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Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry

Third Edition

Marie B. Teixeira

CRC Press

Taylor & Francis Group

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Boca Raton, FL 33487-2742

© 2020 by QARA Compliance Connection, Inc.

CRC Press is an imprint of Taylor & Francis Group, an Informa business

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Appendix

Appendix

Appendix

Appendix

Appendix

Appendix

Appendix

Preface

Since the design control requirements were formally mandated by the Food and Drug Administration’s (FDA’s) Quality System Regulation (QSR) in June of 1997, and multiple revisions have been made to the International Standard ISO 13485, expectations for compliance with design control requirements have evolved. Further, as regulatory authorities have become more focused on ensuring the safety and efficacy of products, what may have been considered acceptable a number of years ago may not be acceptable today. As such, a company’s design control program should be dynamic in nature and continue to evolve in accordance with current standards and industry practice.

It is hard to believe that it has been over 16 years since the book was first published and, although the design control requirements have not changed significantly during that time, my participation in FDA and Notified Body audits have implied that the deliverables required to demonstrate compliance have changed. Having been responsible for implementing quality management systems to meet domestic and international requirements and working as a consultant to medical device manufacturers for the past 20 years, I have had the benefit of working for and with all types of companies, both large and small, manufacturing a broad range of devices and using varying design control systems. This exposure has enabled me to develop practical methods to meet standard requirements and comply with external regulatory body requirements.

My main goal in writing the third edition is to keep the book current with respect to design control requirements and current with respect to the methods used to comply with third-party expectations for compliance. In this third edition, the scope of the book has been updated to address ISO 13485:2016 requirements for design control and to reference associated Medical Device Single Audit Program (MDSAP) design control requirements. The book has also undergone a major revision in an effort to provide more detail for understanding and implementation of the design concepts. Additionally, the majority of the appendices have been revised or replaced with more current templates.

In a book such as this, which covers the design control requirements applicable to a broad range of products and companies, it is often difficult, and likely impossible, to include every opinion or interpretation of the requirements or present the information in a manner that addresses everyone’s specific situation. Given this diversity, the intent of this book is to present a practical review of the design control requirements and provide practical and proven tools and techniques for meeting the design control requirements and third-party auditor/investigator expectations. Manufacturers can and should seek out technology-specific guidance on applying design controls to their particular situation.

Author

Marie B. Teixeira is the founder and principal consultant for QA/ RA Compliance Connection, Inc. in Odessa, Florida. QARACC is a worldclass consulting company providing expert management and guidance for its clients in all aspects of global quality management and regulatory affairs. Under her direction and guidance, her clients have received ISO 9001, ISO 13485, CE, and MDSAP certification and obtained regulatory clearance for their medical devices internationally.

Before beginning this venture, she was Director of Quality Assurance and Regulatory Affairs at Bioderm, Inc., a start-up medical device company in the Tampa Bay, Florida, area where she designed, directed, and implemented the policies and procedures that established this company’s compliance with global regulatory requirements.

Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs at Smith & Nephew’s Wound Management Division in Largo, Florida. In addition to directing the planning, development, and implementation of Smith & Nephew’s ISO 13485, FDA GMP, and MDD 93/42/EEC regulatory efforts, she implemented and directed the company’s internal audit program and management review system. It was her direction and guidance that allowed Smith & Nephew’s Wound Management Division to achieve ISO certification in less than a year, as well as their MDD certification one year later.

Ms. Teixeira began her career as a Quality Engineer for Raytheon, GTE Government Systems, and Sparton Electronics. During her tenure at these companies she was responsible for establishing and implementing quality assurance programs and procedures, leading supplier and customer audits, developing and performing quality system and auditor training, initiating and managing corrective actions, and developing and implementing supplier certification programs. During her tenure at Sparton, she managed the company through its initial ISO certification and subsequent surveillance audits.

Marie Teixeira holds a BS in Industrial Engineering and Operations Research from the University of Massachusetts at Amherst. She is a member of the American Society for Quality. Ms. Teixeira is an ASQ-Certified Quality Manager and Quality Engineer and an Exemplar Global Principal Auditor. Ms. Teixeira was also an active member of an international task force CEN/TC257/SC-DETG10—whose objective was to standardize medical device nomenclature. Ms. Teixeira recently authored her third edition of the book titled Design Controls for the Medical Device Industry. She has also published numerous quality-system-related CD-ROM training modules and related informational handbooks and has conducted numerous quality system training seminars.

