I love farming, particularly growing fruit-bearing trees. It starts by planting seeds in a pot with soil. There are two types of seeds – monocots and dicots. I am really fascinated with the dicot type, also known as dicotyledons, for having two embryonic leaves. It is amazing to see the seed starting to grow with two embryonic leaves and a new leaf emerging in between.
Many years ago, I was given the opportunity to lead a company with over 200 employees. I learned that to be effective in whatever you do, you often need to manage two things to survive and grow, like a dicot seed with two embryonic leaves supporting and managing the growing leaf. This can arise when managing a company, team, investors, stakeholders, or even yourself. Most of the time, making a decision is a balancing act between two opposing situations or conditions which I call a “dicot” event. A dicot event is always a complex problem and seemingly unsolvable, particularly when dealing with people and the organizational ecosystem in which we live.
Fast forward to today: I’ve become very interested in a technique for managing two opposing conditions popularly known as polarity management. It is a type of management tool, that honors opposing, seemingly conflicting values and finding a balance between them. These can be likened to opposing “negative” and “positive” charges, or “North” and “South” poles. When you think of polarities, it means considering different ways of understanding and dealing with a situation, and accordingly, resolving issues in a clear and manageable manner. Like a dicot event, polarity management usually has two sides or concepts and harnesses the benefits of each side, thus creating an environment where both options are encouraged, managed, and given room to grow.
Applied to medical device commercialization, a polarity could be anything with opposing issues or concepts. Thinking in terms of polarities could be as simple as “breathing in and breathing out” as illustrated by Barry Johnson in his book, Polarity Management: Identifying and Managing Unsolvable Problems.
Polarities may be present in our product development processes, and by understanding them, we gain new perspectives on possible courses of action. Opposing polarities are captured in a “polarity map” wherein each side of an opposing idea or concept is outlined and the benefits of both sides are considered without compromising one or the other. Moreover, the map outlines steps for action that encourage the opposing ideas or concepts to thrive and co-exist. The map also identifies the early warning signs of downplaying one side while focusing on and praising the other.
Let’s explore the 7 most common polarities in medical device commercialization
- Technology vs. market-driven medical devices
Technology-driven products mostly come from university-based companies or research institutions. These technologies arise as a result of their research, investigations, and explorations. Their findings may or may not have any marketable application, but it is hoped that a market may eventually emerge. For market-driven products, development efforts are dictated by the target clients’ needs, and the intended use is clearly identified. With a market push, technology can be developed or integrated into a product.
If one focuses on the clients’ need to develop a product, they will surely need a technology to accomplish it, which may not be available. On the other hand, working on technology without looking at a possible medical application will put the technology on the shelf and most often make it less attractive to investors.
Both approaches have their own advantages and disadvantages. As a MedTech innovator and entrepreneur, one must balance factors such as cost and profitability, development time, technological maturity, market-entry, regulatory considerations, and the various aspects of risk associated with the product. Is the company working on a technology with an undefined market? Is the company trying to meet a client’s needs without a definite technological solution?
- Create a new market vs. leverage an existing medical device market
This is another polarity related to the market. One option is to create a new market and the other is to leverage the existing market. There are a lot of start-ups that claim they have no product competitors. The absence of a similar product signifies a new technology with no predicate device. Therefore, it is implied that the company would like to create its own market. With no distinct market segment, this is a hard sell. However, if the product is novel and disruptive, it creates an excellent opportunity to make a plan, campaign, and establish the product’s market demographics. On the other hand, leveraging the existing market would position the product in a competitive landscape in which the necessary innovative features provide a better or equally attractive product that can be easily identified.
Developing a new medical device based on known needs and customer demands is a very plausible proposition. The profitability risks are much lower, and the product commercialization path can easily be mapped. On the downside, the market being entered could be crowded enough that the overall business profitability and life span of the device could be shorter. In the medical device business, the “de novo” regulatory path for low risks novel products is the fastest-growing pathway for bringing devices to the market. It gives the company the opportunity to avoid the more rigorous standard route (i.e., PMA, 510K). In the end, a company needs to balance both poles of creating a new market and leveraging the existing one.
