21: Where it all began....

Issue 21:

As we start 2025, I want to go back to the beginning. Back to the overall view of preparing a commercial position for your product during product development, and the many things that must be incorporated in your planning.

If you have been following this far,

--you have, haven't you? ??

--then you have seen various opportunities associated with preparing the product's commercial position during development. Now I want return to the place we started just over a year ago, and to tie it all back together. My thought is to use this issue as a summary of the elements, and then future newsletters to discuss each individual component in turn. As a company manager or officer -- continuously in the middle of investment, strategy, market , technology, partnership, and other decisions that you and your team will face --there are several decisions that will determine the fate of the product you are developingThey may even determine the fate of your entire company. Let me start by describing a common development and commercialization process. Come along for a brief ride....

What Could Possibly Go Wrong....?

You have obtained access to a cool technology that you and your team feel has a clear place in the market. You form your team, and keep your development under wraps as you work on it, so that no competitor can anticipate or reverse engineer your work. Your team develop some impressive features and embed them in the product. They are self-evidently attractive, and customers will certainly be excited by them. To make the strongest product, you add all of the most attractive of these new features. The design is targeting the primary user, the surgeon in your case, and is intended to create an extraordinary experience with the product. The surgeon you usually use for product development work and design feedback is very excited about the design -- it incorporates his own recommendations. You settle on a design, plan for manufacturing, and add up all of the costs to identify a price point that will be profitable for you. You connect with the regulatory body to seek approval. A few months before launch, you call in the marketer for an assessment, and direct them to build the marketing message and plan a launch, nationwide. The sales force is armed with your launch message, and ready to go.

What will happen? Any predictions?

Is it obvious that failure is immediately ahead? Each choice above is very rational. Each makes sense - and yet, each contributes to failure. Some are failures of omission. Some are failures of sequence. Some are failures of vision or planning. Some are failures of selection or decision. All are failures of process and planning.

Let me count the ways....The Articulate Process

1. An important, unsolved problem that is meaningful to your customer. It all starts with the problem - not the technology. A technology push (AI for toast making, anyone?) will likely fail. But solve a problem that matters to your customer, one which they have no other solution for, and you have something - regardless of the technology that you use.
2. Customer discovery and needs. Spending enough time with customers to understand the outlines of their problem, the characteristics and segments of your customer population. Which customer roles will be involved in the purchasing decision in the sale? You can then form the outlines of your Design Inputs.
3. Survey of competitors and current solutions to the identified problem. Is there space for your new solution? What is the state of performance of current solutions, and how much better (or cheaper, or simpler) can you be? Is the business model right? Should your product be a service, for instance?
4. Willingness-to-Pay Conversation - Everyone wants to do this at the end. But as we will see, understanding the value that your design brings to your customers - and therefore whether they will pay, and what they are likely to pay for it --is a crucial input to the product target and overall design. In this process, you also discover which features belong in the product - because the customer values and will pay for them. You also learn which should be excluded - because they don't and won't.
5. Establishing and strengthening a proprietary position - It is all for naught if a fast follower can simply copy you or work around your solution. Or if a competitor can claim that you infringe their IP. Most will think of covering their technology by a patent, but there are other, additional strategies to establish a proprietary position. And a single patent is rarely broad enough to be a barrier to your competitors.
6. Iterative design, beginning with a Minimum Viable Product - Perfection is not your goal. Iterative improvement is your goal. Your customers will tell you when you are done. Design control, Verification and Validation are here.
7. Planning your Regulatory Path - Selecting predicates, Interactions with Regulatory bodies, Classification and Request for Determination (or possibly not!). Investigational Device Exemption studies. Accelerated pathways. "Stepping stone" pathways for indication and portfolio expansion. Post-Market studies and evidence for new indications.
8. Claims and Evidence Planning - Focusing on the specific features and solutions your customers have told you they value in #2, #3. Plan and execute on proofs of these claims. Select Key Opinion Leaders, Publication and Podium strategies, Advisory boards, Value and Health Economics evidence.
9. Planning the Product and Launch Messaging - Selecting market entry points, land and expand, test and learn, A/B testing, etc. Assembling value propositions and evidence for each of the decision makers in the complex sale. Influence campaigns, Social Media, Digital Marketing approaches, Contact Relationship Management tools. Branding and messaging your value.
10. Tracking your Customer Experience - Building learnings into further iterations, line extensions, indication expansions, etc. Knowing your customers in depth. Monitoring for market trends and shifts.
11. Portfolio Planning - Including market sizing and segmentation, portfolio expansion and technology roadmapping as you move beyond a single product to a company with many offerings.

I plan to cover one or two of these in each of the next several newsletters. In doing so, I hope that the magic of innovation will again sparkle for you, and the pieces will fall together. Many people see a section or two of this path. I hope to give you the picture from the executive management seat, where you can see it all, and how it becomes a business. Please come along for the discussion!

Working on a problem for your company? Need some help in business or product strategy, or in planning your commercial future? Let's talk.

(c) 2024, 2025 Todd M Boyce. Some images created by me with Adobe Photoshop 26.3 (beta) generative feature (Firefly) and also from DALL-E3.