The beginning

The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.

In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.

Overview of 21 CFR part 820

The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.

Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.

DHF

Subsection j) of 21 CFR part 820 says:

Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”

DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.

Here are some key interpretations of the DHF guidance that medical device companies should take note of:

• A DHF must be maintained for each type of device that you manufacture. For similar versions of the same device, you can include all of the data in a single DHF.
• The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.
• The DHF must either contain or reference the necessary documents, which means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.

What belongs in your DHF?

Below, we’ve listed the steps of the design controls process and what documents should be included with each step:

1. Design input: include your design plan document, developed according to this part.
2. Design output: Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. The outputs are normally documented in models, drawings, engineering analyses, and other documents.
3. Design review: is a formal review of the medical device design by representatives of each design function participating in the design efforts as well as other interested parties. The design review must be documented in the DHF and include review date, participants, design version/revision reviewed, and review results.
4. Design verification: is the process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified verification method and verification results.
5. Process validation: is the process in which the device design is validated using initial/low volume production processes. The purpose of the process validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes.
6. Design validation: Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
7. Design transfer: Design transfer is the process in which the device design is translated into production, distribution, and installation specifications.
8. Design changes: Design changes is the process in which the design changes are identified and documented. Also known as engineering change or enterprise change.

References

1. Harnack, Gordon (1999). Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.
2. FDA Staff (October 7, 1966). “Part 820 ”. Federal Register. 61 (195): 52657. ISBN 9781932074109. Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN 1932074104.

External links

• CFR Title 21 Database

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It’s difficult to predict the success of a new product. Even the largest, most mature companies have created products that fail to gain market acceptance and profitability. And as we’ve seen in numerous industries, product success can’t be guaranteed by financial investment or process optimization.

With the need to move fast in the light therapy market and an inability to guarantee success through any means, we continue to seek ways to manage the inherent risk in product development.

There is a gap between user wants and user needs and while it is easy to assume that the difference might not be clear, taking an empathetic approach creates a finer line between the two. Although Creative Directors are problem-solvers at their core, they achieve this by building data-based frameworks for visualizing how best to serve their target audience.

It is no longer about market data assessment and sales hands-off alone; there is a need to properly distinguish between user needs and wants while choosing how best to attend to those needs and paying just enough attention to user wants. Understanding the user metrics for this analysis and insight might seem daunting, especially when the aim is to improve product experience directly, but taking a design-thinking approach helps make better sense of the process.

What Exactly is Design Thinking?

Popularized by IDEO, Design Thinking is a human-centered, empathy-first approach to creativity and innovation. Its underlying principle focuses on user needs, aspirations, wishes, concerns, and frustrations in attempting to solve their problems. Interestingly, Design Thinking focuses on the most important view from which problem-solving should be approached; the users. When problem-solving is approached from a user’s point of view, it allows for uncovering novel insights into the product’s user flow, thereby finding the right solution to the right problem.

The Design Thinking process is quite similar to the Agile methodology of Product Management; as a matter of fact, Design Thinking helps to materialize the otherwise abstract concept by allowing ease of iteration and faster user-testing processes. Implementing design thinking in product management makes it easy to consider expedient user experience factors. Top on the list includes:

1. ‘Predicting’ your users’ thoughts: Steve Krug, author of Don’t make me think, suggests fully understanding users’ needs and subsequent workflow, so much so that you can correctly predict their next move (no, you don’t have to be a mind reader to achieve this). This is a basic fundamental that connects directly between design thinking and product management.
2. “We should listen to our users’ needs to the point that we know and tell them what they should be thinking.” –Steve Krug.
3. Make your users think less: Hick’s law is the 4th law of User Experience; it suggests that your design should minimize how much your users have to think when interacting with your product.

Kaiyan Design Thinking Steps

Companies employing design thinking are allowed to release products more often, gather meaningful customer feedback, and validate a product’s use and vision in a marketplace while sustaining a high level of customer satisfaction, as one release builds on another to add features customers desire most.

