Medical Device

Industry
Healthcare landscape
 Government hospitals – It includes healthcare centres, district
hospitals and general hospitals
Hospitals
Private hospitals – It includes nursing homes (mini hospitals),
and mid-tier and top tier private hospitals

It includes manufacturing, extraction, processing, purification

Pharmaceutical and packaging of chemical materials for use as medications for
humans or animals

It comprises businesses and laboratories that offer analytical or

Diagnostic
diagnostic services, including body fluid analysis
Healthcare
It includes establishments primarily manufacturing medical
Medical Devices equipment and supplies, e.g. surgical, dental, orthopaedic,
ophthalmologic, laboratory instruments, etc

It includes health insurance and medical reimbursement facility,

Medical
covering an individual’s hospitalisation expenses incurred due to
Insurance sickness

Telemedicine has enormous potential in meeting the challenges

of healthcare delivery to rural & remote areas besides several
Telemedicine other applications in education, training & management in
health sector
Global Medical Device Industry
Global Medical Device Industry

KPMG Report 2018 KPMG Report 2018

Indian Medical Device Industry
Indian Medical Device Industry

With one of the largest populations in the world with a large disease
burden……

What could be some of the reasons for low Medical Device Industry
Size?

What about China?

Medical Devices
• The term “medical devices” includes everything from highly sophisticated
computerized medical equipment down to simple wooden tongue depressors.

• The intended primary mode of action of a medical device on the human body, in
contrast with that of medicinal products, is not metabolic, immunological, or
pharmacological.
Medical Devices
Medical device” means any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article used for…..
Why Does this Industry Exist
Surgical
Diagnose Monitor/control Implants
Interventions
Help people live healthier
Find the disease/condition Diabetes monitoring Complement Surgeons skills
lives
Help people control Critically ill patients Improve surgical outcomes

Laboratory

X-Ray/MRI
Medical Technology
Diagnosis, prevention, monitoring, treatment or alleviation of disease (eg glucometers)

Diagnosis, monitoring, treatment, alleviation of or compensation for an injury (eg meniscus

repair devices)

Investigation, replacement, modification, or support of the anatomy or of a

physiological process (eg heart valves)

Supporting or sustaining life (eg Heart Lung Machine)

Control of conception (eg intra-uterine devices)

Disinfection of medical devices (eg plasma technology in Sterrad)

Providing information for medical purposes by means of in vitro examination

Medical Devices: Safety, Performance, Risk

https://www.youtube.com/watch?v=p3z9FLYijrQ

https://www.youtube.com/watch?v=LH7Q5nFm51Y

https://www.youtube.com/watch?v=3Nf6Q2skGOM

https://www.youtube.com/watch?v=Nae1hWRGpPQ
Medical Devices: Some Terminology
Adverse Event: a problem that can or does result in permanent impairment, injury or death to the patient or
the user

Effectiveness: a device is clinically effective when it produces the effect intended by the manufacturer relative
to the medical conditions.

• For example, if a device is intended for pain relief, one expects the device to actually relieve pain and
would also expect the manufacturer to possess objective evidence, such as clinical test results, that the
device does in fact relieve pain.

Effectiveness can be thought of as efficacy in the real world clinical environment

Also called Efficacy

Incident: an unusual (unexpected) event associated with the use of a medical device.

May or may not lead to problems. All incidents should be investigated for potential problems
Medical Devices: Performance

• Performance, however, may include technical functions in addition to clinical effectiveness. For example,
an alarm feature may not directly contribute to clinical effectiveness but would serve other useful
Purposes

• Performance is closely linked to safety.

• For example, a blood collection syringe with a blunt needle would perform badly for collecting blood and
could inflict injury.

• A patient monitor that does not perform well could pose serious clinical safety problems to the patient.
Thus, the safety and performance of medical devices are normally considered together.

• It is incumbent on the medical device manufacturer to demonstrate that all possible risks associated with
the device are identified and adequately addressed
Medical Devices: Safety and Risk
Management
Regulations are rapidly evolving

Safety and Risk Management

• Absolute safety cannot be guaranteed

• It is a risk management issue

• It is closely aligned with device effectiveness/performance

• It must be considered throughout the life span of the device

• It requires shared responsibility among the stakeholders

https://www.youtube.com/watch?v=uerMJMjo9_E&list=PL4BPHN4r1ZiiMFQhjjwQa6pNLmlqbxlQZ&index=1
Medical Devices: Risk Assessment

• Many medical device problems cannot be detected until extensive market experience is gained

• For example, Stent: an implantable device may fail in a manner that was not predictable at the time of
implantation

• The failure may reflect conditions unique to certain patients.

