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Top-Down and Bottom-Up Modes in Medtech

clinical strategy market driven innovation regulatory strategy Aug 31, 2022
top down bottom up modes medtech

Written by Eric Sugalski

Consider this analogy..  You are driving across the US, planning for a week to travel from coast to coast. With elevated gas prices you want to optimize for fuel consumption.  Without much thought or preparation, you hop in the car and start down the roads you know. Within an hour, your journey becomes a bit more interesting and uncertain. The towns are not as familiar, and the sign posts call-out distant cities that may (or may not) be on the most direct route of your trip. 

For the sake of the analogy, let's call this bottom-up mode. You're in the driver's seat, making headway, and jamming to your favorite road trip playlist. You're feeling every bump on the road, watching the other travelers in route, refilling the tank when needed, and cruising into the great wide open. It's exhilarating and nerve-racking at the same time.

By contrast, let's say that before you hopped in the car, you plotted your route. You looked at the highways that would result in the most direct line of travel. You evaluated traffic patterns in major cities, optimal places to stop for fuel and lodging, and earmarked some interesting sites to visit along the way.

Before driving, you did your research and pulled together a well-informed plan. You have a strong sense of where exactly you're going, how long it will take, and how you will get there. Let's call this top-down mode. You haven't made an inch of progress yet on the road, but you feel secure and prepared for the journey.

Most of us planning a road trip like this operate in top-down mode. We understand the costs of uncertainty and opt for a more direct and certain path. The idea of wasting time, the prospect of backtracking hundreds of miles, is just not worth it. The time and effort put into the plan will pay for itself many times over while on the road. 

But most medtech ventures -- even ones that raise sizeable investment rounds -- operate primarily in bottom-up mode. The thinking is "we need a prototype, a proof-of-concept, an MVP before the longer-term market factors really matter." The top-down plan is deferred or avoided altogether, and the only certainty is long and expensive redo loops.

Medtech teams need a balance of bottom-up and top-down modes. The executional team is vital, but without the right plan in-place, all of that hard work in execution is likely misdirected. 

Following are 3 tips for infusing elements of top-down thinking into your medtech venture:

1. Quantify your benefit relative to standard of care?

Top-down thinking starts by understanding and quantifying the clinical benefit you expect. But before you can quantify your product's benefit, you need to first clearly define the baseline. What is the standard of care? What is the anatomy, physiology, pathophysiology? What is the prevalence rate, incidence rate, diagnosis rate, morbidity rate, mortality rate? Which of these data best characterizes the problem you aim to solve? Are you able to to quantify this measurement?

After (and only after) you have gained a clear perspective on the standard of care and how it is measured, you should estimate your expected outcomes. What percentage improvement do you anticipate making? Is this for a sub-population or the entire population? What is the basis over which you are able to stake the claim of clinical benefit? What is that big assumption -- there's always one -- on which this clinical benefit hinges?

Your clinical value proposition is the expected clinical benefit you will provide over the standard of care. It's critical for you to nail this up-front. This is your North Star.

Closely linked is your economic benefit. What are the economic consequences associated with the negative outcome you aim to improve? Which healthcare stakeholder currently absorbs this cost? How well do they understand this problem and the associated costs? If the stakeholder is unaware of this problem and the associated costs, it may be very difficult to enact change. Helping customers recognize a problem is much more difficult than addressing an explicit problem that is front and center. 

Your intended use, clinical indications, user needs, design inputs, hazards, risks -- they all flow from this topic. Medtech starts at the standard of care. A bottom-up mode is likely to bypass these critical factors resulting in developing the wrong product and requiring long and expensive redo loops. 

2. Determine your regulatory and marketing strategy.

Too often, there's a knee-jerk assumption that a medical device will be 510(k). For Class II devices, this route is the least onerous in terms of regulatory timelines and clinical requirements. But what most companies aren't thinking through at the front-end are the marketing trade-offs that come with the 510(k) route. This route proves equivalence with an existing commercial solution. In effect, you are develop a "me too" product -- one that is very similar a previously cleared device.

But presumably your device is going to have a noticeable impact on clinical care and healthcare economics. Otherwise, you wouldn't be doing what you're doing. How are you going to accomplish this impact if you are effectively proving equivalence? Is it through improved usability, superior materials, refined algorithms? If so, these characteristics will be different in your predicate device -- the one through which you aim to prove equivalence. Calling out these differences through a comparison table, and taking an honest look at the equivalence between intended use, clinical indications, and primary product functionalities is an important top-down step to pressure test your regulatory strategy.

Now if you are taking this 510(k) route, what will you be able to say in your labeling? What medical claims will you be able to promote? What will you NOT be able to market or promote with your 510(k)? Perhaps you are taking a tiered approach --that is, establishing regulatory clearance through an initial 510(k), running post-market clinical studies to provide superiority over the standard of care, then seeking a label expansion afterward?

This is a logical and common approach, but it's one that requires extra foresight, preparation, and investment. It's best to use a top-down mode to think through these details in advance and create the right regulatory and marketing strategy. A bottom-up approach typically defers these critical topics and faces major recalibration when more onerous regulatory pathways, premarket clinical study requirements, and/or promotional limitations arise late the game.

3. Define your evidence generation strategy. 

As part of your regulatory and marketing strategy, you need to understand how you will be capturing evidence. Will usability (or human factors) testing be required to evaluate a change in the intended use? Will preclinical endpoints need to be achieved before an IDE is approved? Will long-term biocompatibility studies need to be completed to prove patient safety prior to clinical use?

A top-down mode will map out these critical activities and represent realistic timelines and budgets for each. The evidence collection process is often one of the most time and cost intensive parts of medical device development. Thinking through these top-down details will ensure that you (and your stakeholders) have the right expectations in-place.

But the evidence generation strategy starts by defining the evidence you need to capture. This comes from regulatory standards associated with product classification codes, guidance documents, total product life-cycle (TPLC) reports, risk assessments, and the marketing claims you need to compel adoption of your device. The typical bottom-up approach defers these topics, focuses exclusively on design-build iterations, and comes to discover the required evidence generation requirements much too late in the game. 

Summary

Top-down and bottom-up modes are two very different ways of thinking and working. Combining both modes and requisite skillsets are needed to effectively and efficiently reach the critical medtech milestones. However, we find that most early-stage ventures could benefit from greater top-down thinking.

At Archimedic we help companies develop comprehensive top-down strategies that account for the pre-clinical, clinical, regulatory, marketing, and commercial strategies. Then, we vet these strategies with regulatory bodies, target users, and subject matter experts. When the right plan is developed that meets the long-term market objectives of our clients, we help them execute each detail with speed and precision. If you are seeking support in refining your medical device strategy, fill out the form at the bottom of this page to start the conversation. 

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