Bio-design Exam

•When a team fails

"problems are often blamed on 'poor communications,' an overly broad label for a range of personality differences that can create tensions and misunderstandings."

•1862

- President Lincoln - Dept. of Chemistry - precursor of FDA

•1906

- Roosevelt - Pure Food and Drug Act - founding of FDA

•The FDA is located within DHHS:

-9,000 employees -$1 billion budget -Costs each American $3 / year.

High level engineering analysis

-Early prototypes, sketches, and drawings

•Defining the requirements

-Functional requirements -Physical and performance requirements Identification of safety concerns

Voice of the costomer

-Identification of user and user needs -What will "Wow" the customer

•Most managers agree that people rarely fail due to a lack of knowledge, skills, or intelligence

-Invariably fail because they are unsuitable in terms of temperament and motivation."

•"A team in the workforce is often formed according to the technical knowledge of its members.

-Little is known, however, regarding the non-technical factors that determine team performance above and beyond individual competency.

Multi-Faceted Teams purpose

-Making Design Possible

•Represent different company departments

-Management / Financial -Marketing -Regulatory -Manufacturing and Quality Assurance -Research and Development (Engineering Design Team)

•Analysis of market

-Market size, intellectual property, regulatory

•Tolerance and understanding (empathy) of another individual's behaviors and actions are the largest benefits that personality tests have to offer teams

-Personality type mismatches don't inherently make a bad team -Misunderstandings of expectations and ineffective communication creates a bad team -Good leadership is founded on creating effective communication amongst team

•Engineering Design Team

-Team leader and team members (electrical, mechanical, materials, computational, etc.)

Food Drug and Cosmetic Act (1938) section 201(h):

... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1.recognized 2.intended for use: 3.intended to affect:

2.intended for use

2.intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

Subpart J - Corrective and preventative action

820.100 Corrective and preventative action

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Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices.

(a) Identification.

A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

What is the FDA

An administrative agency in the executive branch of US government.

Regulatory Envioment

CSA IEC JCAHO ISTA USPTO FDA ASTM EC GHTF ISO

what is designed involved with?

Involves devices, processes, re-engineering, systems, optimization, regulations, finances, innovation, invention, entrepreneurship, etc

Design: Prototype Elements

Preliminary Product and/or Process Design •High level definition of product and process designs •Evaluation of some version targets •High level system trade-offs

Design: Prototypes and Testing

Refinement & Verification of Detail Product and Process Designs

Subsequent legislation

Subsequent legislation

Popsicle stick or Tongue Depressor?

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES Subpart G -- General Hospital and Personal Use Miscellaneous Devices Sec. 880.6230 Tongue depressor. (a) Identification (b)Classification. Class I (general controls)

The FDA's authority comes from:

The FDA's authority comes from the Food, Drug and Cosmetic Act (1938)

is design research or craftsmanship?

design is NOT research or craftsmanship!

Design noun

drawing, arrangement, pattern, plan, art of making designs

•Design Considerations:

economic, environmental, sustainability, manufacturability, ethical, health and safety, social, and political considerations

Mixed Product Use Environments

hospitals and out-patient (home), and surgery rooms, ICU rooms, private doctor offices, MRI

FDA is also incharge of

includes the responsibility of ensuring that no adulterated or misbranded food, drug or medical devices enters into interstate commerce.

Design verb

invent, intend, devise

•1937

— Over 100 people died after consuming a raspberry-flavored sulfa elixir which consisted of 70 percent ethylene glycol... antifreeze

Balancing Individual Skills with Personality Types

•"A team in the workforce is often formed according to the technical knowledge of its members. •When a team fails: communication failure. •Most managers agree that people rarely fail due to a lack of knowledge, skills, or intelligence

7.Preparation for Production

•Refine process for manufacture

Learning Objectives (lecture 3)

•Understand - FDA history •Apply - Medical Device Classification •Understand - Controls •Apply - Design Controls •Understand - BME 3801 / 4801 SOPs •Apply - SOPs

Snake Oil, Cure All!

•Unregulated "patent medicines" •Many contained alcohol or narcotics or worse...

Design: Requirements

•Voice of the customer •High level engineering analysis •Analysis of market •Defining the requirements

•Team training associated with the Myers-Briggs test was very helpful

-Teams should be provided with information on psychological type to help members understand each other better -Demonstrate benefits rather than the limitations of working on a team •Full potential of using teamwork in organizations can be tapped •Productivity gain that many experts predicted from using teams may be realized

•No particular combination of personality types performs better

-Type preferences of team will affect behaviors and decision making processes -Deeper understanding of each other's preferences helps frame context -Helps eliminate concern that other person is just being aggravating -Psychological training (empathy training) greatly increases effectiveness

General controls may include:

1.Design registration 2.GMP manufacturing 3.Premarket approval

A Class III device requires...

1.General exemption 2.Special exemption 3.Premarket notification 4.Premarket approval 5.All of the above

The FDA is associated with what branch of government?

1.Legislative 2.Executive 3.Judicial

Special controls may include:

1.Mandatory performance standards 2.Manufacturing registration 3.Marketing studies

What FDA center regulates medical devices?

1.The Center for Drug Evaluation and Research (CDER) 2.The Center for Biologics Evaluation and Research (CBER) 3.The Center for Devices and Radiological Health (CDRH) 4.The Center for Food Safety and Applied Nutrition (CFSAN) 5.The Center for Veterinary Medicine (CVM)

1.recognized

1.recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

3.intended to affect

3.intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Other Design Steps

6. System Prototype Development 7. Preparation for Production 8. Production, Testing, Certification, Delivery 9. Operation, Support, Decommissioning, Disposal

(b) Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

Class I: General Controls

Class I: General Controls Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.

