Category Archives: Risk Management

Six Steps to the Epiphany: Get This Right and Go Big

By:  Steve Haralampu, Sc.D. & Bill Skea, Ph.D.

Toaster

Every technology company strives to offer the best thing since sliced bread. Achieve commercial excellence with these key insights.

Successful commercialization of a new technology has more to do with marketplace needs and product execution than with the technology itself.  The main factor driving success is the customers’ perception of value:  “What does it do for me?” and “Is it better, faster, or cheaper?”  Technology rarely sells for technology’s sake.  We will discuss some factors to consider during the commercialization process.  Although the concepts are generally applicable to all product development efforts, we concentrate on how these relate to the introduction of new tools for life science R&D and diagnostics laboratories, especially within startup companies or other small organizations.

Changing Priorities: Transitioning from Bench to Product Development
Product development and commercialization is a truly multidisciplinary activity, especially at the beginning of the process:  the product specification.  The focus should be on filling customer needs.  Traditionally, sales and marketing is the conduit to the marketplace, and they should be involved in defining what the customer wants, but too frequently they are the sole drivers. Scientists that develop novel technologies have unique insights into their potential for being revolutionary, and to see outside of the conventional box.  How a product is specified and developed also depends upon design and manufacturing constraints.  The main design constraints are product complexity, such as automation, which drives product cost and time to market; and design for manufacture and assembly (DFM/DFA), which also drives cost, and whether a product can be made or repaired.  Finally, the whole process is driven with money.  Finance must be at the table to assure that the product development and commercialization effort is affordable.  A product funded for 95% of its commercialization is still not a product.  Resources must be available to cross the finish line.  Therefore, an agile team of scientists, engineers, marketers and financers, each with the ability to wear many hats, and each with roughly equal input, drives a successful product commercialization effort, since each has a stake in the outcome.  Since the product development effort is usually a period of intense activity, and is an activity with which a small organization is not constantly involved, it makes sense to share some of the workload with external resources. Otherwise, at the end of the process, an organization can be stuck with excess headcount.

A major consideration in the specification and design of a product is developing a strategy for how it will be manufactured and distributed.  Manufacturing entails investment in manufacturing space, equipment, and personnel.  This investment can be significant, and can be the burden that breaks an organization if product rollout is late, or sales do not meet projections.  There are many vendors that provide contract-manufacturing services.  Whether it is the whole product, product subsystems, or final assembly and packaging, the use of contract-manufacturers can significantly reduce financial risk in the early stages of a product’s life cycle.  Determining how vendors play into the overall manufacturing scheme can impact product design.  It can be extremely valuable to give your contract-manufacturing vendor a seat at the table during product development, to assure a design for manufacture, and to avoid surprises late in the game.

Associated with early-stage manufacture is a realistic sales projection, or a willingness to manufacture to orders.  Excess inventory of an expensive laboratory instrument ties up huge amounts of capital needed for an organization’s growth.  Maintaining financial flexibility during product rollout is important should it be necessary to redirect efforts into sales or applications development.

Six insights to keep you on the path to success
All of this is common sense, and most managers feel like they would never fall into any traps posed by the product development and commercialization process.  This does not seem to be the case, however, since there are so many examples of organizations that stumble, sometimes fatally.  Heeding the admonition, “Those who cannot remember the past are condemned to repeat it.” we give some real examples from which we can learn.

  • Technology Evaluation/Due Diligence Alone Is Not Enough

Even before a technology is approved for product development, before a startup is approved for funding, or during due diligence of an acquisition target, the projected product development process needs to be evaluated.  Sometimes inventors are so close to the technology that they do not recognize the marketplace landscape they are trying to enter.   This can be particularly true, for example, when a technology is developed by physicists and/or engineers and is to be applied to diagnostics.  It is typically not within their realm of experience to understand the technology alternatives or regulatory landscape.

      A clear sign of being too focused on the core technology is making the statement, “We have no competition.”  A core technology may be so revolutionary that there is indeed no competition that performs its specific task.  What can be unrecognized is that there are perfectly adequate alternative technologies for performing the task.  One team of inventors developed a methodology for detecting metabolic stresses within living cells.  Another established company had a similar physical product already on the market.  When the team was asked how they were better than this competition, their response was, “They’re not competition because they measure amplitude modulation, our invention measures frequency modulation.”  One needs to have very solid intellectual property protection if one plans to enter a marketplace and not expect competition when the method of data analysis is the only point of differentiation.  The technology is good, but the inventors did not adequately evaluate its potential versus competitive stresses.

