David C. Robson, Principal, Robson Advisors03.14.18
A project manager’s job is never easy. Much of their job is related to figuring out a plan, foreseeing and mitigating risks, and keeping all various resources focused and working in sync with each other. They often carry all the project’s responsibility, but not much of the authority. When things go wrong, they often get stuck delivering the bad news, explaining how it happened, and how it’s going to get fixed. A project manager’s job is rarely glamorous. However, for many there can be a great sense of accomplishment when the plan comes together and the project ends successfully.
Client project managers (CPMs) are increasingly tasked with finding and managing outsourced service providers (OSPs). OSPs are specialists and often experts in their particular field. The best OSPs can significantly improve a client’s path to success in terms of risk reduction, improvement on project schedule, or perhaps even in the streamlining of regulatory compliance. Using these expert resources is commendable, but they must be monitored and managed differently than traditional internal resources even if they are co-located with the client’s team.
Managing OSPs requires a different kind of oversight. When a CPM runs a project using their fellow employees, the team shares the goal of the company’s well-being and future success. If the project isn’t successful, there’s the potential the company might not be viable and could risk each team member’s job. Although it’s not guaranteed that everyone will get along or be effective, the project manager’s role and oversight responsibility is relatively well understood.
The majority of OSPs are honest, ethical, hardworking, and well-intentioned people and organizations ready to sacrifice nights and weekends for the client’s benefit. There should always be a symbiotic and mutually beneficial relationship between the client and outsource companies. However, using OSPs adds complexity and potential conflicts of interest, which must be watched. This doesn’t mean constant paranoia, but the CPM should regularly double-check to ensure their company and OSP continue to align. The CPM must react immediately to misalignments so the program doesn’t derail.
Following are several objectives the CPM and client company’s senior management should regularly monitor. These areas of inquiry and monitoring apply to any outsourced effort or activity—design and development work, component supply, or manufacturing.
Ensure the OSP uses the best possible team members. The client is the customer and should be a savvy and somewhat picky shopper concerning human resources applied to their program. The CPM must always provide the best team to the project. Since much of the OSP’s work is done out of direct client sight, it’s harder to know if the “best” team is always used. Lower level or less critical project tasks can be effectively assigned to less experienced OSP team members, but for critical and expert level work the CPM and their team should be aware of the expert’s credentials and experience. They should also watch for a good chemistry/personality fit, especially considering close and long-term contact. Further, the CPM should overtly ask who is doing the work throughout the project, especially if clues surface that mistakes are being made or dates are being missed.
Ensure the service provider is aligned with goals and priorities. This falls squarely into a CPM’s routine, but it’s surprising how many client companies fall in the “I’m sure they’re doing the right thing” complacency trap. The CPM must check in with the OSP at least on a weekly basis to confirm all activity streams are moving forward according to plan. Subtle shifts in focus, deliverables, or date slips can indicate misalignment or misunderstanding. It’s better to be a little too worried than a little too laissez-faire.
Ensure the service provider’s expertise and capability. The CPM must regularly confirm the OSP’s capability beyond its individual team members. Sometimes client companies pick the wrong service provider who wins a project not quite in their wheelhouse. Unforeseeable circumstances may also change the project’s complexity or scale, rendering the OSP no longer the best choice. Perhaps an engineering OSP needs human factors inputs before pursuing a product configuration. The incumbent OSP will be inclined to “struggle through,” whereas the client might be better served finding another OSP. Here, the CPM will likely be one of the first to notice something is amiss. Mitigation steps can then be enacted or the work may need re-routing to another service provider.
Ensure the service provider uses the budget and schedule well. Money is always the “third rail” of relationships between a client company and OSPs. Ideally, a budget would be established initially and never dealt with again—unfortunately that’s not how the world works. The CPM and those responsible for budget oversight must regularly examine the OSP’s submitted hours and expenses. Minimally, the CPM should request a monthly summary of hours booked by individual team members, counts of units built versus plan or tests completed, or metrics providing insight into the OSP’s efficiency and diligence in budget management. Disciplined oversight and transparency will help both parties through unexpected budget adjustments, since the CPM will be confident that the OSP is being careful.
