Star Medical Device Engineers Know the Business of Product Development

Electrolux PDPStar 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.

Star engineers are passionate about deeply understanding user needs because they want to design the product that customers love, without over-designing the product. Star engineers focus on COGS and manufacturability early in the product development process. They know that great manufacturability is designed in, and they choose designs where costs will fall with scale. They search for part count reduction, and they design for product reliability and adequate performance margin (because they know that customer returns and scrapped product kills costs).

Star medical device engineers understand their company’s product development process as a procedure to help guide the company to business success. The product development process is designed to manage an investment in activities that produce a design for a product that can be manufactured for acceptable profit margins at volume. Medical device companies use a phase-gate approach to systematically de-risk investments, and to identify low-return projects before investing too much.

We invest a small amount upfront in a concept development phase, to verify the magnitude of the market need, to begin to learn about user needs, to de-risk the technical feasibility of the project, to study the environmental headwinds and tailwinds, to create the detailed plan to execute the product development project across all functions, and to develop a meaningful estimate of the investment and time required, and the projected sales and profits. If all still looks good, we invest in a product development phase, where we design the product and its manufacturing processes, we go deeper on learning the market needs, and we begin the long process of teaching the market about their own needs and the benefits of our solution. When we are ready, assuming the business prospects remain in our favor, we invest in verifying that our product meets requirements so that we are ready for true market validation of our product – first clinically and ultimately in the commercial market.

Well designed product development processes are not simply boxes to be checked, but deep essential questions to be answered: Is the market opportunity sizable and ready for innovation? Will our product really meet our user’s needs, will customers prefer our offering to competitive products, and will they pay a price that returns acceptable profits? Is our product manufacturable and reliable and serviceable? Have we accumulated the data and developed all the evidence we need so that our sales team can market and sell the product? Is every functional group in the company fully prepared for the next phase? Star medical device engineers know that this business orientation is the difference between product development and a science project.

I’ve seen more than my share of science projects – for example, an advanced tattoo removal laser that completely lacked compelling clinical evidence, and an over-designed retinal photocoagulator with COGS higher than the competitor’s average selling price.

I’ve also tasted the delicious fruit of product development done well – the world’s leading left ventricular assist device that saved thousands of lives and cost much less than a heart transplant, lasers for ureteral stone removal that prevented tens of thousands of surgeries and hospitalizations, the world’s leading hair removal lasers that made millions of lives happier, and vascular lesion lasers so precise they can safely remove pediatric port wine stains.

Star medical device engineers are driven to develop winners. They want to build a great device and a great business. They’ve learned that it’s not enough to master the skills of engineering – star medical device engineers also master the business process of product development.

More in my series on Star Medical Device Engineers:

https://jaycaplan.com/category/star-medical-device-engineer/

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