Chapter one Introduction

Quality system requirements apply to all organizations providing medical devices regardless of the type or size of the organization. Medical device manufacturers are required to establish and maintain quality systems to help ensure that their products consistently meet applicable requirements and specifications.

In the United States, the quality system requirements for FDAregulated devices are codified under 21 CFR Part 820—Quality System Regulation (QSR). Likewise, ISO 13485 is an international quality management system standard applicable to medical devices. ISO 13485 is considered compatible with the QSR. The QSR and ISO 13485 Standard include the requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing finished medical devices. Manufacturers are expected to adopt current and effective methods and procedures to control the design and development of medical devices.

What is “design control”? Design control may be thought of as a system of checks and balances that ensure that the product being developed will meet the performance requirements for the product; the applicable statutory and regulatory requirements for marketing and distributing the product; the needs of the end user (i.e., customer); and is safe and effective for its intended use. Simply put, design controls are a documented method of ensuring that what you think you are developing is what you wanted to develop in the first place and that what finally comes off the production line is what the customer needs and wants and you can legally market and distribute.

Why design controls? The Safe Medical Devices Act of 1990 (the SMDA), enacted on November 28, 1990, amended Section 520(f) of the Food Drug and Cosmetic Act, providing the Food and Drug Administration (FDA) with the authority to add preproduction design controls to the current Good Manufacturing Practice (cGMP) regulation. This change in law was based on findings that a significant proportion (44%) of device recalls

were attributed to faulty design of product believed to be due to an inadequate allocation of resources to product development.1 FDA published the revised cGMP requirements in the final rule entitled “Quality System Regulation” in the Federal Register of October 7, 1996. This regulation became effective on June 1, 1997, and remains in effect today.

When the FDA first began inspecting medical device manufacturers for compliance with the design control requirements, they kept track of the areas where manufacturers were most deficient. The results of 157 inspections from June 1, 1998, through September 30, 1999, showed that inadequate design and development planning was the most significant problem area.2 Now, almost 20 years later, compliance with design control requirements still remains a problem for medical device manufacturers with the majority of inspectional observations and warning letter citations under the design element having to do with design validation, the design change control process, and a lack of, or inadequate design control procedures.

From 2011 to 2016, the FDA issued 3,884 warning letters to medical device firms for quality system (QS)/GMP deficiencies. Of the warning letters issued, 647 (17%) included design control citations.3 If we look at the most recent available data from CY2016, warning letter citations for design controls continue to hold steady at 18%. The breakdown of the design control subsystem citations for CY2016 is shown in Table 1.1 4 Inspectional 483 observations from CY2016 are consistent with warning letter citation areas of noncompliance.

If during an FDA inspection of your facility any major deficiencies exist, the FDA will classify the Establishment Inspection Report (EIR) as

Table 1.1 Design control subsystem warning letter cites 2016

Total Citations = 37

21 CFR 820.30(g) = 9

21 CFR 820.30(i) = 8

21 CFR 820.30(f) = 4

21 CFR 820.30 = 3

21 CFR 820.30(j) = 3

21 CFR 820.30(a) = 2

21 CFR 820.30(e) = 2

21 CFR 820.30(h) = 2

21 CFR 820.30(a)(1) = 1

21 CFR 820.30(b) = 1

21 CFR 820.30(c) = 1

21 CFR 820.30(d) = 1

1 Preproduction design controls were added to the Safe Medical Devices Act in 1990. This Act provided FDA the authority to add preproduction design controls to the cGMP regulation. This was felt necessary due to findings that showed a significant proportion, 44%, of device recalls were attributed to faulty product design. The proportion was even greater for software-related recalls at 90%

2 FDA QSIT Workshop, Orlando, FL, October 1999.

3 FDA—Medical Devices. WL Citations by QS Citations (CY2011–CY2016).

4 FDA—Medical Devices. CY2016 Design Control QS Subsystem WL Citations.

Official Action Indicated (OAI) and, based on the significance (risk) of the device and the findings, will determine which administrative and/or regulatory action to initiate. Such actions include, but are not limited to, issuance of a Warning Letter, injunction, detention, seizure, civil penalty, and/or prosecution.

