canstockphoto21149339 medical device developmentInnovative medical device development is challenging and often accompanied by worries about efficiency of the work, timeline and cost.
I have worked both as a Project Manager for a client purchasing engineering and IT services and as a Project Manager for a vendor of medical device development services. Over the years, I have noticed a gap between the respective perceptions of client and vendor with respect to design activities, work progress and deliverables.
This blog analyses gaps based on the traditional project management parameters of cost, timeline, quality, and communication and offers suggestions to close them.

1. Cost – wow, so expensive!

Other than health itself, there is nothing more valued than money. As a client, you constantly worry if you will have enough funds to finish the project. It took so much effort to raise that capital that you want to spend it wisely and frugally. You worry about unnecessary expenses and being over-charged for the actual work done.

The vendor, on the other hand, estimates the total project cost from concept to transfer to manufacturing and figures out what to prioritize in the design cycle without jeopardizing functionality and industrial design. The first step is to accurately capture the business requirements so that the design efforts are aligned with device realization objective. Focused effort is placed on scientific calculations, simulations and 3D models. Sometimes the only deliverable possible within budget is the proof of principle. That in itself is essential as it proves that the technology actually works!

The front end development work is expensive because it addresses technical risks and uncertainties. It is also the most important investment of time as the team builds the foundation of the technology– the innovation that requires design adjustment, tolerance, fit, in order to lead to precision and performance.

One way to manage costs and cash flow is to have an open dialogue with the Project Manager and decide on a Honda Civic or a Lamborghini approach before proceeding…

2. Timeline – are we done yet?

Time is money. Clients want to reach the market as soon as possible in order to be first and claim a segment of the market. At times however, they may need to pause product development activities, particularly when dealing with organizational structure, financing, regulatory issues such as the need to deploy a quality assurance program. There is usually an expectation that one can resume design activities when ready.

The vendor needs to prioritize and commit resources to the project. Once assigned, engineers and designers educate themselves about the relevant clinical claims of the device and gather other contextual requirements in order to develop the right technology. Once initiated, the creative team has lots of momentum and gets deep into technical problem solving. Passionate about their work, they can continue to refine their design for a significant period of time. Pausing their efforts may lead to them being re-assigned on a different project as they are often the specialists in a particular medical physics area such micro-fluidics, lasers, or ultrasound that is required by multiple projects.

Time blocking is probably the best approach to managing the timeline. Agree with the Project Manager to have regular design meetings and limit effort on a particular aspect of the design. This will provide you with a time structure that you can start/stop at will.

3. Quality and Value – can the design be changed again?

Are you, the client, seeing the same quality in the deliverable as the vendor? Unlikely. Does it feel like the design is falling short in user interface, surface finish, form or medical aesthetics? Clients are trying to get the most marketable medical device and worry constantly that they will not achieve business objectives.

The vendor goes through several design iterations before reaching desired functionality, build logic, and targeted industrial design. Certified ISO 13485 project teams have to follow a rigorous design process that ensures reliability, repeat-ability, and workflow optimization.

The key to success is to work collaboratively to develop design requirements and specifications. Once signed off, these requirements become the starting and finishing points of the design and development cycle. There is an impressive amount of subjectivity when it comes to design details, such as contour lines and surface finish, and design updates can go on for a long time. At some point, you may want to discuss with the Project Manager when the design is “done, done”.



 

4. Communication – where are we at?

You may need to be informed at each step of the product development cycle, or you may be satisfied with a regular bi-monthly progress report. Clients may also have to report to a board of directors or financing advisors. They want to make sure that the design being implemented will align with their medical device vision. These clients clearly outline the business requirements and become involved in a lot of design decisions.

The vendor is trying to achieve a balance between “productive” time used to design, build, and test, and “information sharing” time for the purpose of providing progress reports. The vendor is also trying to reach the right balance in communicating risks so that there is no surprise if a risk materializes into an actual issue with cost or timeline impact.

The level of information one needs varies from business to business, and individual to individual; there is no right level of communication. Clients need to be able to answer where the design is at when asked by stakeholders and at the same time, they need to focus on growing their business. Know your information and communication needs and discuss them with the Project Manager in order to reach that right balance.

How do you close the gap between your expectations as a client and the vendor’s deliverables?

Start with healthy two-way communication and systematically address points of importance and priorities with the Project Manager. This will ensure the design team effort is well aligned with targeted budget, timeline and quality. There is no denying that designing and building a medical device is a challenging and complex endeavour. Minimizing surprises, controlling costs and setting time blocks will make it easier for all.

Once you see the design team slowly delivering impressive performing technology, you will gain confidence in its ability and will start enjoying this ever evolving journey.

Martine Janicki, PhD, PEng, PMP is Project Manager for IHealth and a former StarFish Medical PMO.  In addition to providing blog contributions, her project management systems and philosophies guide our project managers in product definition and development. 


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