Medical Device Evaluation: Fill & Download for Free

As a Neurologist, the key simple medical device was the safety pin:Useful for multiple examination procedures:Babinski testsSpinal sensory level testsDepth of coma evaluationRoutine sensory testing of pain modalityHigher cortical function tests (e.g., cortical proprioception – distinguish from a similarly sized paper clip with eyes closed)Peripheral neuropathy assessmentEvaluation of spinal root radiculopathiesEtc.

All engineers need to be aware of risk management and the tools that are used, but we don't often need someone with that label. Generally, in most organizations risk management would fall under Quality Engineering.For example, the medical device industry takes risk seriously, as there are defined procedures to mitigate device risk. Here is one example:Risk Management - Sterling Medical DevicesHere is a quote from their website:“ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and management. This standard helps guide the process for medical device manufacturers to ensure that the product is safe. Sterling’s experts can provide companies with support and documents needed for the ISO 14971 application”Please note that both ISO 9000 and ISO 13485 have requirements for quality management (such as a quality manual) but most startups are not going to try to get ISO 9000 certified. Here are some other websites of interest that explain medical device risk:https://www.orielstat.com/blog/iso-14971-basics-explained/Understanding ISO 14971 Medical Device Risk ManagementBut again, risk management depends on you market. I already addressed medical, but someone who create as aerospace startup would have to manage risk as well, especially if their services include manned aircraft in any way. A few year ago I designed a microphone amplifier so older mic could be used in new aircraft, and even though our customer managed the certification process, it was quite eve-opening as it was my first exposure to FAA requirements, as opposed to FDA.One caution concerning moving into an entirely new industry is you “don't know what you don't know,” so its advisable to have someone on your team that has relevant industry experience. In many cases it’s great to have an outsider’s view of an industry to offer some healthy “disruption,” but the last thing you want is a ground breaking new technology to be being slapped down because you didn’t consider something obvious to an industry veteran.I did not address risk from a project perspective. From a project point of view, we look at risk as items that cause a project fail to meet scope, schedule or budget (in the strictest sense some risks can have a postive outcome, but we will limit risk here to negative consequences)The main tool is a risk register, which is maintained byb the project manager.Guide to Using a Risk Register (Example Included) - ProjectManager.comThe idea is to identify anything that can impact the project, assign it a priority (through qualititive risk analysis) and then determine a countermeasure (or more) if it occurs.This would be part of your overall project plan, but keep in mind it is also a living document.Traditionally, many companies in regulated markets perform the first form of risk management quite well. Its the second for I listed that can be a hard sell.Here are a few Risk Management Dilberts. Hang them in you cube at your own peril!

I think you have a misconception about the VC investment process.VCs invest in companies and the companies are responsible for their own R&D. The VCs actually invest in these companies because of their proprietary R&D capabilities. The companies may outsource some product development work but the core product development happens at the company.Let’s use a VC that specializes in investments into medical device companies as an example. The VC looks for entrepreneurs who are developing medical devices. The VC evaluates hundreds of potential investments into medical device companies and picks a few a year to invest into. The VC is looking for a medical device idea that tackles a big problem in a unique way that is less expensive than the current methodologies and perhaps also more efficacious. The idea also needs to be grounded in defensible intellectual property and have a team capable of executing on the business plan. It wouldn’t be unusual for a medical device company to use a design firm to help optimize the product design but the core IP of the product would come from the company, not a design or R&D firm.A VC firm generally does not come up with its own idea and hire R&D experts to develop the idea. VCs invest in companies that have their own R&D capabilities.VCs could potentially use a relationship with an R&D firm to help conduct due diligence on a company they are evaluating. However, the ideas the VC is evaluating, even when they invest in a particular sector, are so specific that the VC would generally look for diligence help if needed with someone with that specific expertise. The needed expertise would change from deal to deal.I wouldn’t think a VC would look to a parnerahip with a specific R&D firm.