Implementing design thinking into product development can be broken down into 5 steps:

1. Define — Customer Vision. You need to begin the development process by clearly defining the target customer’s underlying needs, developing a deep understanding of how a prospective solution improves their condition — a key principle of design thinking. Empathize with your users. Find their jobs to be done. Next, you need to define a prospective solution’s functional requirements and the core competencies required to support the solution for those jobs to be done.
2. Share — User Personas. Having defined the customer’s needs and the solution’s functional requirements, the next step is to host a meeting with all team members to share a common vision of the project. User personas should be defined and explained to the whole team. Your objective is to establish roles for each team member, with everyone understanding how they support the project and how each individual contributes to the project’s success. You want to avoid having team members merely given tasks without the context of how their tasks fit into the larger development. This approach allows team members to consider the entire project as they perform assigned tasks throughout the development, reducing the likelihood of misaligned pieces when the project is assembled as a whole.
3. Prioritize — Planning. The third step in this process is to meet with the project’s management team to categorize features slated for particular releases. The Kano model may be helpful to organize features in categories such as “Basic,” “Performance,” and “Wow.” The idea is to balance each release with features from each category, being mindful not to fill a release with features from only one category, such as having a Basic features release, or a release with only Wow features that doesn’t include a set of basic features required to make a product viable. The outcome of this step is a plan to introduce features to the marketplace through frequent releases with incremental customer value — another key design thinking principle.
4. Implement. The fourth step is where product releases are developed. It’s important to remain mindful that design thinking is an iterative process requiring feedback and validation. As such, each implementation needs to enlighten: include mechanisms and processes that will let you examine customer experience after each release. Apply web analytics or specialized tools that provide extensive commentary to analyze customers and gather valuable feedback. It is important not only to collect data but to make it work: make sure that the results of any feedback are added to the backlog to improve your product constantly.
5. Validate. The fifth and last step in the process is to review feedback on a particular release, validate the vision, and begin the process all over again with step 1. This focuses each release to meet the specific needs of a target customer, creating a building block approach to product development that provides incremental value at low risk. Accept that users may not immediately accept your concept. Try to be objective, don’t see things in black and white, and restructure your vision to improve your product.

Most of the companies jump straight to point #4, which is a terrible mistake.

To make things clear, structure your tasks: build up a framework, define both focus points and sticking points of your research, and remember that most questions have two answers — the one that appeals to business and speaks to a customer.

Development Cycle — Solving a Crime

Think like a detective when starting a product development cycle, and ask these questions:

Who?

Who is going to use your product? What are their habits and preferences? It is essential to understand real user needs and how they are addressed without your product. Define the key problems and set your sights on them. What’s the context of use? What is their motivation behind using your product, and how can you inspire them to make the most out of it?

Where?

Think big. What is the place of your product in the ecosystem? Sometimes it may be just a part of greater service. Keep in mind the environment of use since it creates a general customer experience.

When?

Whether you like it or not, time is vital for your project. “Done” is better than “perfect.” That’s why it’s important to keep the scope of your project in mind, to limit it to essential things for a quick market release.

Why?

What is the real value of the product for your customer and your business? What issues does it address, and in what way? Why did you create it, and what’s its role in the company development?

These questions are essential for creating a general perception of the main problem you are solving for your client: it’s so easy to get side-tracked with a load of on-demand, seemingly effortless tasks. Besides, it’s impossible to solve a problem that doesn’t exist, so why carry an extra burden? When details are pushing you to the limit, take an imaginary step back and see the problem from a different angle. Visualize the role of a certain detail in the general canvas of your work. It does not mean you have to bury your project under piles of documentation. We all know that red tape is more about restricting rather than making things easy, and freedom is essential at the initial stages of any project. This is how innovation is born; under conditions of free thought, bright vision, and sheer inspiration.

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Over the past few years, design thinking has quickly gained momentum in the business world. Some of the world’s leading brands have embraced design thinking as a means of optimizing product innovation. At its core, design thinking is a methodology for creative problem-solving. In stark contrast to analytical thinking, which involves breaking down ideas, design thinking involves building up ideas.

While design thinking has firmly implanted itself across product development teams, it has not secured a stronghold across sales teams — yet. Characterized by routinized activities, traditional sales methodologies tend to be at odds with the iterative methodology underpinning design thinking.