- Product affordability vs. profitability
How about the polarity involving product cost and desired margin? The consumer’s perspective on a product’s cost is the “product’s affordability”. A MedTech company might have premium quality and technically acceptable medical devices, but one which carries a very high cost and is a financial nightmare to maintain.
Developing a product in a highly regulated ecosystem (like the medical device space), is generally very expensive and time-consuming. It takes years and a large financial investment for a product to reach the market. In a resource-limited country, medical devices are often badly needed, but their cost is not practically affordable. On the other side, lowering the device price may affect the overall profitability of the company that produces it. In the worst case, with an excessively low-cost product, the company would not earn enough to continue its operations.
In terms of product development, scientists and engineers may have a difficult time designing a sufficiently low enough cost device to improve affordability. However, this effort might drive the identification and replacement of high-cost components, improvement of processes and inefficiencies, and automation of production. On the negative side, sacrificing product specifications or shortcutting the development process will surely affect the quality and performance of the device. Reducing the product cost by optimizing functionally without affecting quality while maintaining the profitability of such a product is ideal. There should be a trade-off – or a sweet spot – in which the product is priced at maximum profitability. Of course, other critical factors (i.e., production volume, yield) must be considered in the final determination.
- Development cost vs. time
Cost and time are always a polarity in medical device development. Increasing the resources may reduce the development time yet increase the overall cost. However, in reality, reducing time is not only about increasing resources. Some activities can be done in parallel, and some are sequential in nature. Therefore, adding resources may not necessarily save time. It is necessary to understand the target timeline for a project to determine whether there is a time constraint. If there is, the discussion will circle back to milestones or deliverables to assess whether the identified tasks can be realistically done in the given timeline. With this knowledge, the product development cost can be determined.
On the other hand, if the priority is development cost, with no definite time constraints, then resources can be optimized based on the given scope of work. Looking at the program level, the scope can be reduced to lessen the cost of certain activities. However, considering the highly regulated stages of medical device product development, the overall product development cost to launch would likely still be the same. Historically, medical device development is costly, and devices require years to commercialize.
- Unregulated vs. regulated product development
This is a dilemma for MedTech start-ups that would like to enter the market quickly. Most start-up companies have very limited funds. They have innovative technologies and smart ideas about how to make their product. The issue of regulated and unregulated devices arises when start-ups want to quickly bring their product to the hands of the targeted clients, get feedback, and iterate. Experienced entrepreneurs know that eventually a medical device will be heading to a regulated space.
If a company is not sufficiently funded or still raising seed funds, it may opt to go the path of an unregulated approach. It is a compelling alternative to avoid regulatory submissions and go ahead first with an unregulated option. The product could launch as a consumer product in the health and wellness space, or as a product for research use only.
The regulated approach is costly, time-consuming, requires lots of documentation, and requires comprehensive technical testing and evaluation. The advantages of the regulated option include proper documentation, well-managed risks, organized product development procedures, well-engineered products, and probably, higher-level confidence that the product will succeed.
On the other side of the polarity, the unregulated option enables a company to test a product in the client’s hands, gain early feedback, do rapid iterations, bring in early revenue, improve the product’s maturity and attract early investors. The disadvantages include the added cost of going back to document processes, being exposed to risks, failing to secure a bigger market share, and the possibility of rebuilding the entire product. For a start-up, this is a crossroad that requires tough decision-making.
- Traditional vs. fast-track product development
Agile product development, rapid prototyping, and fail-faster principles are buzzwords for most start-up companies in the medical device space. Making it to the market first has enormous advantages. There is no perfect product, and it is better to fail fast and iterate rather than wait for the product to mature and lose the market. Fast-tracking product development is a very attractive methodology and has been proven effective in many consumer products.
On the other hand, the traditional product development mindset consists of identifying product requirements, brainstorming the risks, creating a system architecture, and designing it methodically before creating a prototype for the potential end-user to test. Using this methodology, the company would like to be sure that all the possible prototyping steps are well documented and planned out. However, this process takes a lot of time and primarily consists of documentation in the initial stages.
