If you’re not aware of what a project manager for medical device companies can do, it can be easy to be trapped into thinking you can manage without them – reducing your financial investment.
But that would be a mistake.
PMI defines project management as “ the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements.” They also say that organizations that undervalue project management report an average of 50% more of their projects failing outright.
A good project manager manages and optimizes the company’s human and non-human resources to reach project goals on time and within budget. And they do this keeping overall company goals in mind. Making them well worth the investment.
In the medical device industry where the stakes are much higher – with high risks, stringent regulations, and quality checks at every level – project managers and project management consultants play an even bigger role.
A good medical device project manager knows how to adapt the latest project management tools and techniques for medical device development and process improvement. They should know how to implement these techniques to control costs, speed outcomes, and manage risks in a healthcare environment. That also means an ability to understand and work with applicable product safety standards and market regulations for medical devices and healthcare.
Project managers for medical device companies manage projects across multiple functional areas.
For example, Waddell Group provides medical engineering consulting and project management to medical device companies to help navigate complex regulatory and quality processes. Our expert medical device consultants predominantly manage projects that fall under one or more of these 8 umbrellas:
- Design and Development Projects including New Product Development
- Process Development
- Building Site Location and Design
- Due Diligence for Investors and Company Boards
- Quality and Regulatory Project Management
- Recall Management
- Mergers and Acquisitions:
- Variety of Other Engagements Needing Improved Leadership and Communication
With the help of the right medical device project management consultant, you can look at the bigger picture of the project instead of focusing on only one aspect of the whole.
To manage these medical device projects successfully, project managers need to have knowledge and experience of:
- The technicalities of a medical device development process.
- Current market, geographical and industry-specific boundaries.
- Various medical device industry niches and their differences.
- Legal, quality, and regulatory requirements specific to the medical device project.
- Risk management.
- Design controls.
- Process optimization.
- Quality management systems for medical devices.
- FDA, EN ISO, CE, and other quality and regulatory bodies.
To name a few.
A good project manager for medical device companies:
- Is aware of a) The intent of the project b) Why the company is doing the project c) The profitability and trade-offs required to achieve the project goal. They also convey the same to the team.
- Is skilled at identifying the early warning signs of a medical device project going off track. That way they prevent the project from getting derailed in the first place.
- Has expertise within one of the disciplines required for developing medical devices. A medical device may include a combination of electrical, mechanical, biomechanical, software, or pharmaceutical components. If a project manager has experience or education in a related field they are much more likely to be considered peers by the technical talent on the team. Making project management smoother.
- Creates a supportive environment where the employees enjoy being a part of the team. Where they feel that their opinions are valued.
- Is conscious of who they have on their project team. A medical device project team can have admin and support staff, technicians, chemists, microbiologists, QA personnel, etc. A good project manager should know how to get the most out of everyone while benefiting the team and the medical device company as a whole.
- Helps the team members build their personal brand and reputation so that they can establish themselves and set a path for their future.
- Ensures that any exceptional talent who works on the team must be able to play well with others, be held to the same standards as each member of the team, and be willing to have their solutions challenged.
- Has a high Emotional Quotient to understand their team members’ verbal and non-verbal cues. Plus keep them motivated and high functioning.
- Clearly understands the reason behind undertaking the project and what the project means to the company and stakeholders.
- Is able to “honor their word” and clear up the resulting mess if they cannot do so.
- Makes sure that the right seats are filled with the right people before driving the bus. That means getting the wrong people off the bus and looking for the right people when there is a gap.
- Knows their (and their teams’) ‘personal why’ to lead from a palace of passion and purpose. Especially since they’ll be better able to understand what makes the team ‘tick’.
Looking for a skilled medical device project manager or a project management consultant who knows what they are about?
We provide strategic-level project leaders and project management consultants for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. Our team of experts has worked with start-ups and Fortune 100 companies. There’s no project too small or too large for our strategic-level project leaders for the medical device industry. Take a look at our work and see how we can connect you with a medical device project manager perfect for your needs.