Project Planning

Good planning is the basis of any successful endeavor. Planning helps you to make good, well-considered, robust plans, that, when successfully executed gives great products. A good plan will:
* State the current situation.
* Have a clear aim.
* Use the resources available.
* Detail the tasks to be carried out, whose responsibility they are, and their priorities and deadlines.
* Detail control mechanisms that will alert you to difficulties in achieving the plan.
* Identify risks, and plan for contingencies. This allows rapid and effective response to crises.
* Consider transitional arrangements – how to keep things going while implementing the plan.
A product planning cycle looks something like this:

1. Analysis of opportunities gives reality to the plan. It is important to explore and exploit all available opportunities to determine what is to be done. Creativity tools, SWOT Analysis and Risk Analysis can help to identify opportunities for development or improvement.
2. Definition of the aim gives your plan a goal to focus and concentrate its energy on. A well defined plan will prevent wastage of resources on irrelevant issues.
3. Explore options helps to generate as many different ways for achieving the aim as possible. By spending time looking for these you may find a better solution than the obvious one, or may be able to improve the obvious solution with parts of other ones.
4. Selection of the best approach is sometimes a tough call. This can be made easier by considering the resources and time available or with the use of Decision making tools like Grid Analysis or Decision Trees.
5. Detailed planing shows how to implement selected option. It helps to work out the most efficient and effective way of achieving the aim defined. It is the process of determining who will do what, when, where, how and why, and at what cost. Gantt Charts and Critical Path Analysis can be immensely helpful in working out priorities, deadlines and the allocation of resources.
6. Evaluation of this plan makes sure that the plan will be worth implementing. If it is not, return to an earlier stage and either improve the plan or make a different one. If no plan looks to be producing enough benefit to justify the cost, it is best not to make any changes at all.
7. Plan implementation is the next step once a course of action is selected, and has been proven to be viable.
8. Plan closure involves examining results and drawing conclusions. It is important to identify any mistakes, both to rectify them and to learn from them. The feedback is also noted for future planning.

Creating Ideas

Creating new ideas is the basis of any successful company. Innovation and creativity are the main requirements to compete and keep the business running. Creating ideas require understanding of the problem at hand. This usually arises based on user needs. Once specific a user problem or an unmet market need is identified, creating ideas is the next step. This might involve one or all of the following idea creation tools.

Brainstorming:
This technique is used to generate creative/original ideas over a broad range of options and within a short period of time. The problem being discussed is reviewed at the beginning of the session until it is understood by the entire discussion group. After about 2 minutes of silence, the members are invited to read out their ideas one at a time. All ideas are recorded and kept visible. Members can modify or build on other members' ideas. There is no criticism of evaluation of ideas, so as to keep the thoughts flowing. Once all ideas are recorded and several minutes of silence ensues, the session is declared closed. There are several modified versions of this basic brainstorming technique -
* Round-robin brainstorming - Allows all team members to participate and generate ideas without being influenced/overshadowed by a dominant member.
* Wildest-idea brainstorming -
* Reversal - Instead of asking, "How do I solve or prevent this problem?" ask, "How could I possibly cause the problem?" Instead of asking "How do I achieve these results?" ask, "How could I possibly achieve the opposite effect?" Once the ideas are collected, they are reversed to engineer original solutions.
* Starbursting - Focuses on evaluating ideas by asking questions rather than providing answers. Helps to understand all aspects of the new idea/product.
* Charette - Used to brainstorm multiple issues with multiple stakeholders. Involves organizing people into several small groups, each of which brainstorms ideas one-after-the-other until everyone involved has had a chance to contribute fully.
Brainstorming focuses on quantity - it aims at collecting many unusual ideas which may be combined or modified to yield productive ideas.
* Nominal Group Technique - It is a more structured brainstorming approach where once the subject is discussed, the group is allowed 5-10 mins to write down any ideas in silence. Each member then states his/her ideas one at a time and the ideas are noted and then discussed in detail. Based on a voting system, priority numbers are assigned to the ideas.

Affinity Diagram:
This is used in the case of large, complex issues with multiple factors. Ideas are put down on sticky notes and spread across a large surface. When related ideas evolve, they are put together in pools. Ideas can be grouped and regrouped such that patterns emerge and each group is given a title like, specifications, safety, quality, finance, etc. This will also help in assigning further tasks.

There are several other creativity tools that can aid in developing ideas for new products. More information about these tools are available at http://www.mindtools.com/pages/main/newMN_CT.htm#other

Usability Testing

Usability testing culminates the full testing of a product to ensure that the product is ergonomically designed according to user needs. This process involves iterative prototyping of the product such that all components of the design can be tested, refined and retested throughout development. Usability testing requires;

1. A prototype - A working model of the device is essential to simulate the device-user system and the user interface as defined by the device hardware and software. Mock-ups, storyboards, screen prints or other interactive computer models can be used to evaluate the efficiency of the user with the interface design.

2. Scenarios - Some usability testing requires written scenarios to allow participants simulate a working environment (like a operating room) where the device is used. This would allow for checking the realism and accuracy of the device. Physicians or other healthcare professionals can help with this step.

