Expert Interview Series: Diana Procter, President of Management Systems International

 In Medical Product Design

Diana Procter, President/Entrepreneur at Management Systems International, an International Standards (ISO) management consulting firm for over 17 years.

Diana Procter is an ISO Standards Consultant at Management Systems International, an International Standards management consulting firm. MSI leads companies to earn ISO certifications nationwide, while helping them to sustain compliance to the standards. MPE (Formerly Mindflow Design) is currently going through the ISO 9001 certification process with Dina’s guidance. Through these certifications, Diana has witnessed transformations at a number of companies across the country. She’s been running MSI for over 15 years, and has taken part in over 250 audits.

A platform of efficiency
Upon completing an ISO 9001 certification, companies have streamlined operations and a new level of confidence and understanding within their marketplace. “Standardized processes let a company get a new product to market faster,” explained Diana. “They’re able to capture more market share by getting there first with a reliable and safe product.” Non-certified companies present a greater risk of safety issues or quality concerns, two factors that can lead to recalls.

Diana noted that “before ISO implementation, companies operate ad hoc. At the time of the certification audit, they have established processes they can rely on.” The implementation creates “a platform of efficiency,” leading to a path of limited deviations, or no deviations at all. Every employee at an ISO-certified company knows these processes, so they all know how to deal with nonconformity.

“An ISO certification improves a company’s approach to client relationships.”

Return on investment
“Design,” Diana pointed out, “is a complicated process. It can go on for a long period of time, with lots of moving parts.” The product you’re designing has to be usable and you need to be able to “verify and validate” to ensure it has the needed qualities.

From planning, to concept, to going back and forth when things don’t work, it’s an involved process that can benefit from this certification. The goal of the medical design process is to hit the target market, creating the best product for the end user while delivering return on investment for the client. In order to do that, the design firm must balance money when there’s no absolute market for the product. Diana used the iPad as an example: When Apple designed it, the iPad wasn’t something the market wanted. However, Apple was able to deliver a successful product because of their design process.

Design innovation
An ISO certification can be used to drive innovation. Diana noted that a company can’t improve any process unless it’s documented, so writing down and reviewing each process is an important part of the certification preparation. “Bringing in someone who can read procedures will get them onboard faster. Faster to innovate, and you can refer back to defined procedures if something goes wrong.”

Delivering superior service
An ISO certification can improve a company’s approach to client relationships. “An ISO certified company will ask the right questions up front,” Diana pointed out. “Certified companies are always on the same page, always getting clarification, cutting down on surprises that pop up, including price.”

These companies understand how to do their due diligence early in the process, and how to deliver superior service to the end user.

MFD: What are some of the main benefits companies can expect from completing ISO 9001 certification?

Diana: The main benefit would be that prior to implementation, most companies are operating ad hoc. They know they have customers, they know they have orders, and they’re going to do what they can to satisfy them. By the time we get to the point of their certification, they have consistent established processes they can rely on, so each and every employee of that company knows where to go to say, “How do we do something?”

From there, it creates a platform of efficiency and it helps to lead the path to no deviations or limited deviations. Every employee knows how we interact with customers, how we actually do our work and what do we do if we do come across a nonconformity, since nonconformities will happen in less instances.

“We’re going to make sure that we’re doing processes efficiently and effectively for the customer.”

If we were to have a nonconformity, what’s the first order of business? How do we contain it? How do we fix it? And how do we get the product back on track versus going to extremes and actually losing the customer because the nonconformity was not managed well. We’re going to make sure that we’re doing processes efficiently and effectively for the customer, and, in the end, continue to be improving the processes therein reducing cost.

MFD: Which of course is one of the benefits that gets passed on to the customer or client.

Diana: Yes. It should express a greater value. It’s going to help you improve your competitiveness, and just overall make the company stronger as a whole.

MFD: Could you speak to some of the benefits that the customers of certified companies can expect?

Diana: Customers know a certified company is looking out for them. For a lot of activities that we’re doing, the customer doesn’t have the expertise, which is the reason why they’re going to the MindFlows of the world. Because these companies are knowledgeable and they’ve created these consistent processes, the customer should get a feeling that they’re being looked out for, and that there are consistent processes established in order to accommodate meeting all of their requirements. These days, everything’s getting complicated with all of the regulatory requirements, statutes, precedents and legal standings. Sound methodologies are in place to make sure that we’re looking out for our customers’ interests and building them into the overall processes.

For example, the Zenefits CEO had to resign because they didn’t build procedures to meet all of the regulatory requirements. So here is this insurance company that has to meet each state’s regulatory requirements and they were found to not be in compliance. The CEO had to resign immediately. The benefit of the due diligence is that we’ve thought out what’s necessary for this customer and we’re making sure that we’re following through on all the obligations.

