Hang In There – Project Management Lessons from the Trenches

I saw red the other day during a disagreement with a supplier we are working with on a product development project. It happened during a discussion about a design issue for a medical device product. Without going into too much depth, the supplier has been tasked with fixing a design flaw in the device. A couple months ago, the supplier had quite a few more tasks assigned to them as well. But as the project manager, I observed the supplier not being able to manage the volume of tasks. I decided to take most of the tasks away from the supplier and added them to our plate instead. Not a big deal. In fact in probably made the most sense for the client any way. Doing so allowed the supplier to have a single major task: fix the design flaw.

It’s been nearly six weeks. The design flaw remains. Each week seems to be a replay from the week before. From my perspective and the perspective of the client, the supplier has made marginal progress at best. Confidence in this supplier declined more and more with each passing day. Last week, the client and I discussed a strategy. One tactic was to have an “all hands on deck” brainstorming session with the supplier. Another tactic was to find alternative suppliers just in case.

We held the all hands discussion. Some good ideas came out of the discussion. The supplier provided a schedule as to when prototypes would be in hand to evaluate whether the concept had merit. As this date approached, the supplier backpedaled and pushed the date out. My patience has been wearing thin for a while. With each delay and day that pass, the depth of discussions I have been engaging with alternative resources has increased. Finally, the supplier set a time for the client and I to visit to review the prototypes.

When I arrived for the meeting, the lead engineer at the supplier was still tinkering with the prototype. It wasn’t right. I sat there patiently. The client was aggravated. The engineer assured us he could make tweaks here and there. He just needed five more minutes. Ten minutes after this statement, it was very clear that the prototype would be ready another day. We left.

The results of this meeting made it clear to me that I was going to have to engage another resource to fix this design flaw. I requested CAD source files from the supplier. They said no. I called the supplier to understand why not. I was told that the client does not own the source files and has not paid for these. CAD would not be provided. Keep in mind I did share with the supplier last week that we had to consider looking for other resources due to the project delays encountered. The request for the CAD data was a clear signal to the supplier.

He got defensive. He said the classic line that “. . . this is how product development goes . . . ” That line is total bull shit and a cop out. Especially since I have been doing my best to give the supplier a single task focus and not burden them with other tasks. The supplier also then chastised me for working with a couple resources he connected me to for the project, stating I was stealing resources he brought to the project. His tone was condescending. I did my best to keep my cool. The supplier then told me to “hang in there”. Are you kidding me?!

If you know me, you know I’m very much a “silver lining” kind of guy. I’m trying to find the silver linings from this experience. I have a few:

  • When working on a product development project, ensure that resources are compensated for their time. Do not work with suppliers who choose to not charge for the time for their resources and instead roll the costs into tooling and eventual manufacturing.
  • I’ve yet to find a contract manufacturer who can handle product design. I’m sure there are exceptions but so far in my experience product design and contract manufacturing are conflicting skill sets. And for that matter conflicting areas of interest.
  • Micr0-managing resources on product development projects is necessary until the resource proves otherwise.
  • All project resources lie about when they will have stuff done–myself included. Okay, maybe “lie” is a little harsh. Yes, I know when a resource provides a date when something will be done that more times then not, this is the intent. But I also know it’s wrong.
  • A project manager needs to have direct lines of communication with all resources working on a project. It does not work to communicate via a middle person.
  • Despite what the client wants and how pushy they might be, I need to stick to my experience and convictions about how to navigate through a project. For example, if the project is a product development project, we must finalize the design first before even thinking about manufacturing.
  • When resources screw up, they probably won’t admit it. Instead, they will probably make every attempt to cover their tracks to fix the mistake before you find out. If you find out before it’s fixed, they will probably blame someone and something else.

You Should Have a Back Up Plan for the Back Up Plan

A few days ago, I powered on my laptop to start the day. I stepped away to grab some coffee while the computer went through its startup sequence. When I returned to my desk, I noticed the lights were on but the screen was dark. I did some trouble shooting, including connecting the laptop to an external monitor. The computer seemed to be okay. The screen not so much.

I did an internet search on a second computer and found out that I probably had a dead screen. I called the technical support for my computer manufacturer. They said I would need to send it in and it might take up to 10 days. Ugh. I decided to check out the big name computer repair resource. Same story. But I needed my laptop. As a stop gap, I at least needed to retrieve the files off the hard drive. It had been a while since I last backed up my hard drive. Shame on me. I wasn’t very prepared.