 

  • Listen to the Customer (sometimes)

It is important for a product to be successful that it fulfills some unmet need of the customer.  Although this is true, end users do not always recognize their unmet needs, especially with regard to technologies that require a paradigm shift.  Therefore, asking sales and marketing to poll customers for their needs, tends to generate feedback that is incremental improvement of known product forms.  Apple, Inc. has been a leader in creating marketplace needs for its new products.

With respect to laboratory products, it is important to understand the customers’ workflow.  A product might do amazing things, but if it does it in a way that is not helpful, it will not be a success.  One company had an interesting platform for growing cells.  Their development team designed a product that compared a control to a test under a wide variety of environmental conditions.  This seemed logical to the design team.  However, research is normally done using plates with 24 or 96 wells, not just 2.  The company had a good idea, but its execution did not meet the most common workflow.

Small organizations tend to focus on the new technology.  A lot of this is driven by the fact that completion of the technology development is going on concurrently with the early stages of product development, and, after all, new technology perfection is what the small organization is all about.  One company developed a technology to separate proteins in a way that enhanced the research information obtainable once the proteins were further analyzed.  Unfortunately, that company did not provide the customer with an adequate way to retrieve the separated proteins from its product and into the downstream analyses.  Although the technology met customer needs, the overall product system execution was not useful in the laboratory workflow.

  • Customers Don’t Like to Read Instructions

Once a technology is demonstrated and shown to be useful, the technology development must focus on making that technology execution robust.  An inadequate technology execution is when:  failure rates are high, and it takes a skilled practitioner in the technology to recognize the failures, but when it works, it’s great!  Technology developers need to realize that they probably have an extraordinary skill at getting things to work, while the customer may not be willing to invest this kind of time to come up on the learning curve.  Technology developers deal with the technology 100% of the time, customers deal with most technologies only a fraction of the time as part of a larger workflow.  Therefore, they cannot focus on the nuances of running a finicky product.  A technology needs to be simple (sometimes requiring significant automation to conduct the difficult tasks) and needs to work reproducibly and flawlessly.  One company’s product was based on an array of test sites.  Each test site had >99% reliability, but since there were 41 test sites on the product, and each needed to work for the product to have worked, there was only a 65-70% chance that the product worked.  This was unacceptable in most laboratory situations.

  • Beware: The Misguided Cost Estimate

Especially with regard to the micro- and nanotechnologies being developed today, product cost estimates that drive the business plan can be based on faulty/excessively optimistic assumptions.  One company developed a rather extraordinary biochemical sensor that was based on a silicon chip only 0.2 x 0.2 mm.  The materials cost for the sensor was only cents.  Micro- and nano-scale products use very little material because of their size. The fault in the analysis was that the nanosensor still needed to interface with a macro world.  The product cannot be a box of grain-of-sand-sized sensors.  A housing to allow a customer to handle the sensor, along with the appropriate plumbing to get the sample prepared and to the sensor cost as much as an alternative sensor technology for the base application they chose.  The core technology probably still has great potential, but an application needs to be found where its small size is the advantage, and enables sensing in places unattainable by the alternative technology.

  • Product Design is a Predictable Task, or is it?

Many aspects of product design are predictable.  It is merely the engineering task of finding OEM components or designing custom parts and fitting these together in an operable system.  What could go wrong?  Missing cost targets, inappropriately setting priorities, or inadequately integrating systems are frequent issues.

Engineering design is fun for those involved, but sometimes it is hard to know when to stop. Over design with too many features can make a product too expensive, and/or unreliable.  Some features are just annoying.  One company decided to have its product send a stream of text messages to the operator’s cell phone updating the instrument’s status.  This sounded novel and useful, but in practice was just annoying.  That same company decided to custom design most of its mechanical components.  This approach was in some cases expensive, but more importantly did not leverage the knowledge base of OEM suppliers.  Consequently, some components did not perform as expected, which ate up valuable development resources to debug components that could have been purchased with proven performance.  Too much time was spent resolving issues that could have been purchased, and defocused the team from its core technology and applications development.  This company failed.

We are accustomed to seeing sculpted cases used in consumer products around us.  It is an attractive concept to create products with an eye-popping “look”.  This is possible for products manufactured by the thousands, but sculpted skins for products manufactured by the hundreds can be surprisingly expensive.  This is an example of an inappropriate priority in a resource-limited environment, and where paint might be a better alternative.

