One of the challenges in medical device development is managing the tension between technical readiness and market enthusiasm. It’s exciting and validating when a client expresses early interest in a product still under development. This often signals strong product-market fit and can be a huge boost to team morale. However, that excitement can quickly turn into pressure to accelerate timelines, share unfinished samples, or even skip over key development milestones like Design Transfer, Verification, and Validation.
The risk is that once a client begins integrating a technology into their own systems, any setback such as a failed test or design change can have ripple effects not only on your own project timeline but also on theirs. This can damage trust, reduce flexibility, and expose both companies to financial and reputational risk.
So how can we strike the right balance? Open communication with clients is key, being transparent about development status, known risks, and upcoming milestones can help manage expectations without discouraging enthusiasm. In fact, involving clients in feedback loops can strengthen collaboration, provided there’s clarity on what is and isn’t finalized.
What other strategies can project teams use to manage early-stage client engagement while protecting the integrity of the development process? Would it be effective to establish staged licensing agreements or internal policies that prevent samples from being distributed too early unless approved through a risk-based review process?
Project teams can implement a phased approach to client interactions to manage early-stage client engagement while maintaining the integrity of the development process. This could include establishing clear milestones and decision gates where client feedback is solicited and integrated in a controlled manner. Additionally, staged licensing agreements can be effective, allowing clients to access certain aspects of the technology at predefined stages, contingent on meeting specific development criteria. Internal policies requiring risk-based review before distributing samples can also help ensure that only sufficiently vetted prototypes are shared. This approach protects the project timeline and quality and builds trust with clients by demonstrating a commitment to thorough and responsible development practices. How can we further refine these strategies to balance client enthusiasm with the need for rigorous development?
I think the aspect of sharing unfinished designs can be improved. Even though sharing a successful idea can boost the morale of the team, it can be just as devastating if one small thing goes wrong. Therefore, I think it is important to limit exposure of these early design models. If there is an integrated technology from another company as stated in the post, it could ruin the trust in the business relationship. However, if early samples were to be shared, they should be able to check certain boxes when they are tested thoroughly.
Like the previous post highlights, both staged license agreements or internal policies are strong choices in preventing early samples from being unveiled prematurely. In my opinion, in this matter I would choose internal policies to help facilitate this. The teams that handle the development and risk management of the product are going to be the most knowledgeable about the chronological prototypes they produce. This gives the teams more power in showing what they want and what they are confident with their device.
Adaptive project management is how projects are executed in today's environment. Unlike traditional methodologies, this approach embraces flexibility and adaptability, continually allowing teams to learn and improve throughout the project's lifecycle. A defining feature of adaptive project management is its emphasis on client collaboration. Engaging clients actively in the project process enhances outcomes and fosters a sense of ownership. The other strategies to manage early stage client engagement are,
1) Understanding the client's role,
Client as the Central Figure: In adaptive project management, the client is not just a stakeholder; they are the central figure driving the project's direction. Their input and approval are critical at every stage, ensuring the project's outcomes align with their vision and objectives.
2) The Importance of Client Feedback and Approval: Client feedback is a cornerstone of successful adaptive project management. Regular feedback sessions ensure misunderstandings are quickly resolved, making the approval process more efficient and effective.
3) Building Trust with the Client: Establishing and maintaining trust is essential for a successful client-manager relationship. Trust is not only built through transparency but also through consistency. Meeting deadlines and commitments, admitting mistakes, and demonstrating a willingness to learn from them are practices that reassure clients of a team's reliability. This trust becomes the foundation for long-term relationships that benefit both the client and the project team, facilitating smoother project execution and greater success.
4) Collaborative decision making: This strategy emphasizes the importance of making decisions with the client rather than for the client, fostering a sense of partnership and shared responsibility for the project's outcomes. Collaborative decision-making places the client at the heart of every strategic move, ensuring their insights and expectations shape the project's direction.
Licensing is a niche area of law, requiring both Intellectual property and transactional expertise.
A study published in the Journal of Pharmaceutical Sciences proposes a novel risk-based methodology for lot release, aiming to assess the risk that a lot declared to have passed truly meets product specifications. Implementing internal policies that require a risk-based review before sample distribution ensures that only products meeting predefined safety and efficacy criteria are released, thereby protecting the integrity of the development process. The licensor’s optimal contract depends on his risk attitude, the information regime and the licensee types he is facing. Under complete information, the results from the single-stage R&D licensing model are preserved. In particular, we find that the optimal contract for a risk-neutral licensor contains a single upfront or milestone payment, the choice of which is based on the relative valuation of the licensor and the licensee for that particular payment. The optimal contract also avoids using a royalty rate to achieve optimal project execution, which maximizes the value that the licensor can extract from the licensee. Risk-aversion induces the licensor to prefer earlier payment, and may lead him to combine upfront and milestone payments in the optimal contract in an effort to balance risk exposure and nominal value of the payments.
Ref( https://www.sciencedirect.com/science/article/pii/S0377221712006789#s0085
https://jpharmsci.org/article/S0022-3549(19)30646-X/fulltext)
This is a topic I was interested in discussing as well, especially after getting started on this week's simulation. In the context of the simulation, it seems as though there were some disclosure issues: the client fully implemented the product without knowing that it was not ready to bring to market. Outside of the scope of the assignment, I was very curious if this was something that could actually occur in a real life setting. Is it legal to distribute a sample prior to verifying it meets requirements? If so, is that really ethical to do? As mentioned throughout this thread, I believe the best way to handle a similar situation would be to provide full disclosure to clients and make sure whatever you are providing aligns with their needs. Prioritizing qualify products is also much more important than rushing products to bring them to market sooner. Ultimately, you will run into long term problems and dissatisfied clients otherwise.