Ensure the service provider’s senior management is sufficiently involved in the program’s oversight. The client should expect excellent service and take steps to ensure it. Guaranteeing the OSP’s “bosses” are engaged will help. Regular contact and a familiar relationship with the OSP’s senior team keeps the project on their radar screen, and helps the OSP’s project team maintain focus by having an internal management champion.
Ensure the team constantly assesses and retires risk-to-success of the project and business proposition. Risk-to-success encompasses everything that may cause a project’s or company’s business objectives to potentially fail. Simply put, the product design has failed if business objectives aren’t met. The device must meet a myriad of criteria even if it is a great clinical solution. Many of these criteria may be in mutual opposition to the “best” solution for criterion like cost of goods. A delicate balance must be struck in order to ensure clinical outcome, technical function, cost of goods, regulatory acceptability, reimbursement considerations, capital expenditure, patent strength, usability, user acceptance, and so on. Especially in the project’s early stages, the CPM must guide the internal and OSP teams in identifying and retiring the biggest risks-to-success first. The OSP may not have the best perspective on all the risks in play or how best to balance them. The CPM must have a firm handle on everything, engaging the right people within the client organization to ensure balance is maintained.
Similarly, it’s easy for the client company and OSP to become blinded to the project’s big picture implications. There may be compromises made during product development or manufacturing process refinement impacting cost of goods or other critical success criteria. The OSP team is not as intimately connected to the client’s business objectives and strategic considerations. Seemingly harmless adjustments may have unintended consequences. The CPM must be particularly diligent in noting when changes occur and assessing their impact on business objectives.
Ensure plans for appropriate and proactive adjustments to work, scope, budget, or schedule are carried out. Expect changes to the plan for any but the simplest of projects. No Gantt chart or budget projection can truly capture all the contingencies, nor should they be expected to. If a schedule or budget covered everything, it would end up unacceptably expensive, long, and unnecessarily complicated. Rather, the CPM and their team attempts to plot a “Goldilocks” path—not too conservative or aggressive—and hopes to fall somewhere in the nominal. When using OSPs, the client team must be apprised of status on a regular basis and the CPM must establish a culture of proactive truth telling. A remotely working OSP makes it easy to miss or avoid addressing issues until it’s too late and the client may get stuck with a big, bad surprise. The CPM must regularly ask for updated projections and alternatives when it appears things are steering differently than originally planned. Further, the CPM must demand to hear the real information, not a watered down or less upsetting version. In short, the CPM must ensure they aren’t “handled” by the OSP while the OSP madly scrambles in the background trying to rectify matters.
Ensure an open connection to the service provider’s key leadership should problems or conflicts arise. When calling the OSP to fix a big mistake or account for their actions or decisions, the CPM and their management team must know who to deal with and interact directly. A clear and well-understood conflict escalation path—not necessarily in writing, although that’s a good idea—should always be established between the client and OSP. At a minimum, the CPM and client management team must know who to contact when issues arise. It is not enough to have access to the OSP project manager and team members. (They may be part of the problem and will undoubtedly have limited ability to make big decisions and accommodations.) The CPM needs access and at least occasional contact with the OSP’s decision makers and management team. A clear discussion should be had during the proposal review process, so the client understands how the OSP management team—not the sales team—will handle matters.
OSPs will make mistakes—it’s inevitable for larger scale and highly complex projects. These mistakes are sometimes due to carelessness or inexperience, for which the OSP should be called into account. More often, perhaps, mistakes in planning, execution, or budget projections occur simply because developing and manufacturing medical devices is complicated work (no one’s perfect). By keeping a close eye on the OSP, the CPM can reduce the chance of mistakes going unnoticed for too long, thereby reducing the client company’s risk to success. And this, ultimately, is the CPM’s primary motivation.
