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.

Contingency Planning for Medical Device Product Development

Never underestimate the importance of a solid medical device product development project plan. But even the best of plans should be revisited throughout the product development process and adjusted according to the ever changing project landscape. Sometimes, though, we are very good about planning early on in the efforts but forget about the need to update.

I’m up to my eye balls in one of these medical device projects right now. Every minute of every working day, and even several minutes of non-working days, can easily be consumed with going from one fire to the next to try and address product development issues and concerns. Lately, I do feel very much like the good ol’ project manager firefighter. Grab a hose and spray towards the latest and greatest fire. Trouble is, I don’t feel like we have enough firefighters and/or hoses to go around. It also sometimes seems like we have a few fire starters on the team. I don’t think the project fires are being set on purpose. I think, though, it is an outcome of a lot of angst.

Okay, yes, you need to understand something about medical device product development (and product development of any kind, really). Product development really equates to a lot of uncertainty. If we know about an issue, we can plan for, prevent, and address the issue ahead of time. Product development definitely can have more than a few “gotchas” that if not properly prepared can wreak more than a little havoc.

So how do you combat this?

Plan. Do. Plan. Do. Yes, this can seem like a never-ending cycle. But that’s kind of the point, right? At the start of a medical device product development project, is it really possible for me to plan all the details of design transfer? Probably not. My planning efforts should coincide with those project phases, milestones, tasks, and activities nearest to the schedule. I can speculate about future phases of development–which probably is somewhat worthwhile. Spending too much time planning too much detail about phases way downstream, though, is probably a bit of a wasted effort. So much is going to happen that will make those future plans obsolete. As you prepare to exit one phase and enter the next, a revised project plan should help communicate this transition to the project team.

Communicate. Communicate. Communicate. If I had a dollar for every time I’ve talked about the importance of communication with respect to product development, I’d have exactly $1.25M by now. If I had to pay a dollar for every time I’ve dropped the ball in some way with respect to effective project communication, I would have lost $2.5M. It’s so easy to talk about the necessity of good, effective project communication. It’s way harder to actually deliver. As a project manager you should assume one thing when it comes to project communication with each team member: you cannot provide too many details. Also, don’t worry if you think you already said something before. It really doesn’t hurt to repeat information. You also may have to pull information from each team member; don’t expect them to come to you ever.

Have contingencies ready. Always. I don’t care how great your project team is and how much experience they have, as a project manager you have to be a realist, maybe even a bit of a pessimist–at least when it comes to project planning and schedule. You have to learn on the fly what each team member is capable of and likely to achieve when it comes to tasks and assignments. You have to learn who can handle a large list of tasks and work independently and who has to be micro-managed and handle one task at a time. You have to expect that mistakes will happen. You have to expect that assumptions will be proven wrong. You have to be ready with contingency after contingency throughout development. When something doesn’t work, figure out other ways to solve problems. But before pulling the trigger on any contingency plan, be sure to weigh pros and cons with stakeholders. And definitely communicate contingencies to project team members, even if this may mean some uncomfortable conversations.

There Is A Plan. I Promise.

The last few weeks have been a little stressful and hectic. Yes, I’ve felt the pressure as a project manager for a medical device startup. Our efforts had been stalled for too long yet started to make some real progress a couple weeks ago.

Right now, it feels like chaos. Organized chaos, maybe. There are quite a few components, resources, etc. involved in bringing this medical device closer and closer to market. Each day for the past week or so has been spent identifying the critical pieces–those items which either gate future development and/or are stalled for some reason.

And through all the chaos there is a plan. I’m approaching this a little differently than other medical device product development projects. Overall there will be two products–the main device and an accessory kit. Each product has a few components. And each component seems to have its own intricacies and nuances. Yes, there is a plan. But I’ll be honest, it feels very much like juggling right now.

Fortunately, we have a good team–maybe great if we can pull off the aggressive timeline. The team is committed to getting their parts done as quickly as possible without compromising quality.

Where Does Your Real Meeting Happen?

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.

A New Medical Device Startup in Indiana Completes Planning Phase

Okay, I can’t tell you just yet many details about this startup. But I can tell you that the medical device product development efforts are underway and off to a good start.

The startup was very good about vetting out and defining user needs and building the business case before engaging Creo Quality and other product development resources.

And a couple weeks ago, we concluded the Planning Phase of the project. During this phase, the deliverables included:

  • Design & Development Plan
  • Risk Management Plan
  • Project Schedule
  • Design Input Requirements

We also established the company’s Design & Development procedure, defining the project phases and minimum deliverables.

Improving Your Chances for Success

I found an interesting article about medical device product development that talks about the lack of success that many companies seem to have in taking their product from start to finish.

