclosure of confidential information, and contract performance issues.
At the end of January, both LightLab and Volcano issued press releases claiming victory in the most recent rulings. Eric Swanson, LightLab co-founder and editor of Optical Coherence Tomography News, just posted an entertaining summary of the recent court documents. Despite these rulings, the legal skirmishes will continue, and the only safe prediction is that the lawyers will be the winners.