I bought a device to attach to my hard drive and headed home. I watched a YouTube video on removing a hard drive from my computer, which was way easier than I imagined. And before too long, I had extracted files from the hard drive and installed on flash drives and an external hard drive.

I then took my computer to the local computer repair shop. Thankfully, the repair was made within a couple days and at a reasonable cost. Plus, I gained a valuable lesson through the experience. Back up my files early and often.

But the lesson is more useful if I apply this philosophy and approach to other aspects of life. Especially for business. In fact, there is a current project right now where having a back up plan is proving very necessary.

The reality is that I don’t want to have a back up plan. And at the same time, past performance is the best indicator of future results. Taking this into consideration and not wanting to go through the experience of not being prepared, we are actively engaged in evaluating contingency solutions to support product development and manufacturing needs for a startup client. Yes, we hope that the current resources will be able to solve the design dilemmas and be able to transfer the design into production. However, I cannot go to the bank with this just yet. Too much is at stake for the startup. Frankly, too much is at stake for Creo Quality too.

So, we are developing a back up plan. And a back up plan for the back up plan. Sometimes it just makes good sense.

Staying Connected and Finding Resources Is Perpetual

Creo Quality has been in existence now for over seven years. Prior to starting this venture and for a couple years after, I spent a great deal of time networking and meeting people and companies whom I could assist and might assist CQ clients. I attended quite a few medical device and life science events in and around the region. I had quite a few phone conversations, coffee discussions, and lunch meetings during those years. My objective was to establish the most comprehensive network of medical device service providers in the Midwest. Some of the outcomes of these networking efforts include the establishment of ASQ Biomedical Midwest Discussion Group and the creation of the network organization INpact–of which I’ve had the honor to lead both of these organizations. Events from Biocrossroads, Indiana Health Industry Forum, and Indiana Medical Device Manufacturers Council were almost always added to my monthly calendar. Through these efforts, I was able to build a solid foundation of resources and contacts within the medical device industry.

And then, I took a bit of a hiatus from the networking scene. Convinced the foundation was strong enough, I set the cruise control and focused on client projects. From time to time, I needed to make a phone call or email to someone within my network to support projects. This was the routine for the next several years.

A little less than a year ago, there was a shift. I was managing product development efforts for a medical device startup. My ol’ reliable network was not as thorough and complete as it needed to be to completely support this client project. The client had needs and I suddenly found myself without an immediate solution to recommend. Panic set in for a couple days. I began to scramble. I made phone calls, did internet searches, and so on to try and locate possible solutions and resources to support the client needs. Yes, I did tap into my network as well, hoping to find recommendations and connections through my contacts. Fortunately, within a few days, I was in contact with new, possible resources and contacts who hopefully would be able to address the startup efforts.

My network once again began to grow a little larger. The startup and I made decisions on which resources to employ for the product development efforts. A new group of people and resources with whom I had just met were now part of our product development team. A new team of resources with whom I had to sort of relearn and refine my project management skills. Overall, the process has sharpened my skills. Additionally, it has reminded me that I can never rest when it comes to networking.

Okay, I’m less likely to attend larger events like I did many years ago. Instead, I’m a little more deliberate–more specific–about the types of resources and people I would like to meet and network with. I’m reminded by a colleague that every month, I MUST network at least a handful of times. Yes, I know the term “network” sounds a little impersonal. The gist, though, is that I need to stay connected.

This is important for you to remember too. It doesn’t matter if you work within a large corporation or if you think you have the best contacts in the world. It’s important to stay in touch with what’s going on and where you are headed. On this startup project, aside from the new core team, I’ve also met and interacted with quite a few other ancillary resources. These resources will be added to my network too.

Be active.

Building A Culture of Continuous Improvement

Sometimes we work with companies who are pretty set in their ways. And unfortunately, many times these ways are not 100% up to regulatory expectations. Usually, though, when a client hires us, they realize there are things they need to improve. Things they need to do differently. This is why they hire Creo Quality.

We’ve probably all gone through the “5 stages of grief” at some point in our personal life:

  1. Denial
  2. Anger
  3. Bargaining
  4. Depression
  5. Acceptance

Interestingly, it seems as though many of our client engagements also go through these 5 stages too. Our objective is to get to acceptance as quickly as possible. However, I think it is very important to give each of the other stages their time too.

Let me explain a little more.