If any of these deficiencies exist for foreign manufacturers, based on the significance (risk) of the device and the findings, a Warning Letter and/or Warning Letter with Detention without Physical Examination will be considered by the Center for Devices and Radiological Health (CDRH)/ Office of Compliance (OC).

Chapter two Device classification

Before we talk about who is required to comply with design control requirements and what those requirements are, let’s talk a little about medical device classification. Medical devices are typically assigned a device class. In the United States, medical devices fall into three device classes. In Europe, Canada, Australia, Brazil, and Japan there are currently four medical device classes. Additionally, the European and Australian classification system includes a Class I sterile and Class I measuring function category (See Table 2.1).

The amount of control needed for a medical device to ensure its safety and effectiveness is dependent upon its medical device class. A Class I device represents the lowest risk of harm to the user and requires the least amount of regulatory control, whereas a Class III or IV device represents the greatest amount of risk of harm to the user and requires the most regulatory control.

The class to which a medical device is assigned is based upon its safety and effectiveness or “risk.” In the United States, the FDA determines and assigns the device class by considering the following factors:

• Intended use—who is the device intended for?

• Indications for use—what are the conditions for use of the device including the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the device, and other intended conditions of use?

• Safety/risk—what is the probable benefit to health from use of the device when weighed against any probable injury or illness from such use—risk/benefit?

• Effectiveness—what is the reliability of the device?

In Europe, Canada, Australia, and Brazil, medical devices are also classified using a risk-based classification scheme; however, it is the manufacturer’s responsibility to determine device class. In determining the device classification, manufacturers must consider the following:

• Device intended use—what part of the body is affected?

• Device duration of contact—how long the device is in continuous use?

• Device degree of invasiveness—the degree in which the device contacts the patient?

Table 2.1 Medical device classes Country

In Europe, device classification is determined using Annex IX of the Medical Device Directive or Annex VIII of the Medical Devices Regulation. Similarly, in Australia, device classification is determined using Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. In Canada, medical device classification is determined per Schedule 1 of the Canadian Medical Devices Regulation (SOR-98/282). In Brazil, medical device classification is determined per Annex II of RDC No. 185. In Japan, medical device classification is determined by the PMD Act and JMDN Code. Some examples of device classification of medical devices are shown in Tables 2.2 through 2.4.

Table 2.2 US medical device class examples

US class Examples

I Forceps, scalpels, surgical scissors, ophthalmic surgical needles, elastic bandages, examination gloves, hand-held surgical instruments, laryngoscope blades and handles, esophageal stethoscopes, nose clips, ventilator tubing, tracheal tube stylets, oxygen masks, nasopharyngeal airways, hearing aids, otoscopes, occlusive and hydrophilic wound dressings, eye pads, surgeon gloves, patient scales

II Infusion pumps, surgical drapes, diagnostic ultrasound, powered wheelchairs, bone fixation plates and screws, T-piece resuscitators, positive end expiratory pressure (PEEP) valves, wound dressings, apnea monitors, powered emergency ventilators, tracheal tubes, bronchial tubes, DC defibrillators, vascular clamps, piston syringes, oximeters, oscillometers, audiometers, ophthalmoscopes

III Replacement heart valves, silicone gel-filled breast implants, implanted cerebella stimulators, implantable pacemakers, pacemaker programmers, intraocular lens, hip joint acetabular metal cemented prosthesis, shoulder joint glenoid metallic cemented prosthesis

Table 2.3 EU medical device class examples

Eu Class Examples

I CO2 detectors, CPR bags, face masks, laryngoscope blades and handles, dressing adhesive removers, most orthotic or prosthetic devices, ostomy collection devices, wheelchairs, spectacle lenses and frames, fundus cameras, rehabilitation equipment, stethoscopes, examination gloves, hypodermic syringes, incision drapes, conductive gels, wound dressings that act as a mechanical barrier for compression or absorption of exudates, reusable surgical instruments

I sterile Any sterile Class I device—e.g., sterile laryngoscope blades and handles, sterile eye guards/shields, ET introducers and stylets

