Agile Adaptation

January 25, 2021

On episode 3 of Decision Dialogues, Brian Shoemaker, Founder and Principal Consultant at ShoeBar Associates, talks with Mark Willoughby and Laurie Kane Burkhardt about progressing from a relatively comfortable role as a quality manager, which left him feeling unfulfilled and yearning for more, into starting and running his own consultancy.

Brian discusses the decisions he faced, the importance of having a supportive partner who urged him to pursue his new frontier, the role Agile Methodology has played both as a tool to teach companies and in the writing of a book he co-authored, and his adoption of Agile Methodology in his own decision making.

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Thanks for joining us on Decision Dialogues. We’re thrilled to have you along. My name is Mark Willoughby, and I’m a Principal and Wealth Manager and the Chief Operating Officer of Modera Wealth Management, LLC. We created this show with something a little different than your run of the milled financial podcast in mind: to present stories about decisions with a focus on the human side of financial decision making, in the hopes that we might help folks make better decisions in their own lives, too.

Today, my colleague, Laurie Kane Burkhardt, who’s a Principal and Wealth Manager at Modera, will be chatting with Brian Shoemaker, owner of ShoeBar Associates, shoe bar associates focuses on services related to software application and development for companies in the FDA-regulated area. Welcome, everybody to the show, and I’ll hand it over to Laurie.

Thanks, Mark. And thank you, Brian, for joining us today.

Thank you for having me.

You and I have known each other for quite a few years, and I’m so glad that you agreed to participate in this new podcast series. I feel like I know a little bit about what you do just from what you’ve shared with me over the years, but I would appreciate if we could start by you sharing an overview about your business, what you do, and maybe how you got started.

Sure. ShoeBar Associates is the consulting business that I started back in 2005, as an outgrowth of the kind of work that I had been doing for some number of years prior to that. I’d been focusing on software quality, software validation, electronic records and signatures, and related topics, specifically helping companies—largely medical device companies—but more generally, companies that are in the FDA-regulated space, with topics concerned with their software quality.

I’ve had a number of different kinds of clients from people who actually make some kinds of devices. My initial client was a fabric manufacturer in eco fabrics—but medical devices. Well, this company actually did the knitting and weaving of fabrics that were used for hernia patches, vascular grafts, pelvic floor reinforcements, and that kind of thing, and would sell them to medical device companies for use as devices largely for implant purposes. They were going for certification under the ISO 1345, which is an equivalent of ISO 9000, the quality standard, but specific for the medical device area, so I helped them get their software quality processes and their validation of various applications used in their manufacturing and quality process up to speed.

And I’ve worked with other companies that either make things, or needed help in validating software tools. This all got started really back in the 1990s, when as a quality manager within the engineering group at a medical device company that’s no longer there, down here in Westwood, Mass., I was rather displeased with the kind of work that I was doing and was yearning for something where I could be my own boss. And then that company was acquired, and a number of us had to figure out, “What are we going to do when we grow up?”

I haven’t grown up yet!

I hope not! After a period of time, I did a fellowship program, and then coming out of the fellowship program, managed to get myself a job that I worked at for five years, at a company that was doing customizations of clinical trial data management and clinical safety data management. But I still had that yearning to go out on my own, and I credit my wife with a lot of the inspiration and encouragement to go ahead and do this transition to go out on my own. I sought some training in software quality, earned a certification from the American Society for Quality as a software quality engineer, and contacted some people that needed some help with validating certain things.

I was initially associated with a gentleman out of Providence, but part of a year later, he closed down his business, and I kept moving forward with the kind of work that I’d already set up, and that’s how I got started with the client, the fabric manufacturer in North Carolina. So it’s just gradually grown from there.

So I didn’t realize that’s kind of how you guys got started, and I know that you’ve had some twists and turns along the way,

Shall we say!

And I’m just curious, given all of the stuff that’s been thrown at us, particularly this year, how have you had to reinvent yourself through COVID? We’ve all learned to to adapt, but each person has to do it in a way that is relevant to their particular business, and their situation. So how has it impacted your day-to-day decision making and the way you go about your business?

Oddly enough, I’ve been exceedingly lucky. When I chose to go out on my own, I established my own little home office, which is where I’m sitting right now. And part of the work I would do from my home office, part of the work I would do on-site with a client. So when the restrictions of COVID hit, there was very little change that was needed—I just simply started working from my home office. Now, I’ve got to have the tools available to be able to talk with people remotely, so along the way, I signed up for a full Zoom subscription, but other than that kind of thing, there’s been very little I’ve needed to do to adapt—just make sure that I can can get the work done for my clients.