Client calls CQ and says they need help ensuring their quality system meets FDA regulations. Our first step is to conduct a gap analysis. What procedures exist? Is the company using these procedures? Are documents and records being generated as required? And so on. This is usually the first time we encounter “denial”. What do you mean we have to document complaints? Is it really necessary to conduct Management Review every year?

While the stages of grief are not always followed in order, and sometimes are repeated, “anger” almost always seems to follow denial. I mean it’s not “I hate you” kind of anger. But often something like “. . . FDA is just trying to make things more difficult for medical device companies . . .” or “. . . But we’ve been doing it our way for so long without any issues!”

“Bargaining” then ensues. What if we do things this way instead? Can we just write a procedure to meet the regulations without changing our day to day practices?

“Depression” is next. I guess we can put those processes in place; but it will make things so much more difficult.

Depression is often then followed by another round of denial, some more anger, bargaining, and depression. Sometimes clients get stuck in this loop. Our objective is to get them towards “acceptance”.

Yes, change is hard. Doing things a different way, especially if you believe the only reason you are doing so is for compliance reasons, can be trying and difficult to embrace. It’s important to try and shift your way of thinking. Rather than adopt a “this is the way we do things around here” kind of mentality, try to embrace a culture of continuous improvement. But you have to stick to your guns. Especially if you are the authority figure within your organization. If you communicate that change is good, don’t be the first cry baby when things are changing. Don’t be the person that prevents the changes from occurring.

The Importance of Executive Responsibility for a Medical Device Company

I heard a story from a colleague the other day about a recent experience with a large medical device company. Apparently, the company was under investigation by FDA for some reason. During one of the meetings with FDA, the investigator asked the president of the company about executive management and his responsibilities as president. He answered something along the lines that he delegated the executive responsibilities to his management team. I guess the FDA inspector took exception to this and asked everyone but the president to exit the room. We can all imagine and speculate what was said. Let’s just say I’m quite sure FDA expects the president of a medical device company to take executive responsibility seriously and to not delegate this to someone else in the company.

I wish I could tell you I didn’t have similar stories. But I do. With one client, the president said the right words about executive responsibility. However, she seldom followed through. In fact, she usually seemed to be completely disconnected from the day to day business activities and operations and definitely did not have her finger on the pulse of what was happening. Instead, she would assert her passive aggressive personality on the workers, making these people feel inferior and as though they were not good enough to do the job. And then she would be the first to play role of cheerleader when morale was at its lowest. I’m not sure it was intentional, but she kept the emotions of the employees on a string like a yo-yo.

There is another example where the president / CEO was a little disconnect from day to day. His primary role was that of sales and business development. Quality compliance was basically a void and operations left to a micro-manager without all the skills necessary and authority within the organization to do the job as effectively as needed. The president seemed to have little or no knowledge about product complaints. In fact, the company’s complaint procedures were sorely lacking and out of compliance. And despite efforts to get everything right, the president exuded no sense of urgency or purpose about implementing change. Why? Because the changes suggested would mean the head of operations might have to change his day to day duties to ensure compliance. Let’s just say the operations manager did a fair amount of kicking and screaming. So the result was the president did not exhibit any sense of executive responsibilities.

The story from my friend and my two personal accounts all have one thing in common. The medical device companies where the president did not embrace executive responsibility struggled. Struggled to be in compliance. And struggled to thrive as a business. Executive responsibility of course has an element pertaining to regulation compliance. But it is so much more than just ensuring compliance. Executive responsibility is about a company’s vision, strategy, and formula for success. It’s an attitude. A culture. A way of doing business.

When a medical device company’s president and executive management does not embrace the concepts of executive responsibility, the business will struggle and suffer.

Medical Device Design – Get to Minimum Viable Product

Ah, yes! The often talked about yet seldom implemented “design freeze”. If you have ever worked on a medical device product development project, chances are you have had to deal with this issue. What do I mean by design freeze? In theory, a design freeze is a milestone where all the requirements are defined, components and bill of material is established, shape / size / color are set. Typically, design freeze happens prior to design verification and should be set prior to any regulatory submission, such as a 510(k).

The design freeze is a very important time for a medical device project. In my opinion, this milestone initiates the transition from design to development. What do I mean by this? At design freeze, the medical device design is moving closer and closer to medical device manufacturing. Obviously, if you ever plan to manufacture your medical device, you have to know the design first. And if the design keeps changing, it will be hard to manufacture.