I measuring function Devices that measure body temperature; non-active, non-invasive device for measuring blood pressure; non-active devices for measuring intraocular pressure; devices for measuring volume or pressure or flow of liquid or gases delivered to or removed from the body—e.g., manometer, negative inspiratory force monitor

IIa CPAP, endotracheal tubes, incontinence cleansers, protective barrier creams, X-ray film, cleaning and disinfecting products used with medical devices, syringes for infusion pumps, anesthesia breathing circuits and pressure indicators, polymer film dressings, hydrogel dressings and non-medicated impregnated gauze dressings, contact lenses, urinary catheters, fixed dental prostheses, surgical gloves, bridges, crowns, dental alloys, muscle stimulators, TENS devices

IIb Long-term use tracheostomy tubes, wound dressings for chronic extensive ulcerated wounds, severe burns or severe decubitus wounds, blood bags, contact lens care products, condoms, radiological equipment, urethral stents, insulin pens, brachytherapy devices, prosthetic joint replacements, intraocular lenses, non-absorbable sutures, bone cements, lung ventilators, surgical lasers, diagnostic X-ray sources

III Intrauterine contraceptive devices (IUD’s), heparin-coated catheters, bone-cement containing an antibiotic, cardiovascular catheters, neurological catheters, cortical electrodes and connonoid paddles, absorbable sutures and biological adhesives, prosthetic heart valves, aneurysm clips, spinal stents, condoms with spermicide, dressings incorporating an antimicrobial agent to provide ancillary action on the wound, collagen implants

Table 2.4 Canada medical device class examples

Canada class Examples

I Oropharyngeal airways, tympanoscopes, intranasal septal splints, reusable surgical and dental instruments, dressings, adhesive strips, surgical drapes, manual adjustable hospital beds, thoracic drainage systems, intraoral dental lights, surgical microscope systems, endoscopic still cameras, AC-powered keratoscopes, fiberoptic illuminators for endoscopes, leg braces

II Disposable surgical instruments, short-term intravascular catheters, X-ray detectable, non-absorbable internal sponges, oximeters intended only for sampling percent oxygen saturation, ECG machine intended only to be used in a doctor’s office for routine checkups, laryngoscopes, retention-type catheter balloons, daily wear soft contact lenses, orthodontic brackets, preformed dentures, latex condoms, hydrogel dressing, wound and burn, flowmeters, piston syringes, nebulizers, audiometers, steam sterilizers

III Pulse oximeters recommended for use in the operating and recovery room for continuous monitoring of arterial oxygen saturation, ECG machines intended to be used in critical care settings, peritoneal, long-term indwelling catheters, internal saline inflatable breast prosthesis, shoulder prosthesis, amalgam alloys, tooth-shade resin materials, intrauterine contraceptive devices, tracheal stents, female condoms, gas analyzers, infusion pumps

IV Intracardiac oximeters, breast implants, aneurysm clips, HIS bundle detectors, implanted spinal cord stimulators for pain relief, fetal blood sampling endoscopes and accessories, fetoscopes and accessories, external, pacemaker, pulse generator, automatic implantable cardioverter defibrillator, implanted vagus nerve stimulator, cerebral blood flow monitors, fetal pH monitors, closed loop blood glucose controller, closed loop blood pressure controller, collagen corneal shields, tissue heart valves, skin grafts

Chapter three Overview of design controls

Applicability

Now that we have discussed how medical devices are classified, we can determine who is required to meet design control requirements and what those requirements entail—i.e., Who? What? Why? How?

Design controls are a component of a comprehensive quality management system that covers the entire “life” of a device from initial approval of the device design to disposal. Design controls are needed to ensure products meet specified requirements, user needs, and are safe and effective for their intended use. The FDA QSR and ISO 13485 Standard require that you document the method you use to control your design and development process.

In the US, medical device companies that design and develop Class II and Class III medical devices, as well as devices automated with computer software and Class I devices listed in Table 3.1, are mandated to comply with the design control requirements called out in 21 CFR 820.30. Similarly, organizations that require compliance with the ISO 13485 international standard must also comply with design control requirements unless exclusion of these requirements (Section 7.3) is permitted.

