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Is Launching A “Me Too” Medical Device Within A Year Realistic?

June 5, 2013 By Leave a Comment

If you ask an engineer whether or not something can be done, I’ve found that most will provide you with an optimistic response. You usually get an unequivocal “yes, that seems feasible”. And what the engineer fails to provide and you fail to hear is that there is not an infinite amount of money and resources at your disposal to make it happen. But you trek on anyway, believing, or probably better stated wanting to believe what you want to have happen (and likely what your boss expects).

When I was approached by a startup medical device client last winter, I was asked if it would be possible to launch a “me too” medical device within a year. Before answering the question (yes, I’ve been that optimistic engineer), I did give the suggestion a great deal of thought. I also chimed in with quite a few follow-up questions. Satisfied with the answers, I too had mine. Yes, it seemed very probable that we could bring a “me too” medical device to market within a year. And I was sincere.

Now we are about 6 months in. That year target is still within reach, despite all kinds of twists, turns, bumps, obstacles, roadblocks, etc. But the next few weeks will be the telling factor. We have to hit a CRITICAL July milestone to have any hope.

So I’ll push like crazy to make it happen.

Filed Under: All, Ask CQ, Catalyst, Indiana Life Sciences, Medical Device - General, Product Development - General, start-up Tagged With: , , , ,

8 Lessons Learned from Current Medical Device Product Development Project

May 31, 2013 By Leave a Comment

The current medical device startup product development project is still in process. However, there have been several lessons learned already with this project. Here are 8:

  1. Finalizing Design Control documentation may lag a little (and it’s okay).
  2. A good project manager maybe should be a control freak.
  3. Trust project team members. Don’t trust project team members.
  4. Go to my network. Expand my network.
  5. A task is not completed until there is clear objective evidence to support it.
  6. Delivering bad news never gets easier but should not be avoided.
  7. When I’m comfortable, I’m being too complacent.
  8. Communicate, communicate, communicate.

 

Filed Under: All, Ask CQ, Medical Device - General, Project Management, start-up Tagged With: , , , ,

On Budget. On Task. On Time.

May 24, 2013 By Leave a Comment

The other night, I was watching a home improvement show Rehab Addict, when the host, Nicole Curtis, stated: “. . . On budget. On task. On time. . .” I realize home improvements and do it yourself projects have zero to do with medical device product development. However, project management is remarkably similar across industries, genres, project types, etc. As Nicole made the statement, my attention drifted away from her latest remodel to thoughts about current and past medical device projects.

I remember once very early in my career touting that my projects were always on time. And at that time, my employer didn’t really track budgets, so I guess that metric doesn’t really count. But I remember being very proud of being on time with projects. I remember hitting deadlines. Many projects and years later, I’m not sure that those early projects are a good measure of my project management capabilities. Yes, we did bring some good medical devices to market. However, the on time claim was probably a little skewed. That, and the reality is that if you hit your deadlines, you probably aren’t being aggressive enough. And the reality was then the due date was often prescribed to me by my boss ahead of time. Fortunately, my boss either was naive enough or had enough foresight to set a fairly doable date for project completion.

Fast forward to my current project. Like nearly every project I’ve ever had, the due date for this one was also given to me by my “boss”–the entrepreneur behind the idea. The issue in this case is that this is the first time the entrepreneur has ever gone through medical device product development. From the beginning, I have been very critical of the timeline and the budget. I was able to reset the thinking about the budget to a more realistic value. Timeline, while aggressively established by the entrepreneur, continues to be technically possible. Of course nearly every thing has to go the right way the first time.

I think the entrepreneur really knows that launching when he stated will be a difficult and tough assignment to complete. However, he is also the type to push and push to get the most out of a team. And I’m on board. I know the next few weeks are critical to us meeting the overall launch date. But we are on track and the team is for the most part on board making great strides.

Filed Under: All, Ask CQ, Product Development - General, Project Management, start-up Tagged With: , , , , , , ,

Time to Play Design Control Catch Up

May 14, 2013 By Leave a Comment

I’ve written plenty of design control procedures. I understand FDA design control regulations very well. I’ve trained dozens of engineers and medical device professionals on the “rules” of design control. When to document, how to document, why to document.

And now I’m up to my eyeballs on a startup medical device product development project realizing I have to play catch up. Realizing that we are about to initiate tooling and that the design control documentation needs to get to a similar point in development.

The medical device design control purist will quickly tell you that keeping the design control documentation current and up to date with the state of the project is an absolute must. The medical device pragmatist will tell you to do the real development first and catch up the documentation later. I find myself stuck in between these two schools of thought. A few years ago, I would have been standing at the pulpit of design control advocating the need to keep documentation up to speed and current. Today, I have a very different point of view.