However, without some discipline, it can be very easy to keep tweaking your medical device design. If only it had just this one more feature. Oh yeah, and what if we included this component too? Scope creep. Perpetual design. Over engineering. Call it what you will. It’s easy to allow these bad product development practices to seep in without good discipline and clear vision.

A few months ago, I heard the term “minimum viable product” or MVP for short. I guess this term is common with software developers. And I think the term has a placed in medical device product development too. In my words, MVP is that bare bones device that meets your user needs which can be manufactured and introduced into the marketplace. There is a whole school of thought on how MVP approach is a lean startup best practice.

I’ll admit, my practice and experience with minimum viable product concept is new. I suspect many in the medical device industry would argue MVP has no place in medical device product development. I have to believe otherwise. I think medical device industry has gotten too complacent with respect to product development norms. Ask experienced product developers about time to market for a class II device and you’ll likely get responses that it will take 3 years. It’s an easy, no thought required kind of answer, likely supported by years of data and many anecdotes and examples. The response is further supported by blaming long lead times in part on FDA and the stringent regulatory environment.

However, I think it’s time to totally rethink medical device product development. There are ways to get to market faster. Minimum viable product is one approach that could help.


Should I Be Pushing My Client’s Buttons?

Let me set the stage a little bit first.

The medical device client relies on a third party vendor to manufacture their device. The product is a reusable electronic device. If the device has issues at the end customer, the customer might contact the medical device company to troubleshoot and possibly send the product in for repairs. In recent months, the medical device company has been receiving about 5 devices per week in for repairs.

The contract manufacturer went through some internal process changes and quickly got behind on the repairs. The medical device company began experiencing a great deal of frustration and angst while the backlog of repairs got bigger. Eventually, the contract manufacturer began to get back on top of the situation, reducing the backlog of repairs to almost zero.

Now, there is still a bottle neck. There are about a dozen devices still waiting for repairs. However, the backlog has shifted from the contract manufacturer’s court to the medical device company. The company needs to give to go ahead to the CM before the final repairs can be made. Additionally, there are another dozen or so where the medical device company has logged the customer issues yet the product has not been sent in for repairs.

The CM has been good about providing frequent updates. In the most recent update, I reviewed the status of all the pending repairs. I responded with my interpretation of the current situation. I noted that all the open repairs were all being held up by the medical device company.

This is a company who has been quick to point out the shortcomings of the CM. Now that the spotlight is on them, they don’t seem to like it so much. It probably didn’t help that I chose to point this out too. Yeah, I pushed a few buttons.

I applaud the medical device company president, though. He actually picked up the phone and called to talk to me about this. He said I should discuss these concerns directly with him rather than respond to the email chain.

Yeah, he’s probably right. But right now, I’m trying to push for actions.

Medical Device CEOs Should Stay Out of Limbo

A medical device CEO should establish a sound business strategy and communicate the vision for their organization (yes, this is true of any CEO). Being strategic, establishing a clear vision, and communicating throughout the organization is tough. And from my experience, very few medical device CEOs have this ability. Most medical device CEOs operate in a state of limbo.

We have experienced this first hand with a couple of clients. In one particular case, the CEO was highly critical of third party vendors on meeting timeline, deliverables, and expectations. However, he did not provide the same sort of vigor with internal resources and employees. The CEO was being very wishy washy. Saying one thing, yet often doing another.

This sent mixed messages. The employees seemed to have a free ride and were seldom held accountable for their actions (or lack thereof). Yet, he would be quick to bash third party resources, such as contract manufacturers, for their lack of actions.

Interestingly, the contract manufacturer was dealing with a medical device design that the CEO was involved with several years ago. And now the CEO seemed to have memory loss about this. He was suddenly very critical of the design of the device–a design that he signed off on once upon a time.

This CEO operates in limbo and confuses everyone involved with his medical device company.

Tips for Preparing a 510(k) Submission

The past few weeks have been super hectic and crazy busy. I’ve been up to my eyeballs preparing a 510(k) submission for a startup. Good news is that it is sitting on my desk right now and is ready to ship to FDA. The device is relatively simple and straightforward. The submission is too, yet still comes in at ~200 pages.

As I look at the stack of paper sitting on the desk, I begin to wonder if this is how a novelist feels right before sending a manuscript off to be edited. I’m anxious, excited, and a little bit nervous. Regardless, the submission will be boxed up and shipped this week.

And in about 2 – 3 weeks from now, we should get work from FDA whether the 510(k) has been rejected or accepted for additional review.

