IEEE TRANSACTIONS ON BIOMEDICAL
ENGINEERING, VOL. BmE-22, NO. 2, MARCH 1975
If a student chooses to transfer to CSUS well in advance of his graduation, Napa College has the flexibility to allow program changes which aid the transfer student's objective; thus, he may elect courses which will eliminate the need for an extra half semester.
147
a baccalaureate degree some time subsequent to his graduation from a 13MVET program, certain deficiencies in general would exist due to out-of-date or non-transferable courses. However, enough flexibility has been included in the career ladder arrangement to allow students with diverse backgrounds to pursue the program. Each student will be counseled individually, and a specific program of study tailored to his educational experience will be worked out to make up for any deficiencies. The aim of this "career ladder" program is to permit qualified BMET's to pursue a rigorous program leading to a baccalaureate degree in biomedical engineering. It is the feeling of all concerned that the type of arrangement described herein is an important component of a complete biomedical engineering educational program. REFERENCES
CONCLUSION The program described above has been developed through cooperation between CSUS and Napa College, and we are currently developing similar arrangements with other BMET programs in Northern California. It is important to note that specific programs have been arranged to represent the best compromise between the BMET program at Napa College and the electrical/biomedical engineering curriculumn at CSUS under the assumption that the student has decided to transfer to CSUS before graduation from Napa College. In the more [1] Cook, A. M., "An applied bioengineering curriculum," A-fed. Res. ikely event that a student makes the decision to pursue Engr., in press, 1974.
Education for Employment Industry
Biomedical Engineering
by
ALAN R. KAHN, FELLOW,
Abstract-While a considerable number of bioengineers have been trained during the past few years, relatively few have found challenging jobs in industry. This is due in part to the level of development of the biomedical industry and to the type of training received by the bioengineers. However, significant industrial roles have developed for bioengineers including management of R & D projects, clinical evaluation, and collaborative professional relationships with clinicians in the medical community. Bioengineers have not been most effective in the product design process. A need exists for additional training for bioengineers in the role of prgject leadership and in the technical areas of the interface of body tissues with materials and electrical current.
IEEE
application of this training. Industrial institutions concerned with providing bioengineering products and services have not availed themselves of the bioengineer and have provided very little feedback to the training institutions. Another important factor relating to the industrial community can be seen in some of the data on the various corporations. Most of this industry is made up of very small companies selling single products to limited markets. A number of the relatively few larger corporations do not have biomedical products as their major interest and tend to utilize classical engineering disciplines and ignore the biomedical engineering resource. There are very few major companies strongly committed to biomedical instrumentation product lines. This rather fragmented industry must certainly be a disturbingly confusing area when viewed from the standpoint of a new graduate preparing to enter the field or an educator determining how best to
T HE development of the use of sophisticated instrumentation in the care of human patients has been so recent and so rapid that the institutions supporting these activities are only now beginning to understand how to use the people and the technologies effectively. Biomedical engineering education programs have been producing him to do so. highly trained people, but at the same time they have prepare been giving insufficient attention to the opportunities for ROLES FOR BIOENGINEERS During the past seventeen years in which I have been Manuscript received July 9, 1974; revised September 28, 1974. in the biomedical instrumentation industry, I involved The author is with Medtronic, Incorporated, Minneapolis, Minn. have seen several key roles develop for bioengineers. 55418.
148
Medtronic employs bioengineers in three key areas, and to communicate these roles I shall first mention several points about the organization itself. Medtronic's research and product development activities are organized in a two-dimensional management matrix. We have functional departments which provide the necessary services to complete our tasks such as electrical design, mechanical design, drafting and documentation, animal research laboratory, statistical services, materials research, power sources research, and many others. In these departments we employ the best people we can find who are expert in each of these functions. The second dimension of the matrix is constituted of the various programs we have undertaken. Each of our research programs and each of our product programs is managed by someone who has that activity as his major concern and who provides work direction to a team of people who are assigned to that program. This team of people is comprised of members of the various functional departments whose services are required. The constitution of the team varies as the requirements change during a development cycle, but continuity is provided by the program leadership. These program teams and their managers have the major missions to perform, and the rest of the structure is there to support them.
IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, MARCH
1975
The academic process, in general, is heavily oriented toward the development of the individual and in one way or another provides incentive through competition with classmates or fellow trainees. This tends to imprint a pattern which does little to prepare him for the teamwork which will be required at a later date. The role of the bioengineer as a team leader in the industrial environment makes this especially a problem which somehow must be changed in his early training process.
