James A. Dunning, QPC Services05.23.16
I’ve never met anyone who does not readily acknowledge the benefits of design controls (21 CFR Part 820.30). Considered essential for medical device design firms, design controls are invaluable, as they help companies maintain regulatory compliance. However, many device developers do not necessarily assign any value to design controls outside of regulatory compliance. (The specific requirements for design controls are available at http://tinyurl.com/jwgs6)
Design controls include design and development planning. Most of us, as well as our associated companies, love the idea of planning, though we seldom do so unless we are forced into it by the U.S. Food and Drug Administration (FDA), customers, or contracts, etc. The act of planning, even more so than the resulting plan(s), drives clarity and purpose regarding a particular medical device in development. The value of this design and development planning requirement is much greater than merely regulatory compliance.
To illustrate the value of design and development planning, I’d like to share a brief story about a young, innovative medical professional who ran into some trouble because he did not realize the value of design controls.
A young practicing medical professional contacted me regarding the cost of developing a dental device, from napkin sketch to FDA 510(k) clearance. I estimated the cost for him and while he was appreciative, we did not conduct business any further. During my follow-up contacts with him, he said he had been unable to get funding for the product, noting he felt like he “had to prove it would work before investors would fund the product development.”
This young professional obviously had not established design controls as part of his design and development process. If he had, he would not have felt like he had to prove his device worked before he could receive funding. I am not a financial expert, but to me, design and development planning for this professional’s idea was not well-established. I believe it is safe to assume that investors are not interested in funding any entrepreneur, inventor or business that lacks a well-established plan. Through design and development planning, this medical professional could have proven to potential supporters how his medical device would have served an unmet clinical need. Furthermore, he could have shown why his medical device would be a viable alternative to existing products, the expected path to success, the regulatory requirements, design activities, associated costs, the people and possible materials involved, manufacturing equipment, necessary outsourced services, etc. I’d like to think these details would have helped lure potential investors to the doomed project.
Design Input
Have you ever known a person or worked for a company that developed an unmarketable product? I’ve witnessed this gaffe many times. More often than not, these failures were caused by the lack of well-established (or even basic) design controls. Earlier in this article, I discussed design and development planning; both can help device developers avoid commercial failure, as can design input. The design input requirements connect inventors and companies with the people, organizations, and agencies necessary for product development success. At the very least, the process can help identify market needs, though design input should not be the only vehicle used to gauge commercial interest. I am not a marketing expert, but I know that design input requirements can help customers and stakeholders identify and satisfy product requirements. I believe that design controls should be part of the process used to determine the commercial viability of a product in development.
To further illustrate the value of design input, consider that:
Design Output
Another vital part of the product development process is design output. A medical device cannot exist without it. Design output enables companies/entrepreneurs to sell their creations. Design output gives the inventor/seller the objective evidence needed to communicate precisely what the medical device is and the clinical needs it serves. What could be more valuable than that?
Design controls for software, perhaps. Indeed, the requirements of 21 CFR Part 820 apply to all software that either is embedded in a medical device or controls a stand-alone medical device. In fact, there are very detailed requirements identified in documents such as ANSI/AAMI/IEC 62304 Medical device software—Software life cycle processes. I won’t detail the mandates of ANSI/AAMI/IEC 62304 or any other document that discusses software development requirements but I will point out that design controls are very valuable in developing software. The fast-moving, easy-to-change software development process benefits significantly from design controls.
Design Review, Verification, and Validation
Consider this hypothetical scenario for a moment: A company takes the time to establish design and development planning, it identifies and manages design inputs, and generates formal design outputs for maximum salability but does not review the product development process results at key points before deciding to spend more money to improve or market the device. Sound like a smart strategy?
Surely, medtech firms can benefit from knowing whether a product design is safe, effective and progressing according to plan. Design reviews are intended to be checkpoints in a medical device product development process to ensure that design controls are being captured and documented throughout the project. According to the FDA, design and development reviews are conducted to “evaluate the ability of the results of design and development to meet requirements, and to identify any problems and propose necessary actions.” Design reviews are indispensable, even if the product or service under development is not a medical device. Valuable? Definitely.
Design verification determines whether the design output meets design input requirements. More simply stated, it helps companies figure out if the medical device meets specifications. This is a basic component of any design effort, and therefore it is valuable.
So is design validation, which can help manufacturers determine whether the medical device being developed actually works. Design validation is performed in the environment or simulated environment in which the product is intended to operate.
Have you ever purchased a product that didn’t work? Did you ask yourself whether the product was validated? Would you have felt that the product was more valuable to you if it had been validated? In the case of medical devices, the harm that could be experienced from a device that does not work can be life-threatening. The value of medical device design validation, therefore, is unquestionable.
