Startup companies would be wise to heed the words of Andrew Carnegie: “Put all your eggs in one basket and watch that basket.” The “basket” is the project that will make or break a fledgling company, and the project manager’s job is to keep an eye on it.
Randy Nelson, Heraeus
Project management for any complex medical device project can be a daunting task. For companies with resource constraints, typically startups, project management requires skills that are not as critical for an established company.
All companies and projects have the same historic quality-cost-schedule requirements. In an established company, excellent quality is assumed, the schedule is planned and monitored by executives, and the cost is initially budgeted and perhaps not monitored and evaluated until further into the project. Startups must monitor spending much more closely or risk failure.
Startups will typically have a small staff and contract most of the work to outside experts, whether that be development, regulatory, quality, etc. The project manager will manage limited internal resources and a variety of critical external resources, depending on the stage of the project. There are three key skills that become more important for a resource-constrained organization: communication, prioritization and technical leadership.
While internal communication is important for all projects, the project manager must also establish excellent communication with each external resource. Frequency and form of communication will depend on the stage of the project and how well the project is tracking to budget and schedule.
At a minimum, a weekly meeting with detailed meeting minutes is critical to ensure everyone is on the same page (literally). During critical periods, a brief daily update between the external source and startup can ensure quick decisions and schedule compliance or resolution to issues. Too many meetings take unwarranted time and become costly. While face-to-face meetings can be costly and time-consuming, periodically planned meetings can greatly benefit decision making and overall communication.
Planning and prioritization of project tasks depend upon the amount of available capital and commitments made to investors. Ideally, a project manager will plan the entire project from concept through regulatory submission. In reality, a company will have capital available in stages and be dependent on the success of early commitments in order to raise additional capital to complete the project.
It is often prudent to make a commitment only to the initial stage of a project and “watch that basket” to make sure the concept is sound and becomes an acceptable risk for further funding. Without managing priorities, it becomes easy to add unimportant features that cause time and cost delays. Focusing on the aspects of the technology that differentiate the startup from other companies is key to success for many projects. Project managers should prioritize the key differentiators and plan to keep the non-differentiating technology off the critical path.
In an established company, project management may focus on the schedule and maybe the budget. In a startup, the better project managers are often the technical leaders. They need to have a first-hand knowledge of the technical requirements and difficulties for their project and may also be the primary engineer for the project. While not expected to personally solve all problems, the better project managers will be able to identify the potential time/cost/quality risk factors early enough to work with the extended team to mitigate issues and resolve problems before they become larger problems.
The objective for project management in companies large or small is the same: successful development and release of a new medical device. For a resource-constrained startup, project management needs to be tuned to the internal capabilities and funding of the company. Emphasis on these three skills can help make a startup successful for the employees, investors, and the eventual patient.
Randy Nelson is senior director of business development at Heraeus Medical Components (St. Paul, Minn.). Until recently, he was CEO and founder of Evergreen Medical Technologies. Nelson has been responsible for developing medical devices for more than 35 years at both emerging and larger medical device companies and taught a graduate-level course in the valuation of new medical innovations at the University of Minnesota.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.