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Part 8: Tips for Outsourcing Medical Device Development DeviceLab has been doing medical device projects for 20 years, with over 100 major programs completed. Our team also includes members who have worked at other design firms, and have seen lots of different approaches to program management. As a result, we have developed a set of practices that reduce friction, speed progress and maximize synergies. Looking at this body of knowledge from our client’s point of view, we can offer a series of tips for doing business with a firm like DeviceLab. Scope of Projects Our clients have a wide range of capability in-house. Some of them are large, capable companies that come to us for work in a single discipline, like Industrial Design or Software Engineering, because of our talents or experience in the field. Others are startups, seeking to outsource all or nearly all of the development work. There are advantages to both approaches, as well as difficulties. If you bring in just one discipline (say Industrial Design), you save money by using your in-house Mechanical Engineers. However, you also accept the responsibility for how ID interfaces with ME and Software. If both are outsourced, the coordination is our responsibility and occurs between people that work together every day. Outsourcing entire projects to a design firm puts all of your eggs in one basket but also precludes pissing matches between multiple contractors when things don’t go right. Design firms have a culture of moving fast that’s very hard to duplicate in a large firm. So even if you can do some of it yourself, consider the advantages of outsourcing more to a company that does new products every day. Our tip is to use a vendor who has the scope to handle all of the things you need and put as much as you can on them. Micro-management Sometimes, our client contact is a development professional who cares deeply about the process of design. If their ideas about program management differ from the project manager DeviceLab has assigned, our contact may become overly involved in assignments, scheduling, and work tracking in minute detail. This is counter-productive. Our project managers know how to best leverage the talents of the teams we assemble and have a lot of experience in managing disparate assets to accomplish plans. Insisting on justifications for minutes charged (for example) not only takes your project manager away from value-added activities like resolving technical issues but imparts a chilling effect on the team that makes them want to prematurely end activities to meet a budget. Our tip is to resist the temptation to micro-manage a project. Subcontractors Sometimes, DeviceLab doesn’t have a specific skill (or enough bandwidth in a skill) to support a project. We turn to our subcontractor network in these situations, a set of individuals and firms we work with all the time. Our network contains resources with deep technical expertise, but it’s also informed with their observed performance on multiple projects. In this sense, our subcontractors are more deeply vetted than is possible for a company that doesn’t do a bunch of development projects every year. Our tip is to let your design firm choose their subcontractors – you may know a really great resource, but ours are great too, and we know how to work with them. Development Contracts Medical device development work is usually outsourced under a development contract formed between the design firm and client. The contract usually specifies the work to be performed, the requirements imposed, the results expected, and estimated costs and duration. As development work resolves many unknowns, it’s not possible to produce accurate budgets or timelines before a project starts. Attempts to do so only create a dangerous fiction that can be clung to in the face of a very different reality. Moreover,firms that claim to be able to do a large project on a fixed bid are the same ones that come back for more money when you’re 80% done. Our tip is that it’s more sensible to expect rough estimates for whole project budgetary purposes, and specific budgets for only the current phase and the next one. Communications Many companies, especially large ones, have communication problems. People get comfortable in their silos and don’t talk as much as they should. When you outsource a development project, communications can be even worse, but they can also be better. Why is that? The internal communication between the folks at DeviceLab is really great, probably better than in most of our clients, and unlike your internal team members, our folks deal with outside contacts every day. We’re also accountable for communications in a way that often exceeds the accountability of our clients’ employees. What this means is that we can be trusted to hold up our end of important knowledge flows. Our tip is to expect great communication about the project and insist on it from start to finish. Points of Contact: In the same area of communications is the designation of points of contact in a program. Both the client and DeviceLab must make it clear who is the point of contact for each topic or area. We insist that all communications to DeviceLab be copied to the project manager, but we also designate specific points of contact in-house who have assumed responsibility for portions of the design like electronics or ID. To the extent that client employees are also working on the project, it’s important to designate specific ones as points of contact, empower them, and assign responsibility for liaison with the design firm resources. Our tip is to make sure you know who is responsible for each aspect of the project, both in-house and at the design firm. Work Tracking: Every project establishes expectations when started, and nobody wants to wait for the end to know whether those expectations will be met. This impatience expresses itself as a desire for information that purports to measure progress so that the measurement can be compared to the expectation. While it’s true that “% of task effort completed” and “% of task budget spent” can be compared to measured progress, it’s important to remember that the budget is a number you estimated before you began and the % completed is an estimate from a worker still working the incomplete task. It’s dangerous to fall into the trap that the plan is infallible in predicting effort and browbeat individuals because unknown things changed our predictions of reality. Our tip is to use progress tracking at a coarse level – ignore individual tasks and focus on phases to manage budgets and schedules. Planning: You have to have a Design Plan in any medical device project. You may already have created one – if so, that’s great. You may also have a plan for the development project, including things that don’t bear mention in the Design Plan. In fact, most clients walk in with one or both of these plans at some level. So, we see a lot of plans for medical device development,and have written many ourselves. What we’ve learned is that planning new product development is different from planning more predictable activities like putting up a new commercial building. There is far more uncertainty, including the “unknown unknowns,” which are impossible to plan for. Fortunately, reducing this uncertainty is a prime objective of development, so as a project moves forward our view of the future improves. Our tip is to plan the distant future in broad terms and the near future in specific terms, then refine the plan as you progress through the phases. Conclusion DeviceLab gets a lot of repeat business because we’re good at being an outsourced team. To get the best out of us (or any other design firm), follow these tips and you’ll have much smoother sailing. See the Process page on our website for more information on how we do things.

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The Design Process of Medical Devices at DeviceLab: Outsourcing

The Design Process of Medical Devices at DeviceLab: Prototypes

The Design Process of Medical Devices at DeviceLab: Project Management

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