Don’t mishear me. I believe all the intent of design control regulations has been followed on this project. I believe there are documents, emails, notes, action items, etc. that adequately address everything that must be demonstrated with sound documentation and records. The challenge now, though, is to successfully extract this information buried deep in email messages, file folders on computer hard drives, and so on and to ensure it is placed in its proper home in the appropriate design control record.

I feel like now is the time to do so. Not to sound complacent, but I feel like I have time to take a few breaths before the strong push to the finish line. Just better make sure we have everything we need to win this race.

Filed Under: All, Ask CQ, Design Control, Project Management, Project Phases, start-up Tagged With: , , , , ,

How Hard Is It To Tell Me How Much?

May 7, 2013 By Leave a Comment

If you ask me how much it will cost to develop a FDA compliant quality system, I can tell you. If you ask me how much it will cost to manage a medical device product development project, I can tell you.

So why is it so difficult for other medical device service providers to provide an estimate? And why does this process take so damn long! Especially when what I’m asking for is more or less already similar to the stuff you already do? It’s confusing.

Are medical device service providers so bad as estimating costs that they have to turn your request for quotation into a mini research project? I don’t get it.

And when you give me the number, stand by it! Don’t come back a few weeks later with an estimate that is 100% higher than your original number. It’s not my fault that you are a bad guesser. Know your business!

Filed Under: All, Ask CQ, Project Management, start-up Tagged With:

Medical Device Prototyping – A Sometimes Viscous Cycle

April 30, 2013 By Leave a Comment

I’ve talked quite a bit about the importance of prototyping in the past. I’m really appreciating the value of having (or not having) a prototype with the current medical device startup I’m working with. And let me say, that while having a prototype is very useful, having a prototype that is the wrong dimensions may be detrimental. I’ll explain.

This project stalled a couple months ago due to product design concepts. There were a couple of ideas presented on paper along with a 3D prototype that had missed the mark. So, we went back to the drawing board–literally. New thumbnail concepts and ideas were sketched. A few of these were tweaked and refined into 3D images on screen. Progress was being made, albeit much more slowly than I liked.

And then there was a positive turn in momentum, all based on a really smart idea. The contract manufacturer resource, for whom the industrial designer / mechanical engineer works, suggested building a 3D form model to scale in order to give the startup something to hold, versus conceptualizing via looking at computer screen and printed images. It was a great idea. The CM used a chunk of hard wax and machined the basic shape of the device. This was given to the startup, and the result was good. Really good. The wax model was updated a couple times, and before long the shape and size of the device had been determined.

Victory. A small one, but a victory nonetheless. Now the CAD work could focus on the shape. No more thumbnail sketches required. And now, I could hone in on some of the finer details, such as color (more details on this another time). Within a week or so, the crude wax model was turning into detailed, dimensioned design. For the first time in a long time, it felt like this project was moving forward.

It was then time to have another 3D prototype, this time to scale with exact dimensions. The timing of the prototype was discussed last week. It was to be ready Monday. I would review the prototype with the CM and designer and then take to the startup. This 3D prototype, while resembling the wax model, was off a little. And in the days leading up to the prototype build, I reviewed sketches on drawings, showing how everything would go together. It soon hit me that this prototype was bigger than the wax model. I started to realize there could be an issue.

After the meeting with the CM, I took the prototype to meet with the startup. Upon unveiling it, he stated “. . . the butt got big . . .” We couldn’t help but laugh. While the startup can be tough at times, he is nearly always fair. Plus, this is his product. The victory I felt after the wax model experience melted away. It now felt hollow and misguided. We now have to go back to do some overhaul of the design based on the impression left from the wax model. The startup was left with a certain impression about size and features the wax model help establish.

While 3D prototypes are pretty important to medical device product development, realize that they can also be detrimental, or at least damaging. Be sure that you communicate what the prototype is intended to convey. Be sure you are clear about the purpose of the prototypes. Realize that each prototype will leave a lasting impression. Be sure that the impression left is the one you have in mind.

 

Filed Under: All, Medical Device - General, Product Development - General, start-up Tagged With: , , , , , , , ,

Medical Device Product Development Is Like Going to the Eye Doctor

April 4, 2013 By Leave a Comment

Have you ever been to the optometrist for an eye exam and been posed with the question which is better? Then the optometrist flips a lens or two while you stare at an eye chart. Sometimes the letters get clearer, other times blurrier.

My latest medical device product development adventure feels sort of like an eye exam. For a few weeks, we have been back and forth and up and down on the design of a medical device. Do you like this one? How about this one?

Some days, it feels like we are getting a step or two closer to ironing out the design. Other days, further away.

While I so wish we would be able to narrow in and define the industrial design of the device, we are making progress on the electronics design and other components. Soon, it will all come together.

