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When Clients Look Fail to Make Decisions

June 28, 2011 By Leave a Comment

For the past year, I’ve been working for one of those clients that I could write a book about. You know, one of those how-to books, except this would be a how-not-to book.

Without going into too much detail, it’s been a little frustrating. Frustrating because the small team of consultants knows their stuff and has provided solid direction for the client on what to do and how to do it. The problem is the client fails to make a decision either way. But it has been okay; our team moved onto the next issue, identifying issues and potential solutions, hoping the client would eventually make decisions about direction and next steps.

However, decision-making and progress has been really SLOW.

Here we are, a year later, with little real progress to show. Yes, we have uncovered quite a few gaps and issues to address. Yes, we have communicated the ramifications. Yes, we have identified multiple mitigations and paths forward. No, the client has taken no ownership in owning the responsibility to do something about the issues.

I keep hoping that tomorrow will be the day that some decisions are made–any decisions, even ones I wouldn’t entirely agree with. We are just looking for direction. We are just looking for some closure.

Maybe tomorrow . . .

Filed Under: All, Project Management, Strategy vs. Tactics

Medical Device Inventors Need to Trust

May 4, 2011 By Leave a Comment

I had lunch with a friend the other day. We were sharing stories and catching up, mostly about the goings on in Indy’s medical device scene. My friend asked if I had heard from “Tom” lately. Tom previously met with each of us separately to discuss his revolutionary medical device idea. When I met with Tom, I laid out several things for him to focus on and to address in order for him to get to the next step. Tom approached my friend, who is more involved with the funding side of medical device product development. My friend asked Tom several questions, including:

  • Are you willing to give up equity in exchange for funds? Tom’s response: No.
  • Are you willing to give up control and let someone with a proven track record run the business? Tom’s response: No.
  • Do you know how much tooling and development will cost? Tom’s response: No.

Does Tom have a good idea? Maybe. But until he realizes he has to trust others, we may never know. Not to diminish Tom’s expertise, but the idea is easy.  Taking the idea to the next step into product development will be challenging. Frankly, Tom does not have the skill set or experience to do this. Tom has to realize he has to trust others to make it happen. Tom has to realize that to get funding, he will have to give up equity and likely control of his business. If he doesn’t, Tom will only have an idea.

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Filed Under: All, start-up, Strategy vs. Tactics Tagged With: , , , , , , ,

Get Your Medical Device To End Users ASAP

April 19, 2011 By Leave a Comment

I’m working with an Indianapolis-based start-up medical device company. We have been working aggressively the past few months to initiate a clinical investigation. No, the product is not ready for production (although the current version does have FDA 510(k) clearance). The product concept is interesting, and I’ll admit, I’m not sure if it is valid.

There’s only one way for us to find out: get this medical device to the end users ASAP. Hopefully you understand there are challenges and regulations to get a medical device ready for actual use, which sometimes can be costly and extremely time consuming. If you don’t have the budget to go the clinical route, there is still a great deal you can learn by engaging end users in concept generation, bench testing, and simulated use studies.

Your goal should be to find out as quickly and inexpensively as possible whether your idea has merit and what features and benefits are important to actual users of your product. Chances are you will be surprised. Chances are what you think is critical may in fact be trivial to users. Chances are the end users will identify surprises and things you haven’t considered.

End user input into your medical device product development also brings validity and credibility to your efforts. And hopefully you realize, this will also increase your chances if and when you need to raise funds.

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

I’m Your New Doctor . . .

March 31, 2011 By Leave a Comment

. . . but I haven’t been to medical school. Okay, maybe this couldn’t happen.

However, I was recently introduced to someone who has been put in a somewhat specialized position but doesn’t have any experience in the field. It’s a little disturbing to me. Let me give you an example. Let’s say CQ decides to hire a new project manager, and the person we hire has little to no project management experience. Do you think it’s going to work?

What if we told our new project manager to read a couple books and meet Joe, an experienced project manager, for coffee sometime. Joe is really good; I’m sure picking his brain between sips of java will be all this person needs to get going. Do you think this will help our new project manager?

Neither do I. This is why this scenario is a bit of a head-scratcher for me. Why in the world would a company hire someone to fill a position who has no experience in this field?