Fast-tracking follows a similar pathway but focuses more on what is required to move development to the next step, making the process more agile. Fast-tracking in incremental steps has advantages and disadvantages. More and more start-up companies are adopting fast-track development to save time and money. Furthermore, with the emergence of additive manufacturing (3D printing), robotic integration in manufacturing lines, design, and simulation tools, as well as machine-learning algorithms that can predict the options without actual prototyping, most companies are gearing up to incorporate fast-track development. In contrast, traditional medical device product development methodology offers a risk mitigation approach, creating more stable pacing during the implementation of identified tasks. The downside is that it requires a longer development time to complete a tangible prototype.
Medical device product development is a highly regulated space, and most well-funded companies use traditional methodologies because they want to be sure that all documentation and risks have been considered as the basis of the design and prototyping effort. This is the main reason why medical device development tends to be a very expensive and slow process.
Both options have merits and inherent weaknesses. Companies should weigh the possible trade-offs for optimum benefit and speed the launch of their product. Should companies take the fast-track approach and go directly to a manufacturable product or follow the traditional medical device development process? Medical device innovators struggle with this question all the time – it is a polarity that needs to be understood and managed well.
- Outsource development or build in-house resources
Using in-house resources to support medical device product development is a common way the established companies run their mainstream and sustaining products on the market. With internal teams, the company can control the general pacing and speed of product development. The company can hire a multi-disciplinary pool of talents and maintain those within the organization. Furthermore, the presence of these internal resources provides a sense of historical continuity and tribal knowledge, as well as awareness of any internal challenges. The main drawback of this approach is that in the product development life cycle, there is a need for a lot of highly specialized talents to address specific technical and implementation risks. Building such a workforce will increase the number of hired resources thus, making the operation of the company heavy and less efficient.
On the other hand, outsourcing product development is an alternative way to manage a company by maintaining a lean organization with a core workforce. This core team will manage the outsourced tasks that require a specialized skill set not available in-house, or for crucial tasks that may only be done on a confined scope within the life cycle of the product.
Additionally, outsourced, or external partners are often available even after the product life cycle is complete, without the need to retain them in the company. By having a lean organization, outsourcing can reduce the burden of hiring and maintaining workforce resources, particularly when their expertise cannot be fully utilized or is only needed in a short span of time.
Investment-wise, maintaining internal resources tends to be expensive, particularly when considering the overhead cost such as on-boarding, training, human resource benefits, overseeing, and managing day-to-day activities. Most often, it can be cumbersome to manage employees and ensure that they are always used effectively. The most plausible advantage of out-sourcing is that the company can select the best resources on a term contract rather than committing to a longer-term engagement of an internally hired resource. Moreover, the company will be able to access battle-ready, experienced, and highly skilled workforce resources, thus saving time and budget during the project implementation.
This is a crucial and difficult concern – a polarity that needs to be balanced. One may say that the sweet spot is to have a lean internal team and outsource resources for critical, temporarily needed, and highly specialized disciplines. Is that the right balance? This is basically a strategic and tactical issue for a company to decide.
Going back to plant seeding, the dicot is a good representation of polarity. It supports the growth of the plant until it produces beautiful flowers and bountiful fruits. It’s nature’s way of managing growth and development in a challenging environment. Similarly, a well-managed polarity will surely have the same bountiful outcome.
In medical device development and commercialization, there are so many complex and seemingly unsolvable challenges. Probably, most of such challenges may not require a solution but may just need to be well-managed. Most engineering challenges can be solved by equations, predictive algorithms, and experimentation. There are a number of tools that provide guidance in making conscious decisions like root cause analysis (Ichikawa), SWOT analysis, value engineering, logic control systems, or even artificial intelligence (AI) that provide human-like managing and decision-making capabilities.
For me, polarity management is another methodology that offers a simple and straightforward way of understanding opposing ideas, concepts, or issues. I consider it as a dynamic managing process that changes over time and as an organization progresses forward. It is a thinking framework and an analytical process that offers new insights. It is a tool that identifies and understands the opposing issues and provides the ability to diagnose and see things from a different perspective. It is also a guide aimed to develop strategies for addressing dualities that drive effective actions.
Lorenzo Gutierrez is the StarFish Medical Microfluidics Manager. Lorenzo has extensive experience translating point of care assays to microfluidic cartridges. His microfluidics portfolio includes developing a polyvalence instrument for early infant diagnostics at Chipcare.