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

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.

An Entrepreneurs Checklist from Steve Blank

I just discovered a Udemy (pronounced u-da-me kind of like from you to me?). It’s an online platform to learn about stuff from a large variety of topics. While there, I came across a tutorial titled “An Entrepreneur’s Checklist”. So I clicked and watched the short video. I thought it had some value, so I decided to share. There are other videos in the series too that I will check out soon.

Enjoy!

Good Read for Aspiring Entrepreneurs

Over the weekend, I came across 21Times, a resource that claims to help inspire entrepreneurs to turn side projects into businesses. I decided to go ahead and sign up–what the heck.

If the first email from 21Times is any indicator, I’m glad I signed up. The article shared is from Spencer Fry title “How to Bootstrap”. Now I don’t know who Mr. Fry is or how much success he has had. But I found his blog post interesting and thought you might get a few insights from it as well.

Topics covered include:

  • Idea Generating
  • Team Building
  • Off Hours
  • Consult on the Side
  • There’s No Need to Rush
  • Building Organically
  • Making That First Dollar
  • When Investors Come a Calling

Helping Medical Device Inventors Get Started

Do you remember a couple years ago when I put the message out there that Creo Quality was looking to meet “garage inventors”? Ever since, we have been making connections with medical device inventors, entrepreneurs, and startups. It’s been fantastic!

In fact, right now, I am working closely with two very early stage medical device inventors. Both ideas are novel and seem to solve a real problem. In both cases, the inventors seem to be great people who are open to suggestion and are not afraid to admit that there are just things about this process they don’t know.

In both cases, I shared the Building a Business Case questionnaire with the inventor and received the completed responses within a few days. The completed questionnaires are very helpful for a couple reasons–the biggest of which is the fact that the inventor actually took the time to provide responses is an indicator that he is willing to see this thing through. A leap of faith–maybe. But I’ve had plenty of so-called inventors whom I have not heard from since sending the questions.

And for an aspiring medical device inventor who wants a little help and guidance on what to do and when to do it, I’m telling you now you will get some of my time for FREE if you are willing to complete the Buidling the Business Case questionnaire. The links above should guide you to downloading the survey and you can email it to me if you want a little help.

Medical Device Project Management – The Phases

Managing medical device product development projects requires a sound, defined process. We are currently working with several clients on defining and improving their medical device project management processes.

Here are the project phases we recommend:

  • Planning - To identify scope of the project; define user needs and corresponding design inputs
  • Design & Development - To establish product design and detailed specifications; to identify design outputs and verification methods
  • Design Verification - To demonstrate the product meets the design inputs
  • Design Validation - To demonstrate the product meets the user needs
  • Market Release - To launch product into manufacturing and marketplace

We developed a procedure / process that address FDA Design Controls and ISO 13485 Design & Development requirements and have been able to use this as a baseline that we are able to tweak for our clients.

Yes, we believe medical device project management to be our sweet spot. Yes, we believe we can help you with your medical device product development challenges.

Here are a couple other previous posts on medical device project management:

How to Succeed with Medical Device Product Devleopment

Rules for Medical Device Project Management

The Thrill of a Startup

There are few things I’ve experienced that can top the thrill of a startup. And the thrill is greater the earlier you are involved in the genesis. I’m fortunate to have had this experience a few times during my career.

I’m going through these thrills right now with 3 different ventures, each of which is unique and has different founders. One is a medical device. One is a useful software application for use in every day lives. One is an enterprise software solution to help companies with efficiency. Each has their own technical challenges. Each has different obstacles to get to the next step. Yet all are thrilling to be a part of.

From time to time I’ve been asked if I would go work for a large company again. I almost always respond with immediate laughter followed by how much I enjoy working with startups. And I think until you’ve done it and been apart of one, it’s really hard to imagine. Maybe that sounds cliche. The thrill of a startup presents a litany of challenges and opportunities. Yes, I’m well aware that the statistics are not in favor of any startup ever making it. Yet some do. And I can’t wait to be there when this happens.

Make Sure There Is “Pain”

A couple months ago, I got connected to an inventor who has an idea for a new medical device. His inspiration came from literal pain and suffering from a procedure he had to endure as a patient.

Last night, my best friend told me about an idea she has for a new software application. Her inspiration came from figurative pain entering data into her computer.

Both ideas have merit. Both ideas are novel. Most importantly, both ideas were inspired by “pain”.

And I think this is VERY important for any product development endeavor. Your idea maybe the coolest thing ever. But if it does not solve a real problem and reduce / eliminate pain of some kind, then you are probably wasting your time.

