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Polarity Thinking in Medical Device Development

Fri, 10/18/2013 - 3:44pm
Annelies Tjebbes, Biomedical Electrical Engineer, StarFish Medical

Polarity thinking is the management of interdependent, usually conflicting values or issues in a way to create a complementary effect. The medical device environment is full of polarities which often come into conflict or tension. Take for example the tension between well-managed budgets vs. well-designed products. This polarity often poses a significant challenge in medical device development because of regulatory requirements, budgetary limits, as well as the need for well-designed risk mitigation. Polarities, though intrinsically linked in pairs, can be viewed in a very bi-polar manner of "one element against the other" which can result in emphasis on one side of the polarity and neglect of the other.

At the 2013 Engineers Without Borders National Conference, I attended a workshop entitled “A world of both: harnessing the energy of opposites.” This workshop discussed the concept of polarity thinking, which includes managing two sides of a tension and leveraging the benefits of each. In his presentation, the facilitator Russ Gaskin shared a clever analogy using the example of a rip current. Russ explained that though we are taught to swim out to the sides of a rip current when in danger (which in this analogy would be to choose one side of the polarity), that we can harness the benefit of the rip current by using it like a conveyor belt, riding the current out to sea and surfing the waves back to shore.

Now how does this relate to medical devices? Think about the tension between getting a device to market quickly vs. thorough design process. It is fairly evident that a balance of both are required and that a healthy coexistence of the polarity will result in the greatest success.

Another example in medical device development is the balance between device novelty and substantial equivalence to predicate devices. In the medical device environment, technology and products are constantly evolving; In order to obtain patents, one must develop novel products and claims, and in order to gain market traction companies are aiming to sell the newest and most improved devices or technologies. On the other side of the polarity, the regulatory side, novelty and drastic improvements of devices over predicates can substantially complicate the approval process. The preferred route for Regulatory Clearance of medium risk devices in the USA is through the FDA's 510(k) process. This process requires claiming substantial equivalence or equivalence to a predicate medical device, and is weary of claims of significant improvements over predicates. If the FDA sees your device as straying too far from the predicate, a substantially more complicated Pre-Market Approval (PMA) is required.

In this novelty/substantial equivalence conundrum, the way forward for regulatory submission is to highlight the similarities between the device up for approval and the predicate, and diminish the differences. This can be accomplished by choosing an “Indications for Use” statement that is similar to the predicate device, thus reassuring the FDA Assessor that the devices are substantially equivalent. In the mean time you can build up your marketing strategy to highlight the features of your device and its unique selling points.

The ultimate goal of polarity thinking is to harness the benefits of each side of the polarity, and to thrive in an environment where both are encouraged. F Scott Fitzgerald wrote “the test of a first-rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function”. Perhaps we can adapt this and say “the test of a good Medical Device entrepreneur is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function”. Only through exposing polarities and thoroughly investigating them can we really identify how they can live in harmony. This is where polarity mapping comes in. Polarity maps outline the advantages and disadvantages of each side of a polarity, and present a method of leveraging the benefits of both sides without compromising one or the other.

One of the key elements of creating a polarity map is to outline what the action steps are to encourage and help this polarity thrive. Another key element is to identify the early warning signs of downplaying one side of the polarity while focusing on and praising the other side. These elements of the mapping exercise help you break negative cycles of biased thinking towards the polarity, and help you move towards your "Greater Purpose" statement. As an example of a fully fleshed out polarity, click on this link to view a polarity map (.PDF) I created on Collaboration vs. Competition.

Polarity management is often confused with problem solving. Employees may feel that their side of the polarity should be emphasized, and the problem to solve is convincing others to view things from the same angle as them. The beauty of polarity thinking however is that it honors different ways of approaching a situation, and helps resolve issues and tensions in a non-confrontational manner. Drawing out a polarity map allows for reflection and then action, and is a tool used in design reviews, negotiations, performance evaluation, design team alignment, and strategy development.

I have found it extremely valuable to start identifying polarities in my working life as it opens up a new way of looking at something and an opportunity for balance and harmony within my priorities. Polarity mapping is a valuable element of medical device development and can lead to a work environment that thrives on:

  • Efficiency AND quality
  • Change AND stability
  • Debate AND unity
  • Progress AND reflection
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