• For other devices, component failure can also be unpredictable or random.

• The current approach to device safety is to estimate the potential of a device becoming a hazard that could
result in safety problems and harm.

• This estimate is often referred to as the Risk assessment

https://www.youtube.com/watch?v=hkStmOhxAsA&list=PL4BPHN4r1ZiiMFQhjjw
Qa6pNLmlqbxlQZ&index=2
 Medical Devices: Risk Assessment

In practice, risk assessment of medical devices is based on the experience of health care
professionals and on safety design engineering

In the United States, governmental risk assessment of medical devices is based mainly on recommendations
from members of 16 medical specialty panels, and devices are categorized into three classes (I, II, III)

The European Union assigns three classes with class II being sub-divided into IIa and IIb (effectively, also four
classes)

Class I (Lowest risk ) Class II (Higher risk ) Class III (Highest risk )
 Medical Devices: Risk Management

• In classifying devices, potential areas of hazard that warrant consideration include the degree of
invasiveness, duration of contact, the body system affected, and local versus systemic effects.

• An invasive device is usually considered to have higher potential hazard than an equivalent non-invasive
device
• (e.g. there are invasive and non-invasive blood pressure monitors).

• Similarly, devices that have a long duration of contact, that affect vital organs such the heart or the great
arteries, or that have systemic effects are assigned higher classes of potential hazard or risk. The degree of
regulation imposed on any device is proportional to its potential hazard.

• This approach is known as risk management.

https://www.youtube.com/watch?v=nb5kV2LSnFE https://www.youtube.com/watch?v=V746ZO_Wwr0&list=PLb5
6piWuDvCf1iOLEtkG6Iei2EgNVHC0M
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Cardiac
pacemaker Soundness of
should deliver a concept,
minute electrical adequacy of
impulse of a design,
certain size and construction
shape that and testing
simulates the (Verification,
natural Validation and
functioning of clinical trials)
the heart
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Good, functional
medical devices
are produced
when the
manufacturing
process is Good
adequately Manufacturing
managed Practice (GMP)

Poor
manufacturing
non performing
devices
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Delivering clean, Well-sealed

sterile and packaging is
protected essential for
medical devices those medical
to the point devices that
of use must be
Shipping is one maintained
of the hazards a sterile
medical device Labelling:
and its specifying
packaging must instructions for
survive its proper use.
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Misleading or
Has the
Medical device fraudulent advertising
potential to
marketing of medical devices
create
and advertising may increase sales.
expectations
are regulated to
and powerfully
prevent However, may
influence the
misrepresentati deprive the patient of
belief
on of a medical more appropriate
in a medical
device and its treatment and could
device’s
performance lead to patient or
capabilities
user injury.
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

If the vendor is
The sale of not subject to
medical devices regulation, then
by the vendor is there is higher
a critical stage risk of
that leads to the exposing the
device being public to low
put into actual quality or
use ineffective
devices
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Unfamiliarity with a certain User error underlies at least half

technology or operating
procedure, and the
use of products for clinical
indications outside the scope of
those specified in the labelling,
can cause device failure even in
the absence of any inherent
design or manufacturing
defects
of all medical device-related
injuries and deaths
The re-use of disposable devices
contrary to the manufacturers
instructions, and without
proper control or precautions
for minimizing associated risks,
can be dangerous
 Medical Devices: Safety & Performance
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Any of these phases can affect safety and performance

Devices that are

contaminated after Spread of
use (e.g. syringes) or disease
devices that contain
toxic chemicals, can For reusables,
present hazards to proper
people or the sterilization to
environment and avoid cross
must be disposed contamination
of properly
 Medical Devices: Role and Expectation
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling

