David Dobson

The Amazing Contrast Between Teams that Develop Medical Devices and those Who Create Consumer Electronic Products

Over the last several years, I’ve had the wonderful opportunity to work with a couple of very different types of product development organizations.  I’ve managed larger teams of designers and engineers engaged in the creation of Consumer Electronic (CE) products, and I’ve been a part of equally exciting companies dedicated to the development of highly complex medical device and diagnostic equipment.  Both groups have their place.  Both employ highly skilled product developers of various disciplines.  Where the two part ways, is not in the hard skill sets required to design a great product (Industrial Designers, Engineers – ME’s, EE’s, software specialists, etc.), but in the disposition… the different personalities that migrate to either of these environments. It’s hard to quantify on a resume the ratio between a designer’s/engineer’s sense of urgency and their desire to make a given device ‘perfect’.   This is the key factor that determines whether a person will thrive or struggle in either of these environments.

The development of CE products requires fast decision making…..and lots of riskDecision making must be quick and decisive.  There’s no time to dillydally over the details.  Drive a general consensus on what the product should be, assemble a basic ‘product requirements document’ and get it designed and out on the shelves! Every activity is subject to the need to arrive first on the market with a given innovation (or at least very quickly after a market leader introduces their new widget).  The volume of products designed is often more important than a lengthy consideration of what is the ‘right product’ for a given need and market.  CE organizations are speed machines and everyone who works in this type of company needs to learn how make decisions quickly and run fast… or they need to step aside and get out of the race.

Because of the ‘speed to market’ mandate, CE companies are tolerant of potential glitches in their product offerings.  Risk management has a place, but it’s a distant second or third when it comes to overall priorities.  In terms of quality, CE manufacturers seem to think it’s fine to put their products into the market with only limited testing and sometimes with known problems and bugs.  The commonly held understanding is that the consumer will tolerate failures so long as they have access to the latest and greatest technology.  The unofficial quality mantra goes something like this…“We will provide only a level of quality that doesn’t cause us to encounter a predefined level of customer returns”.  This attitude often comes back to bite and kill young companies… and can even bring down larger more established organizations.

The ‘time to market’ imperative is driven by short product life cycles and this translates into even shorter product development cycles.   A CE product is a result of a fast moving technology that is evolving at an enormous rate.  Changes/advances take place yearly… sometimes monthly – they often make the product you purchased just months ago obsolete.  Given that we tend to toss way old technology at increasingly shorter intervals, it’s no wonder that CE product development organizations are the home to many ‘A type’ personalities.

None of the above can happen in the world of medical device development.  Medical device companies value above all things efficacy, stability and predictability.  In order to achieve this kind of rock solid performance, this dependability – the tools, methods and processes used in medtech development must go way beyond what is employed in CE development…and they need to demonstrate significant reliability.  There’s no room for the type of ‘seat of the pants’ innovation and development practices that are prevalent in CE product development offices.

The desire to minimize risk, mandates and drives a more cautious culture of decision making.  Each product that successfully gains regulatory approval and arrives in the medical device market, is a result of a thorough investigation and analysis of ‘work flow’ and an extensive technology evaluation. Determining the ‘right product’ for a given need… is paramount.  The contrast between this and the ‘throw as many products against the wall and see what sticks’ philosophy of product management/development, is immense.

The level and type of effort expended in ergonomic evaluation is also a distinguishing feature that differentiates CE and Medtech organizations.  Extensive ergonomic evaluation of a potential medical device design needs to take place early on in the development process.  Medtech companies employ a type of ‘usability’ evaluation and study that goes way beyond the simple comfort and ease of use issues that are normally considered in a CE study.  The evaluation of a potential medical device needs to include scenario planning that seeks to understand how a person may intentionally or unintentionally misuse a given device.  Insight and preventative measures need to be incorporated into the design of a new medical device so that even in extreme circumstances, a user cannot injure themselves or the patient receiving treatment – not even when a product is being misused.

In terms of risk management and quality, medtech is all about testing, testing, testing.  Through every stage of development – product definition, alpha and beta, and even into manufacturing transfer, every aspect of a medical device needs to go through a thorough battery of tests in an effort to verify and validate all aspects of the device.  At every stage, all details/features of the design are tested and thoroughly documented in order to create a comprehensive record of all development activities and the reasons that each decision was made. The outcome is a proven product/technology that performs in a predictable manner.

Seeing that the two environments (CE and Medtech) are so different from one another, it’s wise for those considering careers in product development – recent grads or those wanting a change – to take the time to understand who they are as a person, the energy level they expend at work, and the processes and speed they inherently use when working through and solving problems.  In order to enjoy your work, contribute and run with the pack, you need to know if you have the basic skills and disposition required to fit into either type of organization.

For those leading product development organizations, it’s important to take the time to understand the behaviour, motivations and problem solving methodologies of those who work within your group as well as those who are seeking to join your team.  The world of Consumer Product Development demands fast decision making, risk taking and lots of energy.  For Medical Device Development, it’s best to have a strong disposition towards analysis, precision and predictability.  The differences are not exclusive, but in general terms, if you want to succeed in either environment, you need to possess the specific qualities that allow you to contribute at a high level to your team and company’s success.

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