Interestingly enough, my plate has actually become more full in the last few months, while the COVID-19 situation is ongoing, for who knows what reasons? People are clamoring to have certain kinds of work done—in the case of my one major client, they’re having a difficult time because of internal bureaucracy, finding somebody for the quality group who’s got the software expertise. And so I’m a resource that they’ve got right here right now, even though they’re paying more for me than they might be for an internal employee.

And I know you used to travel a fair amount and speak at conferences. How has that changed?

The travel, of course, is not happening these days. But an upcoming conference that will take place in the beginning of February, is being planned as a webinar type of conference. In that way, the adaptations are being made—the companies that would otherwise have things where we get together, are doing them virtually. So I will be moderating the Software Design for Medical Devices conference that’s hosted by a company out of London, and that would otherwise be taking place in Berlin. I’ll be moderating that virtually as an online thing, and they’re scheduling talks in such a way that people both in Europe and in the US will be able to take part.

It’s amazing what we can what we can all do via technology now and how we can connect with each other.

It’s made a huge difference.

So reflecting back on your many years already within this business, can you think about, what was one of the hardest decisions you’ve had to make, and how has that affected you and your long term financial goals?

I’d say the most difficult decision was that choice to really pull the plug and hang out my own shingle. There was a period of a good, shall we say, nine months, for things to start happening for me. The first project that I had, through the gentleman that I was associated with to begin with, was not much of a—was not very remunerative at all. But it was a start, with something, and I worked with somebody that I thought was a bit of a shyster. Every experience is one that you learn from, and so I observed what was happening there and said, “You know, this is somebody I’m not gonna try to emulate.” So just screwing up that courage to take the leap, I think was the most difficult.

So it sounds like each one of those interactions allowed you to make decisions to take a take a different twist, or take a different turn.


Can you talk a little bit more about that?

Well, one of the projects that I tried to chain in that first few months, I was talking with people at a company that at the time, based in Alston, I believe, and the one of the people there kind of nailed me with a “Hey, is this going to be consistent with, you know, some international standard,” and I realized that I was a little bit less than well informed on the relevant international standards. So although we didn’t get that project, it taught me that I’d better be on my toes, and ready with the backup information to be able to say, “Hey, yeah, this is very consistent with ISO 1345, or ISO 14971.” You know, I can, I can throw around the alphabet soup with the best of them these days. That was one of the few times that I’ve gotten a little bit beat up. But that’s okay—that happens.

Yeah, so I was just going to ask you about other any of those decisions that you looking back, maybe you would do it a little bit differently?

At one point, I went together with a colleague and a couple of other people to form a consortium. And I really hadn’t gotten a good, clear understanding of the main colleague who was setting this up, and it took me some number of months to realize that the guy that I was allied with, just didn’t have his act together—just didn’t have a lot of self confidence, and was very difficult to work with, and other people were resentful of him, and so forth. Finally, I had to say, “Look Rich, I’m pulling out. I’m out of this consortium.”

It would have helped not to have that, because it was a bit of a waste of time and somewhat a waste of money. But, like so many other things, it was a teaching experience, it was a learning experience. And for my purposes, and for my kind of consulting work, I’m really better off as a solo entrepreneur.

And if I could jump in here, Laurie, because this this part is fascinating for me, Brian—it sounds to me like the main driving factor for you, in making that switch, was you wanted to work on your own,

Largely so. It’s helpful to be able to collaborate with people, and that’s been one of the other things that really helped build the kind of business that I’ve got. I’ve formed strong alliances with a couple of people who do regulatory affairs consulting. In fact, just recently, I was contacted for software quality help by a gentleman who’s got a buddy who’s up in Nova Scotia, and he needed to find a new person to do regulatory affairs consulting. I said, “I know the person, let me put you in contact with her,” and the three of us just spoke yesterday about what he needs and where he needs to go. And so it felt good to be able to say, “Hey, Nandini, here’s a good”—she’s brought me in on a couple of projects, so now I was able to bring her in on a project.

As you’re preparing to make that switch, Brian, from working with other people to working in an entrepreneurial capacity on your own, were you preparing yourself financially for that transition? Because you know, when people make that transition, sometimes it can take a number of years to kind of get back to where you were. Were you prepping for that financially by saving up? Because it sounds like for the first little while, you probably weren’t making the same sort of compensation, as you used to be making. Was that transition difficult, from a financial perspective?

