What does Dysfunctional Development look like?
Many companies experience problems resulting from how their teams go about developing products. Sometimes a company hasn’t defined a cultural “Our Way” that enables them to work together as well as work with their vendors. Sometimes this is a symptom that the company has “grown too quickly”. At other times, a company has trouble quickly establishing a development approach because […]
Incose IW 2016-Systems Engineering
Suttons Creek is excited to announce that Managing Partner, Steven Badelt, PhD has been invited to speak at the Incose IW 2016 Conference to be held January 30 – February 2, at Marriott Torrance, in Torrance, California. A recognized expert in the pharmaceutical and biomedical field, Steven Badelt, Phd, will be discussing the intricacies of […]
Proactive Risk Management
Risk management then: A child dies in 1986 at Seattle Children’s Hospital. Power and ECG cable connectors were compatible, electrocuting the child. Risk management now: Covidien issues field alerts in 2015 due to cross-manufacturer interfaces. Why had no one anticipated these scenarios? Is this reasonable? What can be learned from this when considering the new product […]
Did you just hire the wrong engineer?
Run a strong development team with systems engineering principles and you can hire better people, faster. That’s a major proposition for the pharmaceutical and medical device industries, who are having a hard time finding the right people for the job. “Medtech” should stop hiring only people from “Medtech”, which is a lot easier when you […]
Systems Engineering, Just Good Engineering
I had a great conversation with a colleague while at the 2014 PDA “Universe of Pre-filled Syringes and Injection Devices” conference. Mike is a 15-year veteran of the pharma and medical device world and has seen examples of both good and bad engineering practices. We talked about the discipline of system engineering and why it is […]
Software Engineering in a regulated environment
Lately we’ve been working with many of our clients on the challenges of developing software for FDA-controlled products. From combination product companies developing tools for physicians to medical device companies developing new interfaces on mobile platforms, we’re finding that many of the problems encountered are universal. Simply put, development teams brought in with significant mobile […]
Brainstorming for risks: A bad idea
Risk analysis is a key component of any complex engineering endeavor, but is particularly so when considering technology that may be life sustaining (or life-threatening when something goes wrong) such as many medical devices. Indeed, there is an entire ISO standard dedicated to guiding the medical device manufacturer on how to design a risk management […]
Welcome to the new Suttons Creek Website
Watch this space for SCI’s thought leadership in the development of medical devices, combination products, and the application of systems engineering to complex projects.