See You At The Innovation Showcase

July 12 is a big day. Creo Quality’s UniDoc software will be one of the exhibitors during the 4th annual Innovation Showcase. Attending this event in the past has given me a little bit of perspective as to what to expect during the event. I’m working on some of the finishing touches for tomorrow’s event right now. Good news is that I know the medical device market very well. Good news is that I know medical device regulations very well. We’re excited to have a couple key partners for this venture and can’t wait to hit the market running soon.

I hope you are able to come to the Innovation Showcase. There will be 60 companies exhibiting and reportedly over 1,000 in attendance. If you attend, be sure to find Creo Quality to learn more about UniDoc.

Helping Medical Device Inventor By Paying It Forward

During the past few weeks, I have been helping a person I don’t know and have only met once via a Skype video call get feedback about his medical device concept. The person did not offer me any compensation, nor did I request any payment. I just offered to put some feelers out and see what kind of feedback and responses I could get.

Why? I know I have a top-notch network and am either already connected or easily could be connected with physicians who can and will provide feedback for the inventor. I know that I can help this person understand the medical device product development process just a little better. I know that if the idea isn’t worth pursuing, taking this approach makes the best sense for the inventor–spend as little as possible to find out if the idea is worth taking to the next step. I believe if the idea has merit, this inventor (and maybe others like him) will have an interest in working with Creo Quality.

Yes, it’s definitely a “pay it forward” kind of strategy. Yes, I realize I may never receive any revenue from doing something like this. And that’s okay.

While the feedback is still coming in, I did get one response from an expert in this particular device space. The expert is very interested in helping with a prototype and other business development / research activities. I connected him directly with the inventor.

CQ UniDoc to Be Part of Innovation Showcase

We just received exciting news that Creo Quality’s UniDoc has been selected as one of the exhibiting companies at the upcoming Innovation Showcase on July 12, 2012.

This is awesome, and we are super stoked about participating in this event.

Looking for Physicians and Nurses to Evaluate Medical Device Concepts

I’m currently working on a few medical device ideas–some are mine, others are from inventors and entrepreneurs. I hope to get all of these ideas to a point where I will need feedback from physicians and nurses on the merit of the concepts.

If you are willing to help evaluate these ideas, and/or know others who are too, send me a message or give me a call at 765 315 2736.

Things A Medical Device Startup Needs to Do to Get Funding

I started a discussion on the LinkedIn Medical Devices Group a couple weeks ago titled “What 3 things must a medical device startup do to get funding?” The sub-text I provided was:

We work with medical device inventors, entrepreneurs, and startups. We are often asked to help our clients find funding. It still seems to be a VERY tough market for medical device startup funding. Many clients are often convinced that the most important thing they need to do is build functional prototypes. What are your thoughts?

The comments and discussion thread have been very insightful. I decided to take some of the insights provided and share in this post.

  • Only building functional prototypes will result in leaving substantial sums of money on the table.
  • Investors are concerned about 3 types of risk:
  1. Technical Risk – Does the idea work?
  2. Business Risk – Is the market there?
  3. People Risk – Does your company have the right people with the right experiences?
  • The most important things medical device inventors should do are:
  1. Investigate the market
  2. Request cost estimates for design, regulatory, manufacturing, etc.
  3. Create a business plan
  • Prototypes can be helpful but a well thought out plan showing where and how the device fits within the “system” is more meaningful.
  • Functional prototypes are essential to gain exposure and provide a foundation for research.
  • Implemented quality / regulatory system, business plan, financial and sales projections, experienced leadership, world wide distribution network, and proof of user adoption.
  • 5 things suggested:
  1. Working prototype
  2. Market tests
  3. Business planning
  4. Telling a compelling story
  5. Endurance
  • Answer what the device means for the hospital / end user. Why will the user be compelled to purchase the device?
  • Major factors are:
  1. Business model
  2. Proof of market size
  3. IP ownership
  4. Freedom to operate
  5. Capital requirements & time to market
  6. Demonstrated ability to develop, make, market, and sell
  7. Substantiated exit strategy
  • Answer 2 questions:
  1. Does it work?
  2. What’s the market?
  • Dynamic CEO
  • Define the value proposition. Answer “what’s in it for me?”
  • Will users get paid to use your device?
  • Can users increase productivity?
  • 3 key questions to answer:
  1. What is your key consumer insight?
  2. What is your source of volume?
  3. What is your selling proposition?
  • Proving end-users have been involved at every step along the way
  • Get a cross section of views during development
  • Development process should involve the end-user “decision maker”
  • Determine who really buys the product

Wonderful input from so many experienced people. For me the take home is this:

Yes, a functional prototype is essential (at least at some point during development) to demonstrate your product meets user needs. But a prototype alone is not proof enough for funding. The business model must be meaningful and substantial.

