Do not let your customer doing your QC

I call it the “Microsoft principle” … and it is a mess. For many years, Microsoft is quite famous for delivering half-baked software, which is subsequently improved by patches and “service packs” based on customer findings. Microsoft lets its customers do the quality control (QC) for them.

 

Change of scenery. A couple of years ago, I attended a lean processes workshop. To make a long story short, the resulting “optimized” lean process basically included an abandonment of the pre-delivery inspection process step and a shift of the final QC to the customer. To be fair, some new QC cross-checks were included at handover interfaces within the process … but the proof that the product is finally OK was factually handed over.

I was surprised finding myself alone with speaking up and insisting: “this is simply crap!

At this point I need to admit, that my horizon of experience had been different from the others. Before joining the pharmaceutical company (I was working for at that time), I had had my own little service business for about 10 years. So, I knew by heart, that customers typically wish if not clearly expect to get a product of reliable high quality delivered for the money they pay. And I think, they can expect to get the same. Also I myself do. As a service provider it had always been a wonderful and tremendously satisfying experience getting customer’s feedback that he is vice versa satisfied and happy with a high quality, error-free delivery. I tell you, it is really great to enjoy your own appreciated product.

 

Certainly, a customer needs provide an explicit confirmation of proper delivery which by design requires some kind of  cross-check on his side. But this is not what I am talking about. Ideally he should not find anything. At least no careless mistakes or faulty deliveries which typically would have been identified and rejected by a proper pre-delivery QC.

Change of scenery again. I recently worked with an agency where I typically had to check every delivery several times. In my view, I was doing their work. And we are talking about mistakes which were obvious and would have been solved by a simple pre-delivery cross-check at the agency before reaching my desk. And I found myself asking, why I am doing a part of the job I am actually paying for? I clearly expect (just in case any current of future collaborating agency might read this) a reliable, rock solid product which is finally QCed already before landing in my inbox. This agency was simply annoying me.

Would this be the basis of a long fruitful collaboration?

I do not really think so.

 

Altogether, delivering properly QCed products might be better for business than being “over-lean”. Do not play Microsoft until you are in the same monopoly position.

Satisfy by quality … and enjoy satisfaction and success!

Leaving 2015 positively

2015 has been a good year!

It might not appear as such on the first view. And unfortunately there are always enough “devaluators” who are first and foremost fixated on crises and conflicts.

But a lot of positive and good things happened in 2015 which are worth to look back on. In the German newspaper DIE ZEIT (#52, 23.12.2015) Hannes Soltau, Merlind Theile and Doreen Borsutzki published a remarkable collection of facts.

In 2015 …

  • more people worldwide had access to drinking water
    (91% vs. 77% in 1990)
  • the average life span worldwide increased
    (71 years vs. 65.3 years in 1990)
  • the number of starving people worldwide decreased
    (-17% since 2004)
  • the infant mortality worldwide decreased
    (more than halved since 1990)
  • we had substantially less traffic deaths in Germany
    (2/3 less since 1991)
  • we had less school dropouts in Germany
    (5,6% vs. 9,6% in 2001)

Certainly, 2015 was also a year full of tragic events and fatal developments. But not only. Fading out the good limits the view.

I myself gladly and gratefully look back on 2015. For me personally, it has been a very good year … and the world has had worse before.

Why doesn’t anyone tell him …?

post20141107A zur deutschen Versionnew division head is in town. And he (or she) wants to share his vision and plans with the team members in subordinate departments and business units. First of all, a fair approach.

So, the new boss arranges a “townhall”, which is .. how should I say … a mix of collective self-congratulation, motivational speaker show, and blatant puffery. Actually, the intended purpose is to reduce need for the new boss to deal with each subordinate individually but rather polish off all at once.

Making a digression. Back to the topic …

Well, said new division head stands in front of the audience, perhaps something between 300 and 400 subordinates, and talks about his plans. He mentions that in the past quite a few things had been done quite well already, and that he appreciates those efforts and the great expertise of the teams and people … but that there certainly is room for improvement and optimization. He presents his new master plan, laid out for 5-6 years, at last solving all issues of the division, and which will be the ultimate solution for a prospering future of the enterprise. Goes without saying that the plan crucially includes a reorganisation.

