Moving Your Concept Past The FDA Requires Documentation

There is always a market for innovative medical equipment that advances healthcare, no matter how small the application. Maybe you have an idea that would improve an already existing device or a diagnostic apparatus that would revolutionize the patient experience. If you’re ready to transform your idea into a tangible product, you are at the beginning of possibly a long and sometimes complicated process of acquiring regulatory approval. Documenting every step of the way in a design history file (DHF) is an essential part of creating a new product that will meet with regulatory requirements.

What Is a Design History File?

The DHF is required by the U.S. Food and Drug Administration (FDA). It is a document that details every step of the development process and their guidelines are laid out in this FDA Code Title 21, section 820.30. The FDA requires this document to verify that you and your team’s methods fall in line with regulations for every component of the design control process, which includes the following:

  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

This recording process should generate a veritable mountain of documentation that is compiled into the DHF. The final file should be gathered into one document, that should also include an index for the researcher to follow easily.

How Will It Enhance the Development Process?

As a medical device designer, we know how complex the development process can be for most inventors. A DHF will help you keep everything organized. Knowing that this thorough documentation is required will remind you to keep meticulous notes. These notes can help to overcome obstacles that arise future along in the process by allowing you to backtrack and make adjustments where needed. Also, as you prepare to submit your medical device to the FDA, you can use the DHF to double check your methods. While the FDA requires this file for their own work, it is equally useful on your end.

How Will It Help Meet FDA Requirements?

When the FDA reviews your device, a lead reviewer follows and acceptance checklist that is very comprehensive and includes a review of the digital history file. An agent will review your DHF to make sure your product design & development process was properly documented and every medical device designer involved complied with applicable regulations. One of the main reasons for developing history files is to ensure that product designers for healthcare devices follow a strict code of ethics and product safety is of paramount importance during the engineering design process.

How To Design With Digital in Mind

Today’s consumers have higher expectations of products’ capabilities than ever before. With the fast growth of smart technology, everyday appliances can now perform some pretty amazing tasks, making the ease and convenience once relegated to science fiction a reality available to millions.

With new features come new difficulties.Due to their increased complexity, connected devices must be designed differently than their low-tech predecessors. There are several factors that can influence the user experience that a connected device designer should keep in mind.

Does the Interface Match the User’s Abilities?

During product design and development, the primary focus should be on the intended use and the potential users. Is this meant to be operated by someone with specialized knowledge and previous experience with similar devices? Or is this meant to be utilized by anyone, with no or minimal training required?A new product design engineer familiar with a product’s purpose should first seek to understand the intended users’ technological literacy and plan accordingly.

Does the Design Take Mental Models Into Account?

When confronted with a new technology, people generally try to make sense of the novelty by relying on their history with items similar in form or function. For example, users unfamiliar with a touch screen may double tap a word to highlight it based on their experience double clicking with a mouse.

An IoT product designer can also increase ease of use by utilizing organizational methods that most people easily recognize. Familiar ways of arranging information include:

  • Lists
  • Menus
  • Branching systems
  • Charts and tables

Users are more likely to be comfortable using a product if they can easily navigate the system provided. Asking consumers to learn new methods of organizing information may be asking too much if they just want to do something as simple as checking today’s forecast.

Does the Design Overwhelm the User?

Just because a product can do a lot doesn’t mean your design needs to showcase it all at once. An interface needs to be clean and concise to help users get the most out of their experience in the simplest way possible. Thoughtful design can facilitate ease of use with even the most complicated devices.

As connected devices become more commonplace, the role of an IoT engineer can prove vital to product design & development companies. These innovations not only promise convenience to the average consumer, but practical solutions to businesses and organizations. A connected device designer can contribute to quality of life by creating quality interfaces that allow both expert users and regular people to access the newest technology.

Launching a Medical Startup? Getting Help for Your Product Growth and Design

Working on a startup business of any kind can hold several daunting challenges, including the need for proper funding and expertise to get things rolling. There are likely to be some bumps along the road. When it comes to medical startups, the need for expertise on your team is much greater. Many of the medical devices in development today are taking advantage of sensor technology, cloud-based data communications and application development. So one of the major obstacles to overcome is a decision on whom should be doing the design and development of your product. It is usually a wise choice to consider hiring a professional that are experienced in launching successful medical devices in recent years for the design and development phases.

