Tag Archives: Business

There’s a Medical Device For That

English: Foldable, acrylic Intraocular Lens

Like virtually all cataract surgery patients, my parents were thrilled with their cataract procedures. Why not? After a quick office procedure, their new intraocular lenses (IOLs) gave them  better vision than they had experienced for more than a decade.

Now imagine a world with no devices for cataracts, only drugs.  Imagine taking one or more medications every day for the rest of your life – drugs which could not cure cataracts, but which slow the inevitable progression towards blindness. Imagine the typical chronic-medication side effects: somewhere between minor discomfort and an increased risk of cardiovascular mortality.  How does that sound?

When given a choice, I’ll take medical devices over drugs every time. Here’s why.

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Medical Device Venture Funding Trends – Q1 2013

PWCMoneyTree Medical Device Venture Investments 1995-2013The latest quarterly MoneyTree Report was just released, providing some insight into the state of medical device venture funding in the US. I downloaded and plotted the historical trend data for medical device VC investments in the U.S. from Q1 1995 to Q1 2013.  Click on the thumbnails for larger images.

What do the trends tell us?

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Star Medical Device Engineer – Experimental Protocols

My colleague Chris recently noted: “the right way to do things is often a pain in the butt.” No question that most engineers see protocols as a pain in the butt – yet another file to sherpa through the document approval process.

There’s an important logic behind the practice of doing protocols. Imagine doing an experiment on humans (aka a clinical study) without one. But “good product development practice” isn’t the only reason star medical device engineers write protocols. Believe it or not, star medical device engineers view protocol writing as a key element of team leadership and team effectiveness.

Let me explain. Continue reading

US OIG Warns on Physician Owned Distributors

USDOJ Office of the Inspector General Seal

In 2011 I urged extreme caution for medical device companies considering  selling products through physician-owned distributorships (Caution: Physician-Owned Distributorships Ahead).  This week, the US Office of the Inspector General (US OIG) issued a fraud alert for physician-owned distributorships, stating that “OIG views PODs as inherently suspect.”  Don’t say I didn’t warn you.

Star Medical Device Engineer – Statistical Thinking

Sir Ronald Aylmer Fisher FRS

If you haven’t learned to fear adhesive bonds, you haven’t lived a complete medical device life. Adhesives are truly marvels of transmutation: liquids stay liquid until they magically become solid, and a drop or two of base substance can hold dissimilar materials together with superhuman strength.

Yet control of adhesive processes is always a nightmare. UV fluence or position changes from lamp-to-lamp, and oven temperature varies seasonally. The environment is always too damp or too dry. Dispenser accuracy varies. Somehow the location of your adhesive on today’s device has shifted slightly from last year’s location. With adhesives, you just never know which variable is going to cross the line from in-control to out-of-control. You don’t need a masters in statistics to see that a large number of low-probability process failures adds up to a higher-than-desirable probability of bond failure.

I routinely bore people with my assertion that everyone should be required to study and master statistics in high school. We all need statistics to better understand the world we live in and the news we read. Without statistics literacy, we can easily be misled. In our personal lives, we make financial investments, buy insurance, and make decisions with risks. At work, engineers and scientists need statistics to understand designs, processes and experiments. Sales and marketing people need statistics to understand market attractiveness and sales probabilities. Supply chain and operations experts need statistics to understand forecasts, materials plans, and manufacturing processes. Even accountants and finance types need statistics to understand currency risks, stock options, and financial instruments.

Star medical device engineers master statistics to make better designs in less time. How? Continue reading

Medical Device Startups – Northern California Over New England Again

NE Medical Device Startups 2012Q4In the eight years of data I’ve collected on New England medical device company venture funding, I’ve never seen it this tough. Only four new companies were funded in 2012 (see my complete list below).

You might be tempted to blame VC belt-tightening  or the “Patient Protection and Affordable Care Act.” You’d be wrong.  While the macro environment has its challenges, four new NorCal medical device startups were funded in Q4 alone.

What gives?

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Medical Device Marketing – Segmentation With Procedure Data

Portrait of Jan de Doot and the kidney stone h...

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.

Contrast the typical medical device approach to the sophisticated techniques of consumer product firms. Are you a Barry, Jill, Buzz, Ray, or Mr. Storefront? Best Buy’s in-store staff segments you with a few questions before steering you to the products you’re most likely to want. Amazon suggests possible purchases for you, based on your clicks plus the buying history of other customers who bought the same products you did. Target buys your demographic data to combine with your Target purchase history to create custom coupons for you.

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.

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Star Medical Device Engineer – Specification and Test Development

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.

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Healthcare Venture Capital Fundraising List 2012 Q4

Time Is TightThe glass is half full. I’ve been tracking the fundraising activity of healthcare venture firms for the last few years, and I estimate that there are about 250 VC firms actively investing in healthcare innovation worldwide. In contrast, a list I created ten years ago, at InfraReDx, included about 500 healthcare VC firms. Times are tight in 2013.

Why the drop?

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Star Medical Device Engineer – Attitude

Engineering Department employees, 1962

Engineering Department employees, 1962 (Photo credit: Seattle Municipal Archives)

One of the best parts of starting a medical device company is the opportunity to build a great team. At Fractyl, I’m happy and proud to say that our team is truly awesome – talented, hardworking, committed, and fun. Putting together a great team is not easy – for every position, we’re always looking for a superstar. Somehow we’ve found them.

One of my best friends runs an engineering group at a major contract research lab, and we occasionally commiserate about the difficulty of hiring great engineers. Of course, number one on our list is technical expertise. Don’t knock on my door if you don’t have the technical chops. While technical competence is hard enough to find, my friend and I are both looking for more than mere technical brilliance. The number two attribute on my list of star medical device engineers is attitude.

In an effort to improve performance, my friend gives each of his engineering hires an article from 1999′s IEEE Spectrum: “How to be a Star Engineer” (or here).  It’s a great article that would benefit almost every engineer. The author, Robert Kelley, presents nine strategies that lead to better engineering performance. Attitude is critical.

Here’s the attitude I’m looking for:

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