The product design effort is not complete with a final set of product blueprints.  There is still substantial work to be done producing support materials.  The user manual is not just a set of step-by-step instructions for the customer, but is also a legal document that is used to support safety testing and certification.  It has a particular format and set of regulatory requirements.  Another neglected aspect of product design completion is product packaging.  One company had great success beta testing its product at the university located across the street from their headquarters.  The same could not be said for beta tests at major research centers halfway across the country.  Placing the instrument in a shipping crate was not sufficient protection.  Beta testers received product, with screws missing (loose in the shipping container) and critical components out of alignment.  Needless to say, these beta testers were never converted to customers.

  • Transitioning from Prototype to Manufactured Product

The main pressure of an organization is to get income as early as possible, and to manage cash flow.  This drives some compressed schedules, and encourages cutting some corners.  Sending a product design to manufacturing too early can have profound consequences.  When a design flaw is detected in the design phase, it may be expensive to fix, but it is preferable to fix it before the flaw is replicated by the manufacturing process.  Just think about the costs associated with retrofitting multiple products in inventory, or in the field in comparison with taking the time to assure the design to manufacturing is correct.

Inevitably, some flaws in product design go undetected until the product is stressed in the marketplace.  One company did not make it that far.  They experienced too many bumps in the road during product development, so they were running out of money.  The product still had severe flaws.  They decided to launch the flawed product because investors promised that they would provide more capital if the company demonstrated they could sell product by the end of the quarter.  The company’s management thought that selling flawed products would buy them enough time to fix the product later. Unfortunately, customers were not willing to pay full price for a product that virtually did not work.  No products were ever sold.

Two clichés come to mind:

  • You only have one chance to make a first impression. 
  • If we don’t have enough time to do it right, why do we have enough time to do it twice.

 

In Conclusion
Nearly every function within a company has a vested interest in the success of product commercialization.  The commercial product is the physical manifestation of years of work, and is what will bring reward to the development team.  The product development task requires teamwork between corporate functions that typically do not have much interaction.  Lack of appreciation of the constraints of a given function by team members leads to disaster, e.g., specifications/expectations that cannot be met by the technology or by the design team; specifications that cannot be supported by finance; designs that are difficult to manufacture; executions customers do not want; etc.  The commercialization process is capital intensive, and has very little leeway for errors.  Product commercialization uses unique skills and experience not needed 100% of the time within an organization.  Outsourcing is a great option to minimize risks during this critical growth function.

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The Startup Business Plan: Charting Your Path to Success without Wasting Time

Treasure Map

Your startup business plan will be like a treasure map to show you and the team the shortest path to the gold while avoiding dangerous traps.

By:  Andrew Johnson, Ph.D.

It might seem trendy to ‘just do it’ but it is pretty difficult to make sure that you are ‘doing’ the right things if little forethought has gone into what is critical for your company’s success.   There are those who propose skipping this step, calling it a waste of time.  The reasons given are that as soon as the plan is ready it is already out of date or “we know what we need to do already”.  Many of these views come about from a misconception of what a business plan really is and what it can do.

A business plan is…
A good business plan gives founders the opportunity to clearly state and communicate their vision of the company with the rest of the team,  investors, key opinion leaders and other VIP’s that are critical to the success of the company.  The founder, his senior team and trusted advisors will be able to use the exercise of preparing a solid business plan to simulate how the proposed company will ultimately achieve success.  Think of it as a dry-run.  Gaps in the business model, feasibility issues with the underlying technology, manufacturing scale-up issues and other key elements that are critical for success will easily be uncovered during this effort.  Since this is essentially a simulation of how you envision things to go, any gaps and pitfalls can be identified early before any time, effort or money is wasted.  In addition to this, the business plan will allow the senior team to get valuable feedback from outside industry experts that will have a direct bearing on the company.

A business plan is not…
Having a clear understanding of what does not constitute a good business plan will not only help you in the preparation of the right plan for your organization but allow you to avoid wasting time.