Medical Device Project Management Is Our Sweet Spot

I’ve been working with a medical device client for the past 10 months. The company develops and manufactures single-use disposable medical devices. For most of the engagement, I have assisted the client with quality and regulatory (you know, FDA related stuff) services and support. Since being there, I have observed the performance of the marque product. This product has been in the U.S. market for the past several years and has steadily grown. There are a few competitive products in this space, one from a large medical device company which has a significant majority of the market. However, year after year, my client’s product chips away gaining a few percent of the overall market. This is the upside.

This particular product, though, also represents the majority of the business risk for the client. While the product is an extensive of the other products in their portfolio, it is not a simple device. There are numerous parts and pieces that connect, disconnect, etc. Plus, as the company chips away at the market share owned by the large medical device company and their product, the two competing products are slightly different in their functions and operations. And there have been some issues.

The client has typically played “fire fighter”. When an issue is identified, they respond with trying to fix it. However, I’m not sure the root cause and solution is always understood. I mean no disrespect, but the approach has kind of been throwing stuff against the wall to see what sticks.

Meanwhile, there are numerous other initiatives underway hogging valuable resources at the client. Continuous process improvements. Day to day manufacturing and related issues. The company has also had a desire to launch a brand new product too. All of these activities have sucked virtually all the time away from product portfolio management opportunities. I’ve been observing this for a few months.

The other day, I shared my observations with the executive management team. I shared with them that this current product represents the future growth potential of this company. I shared my concerns that if they do not take the time to evaluate the product’s performance during the past few years and identify ways to improve this product, it’s my opinion that their growth will stall while increasing the overall business risk and exposure. I suggested it is time for them to open a project to review all the data and brainstorm ways to strengthen this product’s position in the marketplace.

The president loved this suggestion. He agreed that it is time to take this on. But he had some concerns about who would be the right resource to manage this project. I was a little confused by this comment. Had I not clearly shown that Creo Quality and my expertise were perfect for this endeavor? As I listened, I realized that this client knows the CQ brand as quality and regulatory–not project management. I realized that while providing invaluable services and support that the client desperately needed, I had failed to convey to them that medical device project management IS the sweet spot for Creo Quality. When I shared this with the company president, he was a little surprised. It was in this moment that I realized a few important things about my business. It was in this moment that I realized I have been managing medical device projects for this client for several months, yet had failed to help them connect these dots.

The CQ brand is all about medical device project management. While it will might be difficult to convey this message to this client, I have to do a better job of demonstrating this core competency and value proposition to future clients.

Updating Content on CQ Website

Behind the scenes during the past few weeks, we’ve been jamming and brainstorming to figure out ways to deliver interesting and relevant content to CQ website visitors. If you happen to read our blog posts, you get this information all the time. We thought we would tweak a few things to make it even easier for others to get this information too.

Here are some of the new updates:

  • Changed the main navigation menus. We had too many choices and sub-choices. So we consolidated some, eliminated others, and added some new ones. Check it out on the CQ page.
  • Added “Medical Device News” page (which is also on main navigation). From time to time, we will update the content of this page, sharing links and interesting news stories from the medical device industry.
  • Added “Tips for Startups” page (which is also on main navigation). We will share tips and advice we discover and share this information with you.

We have a few other things we are in the process of updating. We’ll share when it’s ready.

March 29, 2012 – Verge March Meetup

5255 Winthrop Ave, Indianapolis, IN (map)

Price: $10.00/per person

Here we go!

Calling all founders, software developers, business investors and start uppers…

Our March Verge main event is this Thursday, March 29 at the Speak Easy. Doors will open to ticket holders at 6:00 PM, when we’ll tap into the heart of the Midwest startup community with two powerful pitches from high-potential startups and one deeply engaging fireside chat from a Inc. 500 company founder.

Here’s our lineup:

  • Leap, a mobile app that lets you to challenge your friends and show the world you’re a winner. This startup is straight out of Cincinnati and a top-notch product of the Brandery accelerator program.
  • Scribblr, a more effective way to turn your company email signatures into marketing tools. Not only that, but Scribblr is also a killer intrapreneurship example from iGo Digital’s talented team.
  • Our fireside chat presenter will be Jeremy Dearringer, the Co-Founder and Chief Research Officer at Slingshot SEO. He will share from experience exactly what it’s like to bootstrap a startup and get it off the ground. I’m looking forward to our candid discussion and your questions for Jeremy from the audience.

Like last time, we’re charging a few bucks for cover. So you’ll need to use your PayPal account to RSVP.

This event will open for reservation at 8:30 AM Monday morning.

Fair warning: spots filled up within 4 hours at last month’s event. If you were there, you’ll remember that the energy and spirit of the evening was magical. If you’re pretty sure you can make it, grab your spot now!

On top of our stellar lineup of presentations, we’ll have tasty food, refreshing beverages, and fantastic people from our Midwest startup community. Come learn something new and share from your startup experiences in our evening of startup stories and celebration.