Manufacturer Vendor User

Qualification and
Comply with
training
regulatory standards
As per design Familiar with
No fraudulent claims
standards indications and
contraindications
User training
Meet or exceed the
standard of safety Deploy only for
After sales service
and performance intended use
Post market
Do not compromise
surveillance
safety of patient
 Medical Devices: Regulations
Conception and Packaging and
Manufacture Advertising Sale Use Disposal
Development Labeling
Pre-market Placing on-Market Post Market Surveillance
Medical Devices: Quality Management

A Quality System is defined as the organizational structure, responsibilities, procedures, processes and
resources needed to implement quality management

International Organization for Standardization (ISO) (ISO13485:1996 and ISO13488: 1996). ISO13485:1996
includes all the elements of ISO9001:1994 plus a set of minimum supplementary requirements for medical
devices

Good Manufacturing Practice (GMP) Certification

Medical Devices: Role of patient

• Patients can contribute to adverse outcomes by not following

health care guidelines appropriate to the product, failure to get
regular medical and surgical monitoring and assessments, and
failure to report product problems

• Recurrence

• Patient Rights
Medical Devices: Global Stats

17 Countries that do not have

43 proper regulations accept
14
devices that are manufactured
in compliance with US (US-
FDA) or European (CE) mark
26

USA EU JAPAN OTHER

Country of Manufacture
 Business Markets & Consumer Markets

Is this B2B of B2C?

Hide Dealers Tanners Manufacturers Wholesaler Retailers

Consumers
Business Markets & Consumer Markets

Is this B2B of B2C?

High Grade Steel

Mining Manufacturers Distributor Hospital
Supplier

Patient
Medical Devices
Consumer Medical Devices
• Buyer and consumption of • Surgeon v/s patient
goods can be the same • Knowledgeable buyer
• Questionable knowledge of • Organized purchase
buyer
• Need for Evidence
• Purchase Pattern/behavior
• Need for regulations
• Evidence?
• Impact on patient life
• Mass market
• Essentially B2B
• B2C
Business Markets & Consumer Markets
Commonalities and Challenges

• Understanding of customer needs

• Understanding of opportunities for growth

• Countering threat of product and service commoditization

• Competition

• Creating the importance of the marketing function within the organization

Business Markets & Consumer Markets
Differences

Close supplier-
Fewer, larger Professional
customer
buyers purchasing
relationships

Multiple buying Multiple sales Derived

influences calls demand

Inelastic Fluctuating Direct

demand demand purchasing
Business Markets: Buying Center
Initiators

Gate
Users
keepers

Buying
Buyers Center Influencers

Approvers Deciders
Business Markets: Buying Center
• Requester for something to be purchased
Initiators
• Those who will use the product or service
Users
• Technical personnel who define specifications
Influencers
• Help evaluate options
• Decision makers
Deciders
• Authorize purchase
Approvers
• Actually do the purchase
Buyers
• Select vendors and negotiation
• Power to prevent sellers or information from reaching buying
Gatekeepers center
Buying Center Influences

Engineers need
OT needs on Finance needs
superior
time suppliers better ROI
performance

Doctors needs Purchase In-

Nurses need
better patient charge needs
easier handling
benefit better rates

Administrator Plant Head Service team

needs supplier needs better needs better
reliability Margins product training
What/Who could consist as a buying centre in a Robotic Surgery?
What/Who could consist as a buying centre for the purchase of stents?
What/Who could consist as a buying centre for the purchase of sutures?
Business Markets: Buying Situations

New Task

Straight Rebuy

Modified Rebuy
Business Markets: Buying Situations
New Task

Awareness Product specifications

Interest Pricing
Evaluation Delivery terms & times
Trial Service Terms
Adoption Payment terms
Order Quantities
Acceptable Suppliers
Selected Supplier
Business Markets: Buying Situations
Modified Rebuy

Awareness Product specifications

Interest Pricing
Evaluation Delivery terms & times
Trial Service Terms
Adoption Payment terms
Order Quantities
Acceptable Suppliers
Selected Supplier
Business Markets: Buying Situations
Straight Rebuy

Adoption Payment terms

Order Quantities
Business Markets: Process
New Task Modified Rebuy Straight Rebuy
Problem Recognition
General Need Search
Product Specification
Supplier Search
Proposal Solicitation
Supplier Selection
Order-Specification
Performance Review
Business Markets: Process
New Task Modified Rebuy Straight Rebuy
Problem Recognition Yes Maybe No
General Need Search Yes Maybe No
Product Specification Yes Yes Yes
Supplier Search Yes Maybe No
Proposal Solicitation Yes Maybe No
Supplier Selection Yes Maybe No
Order-Specification Yes Maybe No
Performance Review Yes Yes Yes
Vendor Selection
Vendor Selection Metrics?

