Take Your Medical Device from Idea to Infrastructure to Market in 10 Stages

The old ‘aha’ moment

When it comes to commercializing a medical device, like it or not, you can’t take massive, orderly action without a viable, vetted plan – which leads me to an aha moment that every CEO in the pre-commercial setting needs to hear.

Because while I’d love to say I came up with the gameplan I’m about to introduce to you on my own, as with most aha moments in life, this one starts with an unexpected mentor – for whom I’m deeply grateful.

Earlier in my career, a fellow C-suite executive asked me why we were launching a product to the commercialization phase in full force instead of doing a limited launch.

The question gave me pause.

At the time, I believed that full-force was the best approach.

However, what he said changed how I value action based on due diligence.

He sat me down over coffee and said:

“Our focus should be earlier in the process. I know we’re all really eager to get this product to market but if we hurry, we’ll miss the target. Let’s slow down to get input on the design, market feedback, and value analysis timelines. I’m sure we’re going to get heat for the extra legwork but why not learn early so that when we do scale, everything is tested. That way, we’ll avoid going out and spending millions on the sales force expansion until we get it just right.”

And eager as I was, he was right. I was rushing.

Most of us focus far too much attention on the win (commercialization) and not nearly enough on the journey (pre-commercialization).

And by journey, I mean step-by-step due diligence and orderly massive action activities necessary. Even I was guilty of this.

And while I learned that many roads can lead to success, there is a better way, after all.

The following are some examples of common pitfalls and how a strategic approach rooted in thorough due diligence can help.

Common Barriers

One of the most common pain points for executives is struggling to have a strategic outlook or plan to generate initial revenue.

Executives are often hyped on their products – and that’s a good thing – but it can cause them to rush into launch.

In this case, the barrier is launching products without a clear, strategic plan.

This challenge exists because you just don’t know what you don’t know. Many C-suite executives are aware of the answers they do have but would greatly benefit from validation of their assumptions through limited market releases (LMRs).

When they lack this real-time feedback, it can lead to issues with product performance, market perception, and shipping logistics, ultimately stalling growth.

Cost of Inaction

If CEO’s are stuck in indecision or waiting to see what competitors do first, failing to address this barrier can have significant consequences including:

Skewed Data: Moving forward with theory or assumptions can mean missing out on the momentum gained with real-world testing. Otherwise, data collected may not accurately reflect market needs – or market needs right now.

Misaligned Plans: Misaligned launch strategies may be out of sync with actual market conditions, which leads to wasted time and resources.

Missed Opportunities: Delays in recognizing and addressing product issues can result in missed market opportunities and significant revenue losses.

A Systematic Way Forward

For all the hard knocks I’d earned in my career on the road to commercializing incredible products, they were great teachers.

They solidified the 10 essential precommercialization stages that every company must undergo.

Walk through these with your leadership team and you’ll see that with time and intention spent on each one, the way forward nearly creates itself.

10 Stages of Pre-Commercialization:

1. Market Analysis: Identify urgent unmet needs your technology can fulfill.
2. Value Proposition Refinement: Ensure your value proposition is clear and validated with real feedback.
3. Route to Market: Determine your preferred route to market and budget accordingly.
4. Product Market Fit: Gather and analyze feedback from the first 20 customers.
5. Regulatory Strategy Integration: Design a regulatory approach with a commercial mindset.
6. Sales and Marketing Alignment: Align your marketing strategy with real market feedback.
7. Sales Team Evaluation: Ensure your sales team aligns with your product and company culture.
8. Customer Support Preparation: Establish robust customer support structures.
9. Metrics and KPI Implementation: Set appropriate metrics and KPIs to measure success.
10. Risk Assessment and Contingency Planning: Conduct thorough risk assessments and plan for contingencies.

Results You Can Expect

When you deeply invest in these 10 pre-commercial stages like this, you’re playing by new rules that your competitors aren’t considering.

You’ll know what the pathway to market looks like with confidence – from adding a product to an existing bag, to landmarking a new sales channel, or maybe leaning into education.

You’ll leverage real-time feedback (and know how to get it) so the messaging resonates with the ideal target before its applied to the first marketing piece.

The concentrated effort you put into these 10 specific pre-commercialization activities will deliver you your best shot possible.

But I’ll warn you, once you lead your team in a systematic way like this, don’t be surprised when companies take notice and start knocking on your door to help them bring their innovative idea to commercial reality, too.

You’ve got this.

Stay in (the right) actions.
Steve Sapot