Part I of our series on successful medical device outsourcing addressed how to carefully select a manufacturing partner, plan for the process, and understand the specific benefits a prospective manufacturing partner can provide and how to maximize them.
Once an appropriate provider has been selected, effective program execution can begin. Active collaboration and management of the outsourcing relationship are essential to ensuring successful outcomes. Alignment and communication are necessary components of any outsourcing relationship and involve some important approaches.
When an outsourcing provider’s scope is limited, it’s important that the entire team understand big-picture objectives, making communication vital. Keeping these objectives visible throughout a program promotes long-range, value-based thinking when making decisions and taking actions.
Educating an outsourcing provider on the clinical use of a product – along with clinical, regulatory, and business milestones – helps communicate the overall mission and instill a sense of value and urgency in the team. Maintaining big-picture awareness can be difficult but is critical to effective decision-making and keeping a project on track.
Whether developing a new product or outsourcing production, leadership within the OEM and provider will be called upon to set direction and make decisions on a regular basis. For efficiency in execution and confidence within the team, decisions must be made based on consistent guiding criteria.
Teams, whether internal or external, generally can tolerate change and redirection as they occur naturally during the product lifecycle; however, when the basis for decision-making shifts or is inconsistent, team members begin to lose confidence in the path, and their motivation declines.
Trust is essential to an effective outsourcing relationship. Generally, OEMs outsource to companies that have recognized expertise in the tasks they are asked to complete. Trust between partners in the outsourcing process should be developed during selection and built upon during project execution. It is essential to trust in each other’s expertise and also in each other’s genuine desire to fulfill obligations and meet project goals.
Clearly defining roles and responsibilities will promote clarity in the outsourcing relationship. Set clear expectations, trust team members to execute, and then verify performance.
Whether a company outsources or not, challenges during development and manufacturing are inevitable. When outsourcing, unforeseen problems may disrupt the overall working relationship if not managed proactively. The mark of an effective team is not how it operates when things are going well, but rather how it functions when confronted with challenges and unexpected deviations from the plan.
Anticipating challenges and mitigating risk, via risk analysis, contingency allotments, and parallel approaches, is prudent and will alleviate or temper many challenges.
Problems will occur and outsourced programs should have mechanisms in place to address these problems. Maintaining and regularly reviewing issues lists can aid teams in assessing, prioritizing, and addressing challenges. Put contractual mechanisms in place to address the process for dealing with challenges and the associated impacts on the project plan.
This will not only set the expectation, but also assist in the logistics of addressing challenges — thereby freeing up the project team to focus on solving problems.
High-performance outsourcing relationships bring two or more teams together, with overlapping and complementary goals and objectives. Creating alignment, focusing on common goals, and fostering an environment of trust within an outsourcing relationship will not eliminate problems and allow flawless execution; however, these actions will help build a team structure and business relationship that can adapt and execute effectively.
When well executed, medical device companies can benefit from adding resources to their team to enable faster, more efficient product development and commercialization. To make the most of outsourcing relationships, OEMs must avoid the pitfall of assuming that simply selecting an experienced partner will satisfy all of their needs. Every OEM should recognize the importance of preparing for outsourcing, selecting a partner based on fit and overall value, and actively collaborating with their partner for shared and mutual success.
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