In the ISO world, one of the key things is what we know as the contract review process. When we get an inquiry, we have to anticipate what the customer may not know. We have to surface it and express “Hey, this is going to be required, have you thought of that? And how would you like us to satisfy this?” It can’t be swept under the rug. It has to be brought out, expressed, agreed upon and built into the process.

“Customers know a certified company is looking out for them.”

And now, as we’re doing more and more business globally, what are some of the global regulations that are put upon us? So we helped a major, major financial house company update their system, and they wanted to add on the London site, we can’t say the name, but they had to be cognizant and aware of what the European regulatory requirements are. So we need to prompt the customer, “Always be considering those.” They must be experts in those in order to build those in into checklists, verification, buy-offs, and validation. So, all these regulatory requirements, now they’re becoming more and more bestowed upon us to be cognizant and responsible of.

So I think that the best thing that says customers can expect of certified companies, that there’s a greater level of understanding and that now we’re going to go above and beyond in serving your needs; by gaining knowledge, by clarifying, and helping the company understand what they need to be in accordance with.

MFD: What are some of the most common challenges companies go through in the certification process?

Diana: The set up feels like it’s overwhelming and it can be. A lot of these processes or requirements are very good business practices, they just haven’t been doing it.

Like supplier evaluations, due diligence with customers, measuring customer satisfaction, and holding routine meetings that actually tell you if your processes are effective or not. A lot of these things might seem overwhelming, but if you actually look at it, they’re very good business practices. We finished an ammunitions company out of Idaho, and they were pretty much a startup last year. And as we were going through, they asked “I’m getting a picture, you’re pretty much setting up companies, aren’t you?”

I said, “Yeah.” If a company does their starting up or is pretty close to launching a product, we’re going to do all of the things they need to do in order to be a functioning company: establishing policies, establishing objectives, creating their structures and saying what they’re going to be doing. We’re taking them from the top down as far as their internal processes and how they operate.

The biggest thing with ISO is that it requires you to verify in order to validate that your processes are effective on a routine basis. So once you commit to being certified, the overwhelming piece that companies get to is internal audits of the processes to the ISO requirements. So with ISO, from now on you must continue to verify your processes. A non-certified company would not say, “Hey, let’s check to see how effective our processes are.” I’ve never seen it done.

MFD: How often are those audits?

“All processes have to be reviewed in order to keep the processes in alignment .”

Diana: The best way is to break it out two times a year. All processes have to be reviewed in order to keep the processes in alignment with the changes basically show integrity.
You have these processes, and then you have actions to show you followed them. In the end, does it show that you followed your processes? Somewhere along the line you have to follow up and ask, “Did our activities meet our procedures?” Half of our work is doing those internal audits for our customers.

We do about 200 internal audits throughout the year for a good majority of our customers from the sales process, to the hiring process, to the design process. So if they’ve hired anybody, we’ll look at that process and we say, “Here’s what you say you do, and here’s what you actually did, and here were the things that were not evident that were actually carried through.” The understanding is that you have to be willing and able and put resources in to actually do these internal audits.

The number one misconception of these standards is that these are only for manufacturers. These are actually intended for any size and type of company.
Design is a complicated process. It’s not a three-day turnaround time of designing something. Designing products is something that could go on six to 18 months to longer.

MFD: Exactly.

Diana: There’s a lot of moving parts. At the concept stage, if you figure out your concept doesn’t work so you have to go back, and then you go forward a little bit, and then you need to go back.
So there’s a lot of going back and forth. We’re also talking about a design process that not only one person is going to be doing all the activities. You have to rely on a number of disciplines to be involved. You have to keep everybody on the same page about the requirements we’re trying to hit.

“You have to keep everybody on the same page about the requirements.”

I like to go back to the iPad. When Apple went to design that, it wasn’t something the market knew it wanted at all. This is a product that Apple conceived to see what functionality it should have, with a market that didn’t know it needed it.

There are companies that are designing based on, “We think that there’s a market. We’re going to set out, invest, investigate what kind of market share this could be, and what features we anticipate customers would like,” and then build around that. This takes months. Then you figure out something doesn’t work, and you know the one thing that doesn’t work could affect some other feature. So you have to think about the impact of that as a whole. It’s very much an iterative process, and getting everybody to stay on the same page as to what you’re designing.

All along the way is having a strong foundation of what are we trying to get to. All the dollars and cents have to be in support of that because we all know of engineers that like to design things that there’s just no absolute market for. So we have to balance that all out by doing focus groups, studying, and so forth.

In the design arena, it could be six months or longer. Whatever you’re designing has to be manufacturable and it has to have some reliability.

MFD: Right.

Diana: It’s up to these engineers to anticipate that and build that in. We would think it would be absolutely nuts not to have a design procedure. How do you assign responsibilities? How are the interfaces managed? All these things could be different for each and every design project.

“If you don’t have a design procedure, you’re leading yourself to failure.”

If you don’t have a design procedure, you’re leading yourself to failure in the end. Think about how many hours that takes for engineers. We’re talking $50,000, $60,000, or $70,000 of labor time.

