As you develop a medical device, there will be moments it becomes apparent you need outside assistance.
Maybe you just started a company based on a groundbreaking idea or intellectual property, so you want an external partner to help you develop the core technology. Or perhaps you’re partway through developing a product only to realize you’re not fully addressing user needs or the associated FDA human factors engineering requirements, so you need an outside HFE expert.
No matter the crossroads you’re facing on your medical device design and development journey, MPE (Formerly Mindflow Design) can help.
A Service Structure That Begets Product Development Solutions
MPE (Formerly Mindflow Design) ’s offering is split into four service areas:
- Meaningful innovation
- Design and development
- Human factors engineering
- Manufacturing
These service areas cover every aspect of medical device design and development — all the way from a nebulous idea to a distributed product. What’s more, each of our engagements is customized to meet you where you are.
Select a single service a-la-carte or work with us from end to end. The choice is yours.
Ultimately, you will find a solution to your challenges here. It starts by choosing which service(s) is right for you.
1. Meaningful Innovation: Ideating Feasible Products
The term “innovation” has become watered down from excessive use in the business world. MPE (Formerly Mindflow Design) adopted the word “meaningful” to clarify that our service gets to the heart of what’s important. That is, remembering innovation is the lifeblood of companies in this competitive marketplace.
However, knowing how crucial innovation is doesn’t negate the difficulty of defining the right product. One that is worthy of the investment necessary to take it to market. That’s where the capabilities of our meaningful innovation service — developing core technology and defining clinical needs — come in.
Developing Core Technology
Developing core technology involves proving the science behind an idea your company has is feasible.
Our engineering team can help you develop your core technology. In some cases, we can even develop it on your behalf. This usually means working hand in hand with your clinical or subject matter experts to assure the science and clinical requirements are well understood. Then creating a proof of technology breadboard prototype and testing the feasibility of the proposed technology. Critically, all of this takes place before you pour funds into commercialization.
What if you don’t have a core technology in mind? All you know is you need a product like your competitors’ to fill a gap in your own offering. Perhaps the patent landscape for that type of product is overly crowded and an IP barrier exists. MPE (Formerly Mindflow Design) ’s engineers can work to create a core technology with a path through the patent minefield.
Defining Clinical Needs
What good is a core technology if it doesn’t — or can’t — work in application? If you’re looking to develop a core technology and transform it into a usable product with high market adoption, it must have the potential to meet patient and/or clinician needs.
For example, a technology prototype the size of a small automobile may prove clinical efficacy is feasible. But if the user needs and hospital use-case requires a portable device used by nurses during rounds, the technology is not feasible.
In sum: A clinical need can’t be met without the appropriate technology solution, and a technology isn’t useful unless it solves a tangible clinical problem and meets user needs.
Our team will conduct research to help ascertain whether a concept or existing technology meets the clinical needs and use-case requirements.
2. Design and Development: Crafting User-Friendly Medical Devices
MPE (Formerly Mindflow Design) can parachute into your project at any time. So if you didn’t utilize our meaningful innovation service, you can select any or all of the capabilities within our design and development service.
These capabilities include:
- Applied design research and strategy
- Industrial design
- Digital interface design
- Engineering
And if you did work with us to prove the feasibility of your core technology, we can now convert that technology into a scalable, market-ready solution with the capabilities our design and development service offer.
These design and development capabilities also include human factors engineering, IFU design and labeling as a part of our comprehensive design and development service or as an individual human factors engineering service as described below.
No matter which of our design and development capabilities you need, they all exist to reduce risk, accelerate time to market, and achieve market success.
Applied Design Research and Strategy
Defining clinical needs and developing core technologies requires high-level research. Applied design research and strategy takes it a step further. Together, we’ll look “under the microscope” to extract meaning from user needs that inform tangible product requirements.
The endpoints of this capability are product requirements and a defined plan to get your company through all of the design and development activities necessary to create your product successfully.
Industrial Design
When it comes to industrial design, our multidisciplinary creative team works like master chefs. They combine three ingredients — business objectives, technology targets, and stakeholder needs, to achieve the very best outcome. Our proprietary Guideway Design and Development process also helps the team to arrive at the optimal outcome.
The key deliverables for this capability are typically a design intent specification and concept prototype.
Digital Interface Design
Digital (aka UX/UI) interface design refers to crafting the graphical user interface (GUI) for your medical device. It’s paramount to partner with medical device specialists for this service.
Why?
Because safety and effectiveness are critical when designing a medical GUI. But they’re not always top of mind within other industries. After all, if an eCommerce website makes it difficult to place an order, the outcome may result in a disappointed or lost customer. If a similar difficulty presents itself to a medical GUI user, the outcome can seriously harm that person.
Engineering
When medical devices are involved, engineering is so much more than a single person doing engineering calculations or working in CAD. It mandates a mastery of FDA regulations as well as the processes, requirements, and standards unique to the healthcare industry.
Our engineering team possesses this expertise. They’ll follow the design controls process and merge the core technology with the design intent output to ultimately create engineering specs suitable for mass production.
3. Human Factors Engineering: Ensuring Product Compliance and Ease of Use
Compliance and testing are so important to the medical device development process that we offer human factors engineering as a part of our design and development service or separately, as previously noted.
Let us lead your entire human factors and usability program. We will:
- Define user needs for safe and effective use.
- Ensure user delight for product adoption.
- Evaluate whether your design aligns with inputs and requirements.
- Validate that your product and specs meet user needs.
- Assure regulatory compliance.
- Adhere to IEC 62366, ISO 14971, and all additional usability related standards.
- Mitigate safety and business risks.
- Assure regulatory submission readiness.
At the end of your human factors engineering engagement with MPE (Formerly Mindflow Design) , you’ll have everything you need in your usability engineering file for a compliant FDA submission. We will walk you through everything — from formative and summative testing to IFU development and labeling.
4. Manufacturing: Taking Medical Products to Realization and Beyond
Manufacturing and supply chain challenges are often our clients’ greatest hurdle on the path to product realization. But that doesn’t have to be the case.
In 2021, MPE (Formerly Mindflow Design) was acquired by MPE, Inc., a 40-year-old medical device contract manufacturer. This combination of expertise now allows us to offer complete, scalable product realization services — our “Concept to Completion” model — under one roof.
We oversee the transfer of a design specification package into manufacturing, conduct high mix/low volume production, manage inventory, and ship your product directly to your customers as needed.
Already have your own manufacturer? That works, too. We strive to meet you where you are. Our development team can instead create and seamlessly transfer your design specification package to your manufacturer on your behalf. This ensures your product is never “thrown over the fence.”
Your Customized Medical Device Development Plan Awaits
As you’re reviewing our service areas and deciding which might be right to solve your medical device development challenges, please reach out to us with questions.
And remember: Whether you engage with MPE (Formerly Mindflow Design) for each of our four services, just one, or a combination, our team is here to support you on your journey to a user-approved, saleable product.