Lack Of Planning On Your Part

Should not constitute an emergency on my part.

I’m guessing you have heard this saying a time or two as well.

But based on the actions of a couple of our clients, I’m guessing this saying has little meaning. Let me share a brief example.

A medical device company has several products on the market in the U.S. and many other parts of the world. They are actively pursuing getting their products cleared all across the world. The company relies on distributors in the specific countries to take care of getting products registered. The company has no in-house regulatory or quality resources and has relied on us to serve in this capacity as a very part-time basis.

And when I say very part-time basis, I mean that we help with regulatory issues somewhat after the fact. Let me explain. Company works with in-country resource to register products, unbeknownst to us. In-country resource has an issue with information provided or needs additional documentation and needs a response within a couple days. Company contacts us in a rush with the emergency to help address deficiencies.

This scenario has happened half a dozen times. Each time, we have communicated the need for the company to be more transparent with us, to let us know what products and where they plan to register. However, there is NO regulatory strategy. There is NO business strategy. The company might argue differently. To paraphrase what the company would say is their strategy: To get products registered in every country in the world and sell, sell, sell.

I can ramble on and on. Let me get to the point.

Lack of planning on your part should not constitute an emergency on my part. Develop a vision and strategy to support it. You should have a plan based on the strategy and communicate this plan to your team and resources. When actions are required, keep your team and resources informed, tweak the plan, and course adjust.

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.

The Medical Device Industry in Memphis is Moving Mountains

According to the Greater Memphis Chamber more than 70,000 people work in the life science industry in the Memphis area.  However, most of the local residents aren’t even aware of the bounty of technical jobs that exist there.  Some in the industry are hoping to change that.  “Many of the students don’t necessarily know what kinds of careers are ahead for them if they focus on math and science in middle and high school”, said the Memphis Academy of Science and Engineering’s executive director, Harold Wingood.  But its mentoring program with Memphis medical device maker Smith & Nephew is helping to light the way.

“It’s not just engineers that make the bioscience sector move,” said Gibson “Sunny” Morris with the Mid-South Community College’s Arkansas Delta Training & Education Consortium.  “You can have all the engineers you want, but if you don’t have production workers to make that plant run, it’s not going to be very effective,” Morris said. To that end, his school offers an array of advanced manufacturing programs to help students learn to weld and run machines, among other things.

Also, a work group of medical device companies, university groups and the Bartlett Area Chamber of Commerce are working on a possibly $4 million facility with the up-to-date equipment used in medical device manufacturing to train locals on the specific skills they need to work in the industry.

So, perhaps the mountain is moving to Mohammed instead of Mohammed having to go to the mountain.


Stuck Between Evidence and Policy

We really liked this blog by Peter Kissinger, so we thought we would share it with you…

Stuck. That’s how many of us feel about commercial life sciences. The venture capitalists have abandoned us. The IPO market is largely closed to us. The momentum is once again with IT and all its apps, games and social networking variants. IT and life sciences both tend to cycle with large amplitudes, as reflected for both in the last four decades. IT has the ball today and is running with it. The energy sector is also energized. Meanwhile, innovation in life sciences is struggling like a mouse in a glue trap—and it’s not pretty.

The old guard is moving on, and the new biology, with all of its promise, is trapped between a heavy and uncertain burden of regulation, price controls (AKA “reimbursement”), a lack of confident risk capital and trouble meeting expectations. The science is much more nuanced than was projected to the public. We didn’t lie. We just didn’t know. Massive industrialization of R&D did not work to mitigate the long-expected patent cliff. Over we go. We’ve retrenched from the old R&D model as too bureaucratic, mechanical and uninspired, swinging back to academics and smaller firms as the engines of discovery. 

Politicians speak of small business as a source of job growth, but they must not be, including the many small life-science businesses with which I engage here in the Midwest. The inputs are often university technologies, and funding is tough beyond friends, family, angels and SBIR/STTR grants. Even the proliferating business plan competitions can put a few beans in the pot. The bugs in this system are many.

Universities have been using a playbook based on fear of losing on one of those very rare big wins. Don’t pass the ball for fear of either a touchdown, incompletion or an interception. The safer bet is to stay in the huddle as the game clock runs out. Time and money is lost in the analysis process and the expectation of reimbursement of IP expenses early on. Small angel funds then treat a $200,000 investment as if it were $200 million. That makes sense to them. Capital is a scarce commodity in a recession, and these funds are tiny. 

There are few venture funds left for life-science startups. Those that remain focus on later-stage deals such as driving sales after U.S. Food and Drug Administration (FDA)approval or funding projects that larger firms spin out, de-risked somewhat after the preclinical work is done. 

The good news is that many are aware of this problem and explore new, more open approaches. Perhaps the desire for blockbuster entrepreneurship can pass to a more personalized version that is less bureaucratic, more about doing and then failing fast with grace. Today, we are seeing more corporate partnerships funding projects at small firms as large organizations have become less egotistical and isolationist. 