Tasks to Complete Before Outsourcing:

There are numerous factors one should fine-tune before outsourcing product development:

1. Do your research. If you are an entrepreneur that is partnered with a Chief Medical Officer, together it’s important to understand the processes involved in the advancement and protection of your technology. Such as patents, non-disclosure agreements, and a short list of potential product design partners.

2. Review the product for proper qualifications. Investigate if there is a legitimate need for your product and see if other products currently on the market provide the same solution as your concept. Is the tech available or is there a need for technology development?

3. Know the terms of agreement. Begin interviewing potential design partners and get all the details of ownership and other rights regarding your product and its design organized. Be sure you’re comfortable with these terms before entering into any partnership.

4. Define your objectives.Presenting refined and distinct goals for your product and business venture is likely to be an imperative step in this process.

Benefits of Outsourcing Product Development

One big concern startup owners have is control and ownership of technology, designs and intellectual property. We recommend not signing over your rights and developing a win – win scenario linked to a successful launch. There can be some clear advantages to involving a professional design firm and / or a Chief Medical Officer, as they often have some experience and insights that you may not have. Although the concept or idea may be unique to you, it is wise to know your limitations and accept the expertise of others once your common goals are aligned.Here are some of the most apparent benefits to contracting the Product Development help you need.

  • Save costs in the long and short term
  • Rapidly apply new technologies
  • You can stay focused on your core business
  • Mitigate risk
  • Shorter time-to-market
  • More efficient development

Working with an outsourcing partner can have its challenges, and the keyword to focus on here is “partner”. It’s important to remember that when you hire a medical device development firm, the company you work with now shares interest in the success of your startup’s endeavors. This is the top reason why getting a professional engineering design services on board is so beneficial.

While you are focused on core business initiatives, legal aspects, funding and product marketing, the medical product design experts are focused on mechanical engineering, technology development, functionality and testing phases. Be careful on selecting potential contractors and what they’re offering before signing on for their help.There are some unsavory types that count on startup entrepreneurs being too busy to read the fine print. We will encourage you to read the fine print and get a patent lawyer on your team when you are ready for that.

Definitive Design offers medical design engineering expertise for doctors, medical technicians and forward-thinking healthcare professionals with an idea that is unique and solves healthcare problems. We encourage entrepreneurs to leverage our experience and skills in the area of medical devices and wearable healthcare technology.

Making the Jump to Smart Product Design

Across many industries, the market of everyday consumer products is being transformed by the rise of the Internet of Things (IoT), both on the customer side via new functionality and on the manufacturer side with new insight into customers’ responses to products. Data – collection, processing and transmitting – is where value is found. Amidst the changing market, product development companies have to learn how to make the most out of what smart products allow, while competitors race to do the same. There are a few fundamental aspects to smart products that designers face when transitioning into smart products and services.

What Smart Products Look Like

The capacity to handle data is at the heart of what makes a product “smart” – smart products communicate. This is a broader definition than what many people will likely think of, though. Customers understand “smart”as wearables or home automation systems, but early models of smart integration typically start with gathering feedback on product use. Smart product designers should become familiar with three major components to these technologies:

  • The physical component of the product, already extant but potentially in need of new manufacturing processes;
  • The smart component, which gives the product a virtual “presence”, ranging from QR codes to fully embedded interfaces;
  • The means of connectivity, wired or wireless, between the product and the manufacturer or customer.

Challenges of Smart Business Models

Making a product smart requires significant changes in development resources and allocation of funds, with some of the key issues being outside the normal domain of a product design engineer. The smart components added to the product are not purely physical but will also include software apps running on the product or alongside it (e.g. a mobile app that connects to a device or readsaIR tag). Connectivity must also be maintained with 24/7 support; a failure of manufacturer-side infrastructure can potentially interrupt or disable customers’ use of the product, especially as subscription-based models become more common within the IoT space.