There is just one problem: he (or she) is the 3rd new division head in 5 years already. And the majority of colleagues sitting in the audience have repeatedly heard exactly the same speech. This is still very much present, it hasn’t even reached long-term memory yet. And those colleagues sit on their chairs, listen to the presentation, and think: “What a speechifier! In 2 years max you will been gone again. And then the next one jumps in, and retells the same, that he now knows how it really works. And your master plan is going to be history like all the other big master plans before.”

Summary: Actually the new division head just now makes a fool of himself.

Is that really necessary? Why did nobody appropriately prepare and brief him? Who the heck coaches middle managers such amateurishly? It almost appears as would someone simply follow a checklist … a rather goony one by the way.

An honest and down-to-earth announcement gaining respect and appreciation by associates rather would sound like this  …

“Hi everybody! I am the new boss, and I also cannot turn water to wine! We are going to spend the next 2 years together, perhaps even a bit less. Let’s make the best out of it! So that at the end all of us are able to show some smaller or bigger but nice achievements and progresses, without any unneeded collateral damages.”

“Product Literature Database” (PLD) … what the heck is this?

zur deutschen VersionPharmaceutical companies have an inevitable need for regular if not permanent analysis of literature published on their products. They are not only legally obligated with regards to pharmacovigilance (e.g. processing of any undesirable drug effect reported somewhere) and medical information (e.g. answering product inquires by practitioners and pharmacists). Beyond that, product reports within the scientific literature are a full treasure of real-world product behavior findings which support marketing, competitor intelligence, product innovation, and more.

But we are talking about giant pool of millions of publications within thousands of scientific journals which is growing every single day. Ad-hoc searching and analyzing costs reasonable amounts of money:

  1. Professional literature databases are quite expensive with a market dominated by few providers only, which sometimes behave like monopolists.
    (And to make an early clear statement: no, PubMed clearly does not qualify, especially due to its lack of comprehensiveness and poorly finished content.)
  2. It is very time-consuming to find precise and significant answers by searching and analyzing scientific literature. And the cheaper the source, the more (expensive) human workload is needed.

 

The solution

So-called “product literature databases” (PLDs) or “corporate literature databases” deliver the knowledge about what has been published about your own products … much more efficient than highly redundant and multiplied individual ad-hoc literature searches.

PLDs are sort of subsets of the worldwide literature, including only publications which mention at least one product of the company. Typically, they are filled by automatic search agents (search profiles) or by feeds delivered by database providers.

Well-designed PLDs also provide mechanisms for rating publications, annotating information and signaling predefined events.

 

External PLD providers

UK-based Pi2 solutions Ltd. is an established vendor for customized pharma and biotech PLD solutions and was acquired by ProQuest Dialog this summer. Pi2 traditionally supports Pfizer, and since 2009/2010 also Wyeth (who had worked with OvidSP® for ad-hoc literature research before). A 2013 poster presented at the 9th Annual Meeting of the International Society for Medical Publication Professionals might give some information on general approaches. Beyond that are no public information available regarding Pi2’s market success or market share, and I am quite curious about impact of the new collaboration with ProQuest.

Other potential providers of PLD solutions are major B2B specialist information database and service providers, like Reed Elsevier, Thomson Reuters and Wolters Kluwer, who are factually dominating the mass market for literature raw data. Particularly Elsevier has already shown strong interest in providing more customized and mature services to industry clients. They quite recently build a kind of customized product literature service for Sanofi’s pharmacovigilance by combining their database content with the QUOSA literature management software.

 

In-house PLDs

The Novartis pharma group had their own internal PLD since the late 60’s, called “eNova”. This solution has been the most mature and significant PLD I have ever seen. Novartis not only collected literature on their products, they also applied a kind of in-depth ‘digestion’ of reported product findings and clinical data. As a result, the PLD was able to very precisely answer questions on any aspect of real-world drug behavior at the push of a button. “eNova” was finally discontinued and shut-off by Novartis end of 2013, despite the fact that internal analysis had shown substantial positive impact on productivity and individual time savings for product related literature research & analysis of 93% and more.

Roche once also had an internal PLD similar to “eNova”, which was shut-down a couple of years ago already. As a “side effect” corresponding product literature research & analysis activities and workload were distributed across the organisation. For example, each national affiliate had to substitute the service by an own solution to continue mandatory MedInfo deliveries and to comply with regulatory expectations. It goes without saying that this split-up of different solutions and approaches did not really result in an overall productivity increase nor in overall cost savings.

