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Irvine Medical Device Development: The Choice Is Yours

Irvine, California Great Park: Palm Court

You’re located in Irvine and you have sketched out a great new medical device idea. Maybe you are a start-up, but more than likely you have an established company and your current R&D team simply doesn’t have the band-width or special skills needed to bring your idea to life.

Selecting a medical device engineering team to work with your existing Irvine team may seem daunting – but look no further than Murrieta, where REV.1 Engineering is ready to jump in and move your medical device development forward at hyperspeed.

You already realize that the selection of your R&D team will make or break your medical device development project. We continually encounter clients in Irvine and across Southern California who think the safest move is to go with the lowest bidder.

Hidden Costs of the Low Price Bid

First, an adversarial mind-set is inherent in fixed-rate bidding. Who will lose out on the deal – the client or the contractor? While the contractor strives to spend as little time on the project as possible… your goal is to achieve as much as possible, as quickly as possible. And what gets lost in this transaction? Speed, innovation, and quality. Don’t add the stress, time and money this type of relationship costs – worst case scenario, you end up in court and are back at square one with your medical device project.

Second, think about your product development requirements. If your product is already thoroughly thought out – perhaps you’ve created many similar devices in the past, or you just need a small modification to an existing product – then your requirements might be crystal clear. Typically, this isn’t the case. As the product becomes more intricate, one of two things happens: 1) the contractor balks at the unexpected difficulties and your deadlines shift further into the future; or 2) each change becomes a tacked on cost because it “wasn’t included in the requirements” and an enormous amount of time is spent renegotiating the original contract – and the cost benefit of your low fixed rate bid is nil.

Third, innovation suffers, as a fixed rate imposes time constraints. It’s a lot cheaper to develop what you know – what you’ve developed before, in the same way you’ve developed it. Your novel idea is ground into a medical device development assembly line, and many opportunities for a true breakthrough are missed because the contractor’s focus is to spend as little time as possible on your project.

If you have a product destined to bring something new to the industry, the R&D process for medical devices is inherently complex. It takes time to invent and refine novel devices, and it’s not possible to come up with a fixed rate bid that “expects the unexpected” and places a premium on innovation. As soon as a fixed-rate contractor realizes the development path is more difficult than they anticipated – and that they will make little or no money – they lose interest in your project.

The Perils of Contract Manufacturing

Another type of development that your Irvine company may be contemplating is contract manufacturing. Understand that a manufacturer is far more interested in manufacturing your product than they are in developing your medical device. In fact, medical device development is often not their top skill-set.
In addition, to meet quality regulations, you have to have a spec developer. A contract manufacturer will require spec development be turned over to them – and now you find yourself no longer the true owner of your device. If you find the development lacking and need to move, it can be very difficult to extract the work done to date. And if you need to move to a different manufacturer, that can be equally difficult.

When a contract manufacturer also develops your medical device, they are responsible for everything related to regulatory control. And if you don’t have access to that, you no longer own your device. In an extreme case, our client wanted to move their development to us, and they were literally locked out of the building, the work they’d paid for to date held hostage, and we had to negotiate essentially a “ransom” to retrieve the documentation. (Click here to read more about contract manufacturing and product ownership.)

So if you feel drawn to a low fixed rate bid, or a contract manufacturer offers cut rate or “free” development if you promise them the manufacturing work, consider these hidden costs. If you have an exciting, new, and novel project, find out what an experienced team like REV.1 Engineering in Murrieta can deliver. We bid based on a range of time and costs, which can be calculated using the proper project management tools and methodology. Within this range, there is allowance made for speeding up the project or making agreed-upon improvements. You are in total control and you don’t lose the most important aspect of any project… time.

When your Irvine-based company works with REV.1 Engineering’s outsourced medical device product development, you hold the cards. REV.1 is your R&D team, and you are the spec developer of record. Our development goal is always creating the best product, not a product that can be put together quickly or that fits within certain manufacturing capabilities.

Get in touch today with your Southern California neighbor REV.1 Engineering in Murrieta. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at info@rev1engineering.com and arrange a visit. We look forward to working with you in Irvine to move your project forward  2x Faster.