The medical device sector is just as risky as it is lucrative. Developing new and effective devices can translate to astronomical profits, which is why medical device companies are always in a race to be the first to bring new products into the market. While this is easier said than done, it’s not impossible when you work with the right team.
After the initial ideation and risk analysis, several processes — including design and development, testing, and approval — have to take place before any device is released to the market. Though most would like to get their devices to market as soon as possible, the reality is that each of these stages takes a long time to be completed and can cost a lot of money.
After going through such a rigorous process, it’s essential that all medical devices released to the market have no defects and are fully functional. Otherwise, you may have to recall them, which means losses and drops in the share price.
Over the last decade or so, 83,000 patient deaths were caused by medical device quality issues. Any indication that the device does not meet the desired quality standards will have a detrimental effect on your device. According to a McKinsey report, your share price can drop by up to 10% after a single recall. Plus, there’s the additional problem of tarnishing your product and company’s reputation before it even has a chance to succeed.
Medical device development is serious business, and you can’t afford to get it wrong the first time. There’s too much at stake.
So as much as you want to get products to market quickly, you absolutely cannot and should not compromise on the quality. Get it right the first time, and put in all the time and money you have to from the start. It’ll come back tenfold when your device succeeds.
If you want your device to do well the first time around, then you need to partner with a qualified team of project engineers.
What Is a Project Engineer?
Project engineers are those tasked with the responsibility of managing engineering and technical projects to achieve successful project outcomes. Their responsibility ranges from management of teams and staff to preparing schedules and budgets.
On a day-to-day basis, a project engineer’s tasks may include:
- Drawing up device specifications
- Performing calculations
- Reviewing proposals
- Creating design drawings
Compared to project managers, project engineers have a more hands-on approach to the development of devices. Aside from delegating, they are involved in the process, sharing their ideas and experience with the rest of the team.
Depending on the project’s size, you may need both a project manager and a project engineer. This allows the project engineer to put more focus on the technical side of product development. However, if you have a large project, outsourcing to engineering companies maybe your best option.
How Will a Project Engineer Speed Up Medical Device Development?
In the medical device sector, getting to market first usually means you have reduced (and, at times, zero) competition, not to mention a greater market share in the long run. That’s why it’s important to start your project with help from project engineers who can speed things up, without messing anything up.
1. Develop Project Objectives
Three key elements drive medical device companies as they develop new products. These are:
- Business goals
- Technology objectives
- User needs
Neglecting any of these elements will cause product failure, so you have to give each element the same amount of time, attention, and regard. For instance, without considering user needs, you may develop an effective and efficient product, only to find that there’s no market for it. Conversely, you may focus too much on user needs and technology objectives, which can lead to a highly effective product that users appreciate, but one that won’t actually help you achieve the objectives.
Balancing these three elements isn’t easy. A project engineer can help. Here’s how:
- Business goals: Before initiating product development and rushing to market, a project engineer will help you clearly define the business goals. This will be accompanied by the necessary steps to achieve each goal you identify.
- Technology objectives: Being a highly tech-driven industry, it’s imperative to get your technology objectives right with each project. The project engineer will help you identify the appropriate technology objectives for each project. These include the core tech or intellectual property that will give your device a competitive edge.
- User needs: It’s easy to focus just on the technology side of medical device development. However, users are only interested in products that can meet their needs effectively. Achieving this goes in line with attaining business goals. Project engineers will help identify users’ needs and ensure your device development is geared toward meeting them.
To succeed as a medical device company, you must begin each project by defining your business goals, technology objectives, and user needs. You shouldn’t get started without them.
2. Develop Efficient Methods and Practices in Conjunction with Senior Engineers
The time it takes to get a product to market significantly influences how profitable it’ll be. Even if different devices require varying processes, you’ll find there are some similarities. Instead of starting from scratch each time, project engineers will collaborate with senior engineers to develop efficient methods and practices to launch projects.
Once development begins, they will also do the same for individual projects. By eliminating unnecessary bottlenecks and streamlining the process, you can significantly speed up device development.
3. Develop Specification for Each Device
Medical devices play a key role in sustaining and improving the quality of life of patients. However, if the device malfunctions or isn’t actually efficient, it can put patients at risk and lead to further complications, and sometimes even death. These consequences are frequently a direct result of using a medical device, and can put you in a hard spot, dealing with recalled products and increased liabilities (think lawsuits).
Project engineers help reduce this risk by assessing device requirements and testing. This lets you determine the necessary specifications for each device from the start so nothing is missed and your device can do exactly what it needs to for the intended user.
4. Develop and Maintain a Framework for Monitoring Project Metrics
Identifying and outlining project objectives and device specifications isn’t enough to guarantee success. Everything must be done correctly and on time to ensure devices meet the necessary standards and project timelines.
To this end, a project engineer will come with an appropriate framework and identify the best metrics to monitor the project’s progress. This will allow you to catch errors early on and prevent unnecessary challenges down the road.
Partner with a Project Engineering Team to Beat Your Competition
Medical device manufacturing is one of the most competitive industries. Lots of people have good ideas. Few people know where to turn so they can make those ideas a reality. For your company to remain competitive, you must seek any advantage possible, and one way to do that is by partnering with a medical device project engineering team.
C3 Medical Device Consulting offers project engineering support to medical device companies just like yours. Reach out to us today to get started.