  • Needed only to attract investors:  Yes, it is true that most investors will insist on reviewing your business plan (often they only read the executive summary) before deciding whether they have any interest in a further relationship (never mind making an investment).  However, the real value here is that you will have a detailed strategy mapped out to guide your progress and even a detailed task list for the team.
  • A long, boring document for ‘business types’:  Nobody wants to read or review anything that is boring or valueless.  If you can cover all of the essentials of your business in 5 pages then that is how long your plan will be.  In fact, it is better to start with a shorter plan in the beginning and then amend it as you make progress and learn more about the things that are most important for your success.
  • A static document:  The preparation of a business plan it not something that you complete and then file away for posterity.  It should be a living document that changes as your company grows and as market conditions that impact it are uncovered.  The key here is that with a good plan in place, you and the team will make conscious decisions to make a change rather than just changing course every time something new comes along.  A business without an ‘Evolving Business Plan’ is doomed to run out of time and money by constantly chasing issues that really should be ignored.
  • Something that can be outsourced:  Some of the hard work here can be defrayed by hiring an experienced consultant.  The founder and the senior leadership team will need to work closely with this ‘hired gun’ to make sure that the final product is a business plan that will drive the success of the company rather than a generic business plan (a true waste of time and money) that has little to do with the particulars of your company.

Spending your time creating the world’s best business plan is a waste of time and money
You don’t need the world’s best business plan.  You need the business plan that will provide you with the details and guidance to chart your company’s path to growth and success.  It should be no longer than that and it need not be fancy looking or printed on heavy bond, acid-free paper.  Spend the quality time you need with your leadership team (and consultant if needed) to draft up the best plan you can in a week or less.  You will need to keep updating it and filling gaps but get at least a reasonable one in place early.  The leadership team will frequently make changes to it as progress is made and new findings are uncovered.  Someone with expertise in creating effective business plans can be a great asset to your team in terms of creating a version of it that will be most appealing to potential investors in your market.

Take Home Points:
You need a right-sized plan to help you avoid wasting time and money and…

  • Avoid creating a great product that does not have a ready market
  • Discover that a huge need in the marketplace does not have a viable business model for growing a profitable company
  • Identify what  the next most important tasks are
  • Reveal underlying risks and opportunities that may not be obvious at first

Resources:

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The 10 Essential Elements of Every Successful Life Science Startup

By:  Andrew Johnson, Ph.D.

keys with a success key fob

Paying attention to these 10 essential elements for a successful startup will greatly increase the prospect that you will get your hands on these keys!

Transforming breakthroughs from the lab into successful companies is a daunting but ultimately rewarding task.  For some, there is no better validation of the quality and value of their scientific discoveries than the kind you get when it generates demand from paying customers.  However, according to Shikhar Ghosh, senior lecturer at the Entrepreneurial Management Unit at Harvard University, 75% of startups fail largely because they have neglected one or more of the 10 essential elements of successful startups.1

 

The 10 Essential Elements of a Successful Startup Are:

  1. Compelling Value Proposition: Having a great idea or discovery does not always mean that you have a product or service that will generate the customer demand required to sustain a business.  Having an experienced Board of Advisors can help you figure this puzzle out and will also provide you with the introductions to the industry experts and Key Opinion Leaders you need to feel confident that you have a viable business hypothesis.
  2. Capital:  How much money will you need to keep your operation running until you start to generate revues?  How will you fund the company?  Grants, Foundation money, investments and bootstrapping are just some of the ways that entrepreneurs get the funding they need to get their product or service to market.
  3. Key Resources:  You need key people on your founding team with the technical know-how and business sophistication to shepherd you company from the early days to a real going concern.  In addition to the people, you need to make sure they have access to the resources they require to succeed like adequate lab space, access to equipment, reagents, regulatory guidance etc.
  4. Key Activities:  Seems like an obvious one.  It is critical to develop a detailed roadmap that describes all of the strategies, tactics and activities that need to be successfully completed to reach your ultimate goal for the company.  This plan will include critical milestones along the way so that the team can monitor progress and make course corrections as needed.  Also, this plan will allow you to develop a realistic budget which will help you to mitigate the risk of running out of capital before you have achieved a successful launch.  The best roadmaps break this down to enough detail to guide not only month to month activity but day to day efforts as well.
  5. Cost Structure:  After you have launched your product or service, your focus now shifts towards expanding profitability.  Your Operations team will be looking to reducing the costs of providing your product while your Sales & Marketing team will be executing on tactics that will bring in significantly more leads, and more sales.
  6. Key Partners:  You don’t need to go it alone.  Establishing strategic partnerships can help you expand your market reach when you set up co-marketing agreements and save capital when you share the cost of space, equipment and other resources that you can both profitably share.  Your team will also benefit from the experience and perspective of your partner as your relationship grows stronger.
  7. Customer Segmentation:  This is something that needs to be started way before you are even ready to sell.  It is important to know both who will want to buy your product as well as who will not.  This will not only help you with your marketing efforts but will also insure that you build the right offering.
  8. Demand Creation:  Once you have a good idea who your customers will be, figuring out how to reach them and what message they will find most compelling becomes a lot easier.  Running an effective beta-evaluation with perspective customers will provide you with key insights that will go a long way to insuring that you have a strong product launch and have a Sales & Marketing plan that will quickly scale up to meet the business growth goals you have set for the company.
  9. Sales Channels:  Having a well thought out Channel Management plan will greatly increase the chances that you will have a strong launch.  It is important to know how you will sell to your customers and then develop the resources and team that will allow you to execute this well.  Different channels have different demands and processes.  Be sure to consider whether you will be using a direct sales force, distributors, a combination of the two and how that would work etc.  Don’t’ forget to consider e-commerce!
  10. Revenue Streams:  Another seemingly obvious ‘element’.  Don’t’ forget that you can get revenue for intellectual property that you can monetize through licensing fees if you don’t commercialize it.  Be sure to consider other ‘products’ like extended warranties, service agreements and advanced training offerings for example.   There are many ways to generate revenue besides what you get from sales of your core product or service.
Chart from UpStart presentation