A little later, after negative effects became more and more evident and clear, Roche tried to reactivate their in-house PLD. But unfortunately the reintroduction failed as 2-digit million CHF investments were needed but not provided.

By the way, much more money than continuing the Roche in-house PLD would have costed.

 

Why do PLDs have such a poor standing?

Watching the developments at Novartis and Roche, one automatically ends up with the question for what reason their PLDs were shut-off … despite obvious downsides for the enterprises? Actually, there are some dependencies and basic conditions for the reasonable operation of an in-house PLD. And those dependencies and basic conditions are sometimes contrary to currently practiced management paradigms.

  1. PLDs need long-term view and sustainability. But currently lived management approaches in pharma enterprises are more near-term and quite volatile. Without a strategic integration, a PLD is always in danger falling victim to a short-term budget or structural decision, similar to other internal services. But in contrast to other internal services, such a decision is much more fatal for a PLD, as it cannot be just shut-on again once negative side effects become obvious.
  2. PLDs save money in the in the field. What a fatal dilemma. As a central service, PLD costs are budgeted with a (global) business unit, which does not necessarily benefit itself by the service. On the other hand, corresponding cost savings, e.g. by higher productivity, cut costs for external providers, synergy effects, etc. pp. are effective within the whole organisation, with completely different business units. As a result, budget and benefit are organizationally decoupled. Overall, the enterprise has a tremendous advantage and cost savings by the PLD. But unfortunately this full picture view is less and less shared with individual budget decisions.
  3. PLDs are IT, they are not. Effective PLDs certainly need a powerful IT infrastructure, databases, and more. Unfortunately, this bears the risk to rashly assign PLDs to the IT department. To be very honest, to my opinion that is the wrong place. I also need a PC to work efficiently and powerful, but I am far away from being a software engineer. For me, a clever PLD implementation includes a clear localization within business, at least within a well-established linking function between business and IT.
  4. PLDs are strong as central functions. Only then they can fully exert resulting synergistic effects. In contrast, there seem to be frequent “waves” with in pharmaceutical enterprises to distribute tasks over the whole organisation. The underlying thought is “we save money at Global (e.g. for the PLD), and the work is shared by all”. Funny thought … unfortunately with fatal implications on productivity of associates.
  5. PLDs are designed by information experts for information experts. True, and there are historical reasons. But this approach does not fit to todays reality within pharmaceutical enterprises anymore. During the past 10-15 years, pharma has consequently reduced the number of educated information professionals. As a result, todays users of PLDs are more and more subject matter experts (e.g. medics) without explicit expertise in using professional information tools. And honestly spoken, I so far have not seen many PLDs which serve those new user groups regarding usability adequately.

 

Fazit

An in-house PLD – cleverly designed and implemented – is able to reliably cover the need to know that has been published about a company’s own products. It also prevents troubles with regulatory expectations and authorities, and increases productivity at once.

But “cleverly designed and implemented” also includes a long-term strategic integration within the enterprise as well as a reasonable degree of independence from short-term decisions and tactical changes. Any short-term shut-down of an established in-house PLD bears the risk to create hidden but substantial costs. And in all known cases it had been an irreversible back to zero.

Currently, one of the biggest challenges of PLDs is, to give medics and other non information professionals efficient access to product answers, especially by more productive and intuitive user interfaces. Success will be result of votes by the feet … resp. by the keyboards.

How to maximise the effectiveness of your FTO research – Checklist

post20141107Information research on freedom-to-operate is daily business patent research. But it should never be undervalued. Every single project somehow is a class of its own. And missing the tiniest piece of “public” information can have major impact on the success of your IP strategy.

So, standard guides and how-to’s do not really serve the need for distinct research strategy and brain power. But 10 basic rules might help to be more effective and successful …

  1. Asking questions will be crucial for success
  2. Include non-patent literature
  3. Choose the right information sources
  4. Dare to get external support
  5. Know peculiarities of sources
  6. Know peculiarities of content
  7. Have positive control references up your sleeve
  8. Ensure availability of specialist expertise for special topics and tasks
  9. Carefully interpret results
  10. Stay up-to-date

 

As a it could be of special interest, I added some tips to reduce your costs with FTO research at the end of this post.