Although introducing a successful new medical device has never been easy, it seems like it’s been especially difficult in the last few years. According to a 2010 survey from McKinsey Global, only 39% of 2240 executives feel confident in their companies’ ability to do so. And the cost of failure isn’t exactly cheap—a launch delay or failure can cost millions of dollars. It’s no surprise then that many firms would like to improve in this regard.

Mr. Buntz suggests that while companies spend a lot of time developing product prototypes, perhaps they should also spend time developing sales model prototypes.

To deal with this problem, companies can adopt a custom, highly focused, modular sales model prototype prior to full-scale launch that is designed to rapidly validate the market and business opportunity. Similar to product prototyping, this technique enables a company to identify the viability of a product at minimal cost. A sales prototype enables a company to answer three fundamental questions: Will the product quickly fail after it is introduced? Will the profit margins be sufficient to justify placing the product into a core sales channel? And is the product worth taking to full scale?

Another recommendation to improve the chances of success when launching a new product is to employ outsourcing, when it is useful. Schimelfenig advises companies to look for a partner with a business model that shares risk and shared reward. This ensures that interests are aligned. An experienced sales partner can help deploy customized strategies to accelerate revenue by developing a sales channel for the specific needs of company and product. Things to look for when sourcing a business partner include solid sales support, tight operational infrastructure, and a successful track record building custom sales models.

I believe that if you combine these suggestions, along with our ideas from Building The Business Case and Creo Quality’s medical device product development expertise, you will greatly increase your chances of success in launching a new product.

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Ideas vs. Execution

I came across this blog by Seth Levine in which he encourages usage of some of the same principles that we try to persuade you to instill with our Building The Business Case document.

Mr. Levine states, “Ideas are great. But they’re not as valuable as most people make them out to be, and by correlation, execution is almost universally underrated and in hindsight taken for granted as a given once a company has become successful (and rarely given the credit it deserves).”

I was especially interested when, in referring to what we consider market leaders, he states “Many weren’t the first or only ones to come up with the idea that made their company. What separated them from their competitors was their ability to out execute everyone else in a way that took a good idea and made it a great company. Often, in fact, another company was the early market leader only to have their leading position overtaken by an upstart who was hungrier, more nimble, and more focused on the basics of executing a great business.”

He ends with, “My point isn’t that ideas aren’t important. It’s just that execution of those ideas is far more critical. And it’s worth thinking about that as you consider the operations of your own business.”

This is where Building the Business Case can really make a difference.  Keeping the principles we discuss in mind will “keep you focused on the basics of executing a great business” and therefore help to ensure that your business becomes and remains successful.

I remember when I was in elementary school one of the girls had a Cricket doll instead of a Barbie doll.  Mr. Levine’s musings got me to wondering, “Whatever happened to Cricket?” I’m sure Cricket was basically the same unrealistically perfectly proportioned, flawlessly coiffed doll as Barbie.  Perhaps poor Cricket didn’t have the advantage of having people behind her who were focused on executing a great business. Otherwise she too might still be popular and successful after over fifty years.

Other blogs on Building the Business Case:

Building a Business- The First Step- Know Your Product

The Second Step to Building the Business Case- Know Your Market

Part Three of Building the Business Case – Location, Requirements, and Market Size

The Final Steps- Know Your Competitors

Who Are Your Competitors and How do You Protect Your Ideas From Them?- The Final Steps to Building The Business Case

This is the final installment of our Building The Business Case series.  We have been looking at the questions entrepreneurs need to ask themselves in order to Build a Business Case.

What are the competitive products / technologies / services currently available?:

It’s not enough to just design a great product; you also need to be aware of what other products are out there.  Take the time to do the research to see what other people are already offering.  Sure, the new shampoo you developed smells great and makes your hair soft, but were you aware that there are also 500+ other brands of shampoo out there that do the same thing?

Why is your product / technology / service better than competitive products?:

Once you discover what the other products are, figure out what differentiates your product from them. What do you have that they don’t?  If you can’t come up with an answer to this question, perhaps you shouldn’t be marketing your product.  Does your shampoo perhaps rinse itself, or automatically highlight one’s hair as it scrubs?

Can your product / technology / service be protected via patents and/or trade-secrets?:

This is important so that you get the credit for your idea and someone else doesn’t.   Remember, it’s not your idea to steal if it’s not patented.  Just because you thought of it first doesn’t mean it belongs to you.  Talk to a patent attorney if you aren’t sure if your product should be protected.  You might also want to conisder non-disclosure or confidentiality agreements if they apply to your situation.   It is important to note that once there is public disclosure of your idea, your ability to patent the idea may be compromised. In fact, once there is a public disclosure, your patent rights are gone in most of the world (you have one year from date of public disclosure to file a patent in the U.S.).

Previous blog posts on Building a Business Case:

Building a Business- The First Step

How Well Do You Really Know Your Market?

Location, Requirements, and Market Size

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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.

Location, Requirements, and Market Size- Part Three of Building a Business Case

This is the third installment in our series about Building a Business Case, which covers points that provide guidance and direction to entrepreneurs.