David C. Robson, a principal at Robson Advisors, has spent 30 years concentrating on the development of medical devices. Seventeen of those years were spent working for a full-service product development firm where he interacted with both large and small medical device companies and reviewed statements of work and requests for quotation, wrote proposals, and negotiated hundreds of work agreements. Robson and his partners now offer product development guidance and advocacy to early-stage medical device clients.
Client project managers (CPMs) are increasingly tasked with finding and managing outsourced service providers (OSPs). OSPs are specialists and often experts in their particular field. The best OSPs can significantly improve a client’s path to success in terms of risk reduction, improvement on project schedule, or perhaps even in the streamlining of regulatory compliance. Using these expert resources is commendable, but they must be monitored and managed differently than traditional internal resources even if they are co-located with the client’s team.
Managing OSPs requires a different kind of oversight. When a CPM runs a project using their fellow employees, the team shares the goal of the company’s well-being and future success. If the project isn’t successful, there’s the potential the company might not be viable and could risk each team member’s job. Although it’s not guaranteed that everyone will get along or be effective, the project manager’s role and oversight responsibility is relatively well understood.
The majority of OSPs are honest, ethical, hardworking, and well-intentioned people and organizations ready to sacrifice nights and weekends for the client’s benefit. There should always be a symbiotic and mutually beneficial relationship between the client and outsource companies. However, using OSPs adds complexity and potential conflicts of interest, which must be watched. This doesn’t mean constant paranoia, but the CPM should regularly double-check to ensure their company and OSP continue to align. The CPM must react immediately to misalignments so the program doesn’t derail.
Following are several objectives the CPM and client company’s senior management should regularly monitor. These areas of inquiry and monitoring apply to any outsourced effort or activity—design and development work, component supply, or manufacturing.
Ensure the OSP uses the best possible team members. The client is the customer and should be a savvy and somewhat picky shopper concerning human resources applied to their program. The CPM must always provide the best team to the project. Since much of the OSP’s work is done out of direct client sight, it’s harder to know if the “best” team is always used. Lower level or less critical project tasks can be effectively assigned to less experienced OSP team members, but for critical and expert level work the CPM and their team should be aware of the expert’s credentials and experience. They should also watch for a good chemistry/personality fit, especially considering close and long-term contact. Further, the CPM should overtly ask who is doing the work throughout the project, especially if clues surface that mistakes are being made or dates are being missed.
Ensure the service provider is aligned with goals and priorities. This falls squarely into a CPM’s routine, but it’s surprising how many client companies fall in the “I’m sure they’re doing the right thing” complacency trap. The CPM must check in with the OSP at least on a weekly basis to confirm all activity streams are moving forward according to plan. Subtle shifts in focus, deliverables, or date slips can indicate misalignment or misunderstanding. It’s better to be a little too worried than a little too laissez-faire.
Ensure the service provider’s expertise and capability. The CPM must regularly confirm the OSP’s capability beyond its individual team members. Sometimes client companies pick the wrong service provider who wins a project not quite in their wheelhouse. Unforeseeable circumstances may also change the project’s complexity or scale, rendering the OSP no longer the best choice. Perhaps an engineering OSP needs human factors inputs before pursuing a product configuration. The incumbent OSP will be inclined to “struggle through,” whereas the client might be better served finding another OSP. Here, the CPM will likely be one of the first to notice something is amiss. Mitigation steps can then be enacted or the work may need re-routing to another service provider.
Ensure the service provider uses the budget and schedule well. Money is always the “third rail” of relationships between a client company and OSPs. Ideally, a budget would be established initially and never dealt with again—unfortunately that’s not how the world works. The CPM and those responsible for budget oversight must regularly examine the OSP’s submitted hours and expenses. Minimally, the CPM should request a monthly summary of hours booked by individual team members, counts of units built versus plan or tests completed, or metrics providing insight into the OSP’s efficiency and diligence in budget management. Disciplined oversight and transparency will help both parties through unexpected budget adjustments, since the CPM will be confident that the OSP is being careful.
