4 Tips to Find A Medical Device Project Manager
May 6, 2021 by FlexPro
Written by Mindy Judson, PMP, FlexPro Sr. Project Manager
It’s an exciting time to be in the medical device industry! There is so much movement and innovation in new products thanks to technology advancements. We are now able to leverage software, artificial learning and intelligence, and 3D printing to bring great new solutions to health concerns. The downside can be how to find the right talent and knowledge to keep your ideas and innovations on the right track. The project or program leader should be the COO of the project.
Where the COO has overall strategic and operational responsibility for the organization, the project manager should drive the strategy of the project and oversee its operational aspects.
In this post we will give you 4 tips to finding the right project management talent to help you succeed.
Finding Candidates with the right amount of experience, industry, and level of expertise can be like looking for a unicorn. Thankfully, through insourcing, outsourcing, and direct hiring you may have a few different routes to find the right person. Direct hires may take a bit of time and energy to find. Furthermore, understanding the different nuances of a Software as a device (SaMD) project versus an invitro diagnostic test product can save time and tough lessons learned for the project manager, team, and overall product development lifecycle. Here at the Flexpro Group we have project managers available that come from the technical side of medical devices, knowing the current regulatory landscape and about the latest market developments. Unlike larger firms, we have experienced Senior level PMPs experienced in working on medical devices, leading to less risk and faster timelines to bring your project a successful outcome.
A device must be safe and there are a lot of regulations around its intended use and indications of use. Significant regulatory changes such as the transition from Europe’s Medical Device Directive to the Medical Device Regulation require companies to undergo major revisions to their policies, processes, and systems in order to meet new requirements. These changes can be projects outside of just your device development project to ensure your quality management system and documentation are updated to reflect the improving guidance. Having a project manager with the understanding of this scope of change is imperative to success in a quick remediation effort.
With projects this large and complex there may also be a need to bring in outside regulatory consultants, manufacturing facilities, or other areas of expertise. Most smaller companies don’t have or need to bring all expertise in house. Even larger organizations may find it more cost effective to outsource parts of development. You need a project manager that is skilled in vendor management in a regulated environment. Since often these consultants or outside firms may be assisting with creating regulatory deliverables for the project there is an additional layer to vendor qualifications and auditing that are not seen in other industries. These can lead to delays in timing if not addressed appropriately in the project plan or through prior experience.
Experience is the best teacher. Some of the best project managers you will find have a broad range of experiences across similar industries or parts of the development process. There is actually a lot of crossover in regulatory intentions and processes between the biotech, pharmaceutical, and medical device industries. Having a project manager that has managed these types of projects can allow you to understand how others have been able to apply creative project solutions to common problems related to validations, GMP requirements and documentation, audits, risk management, or supply chain issues.
Your organization is serious about this development of high quality medical devices and invitro diagnostics, and the associated significant investment. We understand the expected return on investment should be managed to deliver that ROI in a reasonable timeframe. At FlexPro we take that as seriously as you do. With increasing competition for top talent in a globalized market while navigating a more complex regulatory environment, project management consultants will continue to offer valuable pathways for planning and completing projects quickly, reliably, and cost-effectively. To manage these types of project risks we recommend having an experienced project manager at your side.
Contact us today to learn how you can leverage our unique and experienced project managers to get your products to market faster.