That transition was made easier by the fact that we had some amount of cushion to fall back on. We were in a good enough position that we could afford a few months worth of—and the other is, again, my sweet wife was so good, because she was working a dump job answering the phones for a tech support kind of situation, but being reasonably well paid for that. She kept saying, “You know, you really ought to think about it, if this is the transition you want to make. This is a good time to do it.”

Interesting. I’m going to hand it back to you, Laurie, because Brian’s transition sounds very similar to my own transition. I had a very supportive wife.

So Brian, you talked a little bit about your beloved wife. I know Chris well, so I know how she has supported you, and you’ve supported each other through many of your decisions. Talk a little bit about how important that has been for that give-and-take, to have a partnership with a significant other, so that you can settle into some of the risk involved in some of your decisions. And that probably goes both ways.

Oh, absolutely. It’s absolutely critical. It has been 100% on the helpful side to know that she’s supportive of my being independent like this. There have been ups and there have been downs; there have been times when I’ve been in between projects, and there have been times that I’ve been tearing my hair out trying to keep up with a number of things going on, and she’s extremely understanding about that. Now, since she retired a little over two years ago, she’s taken on a supporting role. I’m also extremely lucky in that she, being from a quality and regulatory background, has some understanding of the kind of thing that I’m doing. So I can talk about the the projects that I’m working on—of course, I have to be careful about proprietary information. But I can talk about these things that she has, she can go, “Yep. Yep. I can understand where you’re coming from.” That’s been huge, too.

I can just picture your dinner table conversation.

Yes, exactly. I guess I could tell her, “You know, I had a conversation with some guys just today that—they don’t know what they don’t know.”

I know that you that you’re at a stage in your career where you are doing fabulously well. You’ve got, you know, your business has ramped up, and you’re looking forward to how you might transition away from work, you know, being on that treadmill.


Talk a little bit about how you might unwind or unplug, or what do you expect that to look like?

The plan over the next say, year or year and a half, is to wind up as many projects as possible and keep the activity to a minimum number of projects, as time goes along. We’re in the process of the fix up, clean up, pick up process to close out the house where we’re living in Dedham, Massachusetts, and move permanently to the house that we bought in the Finger Lakes. So along as part of that transition process, and moving, I’m also going to want to look at the “big R word” as as I’ve been saying, What does retirement look like? Do I shut the business down completely? Do I keep one or two projects going as, for interest purposes? Chris has looked at me a couple of times and gone, “You’re never gonna retire.” We’ll have to see. But I certainly want to cut back the level of activity. I’ve got seven projects in progress right now. And as I say, I’m at that hair tearing stage trying to keep up with the things that need to be done on each of these.

Along those same lines, Brian, do you see yourself potentially transitioning some of your clients to some of the colleagues that you’ve collaborated with over the years?

That is certainly one of the things I’ll want to do. I had contact from somebody who needed some help with the qualification of a server recently. Although I have some knowledge of that area, I don’t feel like I’m the strongest person for that purpose, so I referred him to a validation consultancy, that’s based out in San Diego. I hope he’s been able to make contact with Dan Olivier and move forward there. I know of several other people who do the kind of work that I do, and I can certainly say, “Hey, this is definitely a need. I’d like you to contact XYZ, because they can they can help you move forward with this.”

It sounds like you’ve been through several phases of your career, both before you launched your business and during. Identify a particular set of advice that you were given by somebody that was prominent in your professional circles, or maybe even your personal circles. What stands out for you, that was impactful?

I can think of a couple of things. Early on, Chris’s sister—my sister-in-law said, “Well, you’re going to have to give lots of talks at conferences!” Well, I’ve done that, and certainly that’s gotten my face and my identity in front of a number of people. So even though if I go over to Europe, and give talks at a conference there, it doesn’t necessarily mean that I’ll get clients in Europe—although I have had some clients in Europe—but it means that expands that circle of people who know me. That was one piece of advice. Do what you need to do to expand your network was really the advice there.

And then in another occasion, when I went to a gathering of the North Shore Technology Council, North Shore Innoventures, they were asking for thoughts from the from the audience, and I just described the type of solo consultancy that I’ve got, and the gent said, “Well, what you might want to do is form alliances with people who do interacting work.” Well, little did he know that I had already formed those kinds of alliances. I knew the people who did regulatory affairs kind of work. I knew some people who do software development, although I haven’t been doing any referencing tips for software development, and a highly significant alliance that I’ve formed is with a colleague who is an Agile coach. We’ve co-authored one book, and we’re in the process of finishing up another. So we’re published authors in that regard.

What is an Agile coach, Brian?

