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Getting an orthopedic device to market is a highly complex task. If you can control the controllable elements, you have a better shot at success. Don’t let lack of planning, poor communication and redundant processes get in your way. At OMTEC® 2022, orthopedic engineers will learn to sharpen their project management and device development skills through three days of education.
Here are four sessions we’re looking forward to at OMTEC in June.
1. (Accurately) Estimate the Cost and Priorities of Your Project
New product development is exciting, and it’s also the lifeline of any company. An organization needs to innovate and provide solutions to stay competitive and relevant, particularly in the medical device space, where technologies change constantly. However, the process of creating and commercializing a new product needs to be cost-effective to survive the ideation stage. A guess isn’t going to cut it — getting a good grasp on what a project might cost is essential.
In this session Shaher Ahmad, Partner at Product Lifecycle, walks us through a team approach to developing an educated estimate of time, money and resources needed to complete a project. While the process developed for each company (and each orthopedic product) will be different, they all involve a deep understanding of every aspect of the project, including the design architecture, regulatory pathway, clinical trials requirements and time it may take to get it done. Gaining insight from multiple perspectives within your organization can help you estimate your project’s cost accurately.
2. Truly Understand Process Validation
We humans seem to love using acronyms. They’re everywhere. And sometimes, they’re misunderstood. In this session Dale Tempco, founder of Dale Tempco Consulting, demystifies the notorious alphabet soup of process validation: IQ/OQ/PQ.
Process validation is connected to FDA regulations and guidance, so orthopedic manufacturers must understand how to develop process plans and protocols properly. Tempco will discuss the difference between verifiable and special processes using real-world examples of both easy and difficult scenarios.
“Product engineers often have features that require special processes or list special processes on the engineering drawings,” Tempco said. “What’s often missing is a definition of the ‘required results’ of the process. For example, a design has a requirement for welding. The engineer puts a weld symbol pointing to the weld joint and states that the weld must be validated. This raises the question, validated to what? A strength requirement? A requirement for radiographic or ultrasonic inspection? For corrosion resistance? If the result of the process is not defined, the process cannot be validated to ensure that design requirements are met. The design engineer may say it’s up to manufacturing to validate the process. This is true, but manufacturing cannot validate a process if the process results are not clearly defined.”
Engineers are expected to walk away knowing the basics of process validation, including IQ/OQ/PQ, as well as how it fits into FDA regulations and guidance and how to handle hard process validation scenarios so that you can be prepared for your next product development project.
3. Save Time Through Automation
Product development has gone more digital, with automation leading to faster times to market and higher instances of meeting revenue targets. Process automation allows engineering teams to stop wasting precious labor on redundant, repetitive, time-consuming and tedious tasks, while enabling the team to meet market demands in shorter time frames.
Automation doesn’t mean replacing engineers’ jobs. On the contrary, it allows workers more time for innovation and revenue-generating tasks.
“People don’t want to spend their time doing repetitive tasks,” said Edwin Chung, Director of Engineering Technology & Applications and speaker for this session. “I absolutely believe that engineers say, ‘Geez, the worst part about this [project] is waiting for something to happen or doing this same thing one hundred times.’”
The issue is that leadership often doesn’t understand what tasks can benefit from automation. Chung will discuss the benefits of process automation, examples of tasks that can be automated (with use cases), as well as a framework for how companies can begin implementing automation.
4. Become a Better Communicator
Good communication is a make-or-break characteristic that every organization needs to experience success. That’s the argument Bryan Warren, President of Trailhead Strategic Solutions, makes in this session. Employees must be able to communicate to their teams, customers, stakeholders, leaders and each other to excel.
“People who work at orthopedic device companies do a fine job of scheduling meetings, defining agendas and fleshing out topics to cover. But self-awareness and getting ideas across are things they’re typically not good with,” Warren said.
This interactive session will lead attendees through meaningful exercises to hone new communication skills, including preparing for a quick call, formal meeting or big presentation, giving effective feedback that will be well-received and improve performance, and having more effective and efficient decision making.
Engineers need technical expertise. But top engineers and project leaders must continuously hone their skills and strive for personal and team improvements. Learning from and applying the advice from industry advisors is an important step in your advancement.
