Wednesday, October 31, 2012
Sunday, October 7, 2012
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.
* 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.
Wednesday, September 5, 2012
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
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
Monday, August 27, 2012
Product Development Process (PDP)
Any company's success depends on getting the right products to the market at the right time. It is a challenge to launch the right medical device in a timely manner when a big part of the process is consumed by FDA regulations which can induce unplanned changes in the development timeline. To overcome these inconsistencies, it is necessary to follow a structured process that instills a regulatory discipline into the process without sacrificing creativity. Such a structured process that contains all the actions necessary to take a process from conception to commercialization is called the Product Development Process (PDP).
A PDP consists of many phases, each of which indicates specific tasks or activities to be completed in that particular time. Early phases emphasize concept formation, product definition and project planning, while later phases focus on development, verification, rollout and maintenance of the defined product. A medical device PDP can consist of the following phases:
Phase 0 - Concept Development
Research and identify market needs, opportunities; evaluate and prioritize; identify a strategic fit; obtain management approval.
Phase 1 - Definition and Planning (21 CFR 820)
Involves design control activities (Refer to Design Contols post); define product and project plan; convert consumer needs to product requirement specifications; maintain a Device History File.
Phase 2 - Design and Development
Complete design process and develop a prototype for testing. Regulatory submissions - 510k. Plan verification, validation and manufacturing phases.
Phase 3 - Verification and Validation (21 CFR 820)
Verify and validate the product for compliance with design requirements, customer needs and regulatory requirements. Regulatory submissions - IDE, PMA. All regulatory approvals must be obtained by the end of this phase.
Phase 4 - Commercialization
Market launch; post-launch evaluation and comparison with competition.
A more detailed interaction of the development and business activities involved in the phases of the PDP can be seen in the figure below. The activities in purple represent design control-related activities and the activities in green are non-design control activities.
(Source: www.qualityprogress.com)
A PDP consists of many phases, each of which indicates specific tasks or activities to be completed in that particular time. Early phases emphasize concept formation, product definition and project planning, while later phases focus on development, verification, rollout and maintenance of the defined product. A medical device PDP can consist of the following phases:
Phase 0 - Concept Development
Research and identify market needs, opportunities; evaluate and prioritize; identify a strategic fit; obtain management approval.
Phase 1 - Definition and Planning (21 CFR 820)
Involves design control activities (Refer to Design Contols post); define product and project plan; convert consumer needs to product requirement specifications; maintain a Device History File.
Phase 2 - Design and Development
Complete design process and develop a prototype for testing. Regulatory submissions - 510k. Plan verification, validation and manufacturing phases.
Phase 3 - Verification and Validation (21 CFR 820)
Verify and validate the product for compliance with design requirements, customer needs and regulatory requirements. Regulatory submissions - IDE, PMA. All regulatory approvals must be obtained by the end of this phase.
Phase 4 - Commercialization
Market launch; post-launch evaluation and comparison with competition.
A more detailed interaction of the development and business activities involved in the phases of the PDP can be seen in the figure below. The activities in purple represent design control-related activities and the activities in green are non-design control activities.
(Source: www.qualityprogress.com)
Sunday, August 26, 2012
Recall Management
The overall process of medical device involves the manufacturer, the FDA and the public (users, retailers). The following image depicts the actions of all parties involved in the recall process.
Source: GAO analysis of FDA information
Device Recalls
A recall is a method of removing or correcting marketed products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall does not include a market withdrawal or a stock recovery (removal of un-marketed devices under the manufacturers' control). Medical device recalls are usually conducted by the manufacturer voluntarily using 21 CFR 7, to protect public health. However, if a manufacturer fails to report a malfunctioning device or initiate its recall, the FDA can issue a recall order under 21 CFR 810 and start legal action against the manufacturer.
Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. Recalls are of different classes depending on the relative degree of health hazard they pose to the user, class I posing the most hazard.
Class I - reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - remote probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A manufacturing firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure.
When a device is found to be in violation of the FDA regulations, it is first subject to a health hazard evaluation by the FDA. Data evaluation is done to detect if the device has caused any diseases or injuries during use, or can contribute to other clinical conditions. Various assessments are conducted to evaluate
* hazards in all segments of population;
* degree of seriousness of the hazard in the exposed population;
* likelihood of hazard occurrence; and
* consequences of the potential hazard.
Based on these results and other evaluations, the FDA assigns a Recall Class to the device being evaluated.
Once the device is assigned for recall, the recall firm develops a recall strategy based on the heath hazard evaluation. The recall firm in most cases is the manufacturer of the device. The recall strategy determines the
* Depth of Recall - level of distribution chain up to which recall is to extend. Can be user level, retail level or wholesale level.