Making sure your Founding Team has the expertise to manage the “10 Essential Elements” is the best way to improve the odds of success for your startup.2

The Secret to Getting this Right
The secret to keeping on top of all these ‘elements of success’ is having a founding team with the depth and breadth of experience and know-how to cover all of these areas.  Each ‘element’ can require very specific skills and tactics.  Furthermore, it is critical that these are customized to fit the particular needs of your company.  The other thing to keep in mind here is that these ‘elements’ are not static in their timing and demands for resources.  Having at least a few team members that have done this before will insure that you get all of this right.  Founders should look to establish a Board of Advisors very early on to help manage all of this and or help you to find these key people for your founding team.

Notes: 

  1. Venture Capital Secret: 3 of 4 Start-Ups Fail
  2. The Life Science Startup: Bringing Innovative Science to Market with the Right Team 

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Life Sciences New Market Risk Alliances: Instinct or Monte Carlo Simulation?

Roulette wheel up close

Be sure to listen to your ‘inner voice’ when assessing risk.

By:  Michael Kaiser

In the life sciences, as in other high-tech sectors, a New Market Risk Analysis (NMRA) is essential to the success of a new product development or business alliance. We can select two choices to undertake a NMRA: instinct based on experience or a Monte Carlo analytical simulation. In both cases there is one author: the human mind.

An imaginary NMRA  
The CEO of ABC, a medium-size public pharmaceutical company specializing in antibiotics wants to make a multi-million dollar investment in QED (1)a small biotech firm that has patented a new agent for the treatment of MRSA (Methicillin-Resistant Staphylococcus Aureus) detection. The ABC executive is aware that other companies are chasing QED as well. The potential for growth and revenue is impressive, given the fact that MRSA infections have become a serious health issue. QED has already benefited from a significant capital infusion from two VC’s and is starting a Phase III trial with a well known clinical research organization. The ABC executive has a lengthy meeting with his QED counterpart, who provides a convincing set of slides demonstrating the efficacy of their product in Phase I and II. Both parties had previously signed a CDA.

Upon his return, the ABC executive reports to his Board of Directors and his top executives. To their surprise, the CEO, a highly respected industry executive with a record of successful acquisitions with both his past and current employers, advises against investing in QED because he is not convinced that their product will remain a leader in the fight against MRSA, as well as carrying a considerable financial risk.  The Board Chairman of ABC asks the CEO if he signed a Master Services Agreement with QED during his visit, to which he answers that he did not because in all his successful 25+ years he has never been so uncomfortable about an investment, and therefore does not recommend it.

The Board has been very supportive of the CEO but fear that his experienced “gut feelings” will not convince ABC’s shareholders.  The CEO stands firm: his instinct tells him that something is not right with QED’s development program. In the end the Board decides to engage an experienced NMRA organization to conduct a Monte Carlo simulation of QED to confirm or contradict the CEO’s financial and scientific trepidations.  Once the results of the Monte Carlo simulation are in, they confirm the CEO’s feelings.  In the meantime, he moved to a top 10 global pharmaceutical company…

(1)   Latin for quod erat demonstrandum, to be demonstrated.

Resources:

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