Class II: General Controls with Special Controls

Class II devices are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user.

Class III: defined as

Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]

Class I: devices

Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.

Class II: devices

Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes.

Class III: devices

Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

FDA History

FDA History

FDA Organization

FDA Organization

FDA Quality Systems

FDA Quality Systems

Class II: general controls

General controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance[2].

Design roadmap

Lecture 2, slide 16

National Academies of Science, Engineering and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years (2011)

Medical Device Classification - I

Minimal potential harm Least regulatory control

Class III: market/documentation requirements

Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.

Medical Device Classification - III

Supporting or sustaining human life Substantial importance in preventing impairment of human health Potential unreasonable risk

Consists of 5 Centers

The Center for Drug Evaluation and Research (CDER) The Center for Biologics Evaluation and Research (CBER) The Center for Devices and Radiological Health (CDRH) The Center for Food Safety and Applied Nutrition (CFSAN) The Center for Veterinary Medicine (CVM)

Lecture 3 (Class 1-26-21)

The Food & Drug Administration and Medical Device Design

Class I: controls

These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.

Class I: general controls

These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)

Activity of the CDRH: Table 1: Major submissions received

lecture 3 (class 1-26-21) slide 14

FDA - General Controls

•All medical devices. •Considered to be the minimum requirements.

Medical Device Fee and Modernization Act, 2002

•Allows FDA to collect fees to review medical device submissions

Medical Device Classification Panels

•Anesthesiology •Cardiovascular •Clinical Chemistry and Clinical Toxicology •Dental •Ear, Nose, and Throat •Gastroenterology and Plastic Surgery •General Hospital and Personal Use •Hematology and Pathology •Immunology and Microbiology •Neurology •Obstetrical and Gynecological •Ophthalmic •Orthopedic •Physical Medicine •Radiology

FDA - Special Controls

•Class II devices. •Assume that General Controls are not sufficient to ensure the safety and effectiveness of the device. •Varies by product. May include:

Successful Teams

•Clear goals: Inspire members •Collaborative climate: Increase knowledge sharing •Principled leadership •Strong interpersonal relationships •Open to discussing issues: Long and short term •Trust •Open to criticism among members •Cohesion

Learning Objectives Related to Teams

•Definition of Team/Success •Cohesiveness/Groupthink •Conflict •Team contracts or working agreements

Refinement & Verification of Detail Product and Process Designs

•Development of designs for components, subsystems & manufacturing •Geometry creation •Prediction & evaluation of attributes •Tracking & trade-offs

Other Design Concerns

•Excessive documentation •Human patients, animal studies, permissions •Design is often iterative •Teamwork, finances, reality •Design Considerations:

6. System Prototype Development

•Experimental evaluation of attributes that do not meet acceptance criteria

Medical Device Industry

•Global market for medical devices exceeds $200B •US market ~ 42% of WW market •US innovation drives the market (more US producers than rest of world combined) •However.. it is increasingly difficult to commercialize •Consumer & agency regulation •Increasing control improves safety and effectiveness at the expense of commercial progress •Overseas manufacturing and product launch

Food and Drug Admin. Modernization Act (FDAMA), 1997

•Increased efficiency of reviews, harmonized FDA and other regulatory standards, QSR

•Considered to be the minimum requirements.

•Manufacturing registration •Label devices per regulations •Submit a premarket notification [510(k)], unless exempt •Manufacture devices per cGMP regulations (Current Good Manufacturing Practice)

Effect of Training about Personalities

•No particular combination of personality types performs better •Team training associated with the Myers-Briggs test was very helpful •Tolerance and understanding of another individual's behaviors and actions are the largest benefits that personality tests have to offer teams

Activity of the CDRH

•Over 12,000 U.S. manufacturers are listed with CDRH •Regulates approximately 1700 general categories of medical devices grouped into 16 major panels of medical specialties.

•Regulates approximately $1 trillion worth of Drugs, biologics and medical devices.

•Oversight over 1 in every 4 dollars spent by American consumers

Design: Specifications

•Product strategy •Voice of the customer!!! •Translate user needs and requirements into specifications •Environment and regulatory •Planned product specification •Development of acceptance criteria and related testing plan (we do this as a separate document)

Multi-Faceted Teams:

•Represent different company departments •Engineering Design Team

Safe Medical Devices Act (SMDA), 1990

•Requires hospitals to report incidents involving medical devices that are reasonably believed to have caused or contributed to the serious injury or death of a patient or employee •Requires manufacturers to conduct post-market surveillance of implanted devices.

The Medical Device Amendments, 1976

•Safety and effectiveness of medical devices •Manufacturer registration •Develop processes for premarket notifications, approvals, predicate devices, and performance standards.

What about Software???

•Software can be a device on its own (standalone), or it can be included in another device, either as a component or part, or distributed separately for use as an accessory to another device.

•Varies by product. May include:

•Special labeling requirements •Conformance with certain FDA guidelines •Mandatory performance standards •Human clinical trials •Post market surveillance

Today's Class:

•The FDA •Quality Systems •Design Control •Why? -Rationale for your design process -Develop professional skills -Better understanding of the role of government, business and individuals in our society

Lecture 2 lecture objective:

•What is Design? -Both the action of doing the process and the product created -It is not research but research may be part of the process •The Multifaceted Nature of Medical Device Design •How to Successfully Work in a Team Environment

Basic but Essential Questions

•Who? •What? •Where? •When? •Why? •How?

The Food, Drug and Cosmetic Act of 1938

•gave authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics