Star engineers excel at failure investigation. Full stop.
We’ve been working on some really interesting failure investigations at Fractyl recently, and I always like to take a step back to learn from my team. Here are a few observations that might help you up your failure investigation game.
Star medical device engineers know that developing great products requires more than just outstanding technical skills. Star Medical Device Engineers understand product development as a critical business process designed to produce a return on investment, and star engineers understand that product development decisions are both engineering and business decisions.
Star medical device engineers want to do great engineering for important medical needs, but they also want to see their products widely used and their companies successful. Stars want to win sales and earn profits. Here’s how.
Alongside the well-known “Move fast and break things” sign at Facebook was another sign: “Done is better than perfect.” The fact that this phrase needed posting is a reminder of the ubiquity of most engineers’ tendency towards perfectionism over timelines.
I tend towards perfectionism myself, but I recognize that perfectionism can work against me and my team. People across my company, and outside my company, depend on me to hit my commitment dates. Trade show dates don’t move, so presentations and product introductions need to be ready. Clinical trial sites make a huge effort to arrange trial dates – coordinating a variety of hospital staff, and postponing normal activities – so clinical product needs to be ready on time. You get the picture.
I had coffee with a former colleague last week, and he told me something surprising he learned about himself. His new company has bench desking, and everyone’s space is a little less than three feet wide. At his previous company, he had a large desk with a sweet window view. He told me that “If someone had tried to get me to give up my old desk I would have put up a big fight, but at my new company, it’s not an issue. The space works. When we hire a new person, everyone squeezes together to make room.”
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.
Lots of great individual contributors ask to become managers. They reach a point in their career where a management role seems like the next logical step up. The management path appears to offer more authority, and probably more money.
Unfortunately, success as an individual contributor is no guarantee of success as a manager, and many high-performing individuals find out later that they hate the responsibilities of management. They hate the amount of time they spend in meetings. They dread the planning and budgeting. They can’t stand dealing with personnel issues. They find themselves putting off work on performance reviews. They don’t effectively delegate tasks, because they can more easily perform the tasks themselves.
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.
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.
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.
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.