Attribute Importance Score Comment

Delivery Reliability
Price
Supplier Reputation
Credit
Technical service
Supplier flexibility
Product reliability
B2B Customer Relationships
How can we establish and maintain better relationships

Risks and Opportunities

Key Opinion Leaders
Who are your Key Opinion Leaders (KOLs)?

1. Who are looked upon by fellow

Key community 1. ABC Classification based on
Surgeons/ 2. Huge Fan following due to success in volume/value
Physicians practice
3. Current Business/Potential Business
 Key Opinion Leaders
Who are your Key Opinion Leaders?

Bariatric Surgery

Dr Lakdawala Dr Manish Khaitan Dr Aparna G Bhaskar

Sports Medicine
Surgery

Dr Sachin Tapasvi Dr Anant Joshi Dr Dinshaw Pardiwala

Stakeholders in the Medical Device Sector
 Exercise: Stakeholders for Medical
Device Company

Surgeons Regulators Insurance/Payors Politicians

Patients Administrators Purchase In-charge DPCO

 Exercise: Stakeholders for Medical
Device Company
Stakeholder Group
Senior Cardiac Surgeons
Junior Cardiac Surgeons
Hospital Administrator
Purchase In-charge
FDA
DPCO
Insurance
Patient
Politician
Med-Device company 1
Med-Device company 2
Med-Device company 3
Med-Device company 4
Driving Growth in Medical Sector
 5P-4A Framework
• Decision Maker • Disease burden
• User • Surgical volume

Physician Patient
Policy Makers

Policy Makers
Payer Provider

• Insurance • Hospitals
• Out of pocket
4P 4A Framework
• User • Adoption
awareness barriers

Awareness Adoption

Affordability Accessibility

• Ability to • Distribution
pay
Fast facts on balloon sinuplasty:
•The surgery is fairly new, approved by the United States
Food and Drug Administration (FDA) in 2005.
•Balloon sinuplasty, as with all sinuplasty surgeries, is
considered extremely effective in reducing symptoms
of rhinosinusitis.
•Increasingly, balloon sinuplasty is being recognized and
fully covered by medical insurance companies.
Functional endoscopic sinus surgery (FESS) is a
minimally invasive surgical treatment which uses nasal
endoscopes to enlarge the nasal drainage pathways of
the paranasal sinuses to improve sinus ventilation and
allow access of topical medications.
Tender Management

What is a tender?

Why Tender?
 Benefits of Tender Management
Benefits for Tendering Authority Benefits for Supplier

• Transparency in process • Transparency in process

• Choice of vendors • Specification/Technology Evaluation
• Specification/Technology Evaluation • More volumes
• Competitive Quotes • Lock-in period
• Volume Discounts • References on demand
• Better negotiation

Predominantly for Government

Steps in Tender Management
Tender Specs (Fix Specifications)

Query/Objection Handling (Open hour)

Call for Closed bids (Receive quotes)

Technical Evaluation (Technology Evaluation)

Price Negotiation (L1/L2)

Signoff (Approval)

Order Release (Purchase Order)

Tender Management
Tendering Authority?

MS

HM HODs

Dean PI

How to handle L1 Trap?

 Tender V/S Local Purchase V/S Rate Contracts

Benefits of Local Purchase Benefits of Rate Contracts

• Private institutions have rate contracts

• Transparency in process when process is managed
• Shorter Approval time
as a process
• Availability of new or advanced products (Products
• Choice of vendors
not available in Tender)
• Specification/Technology Evaluation
• Department budget outside tender budget
• Competitive Quotes
• Volume Discounts
• Better negotiation
Stakeholders in the Medical Device Sector

Exercise
4P-4A Framework
 • Provider • Physician
• Infrastruct • Skilled
Surgeons

Government/Regulatory
ure
Health Care Financing • Capital • Skill Levels

Policy Makers
Access Adopt

Afford Aware
• Payor • Patient
• Procedure • Awareness
economics
• GP referral
• P. Affordability
Questions