3. Requirements and Measures - Requirements are based on user interviews, observations, manufacturer’s experience, market analyses, and literature reviews. These should be quantitative and linked to safe device use. Measures used for testing enable the detection of errors or other events of non-conformance with the requirements. This might be as simple as a verbal response or a subjective impression of usability.

4. Facility - It is important to simulate the environment of device use. Test facilities can be a regular usability lab or a medical facility depending on the resources and the nature of the test.

5. Test Participants - Small testings can be done using two or three employees as participants. However, full usability tests would require larger samples drawn from the user population. For a device intended for a fairly homogenous population, most problems can be eliminated from data obtained with about 10 individuals representative of that population.

Also, it is crucial to obtain performance data from actual device users. If the device cannot be safely and effectively used by test participants under test conditions, healthcare professionals will definitely have problems with the device under actual conditions of use. Thus, thorough development of requirements and usability testing of the design would ensure safe and effective use of the device in its use environment.

HFE and Risk Management

Studies show that the frequencies and consequences of use-related hazards of medical devices might far exceed those resulting from device failures. This necessitates the incorporation of Human Factors Engineering (HFE) principles in the device design process. HFE identifies and addresses potential use-related hazards that arise due to interactions between the user and the device.

Most designers only consider the most apparent (e.g., fire) or well-known use problems and thus limit to only relatively few user actions that cause device failure. According to the FDA, use-related hazards occur for one or more of the following reasons:
• Use of devices in ways that were not anticipated,
• Devices are used in an anticipated way, but inadequately controlled,
• The user's physical, perceptual, or cognitive abilities are not sufficient for the device use,
• The user’s expectations or intuition about device operation are inconsistent with actual device use,
• The effects of the use environment on device operation is not understood by the user, or
• The user’s physical, perceptual, or cognitive capacities are exceeded when using the
device in a particular environment.

The device-user system, thus consists of three major components:
1. Use environments,
2. User characteristics and
3. Device user interface characteristics.
The interactions of these components can thus result in a safe, effective, or unsafe and ineffective use of the device. This can be depicted in the following image.

HFE approaches can be incorporated into the design of medical devices within the risk management process to account for the changes in the device-user system. FDA defines risk management as the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk.
HFE incorporation into risk management can be achieved by four steps:
• Identify use- related hazards that are anticipated (derived analytically) and unanticipated (derived empirically),
• Describe the hazardous use scenarios that can occur,
• Develop and apply strategies that can control these use-related hazards, and
• Demonstrate safe and effective use of the device (validation).
The risk management process by which use-related hazards can be addressed is shown below,

A more detailed description of the process can be found in the FDA document, "Medical Device-Use Safety: Incorporating Human Factors Engineering into Risk Management."

Human Factors

Human factors is a discipline that seeks to improve human performance in the use of a device/equipment by developing a hardware and software design compatible with the user's abilities. It is often referred as human engineering or ergonomics. A medical device can be used safely and effectively only if the interaction between the operating environment, user capabilities, stress levels, and device design is considered when the manufacturer designs the device.

Device design should take into account the basic physical and sensory capabilities, perceptional and cognitive abilities, device expectations, user's mental model of the device capabilities and design, use environments, and all possible categories of users, including the patients themselves.

User interface designing is an important aspect of an ergonomic design. Some basic considerations include,
* Control/Display Layout and Design
* Simple device logic, microprocessing and software design
* Design and code systems to avoid device mis-installation
* Alarms and alert systems
* Device maintenance
* Packaging

The following figure gives a brief outline of the steps involved in usability engineering or human engineering.

Human Factors Standards and Resources
AAMI HE75 – Design Reference
AAMI HE74 – Human Factors Process
IEC 62366 – (Process) Application of usability engineering to medical devices
FDA.gov; FAA.gov

Medical Device Design Process

The process of designing a medical device consists of the following steps:

1. Identifying user needs - This may involve identifying problems with existing diagnostic tools, prosthetic or surgical devices, or recognizing a whole new unexplored market (novel device based solutions for diseases). The primary user of medical devices are physicians who either prescribe or incorporate these devices on/in patients.

2. Reviewing marketed solutions - The next step is to understand the technology and the shortcomings of existing solutions(if any) to the problem.

3. Developing possible solutions - This is the major brainstorming step where solutions are conceived for the problem based on the user needs. Many possible solutions can be obtained to solve the problem.

4. Identifying the best possible solution - In this stage, the results of the previous step are compared and the solution which best satisfies the user needs is selected.

5. Device Design Criteria - The solution selected is translated into design inputs for the design process.

6. Device Design Process - This is a comprehensive step where the design inputs are manipulated to develop a product design.

7. Developing a Prototype - The design is now engineered to produce a working model or prototype of the device.

8. Verification and Validation - This prototype is tested to check its compliance with the design needs and user needs. Based on the outcome of this step, the steps 6-8 might undergo several iterations.

9. Packaging and Marketing - Once the device is ready, it is sterilized and packed according to FDA standards and is ready for marketing.

The FDA regulatory process must also go hand in hand with the device design process. This would enable timely release of device into the market.