Note: Exclusion of design control requirements does not exclude manufacturers from design change control requirements and the need for a design change procedure (e.g., FDA 21 CFR 820.30(i) and ISO 13485:2016 Sec. 7.3.9). Further, Australia (Schedule 3, Part 6, Sec. 6.4), Canada (CMDR 9, 10–20), Brazil (ANVISA 16 Sec. 4.2), and Europe (Annex VII Sec. 2 and 3) require that technical documentation exist to show compliance with essential principles of safety and performance.

Design controls and the bottom line

The main objective of any business is to make money. The question that we need to continually ask ourselves as business people is whether what we are doing is moving us closer or farther away from that objective. Designing a new medical device requires engineers to determine the materials that will be used as well as determine the best way to assemble and test the product. Unfortunately, oftentimes these otherwise bright people forget the goal of the business. They have not been hired to make

Table 3.1 Class 1—Design control applicability

Section FDA class I device

868.6810

878.4460

880.6760

892.5650

892.5740

Tracheobronchial suction catheter

Surgeon’s glove

Protective restraint

Manual radionuclide applicator system

Radionuclide teletherapy source

Devices automated with computer software

the longest-lasting, strongest, most cosmetically pleasing looking medical device. They have been hired to make a medical device that is safe and effective for the application for which it is intended to be used. More importantly, they have been hired to do this and generate the most profit.

All those things like comfort, safety, effectiveness, ease of use, and durability are certainly key elements that will contribute to achieving the ultimate goal, but the prime design criteria are whether the device will make money—at least if you buy into the idea that being in business has profit as its prime objective. Meeting this objective may be as simple as answering the following questions:

• Is this a viable product?

• Will anybody buy this?

• Is it reimbursable?

• Does the product fit into the company’s overall product portfolio and business strategy?

• Can we manufacture it at a cost that will give us the desired profit margin?

The product development process must also address the purchasing, production, marketing, financial, and customer expectations required for the product in addition to all those things that the product must do to be safe and effective for its application. The only way to ensure that all these factors are addressed and that they do not conflict is through the creation of some sort of master plan that ensures that all aspects are being looked at and balanced in relation to each other: in other words, a design control system.

Regardless of whether the design control process is mandated by a government agency, as it is with medical devices, it simply makes good business sense to control what is a very expensive process. No modern company, whether large or small, can afford the experiment-till-youdrop-or-find-an-answer approach made famous by Thomas Edison. Today’s world simply moves too fast and is too expensive. If your company

develops and manufactures medical devices, a design control program needs to be implemented not just because the FDA has mandated it but because there is really no efficient alternative for managing the product development process. An effective design control program will reduce the guesswork, the wrong turns, and the blind spots and provide a structure for sound reasoning and objective decision-making.

Keep in mind, the design control process does not apply to basic research, at least not in the context of this book, or to feasibility studies. However, once it has been decided that a particular product or design will move forward toward production, a design control process must be implemented for medical devices.

When might design controls be considered?

Design controls may be applied to any product development process and may be initiated for a variety of reasons including but not limited to:

• Identification of a new product or market;

• New intended use or patient population;

• Marketing need to satisfy a customer’s request or problem;

• Cost constraints/savings to the customer or company;

• Potential for a process improvement;

• Change to improve safety or performance; and

• Change that is imposed by external circumstances.

What are the benefits of design control other than the obvious mandate?

Design controls help to identify what your customers want and need, what they are willing to pay for, and what your competition is doing. They can even help you identify who your competition really is and where you should focus your marketing efforts.

Implementing design controls at the outset of the design and development process helps to reduce the overall project and product costs by permitting the identification and correction of problems earlier in the design cycle. Identification of discrepancies earlier in the process reduces the amount of costly redesign and rework and improves the quality of the product. Early detection of problems also allows you to make any essential corrections and adjust resources as needed or help you to realize that a product cannot be manufactured or manufactured at the projected cost and may need to be modified or terminated before thousands of dollars are spent needlessly.

The basic intent and underlying principle of design controls is that it will enhance communication and the coordination of interfaces (e.g., team members). A formal design control process puts all project team members on the same page by providing them with a more complete understanding of the product requirements, the user and patient’s needs, and the company’s objectives. Tasks, dependencies, and responsibilities are clearly defined so that their impact on the design project and project team members is clearly understood.

