 At the forefront of the medical device new product development (NPD) process we typically find a list of considerations we’re trying to address within our product all while coming up with a solution which meets marketplace needs. Talk to anyone in R&D, or downstream marketing for that matter, and you’ll commonly hear the list of ‘needs’ for a new product can seem never-ending. What you may find surprising is how often design for manufacturability (DFM) is not considered in the beginning of the development process. DFM is an important, and often overlooked, part of product development which involves designing a product in a way which makes it easier and more cost-effective to manufacture commercially. While embedding DFM into the process early seems like a logical part of the process, what plays out in reality is an NPD process that is focused on creativity and validating a technology yet can lack appreciation for the future state of the product and it’s foray into the market. So why is it companies may overlook incorporating DFM into the development process? For starters, many of us who design products on the front end, have little perspective, or perhaps no perspective on what it takes to actually produce a scalable product on the back end. Unless you’ve worked on a manufacturing floor or you’ve walked through an entire new product introduction (NPI) cycle, it’s easy to misunderstand all which goes into producing a product to bring to market. The design process also requires creativity and ingenuity in order to find new approaches, break common perceptions of technology capabilities, etc. It’s about ideation! Unfortunately thinking down the road about how it will be built for commercial purposes is “someone else’s problem”. To illustrate this point let’s look towards the automotive industry at a product we all know, which also happens to be a heavily regulated industry, like the medical device industry. If you have ever been to a large-scale automotive show, like the LA Auto Show in Los Angeles, CA, what you’ll see are concept cars on display to wow the eyes and entice the senses. Ironically, if those same concept cars ever got to production, you’ll find their characteristics which made the vehicle look incredible are often diluted down to features and benefits which consumers will accept and are cost efficient to produce. Case in point, the two images below shows a 2010 Chevy Volt electric vehicle.  The top image is the concept vehicle – sleek, sophisticated, sharp lines, aggressive character and eye catching. Almost resembles a sports car. The bottom image is the production vehicle – commuter extraordinaire with features which are dull, less angular and more consistent with a car which will be manufactured by the hundreds of thousands. Concept vehicles have their place though – mostly to show off a company’s capabilities and satisfy egos. They just aren’t practical on scale. The truth is if Chevy produced at volume the concept version the average consumer wouldn’t be able to afford it. As a result, they round out the features, slap some plastic on it and Walla you’ve got a commuter vehicle fit for the masses at a price point which coincides with high volume sales. The medical device industry is no different. While industrial design is playing a much larger role today with device design, the fact of the matter is our industry struggles at times with over engineering products just like the auto industry. This can lead to a company losing sight of what the end user needs and wants, as well as if it can actually be manufactured to meet reimbursements. It’s for these reasons it’s important to consider design for manufacturing from the very beginning of the design process. If you do so, you stand to experience the following:
Considering DFM from the beginning of the design process is crucial for optimizing the manufacturing process, reducing costs, improving product quality, and ensuring a smoother path to market. It ultimately results in a more competitive and successful product with potential less risk downstream.  The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of medical device technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
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 Recently our company published a poll online offering up the following question for the medical device community: “What is the most important factor to consider when developing a medical device product?” At the close of the poll dozens of people had cast their votes for what they believed to be the factors affecting product development the most. The poll options included:
If you have been in industry for any length of time you know there are dozens of factors which can and often have a direct impact on the product development process. While there are dozens to consider, such as PRS (Product Requirement Specification), planning, user experience, DFM, etc. what we know to be true is each of these factors carry varying weights of impact. They are not all equal in measure or influence. As our poll launched and picked up steam one of the four factors listed as an option began to take a commanding lead. The respondents, who are largely made up of medical device professionals and executives, had identified a common factor which stood above the rest in its ability to impact positively or negatively the product development process. What was this most important factor? Would you have guessed ‘Having the Right Team in Place’ is the number one factor which determines success when developing a medical device product? ‘Having the Right Team in Place’ was identified by 51% of the respondents as being the most important factor which directly contributes to the success of medical device product development. The other options broke down as follows:  Simply put – having the right team in place covers all of the other areas that potentially could produce challenges during the product development cycle. Whereas the inverse is certainly all too true. When we have the wrong team in place, or teammates lacking the capabilities to facilitate their job as needed by the company, inevitably problems go arise which hold back otherwise good opportunities and technology offerings. Jim Collins, celebrated author (books like ‘Good to Great’ & ‘Built to Last’) and business management guru, is quoted as saying “Leaders of great companies start by getting the right people on the bus, the wrong people off the bus, and the right people in the right seats.” What this means is it’s more about the people than it is the technology or problem you’re solving. This is an important lesson, especially for first time entrepreneurs and startup executives. You can have the best product idea in the world, one that is in high demand, but if you don’t have the right team in place you’ll most likely spin your wheels while blowing out copious amounts of money in the process. We’ve also seen this reality in person dozens of times. As a medical device consulting firm we work with a lot of companies, both start up and conglomerate alike. One of the consistent characteristics we see within the companies which are able to drive success, often times repeated success, is their management team is comprised of experts in their particular field who know how to both lead and operate in the weeds. They both strategic and tactical, able to plan for the long term while addressing todays shorter term needs. As a result, they know how the job is done and therefore can either lead or delegate those tasks helping to guide their department or team to successful completion. When you have the right people on the team (your bus) you will then find opportunities (the medical problem you’ll solve) to move forward with. Following this process you’ll also have a far better chance of facilitating that opportunity through the development process and into commercialization, or acquisition.  About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
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