10 Critical Stages Between your Med Device and Commercialization

10 Critical Stages Between your Med Device and Commercialization – and How to Navigate Them

If you’re looking to hire better, advance your EQ, or improve your leadership in the healthcare and medical sales space, Amazon.com is a treasure trove for quick reads you can devour before breakfast and bulk buy your team before your next NSM.

In fact, there’s more than 2,000 books on mastering the art of leading medical device sales teams alone.

But last I looked, when it’s medical device commercialization you’re after – it’s a paltry 13.

And while surprising, having brought multiple companies to the commercial stage, I can see why.

For most, commercialization is a roll of the dice.

Let’s think about the success rate most companies have for a minute.

According to the US Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) annual report, 18,800 submissions for FDA approval were received in 2022 and just over 6,000 were approved. Roughly 31%.

And though the FDA granted 933 Breakthrough Devices designations since December 31, 2023 (including those under the Expedited Access Pathway Program or EAP*), the path to commercialization can be fraught with disappointment for CEOs.

It’s painful to watch driven, passionate CEO’s give up on a cause and burn through millions only to have their innovative products miss the mark by a hair or launch something too quickly before the infrastructure is ready to support it.

I’ve met extremely bright CEOs who’ve fallen into these traps.

They have customers begging for the product and buzz that sets off a tidal wave of interest at major medical centers.

They have a leg up on reimbursement but are lost on how to leverage those MD Anderson and Cleveland Clinic relationships.

They struggle with strategy to cement distributor relationships, nail down market fit, or even get the product to market – not to mention doing it strategically.

It’s a mess on their way to commercialization and their first $1M – and the variables seem endless.

But the truth is, they’re actually closer to a strategy than they think.

They simply need to prioritize 10 critical stages.

To get a medical device product from idea to infrastructure to launch, these are the 10 critical pre-commercialization stages to consider.

1. Market Analysis
2. Value Proposition Refinement
3. Route to Market
4. Product Market Fit
5. Regulatory Strategy Integration
6. Sales and Marketing Alignment
7. Sales Team Evaluation
8. Customer Support Preparation
9. Metrics and KPI Implementation
10. Risk Assessment and Contingency Planning

It’s actually called my 10-Stage Pre-Commercialization Checklist and it’s a simple guide to direct your energy and your team’s actions (in many pages less than a published book).

This method has helped startups to Fortune 500 companies navigate whether to leverage visibility or education, soar through the Value Analysis Committee (VAC), discover the ideal sales and marketing balance, gather real-time feedback from end users, and plan ways to pivot should there be unexpected regulatory changes post-launch.

It’s an all-bases-covered gameplan.

The reason this works is it prompts you and your leadership team to assess the 10 make-or-break points of the pre-commercialization process so you prepare fully before making your moves.

For example, below are a 5 actions from the 10-Stage Pre-Commercialization Checklist for you and your team to play out immediately:

Conduct LMRs (Limited Market Releases):

1. Gather real-time feedback on product performance and market perception.
2. Use this data to refine your product and launch strategy.

 Refine Your Value Proposition:

1. Clearly articulate how your technology solves unique challenges.
2. Validate your value proposition with feedback from healthcare providers and staff.

Develop a Strategic Route to Market:

1. Decide whether to use your own sales team or partner with distributors.
2. Budget appropriately and allocate resources effectively.

Align Sales and Marketing:

1. Ensure your marketing strategy reflects real market feedback.
2. Set sales goals based on current market realities.

Prepare for Customer Support:

1. Establish a continuous feedback loop for product enhancement.
2. Set clear timelines and standards for customer support.

 What’s Possible

When you deeply invest in these 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.

And as for books on Amazon.com, know this – the road to successful commercialization is unique to each company and product but the due diligence you conduct to create your comprehensive gameplan will tell you more than any book you can read about someone else’s journey.

Or just maybe, you’ll write book 14 after your next systematically successful launch.

You can do this.