Design Transfer and Design Change
Many medtech companies undervalue design transfer but production personnel are well aware of its importance. Design transfer is the process by which product design data (production specifications) are transferred to manufacturing for assembly. Design transfer is not a single event, but begins with the release of the first drawing or specification to purchasing, and ends with commercial release of the product.
Design change can be a bitter pill to swallow. I hate change, or at least I used to before I realized it will inevitably occur, with or without my consent. Rather than fight a losing battle, I decided to embrace change, using its homonym for inspiration. Here’s how it happened:
Years ago, when we actually bought products and services with money—bills and coins (change)—I constantly found myself with unwanted change. I would pay for my item with bills and receive coins back—dimes, quarters, nickels, even pennies. I did not like the sound of change jingling in my pocket or the possibly of it falling out of my pocket. I also wasn’t willing to use a change purse (a little container designed to hold money). So, I would dump a day’s change I received on my dresser at home, and the pile of coins would rapidly grow. I felt like I was always coping with the collection, storage, and redistribution of change.
Then one day, the proverbial lightbulb went off. What if I just keep some change with me, I thought. I could then give the extra dime or quarter or penny to the vendor so he or she could give me change in whole dollars instead of coins. I knew I had the math skills for this, so I tried it. And it worked. I significantly reduced the amount of change (coins) I received.
Of course, loose coins are now a rarity with the explosion in debit and credit card use throughout the world.
However, change—the kind that makes things different—is still as prevalent as it was when I broke my coin-hoarding habit. Design change is no exception. Medical devices change over time because of the education a company gathers about a product during its life cycle. Naturally these design changes must be managed and incorporated into the product, if necessary. For example, a design change should only be made when it adds value—making the device safer and/or more effective. Making unnecessary design changes would be like collecting spare coins unnecessarily. Design control requirements mandate that manufacturers establish and maintain procedures to identify, document, validate or where appropriate verify, review, and approve design changes before they are implemented.
Let’s end with the design history file, or DHF. The DHF is key to a functional design and development process. Access restrictions, back-up, and ease of document retrieval are all important considerations for the DHF. For all intents and purposes, the DHF is the glue that holds the design activities together. It is one of the most important sets of documents that is created during medical device development; it serves as proof that all design control regulations were followed. Essentially, the DHF is the central hub for all issues important to medtech regulators.
Clearly, design controls are a valuable part of the product development process. Don’t you agree?
James Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society.
Design controls include design and development planning. Most of us, as well as our associated companies, love the idea of planning, though we seldom do so unless we are forced into it by the U.S. Food and Drug Administration (FDA), customers, or contracts, etc. The act of planning, even more so than the resulting plan(s), drives clarity and purpose regarding a particular medical device in development. The value of this design and development planning requirement is much greater than merely regulatory compliance.
To illustrate the value of design and development planning, I’d like to share a brief story about a young, innovative medical professional who ran into some trouble because he did not realize the value of design controls.
A young practicing medical professional contacted me regarding the cost of developing a dental device, from napkin sketch to FDA 510(k) clearance. I estimated the cost for him and while he was appreciative, we did not conduct business any further. During my follow-up contacts with him, he said he had been unable to get funding for the product, noting he felt like he “had to prove it would work before investors would fund the product development.”
This young professional obviously had not established design controls as part of his design and development process. If he had, he would not have felt like he had to prove his device worked before he could receive funding. I am not a financial expert, but to me, design and development planning for this professional’s idea was not well-established. I believe it is safe to assume that investors are not interested in funding any entrepreneur, inventor or business that lacks a well-established plan. Through design and development planning, this medical professional could have proven to potential supporters how his medical device would have served an unmet clinical need. Furthermore, he could have shown why his medical device would be a viable alternative to existing products, the expected path to success, the regulatory requirements, design activities, associated costs, the people and possible materials involved, manufacturing equipment, necessary outsourced services, etc. I’d like to think these details would have helped lure potential investors to the doomed project.
Design Input
Have you ever known a person or worked for a company that developed an unmarketable product? I’ve witnessed this gaffe many times. More often than not, these failures were caused by the lack of well-established (or even basic) design controls. Earlier in this article, I discussed design and development planning; both can help device developers avoid commercial failure, as can design input. The design input requirements connect inventors and companies with the people, organizations, and agencies necessary for product development success. At the very least, the process can help identify market needs, though design input should not be the only vehicle used to gauge commercial interest. I am not a marketing expert, but I know that design input requirements can help customers and stakeholders identify and satisfy product requirements. I believe that design controls should be part of the process used to determine the commercial viability of a product in development.
To further illustrate the value of design input, consider that:
- Design requirements start with design input, including feedback from the innovator.
