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WHITE PAPER ON ROLE OF MEDICAL DEVICE INDUSTRY IN FRAMING

DOCTORS AND HOSPITALS AND THEIR DIFFERENCES WITH PHARMA


COMPANIES
The medical device industry acts as a bridge between physicians, hospitals and pharmacy
companies. Pharmacy and physician are among the integral components of the health care
delivery system. Drugs are the necessary tools available to a doctor for a treatment of an
illness. Thus, the knowledge about old and newer drugs is a must for a doctor. Virtually, daily
a pharmaceutical weapon is added to the physician's therapeutic armamentarium. The
information about a new drug is mostly provided by the pharmaceutical industry, through its
sales representatives, brochures, banners, etc. The doctor should also advise and supports the
pharmacy companies and medical device company regarding the invention of new medicine
and device for the benefit of patients.
It has been observed that many pharmacy companies and medical devices companies pay an
enormous amount of money to doctors for the promotion of their medicine, and medical
devices, which may lead to fraudulent marketing practices and many steps are taken by
domestic organization, as well as international organization to check this malpractice. This
kind of activities are not only spoiling the relationship between patient and doctor, but it is
also harming the ethical, social and legal norms of the society.

Relationships between physicians and the healthcare industry, including pharmaceutical and
device manufacturers and suppliers, can advance medical science and benefits patients. In the
development of new technologies and products, the interaction between device manufacturers
and health care professionals can be especially valuable because physicians play an essential
role in the development, testing, and extensive training involved in producing efficient and
safe medical devices, such as heart valves, pacemakers, and medical lasers. 1 Physicians also
provide ideas and feedback, conduct research and clinical trials, and share their knowledge
through participation in medical education programs. Device companies can legitimately
compensate physicians for their actual time and intellectual contributions to product
innovations and training in the appropriate use of devices. However, in an environment where
1 Examining the Relationship Between the Medical Device ..,
https://oig.hhs.gov/testimony/docs/2008/demske_testimony022708.pdf
(accessed February 10, 2016).

physicians routinely receive substantial compensation from medical-device companies


through stock options, royalty agreements, consulting agreements, research grants, and
fellowships, evidence suggests that there is a significant risk that such payments will
improperly influence medical decision making. Researchers are reporting in medical journals,
such as the Journal of the American Medical Association and the New England Journal of
Medicine, have found that such financial industry-physician relationships are pervasive and
that the impulse to reciprocate for even small gifts has a powerful influence on behavior. It
has been observed that free gifts, subsidized trips, etc. lead to an absolute obligation on the
part of the doctors to return some favors to the companies.
The doctors have appreciated that the pharmaceutical and medical device industries make to
the practice of medicine. Without the discoveries made by industry, many of the medical
advances and products of recent decades would never have been possible. However, there
must be appropriate boundaries between practicing doctors and industry. Industry viability
understandably requires fiscal integrity and a margin of profit. Doctors' primary motive
should be to promote the welfare of their patients.
It is tough for the device industry to develop an instrument with in house resources alone,
but it relies on individual physicians to bring forward clinical needs and concepts for devices.
Physicians often actively participate with in-house engineers (who are not clinicians) to both
develop and improve products. For the most part, device companies do not maintain a large
in-house staff of scientists and researchers but instead they employ engineers who can
translate the ideas and needs of practicing physicians into instrument prototypes. 2 Thus, the
device company's resources are more heavily leveraged toward identifying and exploring
clinical needs as defined by procedure-oriented physicians such as surgeons or endoscopists,
and refining prototypes of tools to meet established clinical needs. It is this direct relationship
with the doctor that allows the development and advancement of medical procedures, often
resulting in less invasive procedures that directly benefit patients. Device companies and their
engineers cannot and do not independently develop instruments for medical care. This device
industry-physician relationship has been essential to the advancement of procedural medicine
from the beginning. If this paradigm is legislatively disrupted or destroyed, there will be a
significant decline in the number and quality of new products and procedures developed.
2 Examining the Relationship Between the Medical Device ..,
https://oig.hhs.gov/testimony/docs/2008/demske_testimony022708.pdf
(accessed February 10, 2016).