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Inventor Walked Away From A $4M Offer On Shark Tank

March 28, 2011 By 2 Comments

Last year, I really got into the ABC program Shark Tank. After a few episodes last season, it was no longer on. I totally forgot about the show. Thankfully, my DVR didn’t.

On Sunday evening, I decided to see what wonderful TV program presents my DVR had in store. Yes, two new episodes of Shark Tank were there waiting for me. I sat down to watch episode 202 from 3/25/2011. Of all the episodes, the entrepreneurs on this night had the sharks in a frenzy. Several interesting ideas were presented including Toygaroo (think Netflix for toys) and Wake-N-Bacon–an alarm clock that cooks bacon bedside. Toygaroo accepted an offer from the sharks.

The capper of this version of the tank ended with First Defense Nasal Screens. When I heard what the inventor was asking for and after I saw the product concept, I started laughing. And then, the guy shared that he has a contract in place for a HUGE order. The sharks and I started paying attention. Offers started coming from multiple sharks: $500 for 20% equity and 15% royalty, $1M for 30% equity and 10% royalty, and then the kicker. One shark offered the inventor $4M for the company and was willing to pay the inventor 10% royalty.

The inventor DECLINED the $4M offer because he felt the company was worth $5M.

However, other sharks teamed up to offer $750K for 30% equity and 10% perpetual royalty, which was accepted.

Did the inventor make the right move? I guess time will tell.

What would I have done? Accepted the $4M. Here’s why:

  • The inventor had put up $600K of his own money, with another $400K from friends & family. Had he accepted the offer, the inventor and all investors would have had a pretty decent ROI.
  • If the product were to take off, the investor stood to make a pretty decent royalty of 10%.
  • I could probably figure out how to live pretty comfortably with an extra million or two.

But the inventor believes this is a multi-billion dollar market. Maybe he’s right.

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Filed Under: All, Misc, start-up, Strategy vs. Tactics Tagged With: , , , , , ,

If We Gave Away . . .

March 9, 2011 By Leave a Comment

. . . free medical consulting services, would you be interested in working with Creo Quality?

The emergence of “software as a service” products has been phenomenal lately. And every one seems to have a similar business model: provide the free-mium version with limited features, while providing several other pay-as-you-go monthly service options.

I’m a big believer in price to value. I think when we find something that’s free, the product does mean that much to us.

Do you agree?

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Starting a Business the Right Way

February 14, 2011 By Leave a Comment

Lise recently wrote a post about a friend whose daughter started a duct-tape fashion accessory business. Sure, the story is cute. More importantly, there are several lessons this 10-year entrepreneur can teach the rest of us about starting a business:

  • Provide a product that customers want and will buy.
  • Figure out how to generate revenue and make a profit.
  • Focus on a niche market and product.
  • Keep overhead as low as possible.
  • Build a loyal customer-base.
  • Early adopters will accept an imperfect product.
  • Innovate.
  • Only expand the product portfolio based on voice of customer.

I doubt that Trinity has thought about many or even any of these items. She’s just having fun making wallets and purses out of duct tape for her friends.

However, if you are considering or have your own business, maybe you should think about these lessons and apply them to your own venture.

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Building a Business- The First Step

February 8, 2011 By 1 Comment

At Creo Quality, we suggest that every entrepreneur first build a business case before beginning their venture.  We have come up with twelve questions to help you build your business case.  I will be covering a few of the questions each time in a series of blogs.  Here are the first three questions:

Describe your product / technology / service:

This seems totally obvious, but is the groundwork for your entire operation.  It is something you will have to do again and again as everyone from investors, to regulators, to Great Aunt Sally ask you, “What exactly is it you want to do?”

Why is your product / technology / service necessary?:

Just because you think your product/technology/service is the greatest thing since the invention of the internet, doesn’t necessarily mean it is something that is actually useful to the general public.  Think about why it is, in fact, essential to the industry you serve.

Does your product / technology / service fulfill an unmet need?:

Consider other products on the market and what your product has to offer that they don’t.  This makes me think of whomever it was that came up with the idea for a TV with a remote control.  There were already hundreds of TV’s on the market, but he thought, “Wouldn’t it be great if we didn’t have to get off the couch at all and could simply lie here and control the TV?”  Talk about technology in action (or inaction)…

I will be posting on other questions for building a business case in future blogs.  See all twelve questions in Building The Business Case.

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

Looking for Feedback on 510(k) Process

January 10, 2011 By Leave a Comment

During the past few months, there has been quite a bit of discussion about the FDA 510(k) process for medical devices. I’m in the process of reviewing some of the recent articles on this topic and will be writing a blog post or two, including some of my own experiences with 510(k)s.

If you have feedback on the FDA 510(k) process–pro or con–leave a comment and/or send me a note.

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Filed Under: All, Medical Device - General, Strategy vs. Tactics Tagged With: , , , ,

Helping Communities Pursue Life Sciences

December 28, 2010 By Leave a Comment

Perhaps this post is a little premature. However, Creo Quality is excited about 2011. We have a variety of projects lined up for the new year already.

We are working with a handful of inventors and entrepreneurs, helping them take their ideas to the next stage. I love working with inventors who believe their ideas will change the world.

I’m really looking forward to 2011 for another reason. We will be working with two central Indiana communities to explore opportunities within the life science industry. We expect to start working with the first of these communities in January.

2011 will be a year for Creo Quality to demonstrate the depth and breadth of our services to help both early stage companies and communities. We will show how sound strategic principles are applicable in both spaces.

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Filed Under: All, Catalyst, Community, Strategy vs. Tactics Tagged With: , , ,

A Project That Matters

November 6, 2010 By Leave a Comment

Having projects that are fun, enjoyable, challenging, and meaningful to the customer are rewarding opportunities. But projects like these rarely happen. And I really haven’t been able to find these opportunities through business development.  I think the secret is that these kinds of projects are often times hidden and unknown, especially to the outsider.

We have a project like this now. Our experiences are a very good fit with the client needs. Generally speaking, the client resources are welcoming and open and sharing–they want things to get better. The engagement involves quite a bit of strategy; what we are doing now is not why the client brought us in. Most importantly, we believe the results of our efforts will make a significant difference in the company’s bottom line and also the culture.

This is the type of project that keeps me going. This is why I love what I do.

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Better Luck Next Year

October 22, 2010 By Leave a Comment

I’m an avid Cincinnati Reds baseball fan. And if you follow MLB, you know being a Reds fans has been difficult in the past 10+ years. Yes, 2010 was a fantastic season for Cincinnati. But they were swept in 3 games in the division playoff series against the Philadelphia Phillies.

Better luck next year.

It’s late October (yes, another year has flown by). We at Creo Quality have started to reflect a little about the year. We are pleased but not complacent. We are definitely looking to 2011–yes, next year. However, we are doing more than crossing our fingers in hoping next year is better. We are tweaking our strategy to ensure 2011 exceeds 2010 (and 2010 continues to be the best year ever in our 3+ year existence).

The Cincinnati Reds made some significant changes in their organization (both management and players) a few years ago to be position themselves for the playoffs in 2010. I’m anxious to see how they do in 2011.

What does next year hold for you and your business? Are you crossing your fingers hoping 2011 is a better year than 2010? Or are you actively planning NOW to make sure it’s a better year? Do you have goals and objectives defined? How about a strategy?

I know–tough questions to answer. And often times, answering these questions requires some help. Maybe we can help. Give us a call (765 315 2736) or send us an email (info@creoquality.com) to find out.

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Filed Under: All, Catalyst, Strategy vs. Tactics Tagged With: , , , , ,

You Have To Read People

October 1, 2010 By Leave a Comment

As much as I’d like to believe I’m in the medical device industry, I’m really in the people business. More specifically, my job, more than anything else, is to manage and foster relationships. Until this happens, my medical device expertise means very little.

I’ve taken the Myers-Briggs assessment and am an INTJ. But I have my own business. Which means I need to be less “I” (introvert) and more “E” (extrovert). Sometimes, the “I” gets in the way. Once I understand the assignment, I have a tendency to put my head down and get the job done. Even though my clients want me to get the job done, they really want interaction–they want to feel important and valued. I have to “read” clients to understand what they need and when they need it.

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Paralyze: Over Analyze or Under Utilize

September 29, 2010 By Leave a Comment

James Ryan recently posted a blog “Paralysis by Analysis? What about Paralysis by Action?”

We’ve seen both situations. Analyze something to death. And believing actions equal progress. Check out the post at Lotus Development and leave a comment.

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