Further, design controls provide an interrelated set of practices and procedures—i.e., a system of checks and balances to ensure that outputs meet input requirements. In other words, the product you developed is what you intended it to be, is what the customer wants, it has been verified and validated as meeting all of these requirements, and has been proven to be safe and effective for its intended use.

An idea is born

If you stop to think about how much it costs to research, develop, and then manufacture a new product from the point at which somebody says they need it, to the point when the first batch of product comes off the production line, you might wish you had a way to ensure that your new product was the right one and that it worked right the first time. Think about that whole process. There are a lot of steps, and each step uses your company’s most valuable resource: your people. New product development has a voracious appetite. It consumes people, and people use time and money. Time and money are two of the things that you have to keep an eye on if you want to make a profit and stay in business. An easy way to control this is to do it right the first time—and that is what design controls can help accomplish.

So what typically happens when a new product is developed, or for that matter when an old product is improved? In the ideal world, the customers say: “We want this,” or “We need that and I’m willing to pay more for it.” If they’re not telling you that directly, then you need to go and find out just what it is your customers really want or need. It’s called market research, and it costs money and it takes time. But if it’s done correctly, you will know what kind of product you need to develop to make a profitable sale in the first place and you won’t waste time and money developing something that you know how to manufacture but nobody wants.

Ask the customer

At this point, you still don’t know if you can actually do what they want, but at least you know what you should do. Sometimes the whole thing starts differently. Occasionally, an inventor has a great idea. It may be for

something entirely new, or it may be a better way to do something that’s been done before, in some way that’s better than the old way. This lone inventor then sets off and begins developing the product. He/she risks their own money, time, and other things. One would think that this inventor might want to check to see whether anybody else thought the product was a good idea before moving ahead, but that is not often a question the entrepreneur considers, and it’s often only a personal risk. Suppose, however, that your company has a department full of inventors that you call the Research & Development Department, and they come up with this really cool idea for something new. Do you go ahead and do it because you know you can, or at least think you can? Do you assume you know what’s best for your customers, or do you ask them? Although the answer may seem obvious, it should be stated. You need to ask your customers what they want, and you need to keep asking them throughout the development process, and in fact, throughout the commercial life of the product.

Design controls and the customer

The design control process is a cyclical system of checks and balances that starts and ends with the customer. Product development should start with the identification of what the customer or user wants and what he or she needs. Actually, defining the customer can be far more complicated than it seems. Is the customer the patient, the nurse, the physician, or the healthcare facility? In many cases, the answer is all of these. Answering that question correctly is one of the major obstacles associated with developing a new medical device, or improving an old one. Like many developments in medical devices, the answer will likely be a combination, and maybe even a compromise, among the many requirements each wants and needs. So now that we know that if we make this device there is a market for it, i.e., we’ve done our market research, now what? We need a plan.

Design and development phases

The design and development process is often depicted as consisting of a logical sequence of phases or stages. The influence of design controls on a design and development process is often illustrated with a traditional waterfall model as shown in Figure 3.1. Although this model provides a useful depiction of the design process for simpler devices, for more complex devices, a concurrent engineering model is more representative of the design process. Concurrent engineering is said to blur the line between development and production in that various components of a design may enter production before the design as a whole has been approved. As a result, a more comprehensive matrix of review and approvals is needed to ensure that each component and process design is validated prior to

Figure 3.1 Application of design controls to the waterfall design process. (From FDA, Design Controls Guidance for Medical Device Manufacturers; courtesy of Health Canada, Medical Devices Bureau.)

entering production, and the product as a whole is validated prior to design release. Let’s take a look at how the design control process may be broken down into various phases or stages.

The first phase: Definition—i.e., design input

All we need to do to get started is identify what we would like the product to be or do and who needs to be involved in this product development effort. In other words, we need to define our product, user, and interface requirements, i.e., design inputs, so that we can begin developing the outputs we will need to verify and validate the device design for its intended use. We should also be able to look at our market research data and identify and assess any known or anticipated risks associated with our device so that measures can be taken to eliminate or reduce these risks to acceptable levels—i.e., perform a risk analysis. Finally, in order to successfully manage the design and development project, we will need to establish a design and development plan that identifies all of the activities that need to occur and assign responsibility for each task.

To get started, we need to begin asking some basic but essential questions, which may include, but are not limited to:

• What is the intended use?

• What will be the indications for use?