Matt Eisendrath, Full Spectrum Software - End-to-End Product Lifecycle Support | LSI USA '24

Matt Eisendrath  0:05  
I'm honored to introduce the next round of innovators presenting in this session. Let me give you a brief introduction to full spectrum. So full spectrum is a problem solving company. As many of us are in this industry. The problem is that we focus on our engineering challenges in getting products to market. We work with our clients to help medical devices and life sciences meet their engineering challenges. And we have a range of engineering services that span software development, systems engineering, electrical engineering, compliance and verification. We also provide a range of consulting services to help address directional challenge this often come up in getting a product to market. We work with companies of all sizes, we work with early stage strategics, and at all phases of development. And really at our core, we are a hands on systems engineering and software development development company. This gives us a great perspective on the trends challenges, risks, risk appetites and their movements over time within the industry. developing solutions that will run in the healthcare ecosystem is not simple. And I think many of you know this very well. The vast majority of our programs involve complex regulated products and solutions, which are particularly challenging. Here are a few statistics that illustrate this point. On average, software based development programs will run two thirds over their expected budget, and 1/3. Over their expected timeline. These numbers are worse for complex products, especially first of kind systems, we often use our consulting services to help our clients get their plans organized into a roadmap as a first step, often, a roadmap should be considered should consider the key trade offs the development phases, and risks to be overcome that ultimately reach a milestone such as feasibility IDE, FDA submission or market launch. In order to come up with a roadmap that is meaningful, a deep understanding of the goals need to be understood, but also, some assumptions need to be made. And these should be educated assumptions. This requires extreme discipline, but it's a critical aspect of getting off on the right foot. It is easy to under appreciate aspects of the roadmap in a way that can lead to surprises, you know, at the essence of what we try to provide in terms of value to our clients is not only getting to market, but really illuminating what those surprises could be and avoiding them because they do delay the journey to market. And I wanted to give a few examples of things we see and some of the ways that we address them. One is when a team has a has defined a novel functionality, but they don't know the details of how it will be achieved. Research is integrated into development, the what is defined, but some iteration will be required to figure out the how research is much less deterministic and predictable than development. We help our clients assess where they are in this research and development continuum. So we can provide a more grounded view of the program. Its maturity, the timelines, and take a practical approach to the design controls in short iterations that are used to clearly define how critical and novel functionality will be accomplished. A second issue that often exists is when a core or novel technology is well understood. But the rest of the system that is needed to make the core technology an actual product or solution is under appreciated, is like having a great motor and thinking you already have a car. Today's solutions routinely have more functionality built into them than you would have seen even five years ago in this market, we are routinely helping our clients consider the larger programmatic picture of products ation, and the overall feature set needed to function effectively and valuably in today's healthcare ecosystem. A final set of challenges that is extremely commonplace for startups in particular, who are developing regulated systems that around compliance and particularly verification and testing. This is this is often looked at in a binary way. And we try to provide consulting services to come up with a more nuanced approach. It's not really all or nothing. Putting documentation and design control off until later is risky, more expensive, and often reads leads to surprises. But the thing that I want to highlight the most is some of these key aspects that are important for regulation, also provide great value in terms of tools and outlook on the program. Trying to do it all now on the other hand, can be unrealistic from a budget and a priority standpoint. So what we try to do is really strike a balanced approach to this. There are certain artifacts that will really come in handy such as an architecture, risk assessment, and a verification plan in terms of how are you going to achieve these things at least At the high level early on, our goal is to work with our clients and really develop a balanced proce approach for the overall development program, but also the regulated aspects so that they can become an asset as opposed to a burden. The beauty of the entrepreneurial spirit that drives this industry is that these solutions will be realized and the innovation will move forward. Despite these challenges. Healthcare is a mission driven industry. It is critical that the innovators here push forward with the solutions that they have that will change the frontier and even disrupt the normal of today's ecosystem. It is our hope that some of these words will not be off putting, but rather provide some foresight and some insight into challenges that will come up to make these the realization of these important solutions more realistic. With that, I would like to introduce our first speaker today.