Project planning and Management
Project planning and Management
Complex opto-electro-mechanical medical device design and development can be very difficult, very expensive and can take what seems like an inordinate amount of time to the uninitiated. This is because the optical engineering in the project is itself generally more expensive with more unknowns than the other engineering tasks, optical parts can often take 2 – 3 months to obtain (as they are rarely stock items), and optical design iteration cycles are measured in quarters, not weeks. Depending on the complexity of the design, two or three design iterations may be necessary to achieve the concept phase marketing specifications or design inputs. The cost of optical components is very often much higher than one might anticipate from just looking at a print for the part, and there are a limited number of reliable, high-quality suppliers.
The team size and composition, hierarchies, development and production costs, timelines and logistics of optically-based medical device development (therapeutics and diagnostics) are quite different to their more established mechanical and electro-mechanical counterparts. It is absolutely possible to get a substantial way into a project with a fundamentally flawed design, especially if the R&D project managers or lead designers of the devices are not aware of the idiosyncrasies of optical engineering. The engineering effort to that point can be wasted; any expensive, long-lead-time tooling or T&M equipment purchased, for example for injection molded optics, can be rendered worthless. The testing regimen required to take a complex opto-electronic device to market is also quite different to that of a mechanical device. Many external standards come into play, for example IEC 60601, 60825, 62304, ANSI Z136, complex human factors analysis, etc.
Companies embarking on complex optical / electronic projects should expect to encounter these idiosyncrasies and plan for them. All the companies we’ve worked for where these concerns were ignored or glossed over have failed, some of them expensively. We can analyze for these situations beforehand and advise on potential problems, schedule challenges, opportunities for COGs reduction, etc. We can advise on preparing realistic schedules and budgets, make suggestions for reliable OEM sources of components, scale-up options, etc.
Business Models
Business Models
Companies embarking on optical development projects can also easily arrive at the marketplace with capital equipment, UIs and HIDs that are essentially unchanged from those used in the clinical trials, with no attempt to cost-reduce the device or make it more robust. This often happens because the initial development took longer and was more costly than expected, leading to a cash and time crunch and a need to get to market quickly with whatever has survived the development process phase gates, and with no attempt to solidify the supply chain.
This is a critical mistake, especially in a price-sensitive capital-equipment-plus-disposables scenario or where the COGs of the enabling capital is so high that it cannot be priced into a reasonable razor-plus-razorblade business model. This leads to a need to sell the hardware at less than FBCOGs break-even, or even place the hardware to generate disposables revenue, creating a huge up-front loss and an installed base with enormous inherent warranty and out-of-warranty liabilities having not been through a cost reduction and DFM, Design-For-Service process.
Design Reviews
Design Reviews
Coming soon!
UI Mockups and Surgical Work Flow
UI Mockups and Surgical Work Flow
Coming soon!
IP – Ideation, creation and review
IP – Ideation, creation and review
Coming soon!