Q&A: Systems Architecture in the PD Process

Q&A with a Senior Systems Architecture Engineer on the Product Development Process

Jan Niewiadomski

Sr. Director of Systems Architecture

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1. What role does your team play in the product development process?

The Systems Architecture team primarily captures complex, multi-disciplinary product needs and requirements then develops a suitable architecture and technical approach.  This allows us to review risks and opportunities early in the Product Design process and optimize the product requirements, architecture, and approach to our clients’ needs and constraints.

As the project progresses, we provide technical oversight to ensure that all components are being developed in alignment with the requirements and architecture. Throughout the development lifecycle, as features may be added or market needs become clearer, the impact to the overall system and its elements is evaluated so the necessary tradeoffs and course corrections are made without discontinuity across disciplines.

2. In general, what competencies do you and your team bring to most projects and what are your most frequent tasks?

The Systems Architecture group mainly provides the following competencies:

• Broad technical understanding that spans multiple disciplines, technologies, and industries. This helps us understand potential synergies and conflicts that requirements, architectures, and design approaches involve.
• Theoretical understanding needed for areas such as Algorithm Development, Simulation, and preliminary Power Analyses.
• Experience with Medical Devices is another competency we bring when needed. Deep understanding the process for developing and marketing Class I and Class II devices helps with project estimation, planning, and risk/hazard management

Simulation & Algorithm Development

We have the expertise needed to develop algorithms and simulate solutions for complex signal processing challenges, including adaptive capabilities, machine learning, and low power optimization. Algorithms are tailored to the situation’s unique requirements; whether running on a battery-powered IoT edge device or on a cloud backend or a user application, we develop the optimal algorithm for the overall system.

Medical Devices

Our team has a solid background in medical device development and understands the full development lifecycle from capturing user needs through verification and validation. While performing within the FDA cGMP and Design Control Guidance, we ensure we are well versed in our clients’ QMS and their implementation of ISO 13485 and ISO 14971 to facilitate outputs from our team and client, allowing us to integrate seamlessly.

3. What are some of the most unusual or difficult challenges your team has been asked to meet and how did you meet those?

We are constantly challenged to meet competing Cost, Schedule, Size, Feature, and Power targets.  An example would include 16-year battery life in harsh environments.

Architecting the Spirio 2 was another challenge. Finding an approach that would implement all the complex functionality while providing a stable platform for future features required understanding many low-level technical nuances as well as the overarching system needs and constraints.

4. Which other IPS departments do you work most closely with and what sorts of conflicts may commonly arise that require detailed collaboration and compromise?

The Systems Architecture group works with all IPS departments and tries to find the best solution for competing priorities that emerge from the technical challenges faced by each discipline. We thrive on the healthy conflict since that helps us find an optimal solution.

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