Well, Agile Methodology has to do with development, in circumstances where you don’t know everything to start with, and the ability to be flexible, to take things a step at a time and be testing as you go along. It’s a whole area of thought process that is intended to replace the old waterfall, do all your requirements, then do all your design, then do all your development, coding and so on and so forth, in lockstep sequence, because that never works?

Oh Mark, I’m guessing that you’re gonna be all over that. Tell us a little bit more about your being a published author, Brian. How did that come about, and how has it impacted some of the transitions that your business has been through?

I originally met Nancy Van Schooenderwoert, oh geez, not long after I first got started in business—at a networking event—and we got to talking. And then at one point, she invited me to come over to watch her and a couple of colleagues in some development work that they were doing. They would write a test for a piece of software that had to run on a demonstration board, on some piece of hardware. They’d write the test, and then they would write the code so that they would pass the test. In other words, they were thinking through in small bits and pieces, “What is this supposed to do?” and write a test to demonstrate whether that happens. And of course, the test doesn’t fail when you haven’t written the code. Then you write the code and make sure that it does pass.

And a light went off in my brain, because prior to that time, testing and quality on the software end of things especially, was always that thing that you tacked on at the end, and that the engineering manager, the engineering VP that I worked for, was always impatient with, you know, “We can’t spend all this time on testing, we’ve got to get this product out.” And of course, there would be bugs, and they’d have to go back and fix things. The quality process was always looked at as that boat anchor—that thing that came at the end that weighed everything down, and there was a big pain. In the Agile approach. quality got built in as you were going along, and I thought, “This is the answer to the conundrum that I’ve had all along—how do we get this thing out of that doldrums of being the boat anchor, the thing that we we always cut down at the very end?”

So Nancy and I did a lot of talking back and forth. After several different collaborative presentations that we gave, the idea came up two, two and a half years ago, “Let’s write a book! Let’s put together a book based on the information we’ve we’ve done these presentations, that talks about the basics of how to use Agile in this highly regulated environment.” So the book we came out with was Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples. So now what we’re working on is a follow up to that, where we talk about case studies in use, and we’ve interviewed several different teams at several different companies about how they use the Agile Method in their development work.

So having published at least your first book, does that open new doors for you or new decision opportunities about how to utilize or apply that published material?

It certainly has. Not in every project but in certain projects—because there’s a certain street cred that I have when I talk to some teams, or they talk about while they do their retrospectives every now and then. And then do we have to change all of our user stories into requirements and like, “Oh, wait a minute, wait a minute, hold on a second. You know, I speak that language. Let’s get into that.” So it’s certainly been a help there. It’s given me some credibility, because of course, I put the, you know, “co-author of such and such book and a link to the book on Amazon in my email signature.” And so they’ll see that and go, “Oh, this guy understands this. He’s actually published some stuff about Agile Methodology.”

We were contacted by a gent from a major dental products company not long ago, somebody that we met at last year’s Software Design for Medical Devices . They’re doing a wholesale Agile transition in their company. That discussion is an ongoing debate, whether they want to bring Nancy, and me, and another colleague in, to help them through their Agile transition, but it certainly has opened that possibility.

Mm hmm. You know, it’s funny, you’re talking about this Agile Methodology, which I’m inferring requires a certain degree of openness and flexibility, and I’m just wondering, how have you adapted and incorporated that very methodology in your own decision making?

That’s an interesting question—I’d have to think about that for a while. I’ve always tried to approach the projects that I work on and the clients that I that I work for, in a flexible manner. The Agile Methodology gives me a framework in which to do that. So it’s actually helped in being able to kind of form my thoughts.

Mm hmm. That makes sense.

So let’s kind of step back: You’re getting into what may be the last couple of years of—at least more than full time because I know you don’t have a 40 hour workweek—reflect a little bit about what you might have called your biggest personal success.

I’d say one of the larger personal successes has been to get in front of the the major clients that I’m working for—I’ll step back and say something else first—I have never really had to do much in the way of marketing, and I’m uniquely lucky in that regard. People find me. And for the amount of work that I do, from the people who found me, there was one client that I did a lot of very productive work with. They originally found who I was  as a result of my website—not a lot of them do that. That’s been a help.

Several years ago, I was invited to come in to talk to the members of a particular team at this client company that’s here in Cambridge—although they’re a multinational pharmaceutical company that’s got a medical device division—just to give a day long training, about ISO 1345—that’s the quality standard—and IEC 62304, which is the software lifecycle standard. In doing that training, I got to a point in one of those presentations where they were saying, “Well, hold on a second. You need to back up and really fill in some background. These people are not up to that place yet.” And I said, “Oh, all right, well,” and so was able to take a step back and be more flexible in doing that presentation for them.

