Frequently Asked Questions

Q: How do I know if Devicix is right for my project?
A: The best way to find the answer is to give us a call. We can handle a wide range of projects, both in scale and breadth of technology. After discussing your needs we will prepare a project proposal that describes the best way we can help you. At your discretion we can also subcontract for additional services.

Sometimes we can’t match what a potential client needs. In these cases we tell you up-front and always try to help you find someone else. We’ve been in the medical device industry for a long time and have numerous contacts. For example, we don’t do ship testing of packaged products. But we were able to provide a caller with the applicable standards and refer them to three firms that perform testing.

Q: My company already has an engineering department. Why would I want to outsource my design?
A: There are a lot of good reasons to outsource. The most obvious is that your current engineering resources are not enough for this latest project. Even if your engineers are willing to take on the project you might want to consider outsourcing. Keeping your engineering team focused on their current assignments is one of the most proven ways to ensure that the schedule is met. Handing them a new project, before current projects are complete, risks inefficient multitasking and can cause resources to be devoted to the project that is most interesting, not necessarily the one that benefits your company.

Other major reasons companies outsource are: 1) to avoid taking on a large engineering staff for a single project of limited duration; 2) to know the exact cost of delivering a design in advance (many companies aren’t able to calculate internal NRE costs accurately); and 3) when there is substantial risk that the company may decide to cancel a project after technical risks are evaluated.

Q: Does Devicix manufacture products?
A: No, we do not manufacture. Our clients have said they want us to do design and help them to find the best manufacturer available. This assures our clients of top-notch designs that are not influenced by the manufacturing capabilities found “on the other side of the wall” in the same company. We commit to providing the best design that we can for each project. We will also make sure the product can be and is manufactured to your requirements. There are several ways to do this, including engineering builds of alpha level devices (generally a few complete devices, not prototypes, built by our engineers and technicians), providing “first article” service (by evaluating every detail of the first production products) and on-going engineering and analysis services.
Q: What is the most important first step in medical design?
A: Requirements. Documenting user and client requirements is the most important first step in any design project but particularly so in health care. Yes, we know many managers and engineers consider this “just paperwork” and a delay before the real work of design. Others find it just too dull or are too busy to spare time for requirements. But real world experience proves that by thoroughly defining requirements up-front results in higher quality, shorter time to market and lower overall cost. Working from proper requirements is so important that some of our clients set that as the entire first-phase deliverable of a project. This is your assurance that everyone understands what will be delivered and that the user needs will be satisfied.
Q: So, if requirements are so important, how do we write them?
A: Devicix wants to be a part of the requirements process with our clients. If you’re unfamiliar with design for a regulated environment we can guide you through the most efficient definitions procedure. Even if you’re familiar with detailing requirements we can understand your needs most quickly by participating in the process. Also, we often have technical suggestions that can be considered most effectively at the requirements stage.

There are several tested, step-by-step processes for creating and documenting requirements. We're experienced with most of them and can contribute materials, references and guidance. You can use any approach that works best as long as it results in requirements that are clear and measurable.

Q: Why do we want Devicix as a “partner”?
A: We say we want to “partner” with our clients because it is the best term to describe the relationship that we feel works best. When you work with Devicix you’ll deal with one of the partners: someone who owns the business and knows how important it is respond to your needs. When we work with you we answer your calls, we’re there when the design is being tested or reviewed, and we don’t see changes as an opportunity for extra profit. In short, we try to make your goals the same as ours.
Q: What kinds of work and payment arrangements are available?
A: We can be quite flexible in negotiating contracts. The majority of our projects are done on a time and materials basis with periodic billings based on hours and progress toward milestones. We provide an early project estimate followed by a detailed project plan based on the scope of the project. If your project needs to move quickly we may ask for an up-front deposit so that we can order parts and materials immediately. We typically do not do fixed bids. For most projects, the requirements are fine tuned during the design stage and it is almost a certainty that project scope will shift based on a wide range of factors. Factors could include a change in the competitive environment or uncovering a key requirement during early user testing. Here are some of the pros and cons of the contract types to the client:
Q: Can Devicix help provide funding for a project?
A: We can help, but Devicix does not invest cash in a client’s project. We will consider projects where some portion of the payment for our services is in the form of equity, royalties or licensing. We also have connections with the local venture capital community and can help you present your idea to them.

More than half of our clients are firms with unique, established quality systems. Quite reasonably, they expect us to adapt our activities and documentation to their systems. Placing our own ISO procedures on top of a client's system adds significant burden and can dramatically slow a project. Smaller clients, without existing quality systems, are too early in their business development to need ISO certified procedures and would obtain no benefit from the document retention, contract review and engineering change management imposed by a vendor.

Q: Does Devicix need to be ISO certified?
A: There is no real benefit for a design firm to be ISO certified. We follow the FDA Quality Systems Regulations (QSR), European EN regulations and all other design standards that apply for any region where your product will be manufactured or used. These requirements directly impact design quality. In contrast, much of the ISO guidelines define business practices and processes. Processes defined by QSR and ISO are driven by requirements to create not only the design but also testing and manufacture. These are important to manufacturers or service providers who must demonstrate that they reliably accomplish a procedure. In a creative process, such as device design, ISO procedures can be a hindrance without any payoff in quality.
Q: Why does Devicix offer IP support?
A: Factors related to intellectual property can make or break a project. Until a product is on the market the most visible method of assigning value is in patents and other IP protections. Devicix offers clients a thorough knowledge of the patent process. We know how to assist in capturing new IP, including ideas we have while working on your project. We can understand patent language to develop “design around” concepts. For individual inventors and small clients we can get you started with initial patent filings. For those with an existing portfolio and counsel we can communicate quickly and efficiently regarding factors that impact design alternatives.