* Public Warning - to alert the public of the violative device being recalled.
* Effectiveness Checks - to verify that all consignees have received notification about the recall and have taken appropriate action.
The recalling firm is to submit periodic recall status reports to the appropriate FDA district office. The FDA assesses the progress of the recall through these reports an their frequency is determined by the relative urgency of the recall and will be specified by the FDA for each recall case. A recalling firm may request termination of its recall based on its progress. A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.
Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. Recalls are of different classes depending on the relative degree of health hazard they pose to the user, class I posing the most hazard.
Class I - reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - remote probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A manufacturing firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure.
When a device is found to be in violation of the FDA regulations, it is first subject to a health hazard evaluation by the FDA. Data evaluation is done to detect if the device has caused any diseases or injuries during use, or can contribute to other clinical conditions. Various assessments are conducted to evaluate
* hazards in all segments of population;
* degree of seriousness of the hazard in the exposed population;
* likelihood of hazard occurrence; and
* consequences of the potential hazard.
Based on these results and other evaluations, the FDA assigns a Recall Class to the device being evaluated.
Once the device is assigned for recall, the recall firm develops a recall strategy based on the heath hazard evaluation. The recall firm in most cases is the manufacturer of the device. The recall strategy determines the
* Depth of Recall - level of distribution chain up to which recall is to extend. Can be user level, retail level or wholesale level.
* Public Warning - to alert the public of the violative device being recalled.
* Effectiveness Checks - to verify that all consignees have received notification about the recall and have taken appropriate action.
The recalling firm is to submit periodic recall status reports to the appropriate FDA district office. The FDA assesses the progress of the recall through these reports an their frequency is determined by the relative urgency of the recall and will be specified by the FDA for each recall case. A recalling firm may request termination of its recall based on its progress. A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.
Friday, August 24, 2012
Complaint Handling
Any communication that points to some deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution, is considered as a complaint. As seen under MDR, complaints concerning device-related deaths, serious injuries, or malfunctions must be reported to the FDA.
Manufacturers are to maintain a detailed record of all complaints and solve them in a timely and efficient manner. The complaint handling system of a company can define the efficiency of its Quality System. Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially designated unit. A good complaint handling system can
* Provide a suitable solution to the problem;
* Improve customer relations and customer satisfaction;
* Evaluate weaknesses in the product and help resolve it;
* Increase company's accountability and transparency;
* Reduce medical device reporting;
* Reduce costs and improve production schedules;
* Reduce employee confusion.
The GMP regulations state certain requirements that are to be included in any complaint handling system. All manufacturers should:
1. document, review, evaluate, and file all complaints;
2. formally designate a unit or individual to perform these activities;
3. determine if an investigation is necessary;
4. record the reason if no investigation is made;
5. assign responsibility for deciding when not to investigate; and,
6. determine if the complaint requires an MDR report.
A sample complaint handling system is depicted in the image below:
(Source: http://www.assurx.com/software-solutions/complaint-handling-management.htm)
All complaint records should have some basic details like
* sequential number of the complaint;
* origin of the complaint;
* customer information;
* product information;
* any corrective actions already taken;
* details of the complaint;
* and dates, signatures, assignments, etc.
These records should be maintained by the company for review during FDA audits.
Manufacturers are to maintain a detailed record of all complaints and solve them in a timely and efficient manner. The complaint handling system of a company can define the efficiency of its Quality System. Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially designated unit. A good complaint handling system can
* Provide a suitable solution to the problem;
* Improve customer relations and customer satisfaction;
* Evaluate weaknesses in the product and help resolve it;
* Increase company's accountability and transparency;
* Reduce medical device reporting;
* Reduce costs and improve production schedules;
* Reduce employee confusion.
The GMP regulations state certain requirements that are to be included in any complaint handling system. All manufacturers should:
1. document, review, evaluate, and file all complaints;
2. formally designate a unit or individual to perform these activities;
3. determine if an investigation is necessary;
4. record the reason if no investigation is made;
5. assign responsibility for deciding when not to investigate; and,
6. determine if the complaint requires an MDR report.
A sample complaint handling system is depicted in the image below:
(Source: http://www.assurx.com/software-solutions/complaint-handling-management.htm)
All complaint records should have some basic details like
* sequential number of the complaint;
* origin of the complaint;
* customer information;
* product information;
* any corrective actions already taken;
* details of the complaint;
* and dates, signatures, assignments, etc.
These records should be maintained by the company for review during FDA audits.
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