Therefore, it is imperative for the medical device industry to maintain a healthy relationship
with doctors and pharmacy companies to cater their needs and for the new and advanced
innovations towards the society.3

Professional medical device companies have an especially important role to play in the
process of educating and training physicians in the use of products and performance of
procedures As outlined above; device companies cannot and should not develop new tools
without defined but substantial input from practicing physicians. Once a new product is
developed and ready for use, there is often significant education and training needed to
introduce an instrument or procedure safely into clinical practice. The physician's and PMA's
role in teaching and training is critical and direct physician involvement is needed in
designing educational programs, without which a new tool may cause significant harm when
introduced into general practice. Continued relationships between PMAs and industry are
essential to the continued safe deployment of new medical devices and techniques to the
practicing physician.4
A doctor plays a paramount role in deciding which medical devices or which device or drugs
he/she is using while treating a patient. Sophisticated medical devices are implanted or
otherwise utilized in a hospital procedure or inpatient stay for which the hospital is
reimbursed. The treating doctor decides or strongly influences the decision regarding which
medical device should be used in this hospital setting. Therefore, a device manufacturer has a
strong financial incentive to persuade treating physicians to use or recommend the
manufacturer's devices. We do not know how much money device manufacturers pay to
doctors. In 2005, the orthopedic device market for hips and knees witnessed domestic sales
more than $5.1 billion and worldwide sales of more than $9.4 billion. We found that during
the years 2002 through 2006, four manufacturers (which controlled almost 75 percent of the
hip and knee replacement market) paid physician consultants over $800 million under the
3 Examining the Relationship Between the Medical Device ..,
https://oig.hhs.gov/testimony/docs/2008/demske_testimony022708.pdf
(accessed February 10, 2016).
4 Examining the Relationship Between the Medical Device ..,
https://oig.hhs.gov/testimony/docs/2008/demske_testimony022708.pdf
(accessed February 10, 2016).

terms of roughly 6,500 consulting agreements. Although many of these payments were for
legitimate services, others were not. The Government has found that sometimes industry
payments to physicians are not related to the actual contributions of the physicians but instead
are kickbacks designed to influence the doctors' medical decision-making. These abusive
practices are sometimes disguised as consulting contracts, royalty agreements, or gifts. The
companies and doctors who engage in such kickback schemes are subject to criminal, civil,
and administrative prosecution. Additionally, physician ownership of medical device
manufacturers and related businesses appears to be a growing trend in the medical device
sector. These business ventures raise substantial concerns that a doctor's return on investment
from the venture may influence the doctor's choice of device. In some cases, physicians could
receive significant returns while contributing little to the venture beyond the ability to
generate business for the investment. It is cautioned in a widely-disseminated letter to a
medical device trade association, "given the strong potential for improper inducements
between and among the physician investors, the entities, device vendors, and device.5
For example, physicians who request additions to hospital drug formularies are far more
likely than their peers to have accepted free meals or travel funds from drug manufacturers.
Similarly, a device company's largess may influence a physician to favor the business's
products. As the American Academy of Orthopedic Surgeons observed, "when an orthopedic
surgeon receives anything of significant value from industry, a potential conflict exists which
should be disclosed to the patient." Doctor plays a critical role in deciding which medical
devices are used in the treatment of their patients.

However, the Government's recent

investigations of several manufacturers of hip and knee surgical implants offer some insight.
Doctors should consider carefully the basis of their therapeutic decisions to assure that they
are made in agreement with best possible evidence applied to the welfare of the patient.
Personal gain must never be the compelling reason for our decisions. Incentives for the
industry, intended to influence therapeutic choices, can compromise doctor integrity and
behavior. Doctors have a responsibility to make sure their work is not changed in any way as
a result of sponsorship or any other relationship with a pharmaceutical, medical devices or
other commercial company. Doctors should tell patients, employers and other institutions
where they see or treat patients about the relationship. If the relationship involves medical
5 Z. Transparency, Conflicts of Interest, Physician Owned ..,
https://www.healthlawyers.org/Events/Programs/Materials/Documents/FC14/zandt
_ (accessed February 10, 2016).

research, the doctor must make sure that the relationship does not influence the study, design
or interpretation of any research data or affect the research or education in any way. The
doctor should also tell the relevant ethics committee about the relationship.
The medical device company should adopt a good relationship practice which may include a
series of interaction, encouragement in scientific exchange of information or lead to enhanced
skill that will ultimately cater the need of the people living with the disease. They should
promote the doctor participation for the better understanding of the device and innovation and
research that will ultimately benefit both the sides vice versa. The doctors will be more
familiar regarding the new product as they have actively participated in the process.6
The medical device company should provide transparency while dealing with doctors,
hospitals and pharmaceutical companies. The pharmacy business requires an active presence
in health care committed to addressing these needs. Both groups want to make necessary
moves to improve interactions. Embracing a new era of engagement and acknowledging the
positive aspects of aligning will move this debate from rhetoric to reality.7

6 GUIDE TO PROFESSIONAL CONDUCT AND ETHICS FOR REGISTERED ..,


https://www.medicalcouncil.ie/News-and-Publications/Publications/Professional-Co
(accessed February 10, 2016).
7 Can the Relationship between Doctors and Drug Companies Ever ..,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706999/ (accessed February 10,
2016).