That company then invited me in, probably a year later, to work with their newly minted software quality manager, and I did a couple of months of work there. And then they invited me back again, later, to work with the lady who’s now their quality manager, and I take a software quality role, and I’m a full member of their team—even though I’m an external person. Oh, yeah, and in between, they asked me if I would carry out an internal audit.

So through the series of different relationships that I’ve had with them, I’ve gotten into a retainer situation with this company, and I’m exceedingly lucky in that regard. So that’s been—certainly from a work continuity and financial standpoint—that’s been one of the more significant things that’s happened along the way.

I can’t tell if, because you project such a positive image—or you’ve really had as smooth a ride as you project—I’m guessing that you’ve had a couple of stumbles that you haven’t shared with us. Can you share a particular hurdle that was enough of a challenge that it really opened your eyes and it made you want to change the way you do things?

I’ve certainly had a couple of setbacks. I won’t be coy about that. I did some work with a company, just up here, that was a startup kind of a thing, and doing a development of a particular device, and it was software driven. But they had all of their mechanical, electrical development taking place at a company just up here in New Hampshire. The quality director of that company had a very different approach to things than I did, and I could tell that this guy Jeff basically wanted me off the project. At a period of time, that finally happened, but the client company by that time had been acquired by a major outfit out of Chicago and it was like, “Alright, you know, let’s stick a little closer to the things that I’m comfortable with.” It was a little bit outside my comfort zone. You take your lumps and you go on.

That’s great advice. Can you think of anything you might share with a business owner, that’s just starting out, from a lesson learned standpoint?

I can think of a couple of things. I’d say one of the first things that anybody starting out in a business—especially a consulting business—is take a strong look at that mirror and really understand where your own strengths and weaknesses are. Focus on the things that you’re strong in, look for education, and experience—the things that you need to know more about—be willing to learn, and don’t forget that interaction with other people: both the network that you need to develop, and the kinds of people who you would need to collaborate with. Because no one client, no one company is going to be able to provide everything.

A lot of people who were actually employed in the industry have titled like “quality / regulatory,” and that’s misleading, because people have the strength in the quality area may or may not have the strength in the regulatory affairs and vice-versa. I know that I’m not a regulatory affairs consultant; I know the things that need to be done to document software for regulatory submission. But I would always do that in concert with a regulatory affairs specialist.

I’ve been listening to you share your story and some of your pivot points for a little while now, is there anything that you think is significant about your story or your decision making that I haven’t asked you about?

There’s the persistence element. There were enough months at the very beginning of my business that one could have become quite despondent about how things were developing. The ability to stick with it, the ability to keep the contacts going—to keep the fires burning, as it were—made all the difference in the world. Understand that when you get started, things are going to be slow at the beginning.

So going back to Mark’s question, what did I do to prepare? Well, I had to say, “What do we have in terms of resources that I can pull back?” Now, the kind of business that I have, I didn’t really need to invest in a whole heck of a lot of equipment or space or anything like that—it’s a home office. Yeah, I could have gone out and rented office space, the way the colleague that I referred to before, that I was in concert with wanted to do, but like, why would you want us to throw a whole bunch of money at things like a hat that had the business name on it, and special office space, and all that kind of thing, when you need to get something going first?

So we’re getting ready to wrap up. I want to shift gears a little bit and ask you to share, is there a particular recent non-financial decision that you’ve had to make?

Well, I have to say, we’ll go back to that whole moving process that’s been ongoing. I’ve certainly had to decide to part with a number of binders full of stuff from previous conferences and courses that I’ve taken, like, “I really don’t need that stuff anymore.” So there’s been a bunch of stuff that I’ve ended up tying up bundles thrown into the into the recycling. It’s being willing to get rid of that!

I just really want to thank you, Brian, for taking the time to spend with us, talk to me, and entertain my questions and share a lot of your story that is just so interesting to see how your unique situation has unfolded.

Thank you for the opportunity.

Thanks, Brian. And to echo Laurie, again, thanks very much to both Laurie and to Brian Shoemaker for letting us listen in on their conversation. We appreciate your time and perspectives, and thank you for tuning in. We hope you’ll join us next time on Decision Dialogues for more stories from successful business owners. So long for now.

About Brian

Photo of Brian Shoemaker
Brian Shoemaker is the Founder and Principal Consultant of ShoeBar Associates, which provides services related to software application and development for companies in the FDA-regulated area. Brian consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including Agile Methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.


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