The Projected Future of the Market

Predicting what the market will look like as smart products proliferate is difficult, but a few points are certain. Existing 20th century models of industry will swiftly need to be revamped or abandoned to account for digital connections. Product development companies will thrive by engaging with customers and establishing ways to gather insights on user needs and expectations so that your smart product designer can implement improvements that can be pushed out during software updates. Experimentation is critical as well, finding ways in which smart connectivity can further enhance user experience and exploring new business models both internally and in the customer-manufacturer relationship. The main takeaway should be this: pay close attention to developments in smart technology and the IoT and be ready to act.

IoT Circuit Board Design Is Hot Right Now

26The Internet of Things (IoT) has presented a world where the digital and physical worlds can truly live together. It’s no surprise that more companies are interested in providing connected devices that take advantage of this change in the technology landscape. For startups and manufacturers, this means being on the cutting edge of new technology.

Changes in Printed Circuit Boards

It’s even more crucial to be aware of changes if you outsource your work to an electrical engineer. You want to be sure that you have the newest techniques available and some engineers my be working with yesterday’s technology. PCBs are constantly evolving, becoming smaller and providing more features. Having an idea of what is happening lets you focus on finding the right IoT design engineers for your specific needs.

IoT Design Requirements

When you are embarking on product development for wearable tech devices, you need to be aware of what to put your focus on. There are a few different things to be aware of and we encourage you to prioritize steps with your electrical engineer.

  • Security – As more devices become connected to the digital landscape, it’s crucial that security is sufficient to block any threats. It is becoming more common for security through software to be considered insufficient for this purpose. Hardware-based security methods are often a better option. Perhaps a combination hardware with software security options.
  • Battery Life – Unlike many other devices, IoT products are constantly communicating with a network. This means that having an extended battery life is a must. Some of the things an electrical engineer for IoT devices can do is to optimize power consumption during design and to analyze the integrity of the power source.
  • Flexibility – The majority of applications for IoT are small in size and need to be flexible. This is important due to the size of most devices being designed today. HDI and rigid-flex are two of the ways IoT design engineers can meet your needs on a physical basis.
  • High Standards – Industry standards continue to become more restrictive as more consumers delve into the world of IoT devices. Your electrical engineer should be on top of any new standardization and willing to embrace that sort of challenge.

Making Your IoT Devices Work in Harmony

Your electrical engineer for IoT devices should be forward thinking with a complete understanding of the ways IoT design is changing the way people interact with connected devices and cloud based applications. When you contract with an engineer or designer for your new product, consider the above list first. Having trouble finding a IoT design engineer that is forward thinking? Give Definitive Design a call today and perhaps we can help you get started.

Great Resources for Generating New Product Ideas

Did you know that your most lucrative and sustainable resource for designing new products is right in front of you? The key finding new ideas for a new product is listening to your customers, frustrated consumers and patients that use various medical devices to monitor activity. In today’s world, the traditional wisdom that says product development should only be an internal process is moot. Customers and consumers you interact with are more connected and engaged than ever, and people love to share details about what frustrates them most about a particular product. Often the best ideas come from solving common problems.

But how can you use online research communities to generate new ideas? Inviting your customers to be a part of your product development team can be an eye opening experience. Here’s how you can leverage your customers insights to come up with new consumer product design ideas.

Determine What Problem You Should Solve

The first step to any product development project, whether your goal is to design medical devices or a home improvement tool, is to figure out what your customers value or what problem with an existing product they are challenged with. Your customer base can help you identify what opportunities you should capitalize on or what problem you should solve. Before you attempt to come up with an idea, make sure your direction is relevant to what your customers want.

Your goal should be to get your customers to validate the direction your solutionis providing. If your customers encourage you to solve a specific problem, chances are that others may have similar challenges with that product. You can listen to your customers’ ideas by reading online reviews about a product, conducting research surveys in Facebook or a crowdsourcing app, or interviewing some customers.

Generate, Analyze, and Synthesize an Idea

Many people today are connected digitally with like-minded affinity groups.How big is that pool of people that can benefit from the new idea you are considering?Conduct customer research by strategically formulating your questions and sharing them in a controlled way without giving too much information about your idea away. Ask open ended questions like, “How would you like to see this item perform?” and then digest and evaluate the answers you get back. “What If…” questions help you fine tune your concepts.

Our consumer product design company has been able to help clients flesh out new features to existing product lines just by buying lunch for the employees one day and whiteboarding what comes out of the team’s imagination. A customer’s workforce is a treasure trove of new ideas if you know how to tap into their creativity. The patients of a clinical practice are also a great resource on how you may want to improve the design of medical devices that were used by them. That is a harder audience to tap as a group due to HIPPA and privacy laws but consulting with them one on one with a trusted clinician can be very beneficial. Product design consulting requires us to be open minded when seeking new ideas we may wish to bring to market.

Visionaries Need Help To See Products Come To Life

Most inventors are visionaries that have been inspired to create something they believe to be useful. Often the idea stems from a specific encounter where they saw or used a device that did not perform as effectively as the inventor thought it should. Sometimes the inspiration comes to this visionary through a colleague that describes a procedure, information system or tool that failed them.

The world needs great visionaries to help improve our lives but too often the idea stalls when tasked with bringing this vision to life. The field of medicine is filled with great thinkers and visionaries, but these same people tend to be very busy and find it difficult to move an inspiration for the next great wearable medical device along the path of product development.

Medical Device Development Requires More Than Inspiration

Most of the wearable medical devices that entered the marketplace in 2017 have spent several months to several years in the development pipeline. The question is where does the inventor begin? Our recommendation is to seek out the product development firms that have a proven track record of bringing other wearable technologies to market. There are skill sets that will be required along the way that the inventor or visionary just won’t have themselves.

More importantly is the new product development process needed for your device to succeed. For example, it does not make sense to meet with a mobile app development company before you have a physical design in place. Always start with a summary of the functionality you want for your device and share your ideas with a trusted product designer after there is a formal agreement that will protect your rights and ideas.

Mechanical, Electrical & Software Engineers Should Work in Synergy

The physical design and appearance of your device is very important to the end users and the marketability of your product. If a patient must wear the device, it needs to look and feel right. If a clinician will be using the device as a handheld unit, the design must be easy to use and conform to the environment it will be used in.

Once you have nailed down the mechanical design, an electrical engineer can work within the physical limitations of the device to layout how the electrical design. Often there will be sensor technology deployed in wearable medical devices. So the mechanical and electrical designers may need to make some adjustments to structure & materials for the components to function flawlessly together. Both disciplines can be very complex and it is rare that one individual shares these design skills.

Therefore the stakeholders should foster a collaboration and a project management team may be assigned to track progress, keep the client informed and oversee all parts of the medical device development process. Once the physical and electrical design phases are near complete, then we can start working with the software and app development teams.

Prototyping and Testing Helps Dictate Manufacturing Needs

If an entrepreneur was to hire individuals to tackle the above tasks, chances are you may invest months to identify the right players and several more months to get them to a point where they are producing. Outsourcing your engineering design services has become the norm for most visionaries seeking how to get your invention started. For the prototyping and testing phases alone, it makes sense to choose a partner that has access to 3D printing and additive manufacturing technologies. This world of making functional prototypes has moved very fast and is allowing startups get to market much faster although the equipment and materials can be very costly. Testing will allow you to adjust your design and materials as you discover bugs you never anticipated.

Since actual manufacturing is often the most expensive piece of the puzzle, this engineering for manufacturing stage considers material costs, production methods, anticipated run sizes and delivery schedules. A fully functional prototype will also allow you to present your design to venture capitalists and investors. A manufacturer will need you to show them the money before they invest in materials.

As a medical product design firm in Pennsylvania, Definitive Design has seen the shift towards wearable technologies several years ago. We have partnered with Connected Device Group to bring together the skills you will need to all under one roof. A visionary simply can not do all that is required without the help of a solid team of design professionals.