dreamstime_xs_69893With 15 years of experience as an Industrial Designer I recently accepted a position at StarFish Medical. I hadn’t worked in the medical field before, so the last 3 months have been full of amazing learning and professional development.

In one of my first roles as a senior designer I worked for a soft goods company on the lower mainland. I was hired to design a line of technical “outdoor” and rescue dog coats for manufacture. In conjunction with a number of leading authorities on rescue dogs and virtually no prior experience working with animals, I took on this exciting task. Here are five things I learned that also hold true for designing medical devices.

  1. It’s all about the right material. I was fortunate enough to have the pick of the litter (no pun intended) when it came to materials. In product design you usually have three criteria you present to clients, of which you tell them to pick two; Time, Cost and Quality. Luckily for me the two they chose were Time and Quality.

Understanding your material is paramount. Choosing a fluoropolymer membrane when a polyurethane membrane will suffice is a prime example. In laymen’s terms, choosing a more economic breathable fabric vs an expensive high performance fabric such as GoreTex when the user or use case doesn’t require the latter is good design. This is a great example where all three criteria are achievable. In this scenario they got the best material for the job which happened to be at the lower end of the price range in a time frame which was acceptable.

This also applies in medical device industry, the best solution is not always the most expensive. Knowing your material properties in conjunction with the material requirements is key to efficient design. This brings me into my next point, understanding your Key Opinion Leaders (KOL).

2. KOL are the center of any design process. Getting the right Key Opinion Leaders and understanding them and their needs is crucial. In my canine coat position it was ensuring I was using Labrador retrievers or other such suitable canines. But I also had to design for the 95 percentile, so throwing in the occasional out of spec KOL was sometimes where we got the best information.

In the case of medical device development, choosing the right KOL and understanding their needs is the key.  But like the dog coats, throwing the occasional Chihuahua in the mix sometimes can be exceptionally enlightening. An example of this would be designing a right handed device, specifically for right handed people and getting a lefty to give it a go.  It could open your eyes to perspectives you didn’t realize possible.

  1. Human Factors, try Canine Factors! Designing a technical dog coat produced a number of unique and interesting problems to solve. In human factors you are designing the interface for the device from the user to the device. There are a lot of commonly used tools in human factors engineering where feedback is required from KOL. What happens when your KOL is a moving, excited, scared or hyperactive dog who only has limited resources for communication? Well it’s interesting, that’s for sure. The results are best found from iterative prototyping and testing. When your subject can’t speak, small steady changes with well documented results within a good quality management system (QMS) produce tangible, quantifiable results.
  1. A good QMS is paramount in any design process. The difference between most consumer product QMS and medical device QMS is the FDA/CE. I thought I understood QMS before I joined the medical device field. I did not! In the world of regular consumer goods there are a number of IEC, BC and ISO standards one should adhere to, depending on the product.

In the dog coat industry some of your greater concerns are the client eating the materials, choke hazards, etc. Not very difficult to design around and not a great design challenge. In the medical device industry the concerns are clearly much greater and, as such, the QMS is much more prevalent. At StarFish we have an entire department dedicated to QMS and compliance to regulations.  Quite the contrast to the old days of designing dog coats and your greatest concern was where to source materials. Lesson learned; do not underestimate the power of a good QMS.

  1. Creating and maintaining a good relationship with your suppliers is more valuable than you might imagine. When designing dog coats for manufacture it is important that suppliers and manufacturers understand the importance and reasoning of your choices. A good example is ensuring that all clips and plastic parts are made of polymers that bend and flex and don’t shatter. In a normal situation it is unlikely that a shattered buckle on a ladies handbag would be the end of the world. Worst case it might cause a prick or small cut. But in a dog situation, there is a good chance the shattering was caused by client eating the buckle and it could easily result in an expensive vet visit– or an even worse case scenario, the dog’s death.

Apart from the obvious better lead times and other rapport advantages with suppliers and manufacturers, having vendors understand your company and your use case scenarios, (and not just the high level design) could mean the difference between a quick fix at their end avoiding an outright disaster at your company’s end.

In the medical device industry this is a lot less likely as the QMS protocol is so strict that all suppliers and manufacturers are qualified and consequently audited prior to use in production. But as with all companies some are better than others and in the case of repeat customers, usually a supplier’s friends get preference when it comes to quality, reliability and efficacy.

There you have my five top canine tips for designing medical devices.  I look forward to sharing more industrial design advice in future blogs and welcome comments from readers on medical device design tips they have gathered from other industries.

© Pierdelune | Dreamstime.com – Dog In Its Winter Coat Photo

Niall Redmond is a StarFish Medical Industrial Designer.  He brings 15 years of cross industry experience and a sense of humor to a wide variety of medical device projects.
 

Usability Engineering

 


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