MFD: You were talking a little bit before about design, and that it’s not a three-day process, how there could be a lot of moving parts. How can ISO help manage that project scope and make it as efficient as possible?

Diana: ISO requires looking at things like functionality, performance, regulatory requirements and safety. These are set things that no matter what you’re designing, you have to have these in mind.
Going back to the iPad, what was the functionality they wanted to have for that? You could use it with your fingers, so that’s the functionality. What do they have to design in order to make that happen?
So that went in place. And that told them the return on investment they wanted to have.

MFD: How does ISO help affect that decision-making process, and ultimately improve it?

Diana: At this point we want standardized checklists to exercise expertise. Consider the level of specialty that the customer wants and is willing to pay for. Ask customers the right questions to know what to be designing into the product.

MFD: How does ISO affect the company’s approach to client or customer relationships?

Diana: The due diligence enhancing customer satisfaction. Whatever the customer is after is the thing that companies need to be mindful of all throughout their interaction. Cost very well could be a factor, or it could be having the best darn product out there.

“A company cannot improve any process unless that process is documented.”

We could be doing the best of things, but if the cost wasn’t in the range the customer wanted, then that effort is wasted. Always get clarification as things are progressing. Being on the same page is the mark of a certified company.

MFD: How can ISO certification be used to drive innovation?

Diana: A company cannot improve any process unless that process is documented. We all have an understanding, but unless that process is documented, there’s no way to innovate and improve upon it.

So whatever we do, we’ve got to show how it’s been verified. If a process is X, Y and Z, when they bring in somebody, they can essentially say, “Here, read these procedures so you get an understanding of what we do.” Those get them on board a lot faster. You’re faster to innovate and if something goes wrong you can point back to the procedures.

MFD: Perfect. And I think also you can argue that that also helps manage project scope and keep cost down as well, because God forbid something happens to a team member and you have to bring in someone new. That learning curve is going to be greatly reduced.

Diana: Exactly. So they can jump right in and see what’s happened. That’s why when we have a project we’re going to have a program plan book that gives the outline of what the project is all about, from the company to the historical culture, the processes they have within, how they interact and more or less our whole timeline. So it’s extremely beneficial for that.

MFD: Perfect. And could you give me a bottom line why you would suggest working with a design firm that is certified rather than one that is not?

Diana: Too many uncertainties. ISO for the most part in industry has become a world-known standard. And so from one certified company to the next certified company there’s a level of understanding of what’s required and we’re trusting you’re doing what is required by the standard. So there’s this level of operating and understanding and with no guessing. One of the advantages is that once you’re working with a certified company, it should lessen the number of audits your customer’s going to do.

“This is a company that’s going to understand functional and performance requirements.”

A customer coming in to do an audit of your operation is time-consuming. Once you’re certified there’s an assurance level and there’s a level of confidence. There’s a level of communication and understanding. This is a company that’s going to understand functional and performance requirements and design reviews. This company understands there must be records and that if there’s a nonconformity, it’s going to be addressed. There are 1.1 million companies that are certified to ISO 9001. This standard has been accepted and adopted by 162 member countries that has say in what the words are that are used in this standard.

MFD: So, really no matter where you go, your best choice is with a certified company?

Diana: Yes.

MFD:  And is there anything else you want to add that’s really speaking to the healthcare and medical industry right now in the importance of certification for that vertical?

Diana: Healthcare is revolutionizing right now and changing very dynamically very fast, all with increasing regulation. This due diligence helps to understand the whole industry across the board. We’re not just talking in the US, we’re talking international. Understanding the impacts of all of these in order to ask, “Where is the customer and what is he or she aware of and adjusting to?”

It’s going to make a better long-lasting, life-saving device that’s reliable and less burdensome for the ultimate customer.

MFD: More reliable and less burdensome, I like that. It’s rapid unprecedented change going on right now and I think just having that level of security, those set processes, is going to allow you to adapt a lot faster. Would you agree?

“It’s going to make a better long-lasting, life-saving device that’s reliable and less burdensome.”

Diana: Yes, and the innovation that the design area must have in order to get to market sooner because the quicker you can get to market the quicker you’re going to see your investment dollars paying off. If it takes you forever to get a product out in the marketplace, you’re losing all that market share and perhaps a competitor is right on your tails. You can get to market fast, but is it a reliable and safe product?

MFD: Right, which is really the bottom line there.

Diana: Right, there’s nothing worse than having to recall a medical device product.

Risk management is all through these standards and the thought process of risk is all along these cycles. It takes understanding those risks and knowing what we need to do to mitigate them. That’s thinking outside the box, that’s thinking ahead, and it’s really looking out for sharp edges.

What are the environments that this person, or patient would have to be able to stand within? So those are important questions that a smart design firm would be asking way in advance versus just running along to design a physical product.

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