White Papers & Articles

Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.

​[This article is also featured on episode 72 of the Business Wingmen Podcast Show]
​
Successful performance is everything!  Our ability to execute at work is something we as professionals need to strive towards every day, yet many of our colleagues seem to have forgotten this time-tested reality of business.  As Rory Vaden, bestselling business author and leadership speaker, accurately shares, “success is not owned, it is rented - and that rent is due everyday.”

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:

• Design intent isn’t captured
• Formatting and documentation inconsistencies or it’s wrong all together
• Future efforts to utilize the design for other applications can’t be leverage causing rework
• Models can’t be adjusted or revised easily because the initial designer didn’t put enough thought into their work to think ahead about future changes which may need to take place; the design is static rather than being parametrically driven
• Confidence in the model and the overall design is tarnish
• The company losses time and market opportunity which translates into lost revenue and market share attainment

 
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:

1. Documented processes with consistent templates and forms
2. A systematic way to capture tribal/ legacy knowledge
3. Development and maintenance of a centralized database for product data storage (tools like UpChain, Arena and Windchill)
4. Developing consistent design techniques via training (sketches constrained, DFM, simplified features which are in systematic order, building relations to create predictability, organizing feature tree, design intent)
5. Driving dimension (model dimensions) used in drawing (ease in updating documentation)
6. Implementing a system of checks and balances to ensure work is done properly and in accordance with company processes and policies
7. Consistent discussion, training and guidance focused on designing with the future in mind

 
Key Takeaway:
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.)
 
Action Item:
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. 

​

When talking with a customer about their project support needs, do you use a formalized approach or do you just wing it?

​Interestingly enough, I was amazed to learn recently that the vast majority of consultants (including solopreneurs) don’t utilize a formal process for collecting information when talking with a customer about a project.  As I began asking more questions I learned that this was a habit across the board, regardless of the amount of years of experience the consultant has in business and or their consulting practice.  The conservative side of me wanted to run for the hills hearing this.

Working as a consultant offers a lot of flexibility, however within this flexibility comes lots of room for alternative view points, ambiguity and of course misinterpretation.  When things are loosey goosey we open ourselves up for further opportunity for projects to fail, missing the mark or leaving one or both parties with a sour taste in their mouths at the end of the project. 

One of the best things I learned early in my career from a more experienced person I worked with was the importance of being disciplined in using a standardized system of help in the information gathering discussions when talking with clients.

Why?

​Because if you don’t it’s amazing how quickly people can interpret things differently than what we had assessed, thought or even heard.  What’s worse, is a simple misunderstanding up front at the beginning of a project or relationship can boil up to big issues down the road, including legal actions.
For these reasons I use, and always suggest consultants use, a formal process for evaluating, qualifying or assessing project opportunities with customers.  This meeting or discussion between supplier (consultant) and customer can be referred to as an ‘intake meeting’, ‘scoping a project’, ‘project qualification’ or ‘project discovery’.  They’re all designed to do the same thing – ask questions to obtain information.

When you’re in a discussion with a customer about their project needs you’re really trying to figure out one thing – is this the right project/ business opportunity for me to take on?

The answer to that question is buried in a flurry of Q&A, best served up using a formal approach where we learn about our customers’ needs, thoughts, feelings and desires for the project and work ahead.

Creating a project qualification process document (SOP) before you begin discussing projects with customers ensures you will gather all the information upfront in a consistent manner.  This will also lessen the likelihood of you having to go back to ask the customer for foundational questions to better understand the project.  Here’s some good questions you could use in your project qualification discussions to determine if this is the right work to take on and customer to work with:

1. Why do you [customer] have this need at present?
2. What have you [customer] done so far to address this need?
3. Is there a date the work needs to be done by?  What happens if that date isn’t met successfully?
4. Who is the person who makes final approvals for this project?
5. Is there an approved budget already associated with this project and utilizing a consultant?  If so, what is the budget?
6. What does successful project completion look like?
7. What does an ideal partnership look like between customer and consultant?
8. Are there any other departments or key stakeholders involved in this project?

Keep qualification discussions to no more than 30 minutes if possible.  As a consultant your most precious asset is your time.  All to often customers will spend time talking about things that have nothing to do with the project and or work they’re requesting your help with.  Set the tone at the beginning of the discussion indicating you have 30 minutes to talk through their project needs, then moderate the discussion from there on out.

Think like a consultant – not an employee.  Employees have to do the work their employer asks of them, this is not true as a consultant.  Your job is to listen and provide feedback.  If what the customer is asking for doesn’t add up or isn’t feasible it’s your job to guide them to an alternative solution and or walk away from the opportunity.  Consultants advise and perform the work as an SME.  Be wary of situations where customers are asking you to perform a miracle.  Projects must be grounded in reality, otherwise you may end up as the one to blame.

As you wade through the project qualification discussion with your customer it’s advisable to be on the look out for the following challenges:

1. How will you and customer addressing scope creep up? (talk about this early because the likelihood of it happening is HIGH)
2. How does the customer view suppliers?  (do they treat you like a valued partner or someone to do their bidding and dirty work?)
3. Is the customer realistic in their expectations? (if not, sometimes the best thing you can do is walk away from the business opportunities rather than trying to change it into something it will never be)
4. Are you purely acting as a ‘work for hire’ or does the customer have hard deliverables you need to meet?  Are there repercussions for not meeting those deliverables?
5. What would happen if you were mid-project and your point of contact at the customer left the company or had a situation taking them out of work? 

As you begin to formulate your approach to these discussions and questions it’s highly advisable to jot it down on paper, creating a template or checklist you can use each and every time.
Should you get through the project qualification stage and both you and customer are interested in moving forward to the next stage make sure you put everything in writing that was covered during the qualification discussion.  Be specific and direct.  Your Statement of Work (SOW) is the backbone of your project and incredibly important in outlining expectations, performance and what happens if changes need to take place during the project.

Key Take Away:
As a consultant your most precious asset is your time.  Use a formal and formatted approach to your project qualification discussions with your customers to ensure you collect the right information up front to better determine if the project in question is the right opportunity for you.  Can you deliver the goods inline with the customers expectations?

Action Item:
Create a project qualification template or scoring matrix to use in your customer discussions to obtain all the information needed up front for the project.  This removes all the guess work.  Your template should include both exploratory questions to get your customer talking and sharing with you the in’s and out’s of the situation while also simple ‘yes’ and ‘no’ questions like “is this project approved?.  Once you’ve completed the discussion with your client tell them you will get back to them after you’ve had an opportunity to digest the information you gathered.  This will give you time to allow the information to sink in, time provides perspective.  Sometimes a scoring matrix can be really beneficial in this situations especially if you have multiple project opportunities with multiple customers because it allows you to objectively rank each project opportunity against one another.  Pick the best or most lucrative projects and say adios to the others.