Faster product registration of medical devices in Japan

TOCICO 2009 Conference 

Myths about product registration of 

medical di l ddevice i iin JJapan 

Presented By: Hitoshi Arai, Banyu Pharmaceutical Co., Ltd. 

Co Co-workers: workers: Tadashi Ogashiwa, Yuichiro Iwakiri, smith & nephew 

orthopedics p K.K. 

Date: November 19, 2009 

© 2009 TOCICO. All rights reserved. 

1

About Hitoshi Arai 

• 15 years experience in quality 

and regulatory compliance in the 

area of medical devices, 

pharmaceuticals and cosmetics 

• Has been investigating g g how to 

apply TOC applications in 

healthcare industry which is 

highly regulated by governmental 

bodies. 

• Believes Thinking Process and 

CCPM would be the most 

powerful Kaizen tool to delete 

‘T ‘Touch h ti time’ ’ also l in i the th regulated l t d 

industry 

2 


TOCICO 2009 Conference

Agenda 


1. Environment of Japanese medical device industry 

2. Common issues among companies 

3. An example of solution for shortening regulatory 

registration lead-time using Thinking Process (TP) 

and CCPM 

Note: This presentation is to share my experience at smith & nephew orthopedics 

and has nothing to do with Merck & Co., Inc. and/or MSD 

3 

© 2009 TOCICO. All rights reserved.

Environment of Japanese medical 

device industry(1/6) y( ) 

Key points: 


1. Japan is the second biggest market in the world. 

2. It takes longer time in Japan than in other markets 

to get an approval of a medical device 

3. It often requires more resources in Japan than in 

other countries co ntries to market a prod product ct ddue e to 

regulations. 

4 





Total population and its high aging rate make Japan attractive 

to medical device companies 

Data in 2007 Japan U.K. France Germany 

Total population 

(Thousands) 

Population 

aging rate (%) 

127 127,770 770 60 60,975 975 61 61,707 707 82 82,247 247 

21.5 16.0 16.5 19.9 

Source : AMDD survey issued in July 2009. 

•AMDD: American Medical Devices and Diagnostics Manufacturers' Association 

•Aging population rate: Ration of people who is 65 years old above 

5 





Costs for registration related area in Japan is 17 times higher than E.U. 

For Orthopedics Japan E.U. 

R&D + manufacturing f t i 407 411 

Clinical Trial, 

Regulatory and 

QQuality lit 

106 6 

Sales & Marketing 3960 1645 

WWarehouse h and d 

Distribution 

652 165 

Total 5125 2227 


*AMDD: American Medical Devices and Diagnostics Manufacturers' Association 

*Score 100: R&D ( Before clinical trial) cost per a device in each marketplace 

6 





Average review period in Japan is longer than in other markets. 

PTCA balloon and stent 

pacemaker 



7 





Number of employees per dollar sales in Japan is larger because… 

(Japan as 100) 

• 13 times more employees in quality 

• 3 times more employees in registration 

• Other regulatory g y 

affairs 



8 


M1 




Summary 

1. Japan is an attractive market for medical 

device companies, however… 

22. Need longer period to launch a new product 

3. Need a lot of resources to market a product 

It is commonly believed that these are mainly 

due to regulations. 

9 


Slide 9 

M1 

araihit, 8/31/2009

Common issues among companies(1/4) 

R&D 

Manufacturing 

Registration? 

Sales & marketing 

10 

Distribution 



QC/QA 

Registration is believed to be one of the biggest constraints to expand 

business. Is this true?


Launch a new 

product p 

OObtain 

an approval of 

a product 

Increase sales now 

and in the future 


Assumption: 

We are not able to improve our sales because we 

cannot get an approval of a product in a timely 

manner. Is this true? 

11 



Get an approval faster 

Hire good Need more Need 

experts people de-regulation 


Assumption: 

1. If we could hire many experts in RA, we would get approvals faster than 

in the past. Is this true? And is it good enough?? 

2. Need de-regulation. But is it realistic to expect that government change 

the rules for medical device companies? 

If it happens, can we sell products much better than competitors? 

12 




Summary: 

1. Registration is believed to be one of the biggest constraints 

to improve top-line sales. 

2. It is believed many experienced RA people are essential to 

get faster approvals. The cost will be very expensive. 

3. Hopes de-regulation happens in the future…and believes 

there is nothing to shorten the lead-time at our end now. 

Because reviewing process is out of our control 

13 


De-regulation may be effective. 

But it does not necessary mean that 

we can beat our competitors 

competitors. 

Because the same rule is applied to all 

companies including ours now and 

in the future.