- Intended use of the medical device is clarified through design input. User and patient needs also are explained through design input.
- Incomplete, ambiguous, or conflicting requirements are identified through the design input process (and through design review).
- Design input approval is gained through regulation, a factor that can help keep companies on track during the product development process.
Design Output
Another vital part of the product development process is design output. A medical device cannot exist without it. Design output enables companies/entrepreneurs to sell their creations. Design output gives the inventor/seller the objective evidence needed to communicate precisely what the medical device is and the clinical needs it serves. What could be more valuable than that?
Design controls for software, perhaps. Indeed, the requirements of 21 CFR Part 820 apply to all software that either is embedded in a medical device or controls a stand-alone medical device. In fact, there are very detailed requirements identified in documents such as ANSI/AAMI/IEC 62304 Medical device software—Software life cycle processes. I won’t detail the mandates of ANSI/AAMI/IEC 62304 or any other document that discusses software development requirements but I will point out that design controls are very valuable in developing software. The fast-moving, easy-to-change software development process benefits significantly from design controls.
Design Review, Verification, and Validation
Consider this hypothetical scenario for a moment: A company takes the time to establish design and development planning, it identifies and manages design inputs, and generates formal design outputs for maximum salability but does not review the product development process results at key points before deciding to spend more money to improve or market the device. Sound like a smart strategy?
Surely, medtech firms can benefit from knowing whether a product design is safe, effective and progressing according to plan. Design reviews are intended to be checkpoints in a medical device product development process to ensure that design controls are being captured and documented throughout the project. According to the FDA, design and development reviews are conducted to “evaluate the ability of the results of design and development to meet requirements, and to identify any problems and propose necessary actions.” Design reviews are indispensable, even if the product or service under development is not a medical device. Valuable? Definitely.
Design verification determines whether the design output meets design input requirements. More simply stated, it helps companies figure out if the medical device meets specifications. This is a basic component of any design effort, and therefore it is valuable.
So is design validation, which can help manufacturers determine whether the medical device being developed actually works. Design validation is performed in the environment or simulated environment in which the product is intended to operate.
Have you ever purchased a product that didn’t work? Did you ask yourself whether the product was validated? Would you have felt that the product was more valuable to you if it had been validated? In the case of medical devices, the harm that could be experienced from a device that does not work can be life-threatening. The value of medical device design validation, therefore, is unquestionable.
Design Transfer and Design Change
Many medtech companies undervalue design transfer but production personnel are well aware of its importance. Design transfer is the process by which product design data (production specifications) are transferred to manufacturing for assembly. Design transfer is not a single event, but begins with the release of the first drawing or specification to purchasing, and ends with commercial release of the product.
Design change can be a bitter pill to swallow. I hate change, or at least I used to before I realized it will inevitably occur, with or without my consent. Rather than fight a losing battle, I decided to embrace change, using its homonym for inspiration. Here’s how it happened:
Years ago, when we actually bought products and services with money—bills and coins (change)—I constantly found myself with unwanted change. I would pay for my item with bills and receive coins back—dimes, quarters, nickels, even pennies. I did not like the sound of change jingling in my pocket or the possibly of it falling out of my pocket. I also wasn’t willing to use a change purse (a little container designed to hold money). So, I would dump a day’s change I received on my dresser at home, and the pile of coins would rapidly grow. I felt like I was always coping with the collection, storage, and redistribution of change.
Then one day, the proverbial lightbulb went off. What if I just keep some change with me, I thought. I could then give the extra dime or quarter or penny to the vendor so he or she could give me change in whole dollars instead of coins. I knew I had the math skills for this, so I tried it. And it worked. I significantly reduced the amount of change (coins) I received.
Of course, loose coins are now a rarity with the explosion in debit and credit card use throughout the world.
However, change—the kind that makes things different—is still as prevalent as it was when I broke my coin-hoarding habit. Design change is no exception. Medical devices change over time because of the education a company gathers about a product during its life cycle. Naturally these design changes must be managed and incorporated into the product, if necessary. For example, a design change should only be made when it adds value—making the device safer and/or more effective. Making unnecessary design changes would be like collecting spare coins unnecessarily. Design control requirements mandate that manufacturers establish and maintain procedures to identify, document, validate or where appropriate verify, review, and approve design changes before they are implemented.
Let’s end with the design history file, or DHF. The DHF is key to a functional design and development process. Access restrictions, back-up, and ease of document retrieval are all important considerations for the DHF. For all intents and purposes, the DHF is the glue that holds the design activities together. It is one of the most important sets of documents that is created during medical device development; it serves as proof that all design control regulations were followed. Essentially, the DHF is the central hub for all issues important to medtech regulators.
Clearly, design controls are a valuable part of the product development process. Don’t you agree?
James Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society.