See the complete Building The Business Case document.

Where in the world do you plan to sell your product / technology / service?:

Sure, you can envision people using your product at their business or facility, that’s easy.  But really, where are you going to sell it?  It’s not like you can set up a table in front of the local WalMart and try to convince the passers-by to purchase your product with the loose change in their pockets.  Take the time to consider the possibilities and do research to find out the best route for you to market your product.

Are there regulatory and/or certification requirements pertaining to your product / technology / service?:

It is important to find this out as early as possible and design your products based on the requirements.  It is really pointless to do or plan anything until you know what these are.  “Well, how am I supposed to know what the requirements are?” you may wonder.  Check out the FDA website, if your product is a medical device, pharmacutical, or food.  For other types of products, try the websites of the regulatory organizations in that market, such as the FCC, or HIPAA.  If all else fails, ask people in the industry for guidance.

What is the size of the market(s) for your product / technology / service?:

This could determine how much you are willing to put into your project and if it is even worth the effort to pursue your idea.  For example, manufacturing snow shoes specifically fashioned for The Abominable Snowman might sound like a brilliant idea, but the market is so small, not to mention hard to locate, that you’d be hard pressed to sell any, let alone make a profit.

In the next post on this topic, I will cover the last three points in Building a Business Case which involve considering competitive products and patents.  For the previous blog posts in this series see:

Building a Business- The First Step

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

Kokomo, IN – Moving from Cars to Med Device

Creo Quality recently conducted a strategic assessment to determine the feasibility of developing the life science industry in Kokomo, Indiana.

Kokomo and Howard County have a rich, storied history tied to the automobile industry. The community was extremely prosperous during the automotive industry’s heyday. Several businesses emerged in order to support this industry. Kokomo emerged as a leader in advanced manufacturing, attracting topnotch engineering and technical talent to the region. While the automotive industry has been in decline, many of the capabilities, resources, and technical resources remain. Kokomo’s challenge is to figure out a strategy to leverage its assets and strengths while diversifying its economy to be less reliant on automotive.

Our study determined that GKEDA (Greater Kokomo Economic Alliance) should take a low-risk, strategic approach while considering entry into the life science sector.

GKEDA should:

  • Identify assets with potential to support medical device industry
  • Develop medical device marketing strategy
  • Make GKEDA known
  • Identify other industries where current assets and strengths can be leveraged

As I have mentioned before, I am new to the industry, and I had never really put much thought into the economic development of Kokomo.  It was interesting to me to learn all that this community has the potential to offer our industry.  It also made me wonder what untapped resources lay in other communities in Indiana.

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.

Building a Business- The First Step

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.

Confessions of a Serial Planner

Jon suggested that for one of my first projects, I write a blog on planning.  “Great!” I thought.  I love to plan.  I know a lot of people dread the tedious task of planning and prefer instead to focus on the end product.  It’s enjoyable to envision the kudos and accolades you will receive when you have produced a brilliant product that will revolutionize the industry, not to mention the piles of money that await you.  Call me a control freak, but I love “the plan”.  Something about the organizing, prioritizing, and listing appeals to my inner need to have everything in order as it should be.

Jon sent me a list of his blog posts that dealt with planning to help me get started.  There were 24 under the topic of planning and 25 under the topic of project management.  He has great ideas, from making sure you prove there is a market for your product, to product development planning, to being sure to have an exit strategy.  The planner in me couldn’t help but be impressed and think “This is great stuff!”

Goal setting is imperative in planning.  I like to use a technique I learned while studying and volunteering with The Dale Carnegie Course.  Make sure all of your goals are specific, measureable, and attainable.   A goal such as “I want to be healthier”, might be better stated as, “I will lose 15 pounds by June 1”, or “I will be able to do 3 sets of 50 sit ups by the end of the year.”  These are both very specific, as well as measureable.  The goal also should be something that is realistic and attainable.  Sure, I would love to play for the NBA and therefore be famous and make millions of dollars a year.  But, let’s face it, I’m 42 years old, my height is 5’5”, I have the all the coordination of a newborn giraffe, and I’m a woman.  It’s not gonna happen.  Finally, tell as many people as you can about your goal.  This holds you accountable.

Setting a goal is your first step in planning.  For more information on how to carry out your plan, I recommend the Creo Quality blog. I hear it’s great…

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FDA Clearance – now what?

So, you’ve gotten FDA clearance – congratulations! Now what?

Have you completed a gap analysis on whether you are in compliance with FDA regulations? Before or after you received FDA clearance?


Typically gap anlaysis is more valuable pre-FDA submission. The reason is that depending on the gaps, fixing them can be done parallel to the FDA submission which takes an average of 6 months. This way, when you’ve received FDA clearance, your gaps are fixed and you are in a positive position to get your product to market – especially if the FDA came back and audited you.

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