An example of solution using Thinking 

Process and CCPM(1/11 ) 

The organization I took over the responsibility 


• Expertise; The head of RAQA was not an RA expert 

(that’s me!) and not everyone was registration expert 

• Operational Efficiency; Had to meet aggressive 

operational efficiency targets to generate cost 

savings (e.g. headcount reductions, etc.) without 

having an impact to product quality 

• Had to fully comply with current and future 

regulations and submit applications for new 

products d t registration. i t ti 

Mutual distrust among departments 

14 



Process and CCPM(2/11) 


It was often highly controversial whether a product would require an approval 

process or just a notification one 

Approval Notification 

Implants 

Instr Instruments ments 

•To submit an application pp form • To submit a notification 

•A year long review to register • Able to distribute upon 

submitting a notification. 

15 




Intra-company process External process 

Create registration 

strategies for products 

Documentation work: 

Gather information, craft 

application and conduct 

testing if necessary 

Translation Q&A, discussion 

EtoJ E to J Intra Intra-company company 


Presentation 

Q&A with 

reviewers X3 

Expert Committee 

Q&A 

Approval 

Finalization, document 

check h k and d submission b i i 

RReimbursement i b t 

16 



Process and CCPM(4/11 ( ) 


QQuestion1: ti 1 

Can we find hidden buffers in the process? 

- How and what we should do to encourage people bring 

buffers they have? 

17 





RA experts usually never show their buffers concealed beneath 

RA is a department 

that is in charge of 

registration 

Target launch timing 

can be changed by 

internal and external 

reasons 

RA is blamed by Sales 

& Marketing 

Delay of product launch 

is used as the easiest excuse 

for not achieving a sales target 

Sales & Marketing are 

evaluated their performance 

by top-line sales 

18 


Sales prospects 

Oft Often tend t d to t be b 

Too optimistic




RA experts usually never show their buffers concealed beneath 

People believes a long review 

period is only due to governmental body 

A longer review period 

of registration in Japan 

is well-known 

RA is blamed by 

Sales & Marketing 

Hidden buffers 

are invisible 

to other departments 

RA usually places 

buffers 

inside their process 

19 


RA work seems to be 

very complicated 

to other departments



Question2: 

Shouldn’t we focus on what we can control? 


• LLead d time ti = Reviewing R i i time ti (a ( year) ) + Preparation 

P ti 

• Preparation = Making strategy + Gathering 

information + Documentation + Translation (English 

to Japanese)+ Document quality check 

20 





1. Holistic thinking: how do we see buffers in the process →TOC education 

2. Change g the rules: 

- Do not blame anyone if a project delays. Never allow to blame individuals. 

- Do not count products which are under pre-review by government 

on sales forecast. 

SABA (safety buffers) Parkinson’s law Unreported early completion 

Student syndrome Multi-tasking Network structure 

21 





Answer: 

RReceived i d 88 of f examples l th that t relates l t tto th the aforementioned 

f ti d 

six items that affect the process of a project 

22 




• Now we can see SABAs(Buffers) in the process 


• We tried to re align the process using the concept of 

CCPM 

My initial sketch 

23 


Results of team discussion




• We brought up this concept at a workshop of a software 

vendor d 

Other rules: 

-Strategies must be developed by a whole 

team to share regulatory knowledge/ 

expertise 

- EEach h process must t owned d by b a person in i 

charge 

24 


Results (1/2) 


• The application of CCPM reduced the touch time by 59% in 

theory and 31-69% reduction in actual 

Former Apply CCPM Actual 

Process 

YTD 

PPreparation ti 6 3 22-6 6 

Presentation 1 0.5 0.5 

Q&A (1) 3 1 1-3 

Q&A (2) 3 1 1 

Q&A (3) 3 1 0.5 

Total 16 6.5(59%) 5-11(31-69%) 

* Excluding 1 year standard review time by governmental body 

25 


Results (2/2) 

Number of submission 

& approvals pp 


Multi-projects No head-count increase 

• Before implementation of TP and CCPM, only one application for a new 

product was submitted in 2006. The number became four in 2007 and six 

in 2008, 2008 respectively 

respectively. 

• RA team was not able to carry out other regulatory projects in 2006 than 

a new product registration. However, the team has been managing all the 

projects p j above since 2007 and finished them all now without any y 

headcount increase since 2006. 

26 


Summary 


• Thinking Process and CCPM are the one of the most powerful 

tool to shorten registration lead-time. Because a lot of time is 

used not only by governmental reviewers, but also by applicants 

in preparation and Q&A process. 

• By putting wisdom of experts into strategy making process, we 

can operate multiple projects with less number of people with 

less expertise. p Each individuals has been growing g g through g these 

projects. 

• It is said that the constraint of sales increase was regulatory 

process. Now the company changed its idea, the constraints is in 

sales l & marketing k ti and d try t to t use TP to t review i their th i sales l 

27 


Thank you for your attention and also 

thanks to to the the great great RA/QA RA/QA team 

team 


28

Faster product registration of medical devices in Japan

Create successful ePaper yourself

Delete template?

Save as template?