PRODUCT DESIGN The role of the research and development programs in Medtronic is to examine the feasibility of new product ideas often to the point where models have been constructed and have undergone some testing on animals and perhaps human patients. After this activity has been completed, a much larger program must be undertaken to design, document, assure reliability, and develop manufacturing processes for a product. We call this process product engineering. The skills required to manage the product programs during this phase are very hardware and process oriented, best handled, we have found, by people who combine a strong hardware orientation with an especially well developed capacity for managing people. This process involves the interaction of almost every department within our corporation. We do not find that MANAGEMENT OF RESEARCH AND bioengineers are the most effective people for this job since DEVELOPMENT PROJECTS neither hardware orientation nor management is a major With products such as cardiac pacemakers and neuro- part of their training or experience. logical pain stimulators which apply energy directly to CLINICAL EVALUATION body tissues and which, in some cases, are life supporting, Medtronic must be very closely involved with both the We require that our products be tested on human biological and engineering aspects of our products. The role patients under carefully controlled circumstances before of management of the research and development programs they can be marketed. This clinical testing is performed is becoming increasingly important, and the sophistication for different reasons on different products depending on of the people providing this program leadership is increas- the unique features or types of changes from previous ing. We find that more and more of our programs in experience. For example, simply changing the duration of research and product development areas fall under the a pacemaker pulse by altering the value of a single resistor direction of trained biomedical engineers. Medtronic has results in almost no modification of the device but can a number of programs in both the cardiovascular and have a very significant effect on the performance of the neurological disciplines. Cardiovascular programs include pacing system in stimulating the heart. On the other hand, studies on methods for preventing serious cardiac arrhy- changing from discrete circuit technology to integrated thmias, new methods of cardiac pacing, anrd mechanical hybrid circuit ackaging has profound impact on the circulatory-assist pumping systems. Each of these pro- design but may have no significant impact on the intergrams is managed by a biomedical engineer with either a face between the device and the patient. These two types master's or doctor's degree. The neurological programs of developments would require very different testing proare oriented toward the management of pain and the grams. With the increased use of these kinds of devices in treatment of neuromuscular disorders. That department patients and the interest of the federal government in is managed by a graduate bioengineer who has another regulating them, clinical test programs are becoming a major part of our product development process. It appears bioengineer on his staff. a and technical D scientific to us now that the bioengineer, with his understanding of R & These positions require an of the device, its application, and the body systems it affects, understanding knowledge of the program content, to the most qualified manager for the clinical testing prothe is and the research process, ability provide leadership has a done. It been which are conducted by outside physicians in the to of grams and manage a team people get job our experience that a bioengineer with Ph.D. training is hospitals and universities with which we collaborate. In well based with scientific and technical knowledge and the the drug field, specially trained physicians usually perform scientific methods but is not nearly as advanced in the this type of managerial function, but then the physician ability to manage people and work as a member of a team. is highly trained in chemistry and biochemistry. In the
149
KAHN: EDUCATION FOR EMPLOYMENT
device field, he has no training at all, and the bioengineer appears to us to be the best candidate to provide leadership in the design of clinical test programs and their coordination. Again, it is his task to direct the activities of a team of support people.
ment of people and programs should be an important part of biomedical engineerinig training. One small point I would like to include in this discussion of education is the need for a course of study in the electricity of solutions and tissues. I have encountered very few trained biomedical engineers who have background in the manner in which electrical energy is coupled to tissues or conducted through them. The bioengineer with an electrical engineering background often tends to think of tissues as passive networks of resistors and capacitors in order to deal with the phenomena which take place when electrical current is applied. The bioengineer who is dealing with applying electrical current to tissues or making electrical measurements from tissues ought to have the background to think in terms of ion mobilities, concentration polarization, charge transfer processes, and the other electrochemical parameters which can provide him a better understanding of what he is doing. In summary, it appears to me that there are a number of key roles for trained bioengineers in the industrial community. While the number of job opportunities which exist today are limited because of the fragmentation of the industry, the situation is clearly changing, and a progressively increasing job market is being generated. The industry is becoming more aware of the biomedical engineer as a resource. Educational programs have to do some rethinking and restructuring in order to train their students for this market. I guess if I had to do it over again, I'd make a career of
PROFESSIONAL RELATIONS Another important area involves the relationship between the corporation and the key physicians whose research and clinical activities provide leadership to their other physician colleagues. The stimulus for most of the new ideas MVedtronic has utilized has come from this community of physician leaders. These men are constantly experimenting with new methods and, when they can, with new devices. An important part of their involvement with our corporation is based on our ability to provide them with the best technical and engineering inputs and support. In most cases they are anxious to work with us as colleagues on new developments if we can provide them someone to work with who has a great deal of technical background and, at the same time, understands the medical problem and the applications of the devices. This job of providing a professional relationship between the corporation and the physician is clearly one for the bioengineer. Many of the physicians are ready to accept him as a -colleague in the investigative relationship as well as in the publications which result. These activities represent my experience with the bioengineer in this medical instrumentation industry. It is clear to me that the areas of teamwork and the manage- bioengineering.