Drug discovery happened for decades in smaller firms, but lately, that has been accelerating. This impacts the instrument industry (more auction sites as small firms fail) and the contract research organization industry (smaller projects with fewer molecules spread over more fragile clients). The impact on careers as the pace of creative destruction accelerates is a change we do not like. It is more important than ever to locate in a dynamic life-science cluster where an ecosystem of small and large firms, management talent and capital sources all co-exist. 

Several columns back, I wrote of attempts by professional groups to influence a comprehensive innovation strategy. Great minds are noodling, and the tactical ideas are fine with respect to tax policy and reforming the FDA, but I’ve come to the conclusion that our biggest challenge is spiritual. There is far too much whining and pointing fingers to take time to get down to doing. 

Industry disappoints, and some want the government to do it. Government disappoints, and some want free enterprise to do it. Both play a role and both will screw up now and then. I favor free enterprise because we can screw up on a smaller scale, auction off our equipment and move on. It’s too bad Freddie Mac and Fannie Mae could not have done that too. Government is bad at stopping what it starts. They have no skin in the game other than ours, so they take more of it.  

We’ve started the year 2012 off rather badly, with U.S. debt matching GNP and political candidates and their advocates throwing mud. In free enterprise, we have winners and losers, just as we do in football. It’s OK. Labs and plants will close as others sprout up. If you take a greater risk, you get a greater reward, or more likely, you get nothing at all. This works very well in the aggregate. 

I’ve made foolish investments (in retrospect) and suffered the consequences. Moving from the 1 percent back to the 99 percent is not fun, but I own my decisions. What I like even less is government making foolish investments with my money and yours. There is never an apology.

So here we are, stuck! Your assignment in this critical election year is to explain how and why free enterprise works—warts and all. We must explain the complexity of biology and disease. On both fronts, there will be forces pointing to egregious examples, often out of context, to attract the votes of our friends and neighbors. If we allow this to happen, without countering the shouting with wisdom, we will be stuck for decades. Policy, like medical decisions, should be based on evidence, not magic. Evidence to support policy should not be selected from a menu; policy should be derived from evidence. In 2012, we need to get this right.

Peter T. Kissinger is professor of chemistry at Purdue University, chairman emeritus of BASi and a director of Chembio Diagnostics, Phlebotics and Prosolia.

How do You Market Medical Devices?

So, you’ve developed a great medical device that’s going to revolutionize the industry and save thousands of lives.  How do you market it?  Sure, you can show up at your potential client’s workplace with your briefcase and product sample, but then what?

I came across an interesting article by Gavin Finn that looks at the options for presenting and demonstrating medical device products to prospects. He covers everything from who might be present at the meeting and how to market to them, to creating a compelling experience through audience involvement and demonstrations, to using virtual and interactive technologies.

Finn states, “Fortunately, today’s sales and marketing toolkit includes a number of options for presenting and demonstrating products to prospects—even in the absence of a physical product. In a traditional selling process, buyers often play a passive role—listening to sales presentations, watching case study videos, etc. They have no interaction with the product whatsoever. These traditional selling methods don’t provide the information necessary to make a truly informed buying decision, and that can lessen or kill chances for a sale, or make for a far longer sales cycle.”

“When it comes to sales, who you’re talking to is as important as what you’re talking about. It’s not unusual to have five or more departments involved in the buying process, and each may have different requirements and decision-making influences. For this reason, sales and marketing professionals need to customize their messages with an experiential focus that addresses each decision-maker’s requirements. The customer experience should concisely articulate those benefits in an engaging and memorable way.”

When I was a kid in the 70’s, a neighbor of ours was a Rainbow vacuum cleaner salesman. One day my parents, out of the goodness of their hearts, let him come over to demonstrate his merchandise. I remember as a child that I was quite impressed with the cool demonstrations that he did to highlight his product- dumping dirt on the carpet and vacuuming it up to show the suction ability of his machine and adding scented oil to the water inside the apparatus, thus infusing the house with a pleasant odor.  It seems, even with today’s technology, salespeople haven’t come that far from their roots.  You still have to market to the right audience, get and maintain their attention, and impress them with the abilities of your product (even if that only entails the power to suck up dirt and make your house smell nice).  If it makes any difference, my parents ended up buying a Rainbow that day, even though we weren’t in the market for a vacuum.  So, it must work…

How Do You Explain Regulatory Compliance?

When I was writing the last blog post for Building a Business Case, I really struggled with how to emphasize the importance of understanding regulatory and certification requirements ahead of time so that you could design your product around any codes or standards you need to meet.  Afterwards, I came across “Designing for Regulatory Compliance”.  It really goes into detail on the subject and explains how essential this concept is.

“Let’s start by understanding the goals of the regulatory processes. In general, they exist to ensure that safe and effective products are delivered into the market place with appropriate risk-benefit ratios. Every manufacturer, designer, regulatory professional, medical practitioner, and consumer has this as a common goal. However, if this is the case, why are there continually issues?  The issues originate in the way regulatory compliance is treated during the development process. It is often seen as an afterthought or a necessary evil to be tested for and sometimes gamed at the end of the process when negative regulatory feedback is very frustrating and expensive. Even one request for additional information can be devastating to a company’s plans and financial well-being. Funding for start-ups and small companies is often tied to regulatory milestones.

So what can you do? With existing ‘design for …’ processes, teams consist of the stakeholders who ensure successful execution of the plans. Similarly, companies can incorporate regulatory affairs professionals (or those with extensive regulatory experience) directly into their design teams to ensure that the regulatory concerns and requirements are addressed in planning and subsequent design phases. This approach encourages the team members to use their experience and expertise to design products and test programs that will allow the creation of regulatory-ready products.

Design for regulatory is a valuable concept, regardless of future changes to agency requirements or processes. Other ‘design for…’ paradigms have shown that up-front, early consideration of tasks that are usually performed at the end of the product development process reduces time to market and costs associated with redesign.
The development of a solid regulatory strategy and the incorporation of regulatory resources into the design process will ensure fewer surprises and allow for more efficient and potentially easier FDA submissions. This paradigm can also yield better competitive information and product positioning and potentially create a competitive advantage in the marketplace.”

Mr. Saltzstein, being an actual product designer, explains the process much better than I could ever hope to.

How Well Do You Really Know Your Market? The Next Step to Building the Business Case

This is my second post in a series based on our Building The Business Case.  Building the Business Case is a high-level snapshot/checklist/workbook to provide a little guidance and direction for entrepreneurs.

Last week, I covered the first thee points. The next three items are:

Describe the market(s) for your product / technology / service (e.g. medical device, consumer, industrial):

Make sure you understand the type of market your product will be useful to.  In the long run, this will save you a lot of time and effort.  For instance, you wouldn’t want to waste your time trying to sell a circus elephant to a Wall Street stock broker. That just doesn’t make any sense.

Who will use your product / technology / service?:

This would be your end user, not necessarily the person purchasing your product/technology/service.  Although you may not be selling your product directly to this person, you certainly have to consider their needs.

Who will purchase your product / technology / service?:

This is the actual person purchasing your product/technology/service, who may very well be buying the product for a customer’s use and may not actually be the one using the product.  This is the person you have to appeal to.

I am reminded of the above two items every time I go to the grocery store with my children.  Any box that has Lightning McQueen, Mario, or Buzz Lightyear on it attracts their attention and leads to pleas of “Please Mommy, can we get this? We’ll eat it, we promise!” Ever the diligent mother, I carefully read the label and assure myself that the product does, in fact, have some sound nutritional value before I deem if it is worthy of my purchase. In this scenario, I am the “purchaser” and my children are the “users”.

Next week I will be covering the next three points in Building The Business Case.

Helping Communities Pursue Life Sciences

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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A Project That Matters

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

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 ( to find out.

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Paralyze: Over Analyze or Under Utilize

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.

Remove The Distractions

My wife is not a big fan of when I use business case examples to describe our personal matters. But for me business and sometimes sports analogies are very fitting ways for me to explain my thoughts.

Now it’s a bit of a reversal. Let’s just say over the past few weeks, we have more than our share of distractions in our personal life (one example – a water pipe failed soaking the sub-floor). We have been dealing with all of these distractions and it has taken us away from our primary focus. As I’ve thought about these distractions, I realized our personal situation is very similar to many clients we’ve had. Let me explain.

Many of the businesses we’ve helped lacked focus prior to engaging Creo Quality. Some had lofty visions or at least a fuzzy idea of what type of business they aspired to be. However, they spent nearly every day going from one emergency to the next. Almost always, the resources were burnt out and exhausted. And not surprisingly, these businesses were struggling to move any closer to their big visions. In fact, most were moving further and further away.

In our personal life, we are at the point where we are realizing that too many distractions can wreak havoc on our big dreams and visions. So we are working on removing the distractions and regaining a strong central focus.

Businesses need to do the same thing. Sure, there will ALWAYS be distractions. But not all distractions need our attention immediately. And guess what: Some don’t need our attention at all.

For a business to be as strong and focused as possible, the leaders of these companies need to realize this. Removing distractions can improve the rate of success and get them closer to where they want to be.

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Communities Applying Sound Strategic Principles

During the past two years, Creo Quality has been approached by a number of struggling communities who are interested in improving their economic situations. While in the past, communities who have approached CQ were interested in diving in to something without a strategic action plan, recent endeavors seem different. In particular, we have been approached by a community who wants CQ to help them identify their strengths and opportunities to target opportunities to leverage their competitive advantages and core competencies. While the project is still pending, it has been extremely encouraging to work with a community and economic development officials who have an interest in applying sound strategic principles to their growth plans.

We recently read a story in the IBJ about the city of Kokomo and its Mayor. At one point, Kokomo was ranked as having the highest average wages and is now at the bottom of the list. Now, it’s a battle of the budgets… moving trash cans to one side of the street, closing the city’s day care, etc. The biggest pitfall is that Howard County is not retaining the earnings of its best-paid workers! 20% of Howard County’s workforce lives outside Howard county and this 20% earns 30% of the income generated in the county. Kokomo and Howard County must attract more well-paid workers to live there and attract bigger companies to employ them and their Mayor is working on just that.

This, too, is encouraging to see where a little bit of strategy is being applied to help revitalize Kokomo’s downtown.