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.
If your company lacks a ‘gold standard’ for its product design practices you are inevitably wasting time, resources and funds. Implementing and running a gold standards program is essential to operating at peak performance. Start by developing a best in practice plan. From there setup a review plan to provide feedback on all work performed. Once the infrastructure of your new gold standard system is established you’ll want to assess the skills of your team and develop a training program which can be offered to both new and existing employees.
Author(s): Travis Smith & Tim Humphrey
Read the full article by downloading the below PDF attachment
Like many things in life there is often more than one way to accomplish a task. This is especially true for those of us who fall in the creative space. One persons’ approach in the creative development process (drawing, painting, product design, coding, graphical design, underwater basket weaving, etc.) could be quite different from the person sitting next to them yet it’s possible for both people to arrive at the same destination.
Or so we think.
I recently sat down with a good friend of mine, Tim Humphrey, who I’ve had the pleasure working with for several years teaming up to facilitate a variety of product design and drafting projects in the medical device arena. During our discussion I shared with Tim a frustration I had, and still have, having to do with inconsistencies in people’s design approach. I see this often in product development where the approach one person takes to design a product may on the surface get them to the desired finish line but as a result of their approach it leads to a plethora of unnecessary challenges down the road.
As Tim laughed at me lightheartedly, we found ourselves diving deep into a discussion where in one conversation I found myself both highly intrigued while equally confused and somewhat baffled at the same time.
Here’s the issue as I see it specific to designing in a product development scenario.
Issue: someone is tasked with designing either a product, sub-assembly or component of a new or existing product. As such, their design approach gets the company to a conclusion where the design is technically complete allowing the person facilitating the work to check their proverbial work box and move on to the next assignment. While the work may have technically been completed, it often is done in a fashion which causes all sort of problems down the road for the company, including other employees working on the same project within the same organization as well as their external suppliers.
How is it someone can complete a design project satisfactory on the surface yet problems arise down the road with that very same design which had been previously approved?
Answer: the devil is in the details, or lack thereof, to be more specific.
Tim and I both agreed on the following. The reason why companies and or their respective employees experience this is because they aren’t following a formal and documented ‘gold standard’ for their design practices. Simply put, they lack discipline with design fundamentals. They don’t have GOLD! There is also something to be said about training. If your company lacks proper training to ensure the standards are being followed that too can produce similar unwanted results.
As a result of a lack of design standards and training employees are left to decide for themselves how to complete a task which may get them to the finish line but the approach, process and details along the way can have wild variances and interpretations.
While this may be common place and old news to many of you reading this article, the reality is the actual practice of designing a product with repeatable ‘gold standards’ is anything but common sense or consistent in the workplace. When our approach to design is fast and loose we experience the following:
When these issues show up it causes companies to reinvest dollars and resources into their work in order to move the project forward to get it to a point of where it can be properly advanced along the product development life cycle. This reinvestment is unnecessary and a huge time suck.
For these reasons its vital companies implement a gold standard which their employees and suppliers follow to ensure the work each party is facilitating makes it to the finish line in the same format, intent and approach. This unification of process increases the likelihood design work is done correctly while also ensuring future usage of said designs doesn’t require additional unnecessary iterations or complete redesigns.
Does your company need to implement a ‘gold standard’ for your design and product development practices?
Implementing a gold standard includes:
If you and or your company lacks a gold standard for your product design efforts you are inevitably wasting time and resources. This also has a direct correlation to a suppliers’ ability to help with outsourced work causing the overall project to be more challenging and lengthy than necessary (prototyping, manufacturing, etc.)
Got GOLD? Start right away implementing your gold standards starting with develop a best practice plan. From there setup a review plan to provide feedback on all work performed. Once infrastructure of your new gold standard system is established you’ll want to asses the skills of your team and develop a training program which can be offered to both new and existing employees.
Companies which design, develop and manufacture products often times need additional support to accomplish their goals. These are the three main reasons companies use outsourced engineering service firms.
About the Author
Travis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.