ENGINEERING, VOL. BmE-22, NO. 2, MARCH 1975
If a student chooses to transfer to CSUS well in advance of his graduation, Napa College has the flexibility to allow program changes which aid the transfer student's objective; thus, he may elect courses which will eliminate the need for an extra half semester.
147
a baccalaureate degree some time subsequent to his graduation from a 13MVET program, certain deficiencies in general would exist due to out-of-date or non-transferable courses. However, enough flexibility has been included in the career ladder arrangement to allow students with diverse backgrounds to pursue the program. Each student will be counseled individually, and a specific program of study tailored to his educational experience will be worked out to make up for any deficiencies. The aim of this "career ladder" program is to permit qualified BMET's to pursue a rigorous program leading to a baccalaureate degree in biomedical engineering. It is the feeling of all concerned that the type of arrangement described herein is an important component of a complete biomedical engineering educational program. REFERENCES
CONCLUSION The program described above has been developed through cooperation between CSUS and Napa College, and we are currently developing similar arrangements with other BMET programs in Northern California. It is important to note that specific programs have been arranged to represent the best compromise between the BMET program at Napa College and the electrical/biomedical engineering curriculumn at CSUS under the assumption that the student has decided to transfer to CSUS before graduation from Napa College. In the more [1] Cook, A. M., "An applied bioengineering curriculum," A-fed. Res. ikely event that a student makes the decision to pursue Engr., in press, 1974.
Education for Employment Industry
Biomedical Engineering
by
ALAN R. KAHN, FELLOW,
Abstract-While a considerable number of bioengineers have been trained during the past few years, relatively few have found challenging jobs in industry. This is due in part to the level of development of the biomedical industry and to the type of training received by the bioengineers. However, significant industrial roles have developed for bioengineers including management of R & D projects, clinical evaluation, and collaborative professional relationships with clinicians in the medical community. Bioengineers have not been most effective in the product design process. A need exists for additional training for bioengineers in the role of prgject leadership and in the technical areas of the interface of body tissues with materials and electrical current.
IEEE
application of this training. Industrial institutions concerned with providing bioengineering products and services have not availed themselves of the bioengineer and have provided very little feedback to the training institutions. Another important factor relating to the industrial community can be seen in some of the data on the various corporations. Most of this industry is made up of very small companies selling single products to limited markets. A number of the relatively few larger corporations do not have biomedical products as their major interest and tend to utilize classical engineering disciplines and ignore the biomedical engineering resource. There are very few major companies strongly committed to biomedical instrumentation product lines. This rather fragmented industry must certainly be a disturbingly confusing area when viewed from the standpoint of a new graduate preparing to enter the field or an educator determining how best to
T HE development of the use of sophisticated instrumentation in the care of human patients has been so recent and so rapid that the institutions supporting these activities are only now beginning to understand how to use the people and the technologies effectively. Biomedical engineering education programs have been producing him to do so. highly trained people, but at the same time they have prepare been giving insufficient attention to the opportunities for ROLES FOR BIOENGINEERS During the past seventeen years in which I have been Manuscript received July 9, 1974; revised September 28, 1974. in the biomedical instrumentation industry, I involved The author is with Medtronic, Incorporated, Minneapolis, Minn. have seen several key roles develop for bioengineers. 55418.
148
Medtronic employs bioengineers in three key areas, and to communicate these roles I shall first mention several points about the organization itself. Medtronic's research and product development activities are organized in a two-dimensional management matrix. We have functional departments which provide the necessary services to complete our tasks such as electrical design, mechanical design, drafting and documentation, animal research laboratory, statistical services, materials research, power sources research, and many others. In these departments we employ the best people we can find who are expert in each of these functions. The second dimension of the matrix is constituted of the various programs we have undertaken. Each of our research programs and each of our product programs is managed by someone who has that activity as his major concern and who provides work direction to a team of people who are assigned to that program. This team of people is comprised of members of the various functional departments whose services are required. The constitution of the team varies as the requirements change during a development cycle, but continuity is provided by the program leadership. These program teams and their managers have the major missions to perform, and the rest of the structure is there to support them.
IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, MARCH
1975
The academic process, in general, is heavily oriented toward the development of the individual and in one way or another provides incentive through competition with classmates or fellow trainees. This tends to imprint a pattern which does little to prepare him for the teamwork which will be required at a later date. The role of the bioengineer as a team leader in the industrial environment makes this especially a problem which somehow must be changed in his early training process.