Times are changing. The sales cycle is becoming increasingly complex, and customers are demanding a more personalized experience. If you’re a sales rep, you know you need to up your game and become more innovative. Sales teams are recognizing the value of incorporating a design thinking approach into their daily activities. Salesforce’s sales team, for example, has embraced design thinking in its sales discovery process and has realized a 100% increase in revenue growth as a result. It’s time sales teams more broadly recognize the value of design thinking.

1. Empathize

Empathy is at the core of design thinking. Empathy involves both a cognitive dimension — an ability to look at a situation from another person’s perspective — and an affective dimension — an ability to relate to a person and develop an emotional bond with them.

The importance of empathy in sales cannot be overstated. Empathy is a key predictor of sales success. A groundbreaking study published in The Journal of Marketing Theory and Practice found a strong positive relationship between empathy and a buyer’s level of trust and his/her level of satisfaction. In our current sales landscape where a mere 3% of buyers trust reps — the only professions with less credibility include car sales, politics, and lobbying — seller trust is in short supply and high demand.

Empathy is especially valuable in the sales process because it encourages information sharing. Research has found that, according to buyers, the number one way for salespeople to create a positive sales experience is to listen to their needs. When we’re armed with so much information and data and a slew of AI and machine learning solutions, it’s easy to assume we know everything about the buyer. It’s important to first step inside your customers' shoes and listen to what really matters to them and what is top-of-mind.

2. Define

The defining stage's objective is to craft a problem statement or, in design thinking speak, a point of view. So often, salespeople define the problem before developing an empathetic understanding of a buyer’s needs. The result is solution selling. Solution selling has long past its expiration date. At least 50% of sales reps’ prospects are not good fits for their offering. Only by defining the buyer’s problem can salespeople determine whether there is a lucrative fit.

The define stage involves asking a lot of questions. Perhaps contrary to popular belief, this focus on questioning does not impair sales conversation but enhances it. According to one analysis of 519,000 discovery calls, there’s a clear relationship between the number of questions a sales rep asks a buyer and his/her likelihood of success.

3. Ideate

The ideate stage unlocks the true potential of design thinking, especially in the context of sales. This is when the focus shifts from problem identification to solution generation. And it’s all about quantity — about generating a wide range of possible solutions, not necessarily the final solution. It involves thinking beyond the obvious and necessarily entails significant creativity. How can I craft an offering that is uniquely suited to my buyer?

While often pushed under the carpet in sales, creativity is essential to sales and a key predictor of success. Research from the Aston Business School, a highly-regarded business school in Europe, revealed that sales professionals who were more creative generated higher sales than their less creative counterparts. Another study by Adobe found that companies that foster creativity are 3.5 times more likely to outperform their peers in revenue growth.

When crafting solutions to customers’ problems, sales reps must dig deep for their creative juices. How can you craft a sales pitch that strikes a strong emotional chord with the customer? Which decision-makers, in and beyond the C-Suite, should you involve? If the customer sells a free or inexpensive product or service, take it for a test run. Read through customer community forums and reviews. Don’t let up in terms of stepping inside the shoes of your customer. Only by embracing these types of activities can ideation be optimized.

4. Prototype

The fourth stage of the design thinking process is prototyping — developing more fleshed-out and scaled solutions. Prototyping shouldn’t be done in a black box — otherwise, you are sure to lose momentum. Prototyping is an opportunity to have a more directed conversation with your customer after the discovery calls. The most effective sales reps will involve champions and other affiliates from the customer’s organization in the prototyping process and vet ideas. Involving tangential stakeholders in the solution process goes a long way in making them feel valued and invested in the final solution.

5. Test

The final stage of the design thinking process is to test the final offering. This necessarily involves unveiling the fully fleshed-out pitch to all key stakeholders. During the test phase, salespeople need to be strategic and see themselves on the same team as the customer. They should use collaborative words and phrases — words like “we” and “together.” The “you versus us” mentality is dangerous.

Forrester predicts that one million US B2B sales reps will be out of a job by 2020. Salespeople can no longer afford to rely on so-called tried and true approaches. Nearly six in ten salespeople say that they don't change it when figuring out what works for them. In a world where each customer yearns personalized selling wants, this mindset is problematic. Design thinking — which is especially well suited for solving ambiguously defined problems — is key to establishing a genuine connection with customers and engaging them throughout the sales process. It’s key to sales success.

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