Design Requirements Development

Project Overview

I developed an early-stage requirements document for a next-generation spinal implant system based on benchmarking the competitive set and engaging with users.

  • The project commenced by getting hands-on with the current spinal implant system, using anatomical models while discussing textbook and common procedural practices. We invited an extended team of client stakeholders to share their thoughts on the market and engage in a knowledge gap identification activity to illuminate research questions.

  • We continued by benchmarking a subset implant systems available on the market today. Here I collaborated with the client project lead to identify the competitive set and align around key parameters for benchmarking. I then directed my team including an Industrial Designer and Human Factors Engineer to scour publicly available resources to understand what the other systems offered technically and what the competition was promoting. I then highlighted and presented a set of key takeaways and design recommendations based on our findings.

  • I then embedded within the client project team to engage in user research. Here we sought to understand the clinical workflows and identify unmet needs and pain points related to their current spinal implant system.

    With the client team’s support, I then led a series of cadaver labs with surgeon stakeholders at the client’s facility. This phase of research concluded with the delivery of a research report highlighting our learnings and design recommendations to the team.

  • Finally the project concluded with the development of a design requirement document for the spinal implant system. Here I worked closely with marketing and engineering stakeholders to create a template and capture the design requirements for every feature and attribute of over fifty components. We pushed to incorporate a good-better-best mindset and consider ways to not only match the competition or meet the user need, but consider ways to challenge conventions and elevate the user experience.

Client: A Spinal Implant Manufacturer

Time: 2023, 4 Months

Role: Project Lead, Principal Investigator


Key Takeaways

Identifying Gaps in a Crowded Market

Through our competitive benchmarking and market analysis, we rigorously analyzed the portfolios and specific offerings of over a dozen competitors including the market leaders and those identified as doing new and interesting things in the category. We delivered a report that provided both a technical breakdown of the competitive offerings and an analysis of their market strategy. In this way we were able to serve the marketing and R&D sides of the business, creating a shared resource for use in subsequent design development.

Enhancing an Already Loved Procedure

Walking away from our cadaver labs, it became clear that the current implant system did not have any glaring faults and the surgeons generally enjoyed the procedure. The resulting challenge was to develop take a detailed breakdown of the procedure, pointing out more nuanced pain points and latent needs that could be leveraged as differentiators.

As a result our requirements document and strategic recommendations centered around either maintaining surgeon satisfaction while driving out costs, or creating moments of delight that contributed little additional procedural costs.

Challenges

Keeping the Project Lean

This was a relatively small project with a tight budget, but also a highly technical subject that required focus and attention to detail. To be successful with this engagement, we needed to get to high levels of specificity quickly and work efficiently to answer the key research questions. To this end, I directed my team to take the approach of working through a portion of the analysis, reviewing with the client, and upon approval templatizing an approach for execution. this enabled us to deliver the n

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