Ensure the service provider’s senior management is sufficiently involved in the program’s oversight. The client should expect excellent service and take steps to ensure it. Guaranteeing the OSP’s “bosses” are engaged will help. Regular contact and a familiar relationship with the OSP’s senior team keeps the project on their radar screen, and helps the OSP’s project team maintain focus by having an internal management champion.
Ensure the team constantly assesses and retires risk-to-success of the project and business proposition. Risk-to-success encompasses everything that may cause a project’s or company’s business objectives to potentially fail. Simply put, the product design has failed if business objectives aren’t met. The device must meet a myriad of criteria even if it is a great clinical solution. Many of these criteria may be in mutual opposition to the “best” solution for criterion like cost of goods. A delicate balance must be struck in order to ensure clinical outcome, technical function, cost of goods, regulatory acceptability, reimbursement considerations, capital expenditure, patent strength, usability, user acceptance, and so on. Especially in the project’s early stages, the CPM must guide the internal and OSP teams in identifying and retiring the biggest risks-to-success first. The OSP may not have the best perspective on all the risks in play or how best to balance them. The CPM must have a firm handle on everything, engaging the right people within the client organization to ensure balance is maintained.
Similarly, it’s easy for the client company and OSP to become blinded to the project’s big picture implications. There may be compromises made during product development or manufacturing process refinement impacting cost of goods or other critical success criteria. The OSP team is not as intimately connected to the client’s business objectives and strategic considerations. Seemingly harmless adjustments may have unintended consequences. The CPM must be particularly diligent in noting when changes occur and assessing their impact on business objectives.
Ensure plans for appropriate and proactive adjustments to work, scope, budget, or schedule are carried out. Expect changes to the plan for any but the simplest of projects. No Gantt chart or budget projection can truly capture all the contingencies, nor should they be expected to. If a schedule or budget covered everything, it would end up unacceptably expensive, long, and unnecessarily complicated. Rather, the CPM and their team attempts to plot a “Goldilocks” path—not too conservative or aggressive—and hopes to fall somewhere in the nominal. When using OSPs, the client team must be apprised of status on a regular basis and the CPM must establish a culture of proactive truth telling. A remotely working OSP makes it easy to miss or avoid addressing issues until it’s too late and the client may get stuck with a big, bad surprise. The CPM must regularly ask for updated projections and alternatives when it appears things are steering differently than originally planned. Further, the CPM must demand to hear the real information, not a watered down or less upsetting version. In short, the CPM must ensure they aren’t “handled” by the OSP while the OSP madly scrambles in the background trying to rectify matters.
Ensure an open connection to the service provider’s key leadership should problems or conflicts arise. When calling the OSP to fix a big mistake or account for their actions or decisions, the CPM and their management team must know who to deal with and interact directly. A clear and well-understood conflict escalation path—not necessarily in writing, although that’s a good idea—should always be established between the client and OSP. At a minimum, the CPM and client management team must know who to contact when issues arise. It is not enough to have access to the OSP project manager and team members. (They may be part of the problem and will undoubtedly have limited ability to make big decisions and accommodations.) The CPM needs access and at least occasional contact with the OSP’s decision makers and management team. A clear discussion should be had during the proposal review process, so the client understands how the OSP management team—not the sales team—will handle matters.
OSPs will make mistakes—it’s inevitable for larger scale and highly complex projects. These mistakes are sometimes due to carelessness or inexperience, for which the OSP should be called into account. More often, perhaps, mistakes in planning, execution, or budget projections occur simply because developing and manufacturing medical devices is complicated work (no one’s perfect). By keeping a close eye on the OSP, the CPM can reduce the chance of mistakes going unnoticed for too long, thereby reducing the client company’s risk to success. And this, ultimately, is the CPM’s primary motivation.
David C. Robson, a principal at Robson Advisors, has spent 30 years concentrating on the development of medical devices. Seventeen of those years were spent working for a full-service product development firm where he interacted with both large and small medical device companies and reviewed statements of work and requests for quotation, wrote proposals, and negotiated hundreds of work agreements. Robson and his partners now offer product development guidance and advocacy to early-stage medical device clients.