Filed Under: All, Ask CQ, Medical Device - General, Product Development - General, start-up Tagged With: , , , ,

Medical Device Startups – Keeping the Balance

March 26, 2013 By Leave a Comment

Medical device startups need balance. Specifically, keeping quality, regulatory, manufacturing, product development, and business in order and harmony with one another is a challenge and a must.

Which one rules the medical device startup?

Trick question. None of the functional areas rule. The trick is to keep quality, regulatory, manufacturing, product development, and business in balance. And yes, it’s always a trick. And always shifting and requires adjustment. One day quality might have the ball. Another might be regulatory. And yet another, all functions might share it.

As a startup, keeping the balance is a frequent, often daily, challenge. I don’t possess the magic formula. I don’t have all the answers. Helping startups with this balance is a large part of what CQ does.

Filed Under: All, Ask CQ, Medical Device - General, Product Development - General, Project Management, start-up Tagged With: , , , ,

Don’t Shoot! I’m Just the Messenger.

March 20, 2013 By Leave a Comment

A current product development project has me in a situation that is not very comfortable. A few weeks ago, the project needed to make a “pivot“. I was given the task of finding options. Meaning, I was tasked with finding product development resources who could assist with industrial design, mechanical engineering, electronics design, firmware, tooling, and manufacturing. As project manager for the startup medical device, this task was definitely within my scope. I tapped into my terrific network to try and figure out a path forward. The startup wanted a pretty quick turnaround for quotes. The startup was okay with having ballpark estimates to make a decision. But they wanted to make a decision as soon as possible; the project had already been delaued a few weeks.

I talked with probably a dozen resources. Some options were full turnkey. Others only addressed a particular functional area. I organized all into a matrix to ensure all areas of concern had been identified and to determine rough overall product development costs. I presented the options to the startup, who in turn asked me to provide and support my recommendations. Fine.

After making a decision, I then had the dubious responsibility of informing all the resource providers of the decisions. For most, this was a difficult message. I had to tell them that the startup chose to work with someone else.

And of course when these sources were told “no”, they wanted to know why. Was it cost? Was it schedule? Was it something else? Most took the decision pretty well–this is how the medical device product development business works. We have all been told that our firm was not selected. Others, though, got defensive and wanted detailed explanations. They wanted to schedule a meeting to better understand and have a chance to revise and so on.

I’ve been managing medical device product development projects for 15 years. I admit that delivering “bad news” is still tough for me. But it comes with the territory, like it or not. My job is to inform and communicate. Sometimes, I am just the messenger.

Filed Under: All, Product Development - General, Project Management, start-up Tagged With: , , , ,

Where Does Your Real Meeting Happen?

March 14, 2013 By Leave a Comment

How many times have you been in a meeting when there was lots of discussion about the topic of hand only to have the real decisions happen in the hallway by a couple stakeholders minutes after the sit down? We’ve all been part of this. And it’s frustrating. Why assemble all these people to sit in a stuffy conference room for an hour or so if the two people who are going to make the real decisions are going to do so without everyone else?

It happens. It sucks. It’s the wrong approach too.

I didn’t realize how frustrating this past experiences were until I was part of the right way to do meetings. I have a startup client that has meetings the right way. Seldom does a meeting go over an hour. And during the meeting, there is an agenda. Topics are discussed. Decisions are made, if feasible. If not, action items with due dates are assigned. Once all topics have been discussed (or the hour is up), the meeting ends. When the door opens, everyone goes back to do their thing. No sidebar discussions outside the conference room to undermine the past 60 minutes. Stakeholders expect action items to be completed by due dates too.

I’ll just say it’s very refreshing.

Filed Under: All, Planning, Project Management, start-up Tagged With: , , , ,

Medical Device Startups Get to Revenue

March 12, 2013 By Leave a Comment

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.

Filed Under: All, Indiana Life Sciences, Medical Device - General, Project Management, start-up, Strategy vs. Tactics Tagged With: , , ,

By The Time I’m 40

February 13, 2013 By Leave a Comment

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.

 

How?

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

Also, develop own products, starting with UniDoc.

Filed Under: All, Ask CQ, CQ Story, Funding, start-up, Strategy vs. Tactics, UniDoc Tagged With: , , , , , , , ,

Playing Investor

February 11, 2013 By Leave a Comment

For years, I have been an investor for inventors, entrepreneurs, and startups. No, I don’t write checks or provide capital. My investment comes in the form of pro bono time. I knew when I started my business in March 2007 that I wanted to work closely with early-stage ventures. And I learned just as quickly that many early-stage ventures are hungry for assistance yet often lack funding to compensate for it. This presented a bit of a dilemma. I had just started my business and needed income to take care of my family. Somehow, I had to find a balance.