PRODUCT DESIGN The role of the research and development programs in Medtronic is to examine the feasibility of new product ideas often to the point where models have been constructed and have undergone some testing on animals and perhaps human patients. After this activity has been completed, a much larger program must be undertaken to design, document, assure reliability, and develop manufacturing processes for a product. We call this process product engineering. The skills required to manage the product programs during this phase are very hardware and process oriented, best handled, we have found, by people who combine a strong hardware orientation with an especially well developed capacity for managing people. This process involves the interaction of almost every department within our corporation. We do not find that MANAGEMENT OF RESEARCH AND bioengineers are the most effective people for this job since DEVELOPMENT PROJECTS neither hardware orientation nor management is a major With products such as cardiac pacemakers and neuro- part of their training or experience. logical pain stimulators which apply energy directly to CLINICAL EVALUATION body tissues and which, in some cases, are life supporting, Medtronic must be very closely involved with both the We require that our products be tested on human biological and engineering aspects of our products. The role patients under carefully controlled circumstances before of management of the research and development programs they can be marketed. This clinical testing is performed is becoming increasingly important, and the sophistication for different reasons on different products depending on of the people providing this program leadership is increas- the unique features or types of changes from previous ing. We find that more and more of our programs in experience. For example, simply changing the duration of research and product development areas fall under the a pacemaker pulse by altering the value of a single resistor direction of trained biomedical engineers. Medtronic has results in almost no modification of the device but can a number of programs in both the cardiovascular and have a very significant effect on the performance of the neurological disciplines. Cardiovascular programs include pacing system in stimulating the heart. On the other hand, studies on methods for preventing serious cardiac arrhy- changing from discrete circuit technology to integrated thmias, new methods of cardiac pacing, anrd mechanical hybrid circuit ackaging has profound impact on the circulatory-assist pumping systems. Each of these pro- design but may have no significant impact on the intergrams is managed by a biomedical engineer with either a face between the device and the patient. These two types master's or doctor's degree. The neurological programs of developments would require very different testing proare oriented toward the management of pain and the grams. With the increased use of these kinds of devices in treatment of neuromuscular disorders. That department patients and the interest of the federal government in is managed by a graduate bioengineer who has another regulating them, clinical test programs are becoming a major part of our product development process. It appears bioengineer on his staff. a and technical D scientific to us now that the bioengineer, with his understanding of R & These positions require an of the device, its application, and the body systems it affects, understanding knowledge of the program content, to the most qualified manager for the clinical testing prothe is and the research process, ability provide leadership has a done. It been which are conducted by outside physicians in the to of grams and manage a team people get job our experience that a bioengineer with Ph.D. training is hospitals and universities with which we collaborate. In well based with scientific and technical knowledge and the the drug field, specially trained physicians usually perform scientific methods but is not nearly as advanced in the this type of managerial function, but then the physician ability to manage people and work as a member of a team. is highly trained in chemistry and biochemistry. In the
149
KAHN: EDUCATION FOR EMPLOYMENT
device field, he has no training at all, and the bioengineer appears to us to be the best candidate to provide leadership in the design of clinical test programs and their coordination. Again, it is his task to direct the activities of a team of support people.
ment of people and programs should be an important part of biomedical engineerinig training. One small point I would like to include in this discussion of education is the need for a course of study in the electricity of solutions and tissues. I have encountered very few trained biomedical engineers who have background in the manner in which electrical energy is coupled to tissues or conducted through them. The bioengineer with an electrical engineering background often tends to think of tissues as passive networks of resistors and capacitors in order to deal with the phenomena which take place when electrical current is applied. The bioengineer who is dealing with applying electrical current to tissues or making electrical measurements from tissues ought to have the background to think in terms of ion mobilities, concentration polarization, charge transfer processes, and the other electrochemical parameters which can provide him a better understanding of what he is doing. In summary, it appears to me that there are a number of key roles for trained bioengineers in the industrial community. While the number of job opportunities which exist today are limited because of the fragmentation of the industry, the situation is clearly changing, and a progressively increasing job market is being generated. The industry is becoming more aware of the biomedical engineer as a resource. Educational programs have to do some rethinking and restructuring in order to train their students for this market. I guess if I had to do it over again, I'd make a career of
PROFESSIONAL RELATIONS Another important area involves the relationship between the corporation and the key physicians whose research and clinical activities provide leadership to their other physician colleagues. The stimulus for most of the new ideas MVedtronic has utilized has come from this community of physician leaders. These men are constantly experimenting with new methods and, when they can, with new devices. An important part of their involvement with our corporation is based on our ability to provide them with the best technical and engineering inputs and support. In most cases they are anxious to work with us as colleagues on new developments if we can provide them someone to work with who has a great deal of technical background and, at the same time, understands the medical problem and the applications of the devices. This job of providing a professional relationship between the corporation and the physician is clearly one for the bioengineer. Many of the physicians are ready to accept him as a -colleague in the investigative relationship as well as in the publications which result. These activities represent my experience with the bioengineer in this medical instrumentation industry. It is clear to me that the areas of teamwork and the manage- bioengineering.