I realize reflecting on this 510(k) experience is a bit premature. However, I think there are some tips and pointers I can share while the memories are still very fresh.

Create a plan. 

Preparing a 510(k) submission is a project all by itself. Yes, a good plan helps, especially as you work with others to compile all the documents. The milestones are already set and well-defined in the 510(k) checklist. Review the 510(k) requirements with the team to ensure all agree what is and is not applicable to your submission.

Get organized early.

I created folders according to the particular 510(k) sections. As documents were being drafted pertaining to a particular section, they were placed in these folders. I also used Dropbox to share files online with others, again using the same folder structure. And of course, the folders were numbered and named according to the 510(k) checklist.

Establish a schedule.

I created a schedule as to when each item should be completed and drafted. I shared the schedule with the team, along with who had responsibility for each item.

Review in pieces.

Asking your team to review the entire 510(k) submission all at once is a ludicrous idea. Instead, have the team review the entire submission one part at a time. As each section was drafted, I sent it around to the team for review. This allowed the preparation process and review process to happen almost entirely in parallel.

Stay organized.

Yeah, this is tricky–especially as parts and pieces of your submission are in various stages of completion, review, etc. If you’ve drafted a 510(k), you know that much of the content is repeated throughout. If something changes in one section, there are many other sections that require updates as well.

Go to a copy center to print the 510(k) for submission.

I decided it made sense to go to a local FedEx Office location to have the entire submission printed, page numbered, tabulated, and so on. I was fully prepared to spend the entire day there too. Thankfully, because I was so well organized, I was able to hand off the task of printing the 510(k) with a few minimal instructions. And the cost of doing so was very reasonable.

Cross your fingers?

Okay, this is terrible advice. I know my 510(k) submission is well put together and objectively addresses each required element. I believe the substantial equivalence arguments are well structured, clear, and concise. However, we are dealing with the FDA, which can be a huge unknown.

Why Ignore FDA?

A couple weeks ago, I shared a story about a medical device company seeming to not take FDA 483 observations very seriously. I learned recently, they have done little in the past month to address the identified shortcomings. At first this really bothered me. How could a medical device company be some nonchalant and complacent regarding FDA observations? Seems like you would want to fix the issues as quickly as possible. This medical device company has a different philosophy though.

And I really saw this come to light a few weeks back. When they basically ignored the commitment they made to follow-up with FDA by May 1, the signs were apparent. I was given the responses “. . . I’ve been too busy to deal with FDA stuff . . .” and “. . . we really don’t have any progress to report anyway, so why bother with a response . . .” I encouraged them to follow-up any way, even if the response was a few days late and had little substance. The company did make a commitment to FDA.

After this response went in, it was clear this rogue medical device company was going to do things their way, even if it meant coming up with all kinds of excuses why they could take care of the 483s. I knew I could have no part of it.

Last week, the company asked if we could schedule a call to discuss equipment validation. I obliged, including an equipment validation  expert on the call too. I knew how the call would go. The company was trying to figure out the bare minimum to do on equipment validation, suggesting several ways to skirt their responsibilities.

What a waste! Coming across medical device companies who try to avoid responsibilities of being in the medical device industry is unfortunate. I’m fairly confident FDA will issue a warning letter to this company. Sorry, but they deserve it.

I’m Just Too Busy. I Don’t Have Time.

Yeah, I’ve said this before. And this response is so generic and meaningless. Of course we’re all busy. Yes, there never seems to be enough time.

As a consultant working with medical device companies to implement solutions, from time to time, I need the company’s resources to participate in the activity. I need the resources to review the procedures, forms, etc. I am proposing. I even sometimes need their assistance implementing. I realize that sometimes I am suggesting a change to their comfortable, busy life. However, when we are brought in to identify opportunities for improvement and implement, I need you to find some time to be part of the solution.


Why Would A Medical Device Company Take FDA 483 Observations Lightly?

I wish the tale I’m about to share is hypothetical. It’s not, however.

Several months ago, I was contacted by a small medical device company. The initial conversation led me to believe the company was being somewhat proactive about making improvements to its quality system and internal processes in the spirit of continuous improvement. The company asked me to provide a proposal to revise their QS.

A few weeks went by. The only update provided was the proposal was being reviewed and discussed by the board. Weeks turned into months. No decision.

And then FDA came in for a visit, almost three years to the day from the last FDA inspection. I was asked to participate in the closing meeting. No surprises from FDA. All the 483 observations had been identified by me and others prior to FDA showing up. Despite having a thorough list of issues to address from the FDA inspector, the board was still reluctant to take action.