Fortunately, I did. Through networking and connections, I was able to find a couple of well-funded medical device startups in need of project management and quality system services. Plus, I established a partnership with Anson Group to be a consultant on their bench, if and when needed. These engagements took care of my financial needs and allowed me some flexibility. I could now “invest” in a few early-stage ventures where capital was lacking.

Many asked me why I would do this. To me, the answer was simple. Not all good ideas have funding. Not all good resources are funded either. But the lack of funding did not mean these early stagers didn’t need a little help and guidance. I never claimed to have all the answers. But I was willing to review business plans, have a discussion over coffee, and help make a connection or two. I just wanted to give back–to pay it forward so to speak. Plus, I have been very fortunate to have willing and patient mentors throughout my career who invested their time in helping me every step along the way.

After doing this for a couple years, I began to notice a trend. I put the word out that I wanted to work with medical device inventors and entrepreneurs. And quite a few of these folks found me one way or another. However, I learned that many of these contacts were not as prepared as they should be, in my humble opinion. Many wanted me to do quite a bit of the heavy lifting. Many times, the scenario would repeat itself. Inventor contacted me asking for help, usually identifying market opportunities, regulatory pathway, estimate on time to market, and estimate of budget. I would spend a couple hours researching and provided feedback to inventor. Inventor took the information and never called again, I suspect because he/she wasn’t ready to do anything with the information and/or didn’t like my answers.

So one day, after having done this dozens of times, a light bulb went off for me. The questions and issues each of these inventors is many times the same. Yet, I often times got frustated because the inventor did not seem to be passionate enough to take the idea to the next step. I decided to develop a process for these requests and created a questionnaire called “Building the Business Case“. The process developed was this:

  • Inventor contacts me, seeking assistance
  • I send non-disclosure agreement and Building the Business Case questionnaire
  • Inventor returns NDA and questionnaire, completed as much as possible
  • I review the responses and set a time to follow-up with inventor to discuss next steps
We also wrote a whole blog series about the questions on Building the Business Case. After putting this in place, I was amazed by how many inventors and entrepreneurs were NOT willing to fill out the questionnaire. Keep in mind that these questions are pretty basic and pertain to the business opportunity. A completed questionnaire would be very helpful in writing a business plan. So implementing the process with the questionnaire became a filter, allowing me to more easily identify the inventors and entrepreneurs who are passionate about their ideas and willing to do some of the heavy lifting and homework required.
The process has been in place for a couple years. Yes, I still invest my time in early stage ventures. Yes, I’m still optimistic that one of these will take off and be the next big thing. Product development takes time. And not every idea will go through every phase and launch.
Filed Under: All, Ask CQ, CQ Story, Product Development - General, start-up Tagged With: , , , , ,

Low-Cost Medical Device Design

January 25, 2013 By Leave a Comment

There appears to be an interesting, albeit still somewhat small, movement happening in the medical device industry. There are a few organizations emerging focusing on simple medical device design to solve real problems in under-served markets. We wrote about Jose Gomez-Marquez and the Little Devices Group finding low-cost solutions leveraging existing products and technologies to solve real medical problems.

I recently discovered another similar group called Shift Labs. Their mission is to make low-cost medical devices to help improve healthcare in low resource settings. I was especially intrigued by the low-cost drip clip device designed and prototyped by the Shift Labs team.  I’m also intrigued by this project because it appears as though they leveraged crowdfunding to fund some of their product development efforts.

And I think the Little Devices Group and Shift Labs are onto something. Not only for medical device product development for low resource markets. But also right here in the United States. With all the recent developments in this country, including increased regulation, medical device taxes, increasing cost of healthcare, and tighter investment funding, I think we will begin to see other organizations emerge and mimic the low-cost device and product development approach. I think we’ll see other inventors and entrepreneurs of medical device technologies leverage crowdfunding models to fund their efforts.

Filed Under: All, Medical Device - General, Product Development - General, start-up, Strategy vs. Tactics Tagged With: , , , , ,

Medical Device Accelerator in Memphis, TN

January 23, 2013 By Leave a Comment

The medical device industry has several geographic pockets. Memphis, TN is one of these, especially in orthopedics.

I recently read about this medical device accelerator located in Memphis called ZeroTo510. They seem to have all the key pieces for a medical device concept to get off the starting blocks. Part incubator, part educator, part investor, part mentor. The program is geared towards helping medical device inventors and entrepreneurs get to a FDA 510(k) submission, while providing guidance and direction along the way

While I have no idea how successful this program has been, the model is very intriguing. So much so that I wonder if something like this could be piloted in central Indiana.

Filed Under: All, Funding, Indiana Life Sciences, Product Development - General, start-up Tagged With: , , , , , ,
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