A key factor in selecting an outsource medical device development firm is transparency of data and information. From billing to IP assignment to day-to-day operations, how can you know if you will experience the level of transparency you need to appropriately manage your project?
Here are four questions you should ask… and why these are important questions to ask any firm you consider:
1) How do you track time & materials? How often will I receive information about how my project is progressing against budget?
Time & material tracking can be handled by automated systems that offer immediate, detailed information at any time requested. Each employee logs their hours in a time tracking software as they start and stop on activities all day long for a client. All information is collected in real time and reported out at regular weekly or bi-weekly meetings. But at any moment you can request a detailed report of how much time and how many materials have been allocated for your project to date. If you are getting close on funding, this is an invaluable tool for tracking to budget.
2) How do you assign IP for your clients’ projects? How many patents does your company hold?
At REV.1 Engineering, IP is always assigned to the clients. Often contract engineering or contract manufacturing companies hold their own patents and will try to incorporate those into your design, in order to license it back to your company. These “royalities” are often in addition to what you are already paying. Be sure the company you choose for outsourcing R&D has no competing patents that they will try to convince you to buy or license. While individual inventors of a firm might have their name on a patent for legal reasons, the company itself should not hold any patents, and if they do, ask for details before awarding a contract.
3) What is the experience level of your staff? How much of the work on my project will be done by junior level staffers or by subcontractors? Who will I talk to about my project day-to-day?
Utilizing full-time, experienced and seasoned engineers with many years of specific medical device development experience will bring you the best and fastest results. While you might expect cost savings with less experienced staff, in fact they need more oversight, and you end up getting charged for two resources rather than one. In a smaller, flatter organization, your medical device benefits from deep experience in a wide range of development projects. The project plan should spell out exactly how your R&D team will be staffed at various points, as the staffing needs wax and wane. It’s also important to understand the company’s built-in redundancy and how your project will be covered in case of unexpected illness or emergencies.
4) What happens when something goes wrong?
Medical device development is a complicated process, and things often go wrong – or if not wrong, in unexpected directions. The corporate culture should be to elevate, not hide, problems. Any issue that arises should be put in front of the whole team, including you, the client, to review the situation in detail. Your R&D firm should take a consultative stance and recommend the various options for solving the problem, such as adding more resources or taking a different design path. You can’t solve a problem you don’t know about, and your outsource development firm should always involve you in the solution.
If you are looking for “no surprises” medical device development, look no further than REV.1 Engineering. Our philosophy includes building a project network before work begins and reviewing that network of time, labor, resources, and hourly rates with our clients. We then negotiate any line items the client thinks might be over- or under-allocated and provide a “best case” to “likely case” range of costs. Then, as the project progresses, we report against budget in every regular weekly or bi-weekly meeting.
REV.1 Engineering also holds no IP and believes that if you are paying us to work on your ideas, you own the patent. This makes our relationship with you very clear legally and easy to manage.
Our team of full-time, expert engineers with deep medical device development experience are eager to get started on your project. Give us a call at call at 951.696.3933, we look forward to an exploratory conversation with you.
Eric & Phil