The initial response of the FDA inspection was drafted by the company within a couple weeks. Commitments were made, including the date for the next follow-up with FDA to be sent about a month later. Despite time ticking and check-ins by me, the company was still sitting idle, doing nothing to address the 483 observations.

Two weeks prior to the next FDA response, the board decided to have a meeting to discuss the observations, among other business issues. I was invited to present my opinions on the matter.

After the board meeting, more indecision. No actions being taken. The date for the FDA response was a couple days away now. I strongly advised that the company still send in an update, even if there was very little to report.

The company chose otherwise. I followed up with them seeking an explanation for why. I again encouraged them to still send a follow-up to FDA, even though it would be late.

Not sure if they ever did.

I don’t understand why a medical device company would take this approach with FDA.

Medical Device Product Development Is A Linear Process

If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design & development requirements convey the process as a linear progression. And most every product development and design control procedures I’ve read (and written) also lay out medical device product development in a very methodical, step-by-step fashion.

The trouble is no project ever follows a nice linear progression. Sometimes it seems as though everything is happening all at once. Sometimes it seems like manufacturing constraints dominate before the user needs are even defined.

And this is just the way it is.

With each medical device product development project I’m involved with, I grow more and more comfortable in the midst of the chaos. I also consider myself in a very auspicious and unique situation on these projects. I have an innate understanding and comprehension of the rules. And despite the muddy mess of a picture I might have just painted, there are several rules that must be followed. Having someone that knows how to navigate and apply the rules is important (if I do say so myself).

Please don’t misunderstand what I’m trying to convey. Yes, I definitely believe defining the process IS critical. Yes, you need to have a procedure that lays out the project phases and deliverables. And yes, this process should lay things out in a simple, linear fashion. Just don’t be so naive to think your medical device product development project is going to follow that process to the letter. If it does, you are not pushing hard enough. You have to figure out a way to get things done as quickly and thoroughly as possible. The process and the deliverables are reminders of what must be done.

Medical Device Startups Get to Revenue

It’s refreshing to work with a medical device startup with a focus on getting products into the market as quickly as possible to help patients. This same approach will allow this startup to begin generating revenue from the sale of its own products. I say fresh because it is surprising how novel this concept seems to be.

Okay, of course every medical device startup I’ve worked with definitely wanted to get their devices cleared and sold as soon as possible. But this startup seems different.

  • Initial capital equipment will not have lots of bells & whistles and will be similar to other products in this space.
  • Realization that there are quite a few accessories, kits, etc. which could likely enter the market first and serve as a source of revenue to help offset product development expenses.
  • Makes decisions with enough “facts” and without getting too bogged down with minutia.
  • Trusts the resources hired to do the job. When it’s clear there is a mismatch in needs versus capabilities, makes tough decisions about next steps.
  • Focused on the end-goal: get products cleared and ready for sale.

It’s still early. However, I think we are on the cusp of some exciting things with this startup, especially when it comes to the approach and their business model.

By The Time I’m 40

Yes, I shared in an earlier post that I currently invest time with inventors and entrepreneurs. But by the time I’m 40, I want to be in a position to where I can invest meaningful capital in startups. I have about 2.5 years to achieve this big hairy audacious goal. How am I going to make this happen? My plan is multi-faceted:

  • Continue to invest time in early-stage ventures. Why? The assumption is that a few of these ventures will one day receive funding to pursue product development. Once this happens, CQ should be in a position to continue providing consulting support and be compensated, maybe even with equity opportunities. And maybe, just maybe, one of these funded ventures will have an exit and the resulting equity will have substantial value.
  • Bring UniDoc to market. This is a proprietary CQ software product geared towards helping medical device companies better manage design control and product development documentation and records. We’ve had a couple starts and stops and are at a point where we need to aggressively work towards launching this into the market.
  • Continue to provide consulting services, helping medical device companies with business development, operational efficiency, and project management.
  • Identify and launch other product ideas.
Yes, time is ticking but this is my BHAG. Why? Since starting CQ, I’ve come across several medical device inventors and entrepreneurs whom I think have decent ideas. However, funding, especially locally and during the last few years, has been basically non-existent. I think there are a few very good ideas that are dying due to lack of investment. I’d like to be in a financial position to help make a difference.



Invest in them now, providing advice and consulting. Find opportunity or two with equity, resulting in exit.

Also, develop own products, starting with UniDoc.