 

Step 1 – Asking questions will be crucial for success

FTO research should not be like tapping around in the dark. With the words of a good friend of mine, FTO research should be defining the borders and specs of the football field (“playground”).

So, start your mission with asking questions. A lot of questions. From different angles and viewpoints.

  • What is the scope? What kind and dimensions of freedom do you need?
  • What do you really need to know? And how can you delimitate the search?
  • Who could have worked with the technology?
  • What sources of information should be considered beyond literature?
  • What databases need to be used and where do you find them?

As a patent attorney or research manager, feel mandated to give your information searcher as much background information and direction as possible. And allow him or her to bother and challenge you.

Jointly develop authoritative search keyword synonym groups as well as a sound search strategy, which is a proper balance between quality and quantity. Last not least do some early preview searches in database indexes while developing the strategy, which will give you an impression if your strategy works as well as on volumes.

 

Step 2 – Include non-patent literature

Sometimes it is helpful to think through the backdoor. Non-patent scientific literature can increase the certainty of your FTO. Is there any publication (scientific literature, common press) that might prevent a 2nd party application?

But consider the following peculiarities of scientific literature databases, please:

  • scientific literature databases are bibliographic (abstract) only
  • scientific literature can be searched efficiently only by year but not by date
  • citation analysis (who, where) can give you additional hint for your overall search

 

Step 3 – Choose the right information sources

There are public sources, e.g. for patent literature, like esp@cenetUSPTODEPATISnet, and with other national patent authorities.

Pro’s

  • free of charge
  • quickly accessible via the internet
Con’s

  • limited search opportunities
  • limited service only

You get what you pay.

Specialist information databases on the other hand provide “pre-digested” high quality information. Established vendors are STN, Delphion, Proquest Dialog, and FIZ Technik (in Germany).

Pro’s

  • editorial post-processing
  • added value (indexing, reviewing)
  • extensive and effective search functions
  • crosslinks between different databases
  • option of multi-file searches
  • substantial service and support
    (e.g. helpdesk, trainings, documentation)
Con’s

  • considerable costs (royalties)
  • professional search tools need
    training & experience

So, you pay what you get.

 

Step 4 –  Dare to get external support

External information specialists (agencies and freelancers) provide you a sound information research & analysis competence, a considerable level of flexibility, and – last not least – an independent viewpoint.

But there are a few things you might want to consider and check before working together …

  1. Does the external specialist demonstrate a provable level of professionalism, experience and reliability?
  2. Does the external specialist in addition to information research expertise also provide a particular competence in the technological field or subject of the project?
  3. How will your communication be organized?
  4. How is information security ensured?
  5. Do you have a confidentiality/non-disclosure agreement in place?

 

Step 5 – Know peculiarities of sources

No, I don’t want to give a lecture on professional information research. But again, there are some peculiarities of source databases, you should take into account when interpreting results.

  • database characteristics – consider differences in data origin, processing, update modes, and – subsequently – findability
  • database coverage – consider differences regarding the types of documents covered, the time period covered, publication regions covered, and languages covered
  • database language – consider different languages of content

Taking all together, most information professionals prefer to use multi-files searches (database clusters) instead of single file searches. But a proper level of experience is needed to not just get more, but to ensure that nothing relevant is lost.

 

Step 6 – Know peculiarities of content

Be critical regarding accuracy, completeness and timeliness of any search database content. All databases are full of errors, some created with introduction of the data, some originate from the original document already.

Spelling mistakes

… by patent applicant, by OCR reading, by misinterpretation of special characters with some languages, by data errors during processing. As a result, your keywords do not match.

Solution:
  • truncate your search keywords
  • use character masking
  • e.g. “er!thropo!tin*” matches “erythropoetin”, “erythropoétine”, “erithropoetines”, …

 Applications not using right terminology

… by patent applicant, perhaps intentionally. So, again your – right – keywords do not match.

Solution:
  • think beyond the typical terminology to find additional unusual synonyms for your search keywords
  • truncate your search keywords

Not helpful keywords

… that have multiple meanings or occur regularly but unspecific within the literature. E.g. “protein”, “cell”, “screen”, “agent”, some substance names, acronyms, etc. Those keywords can give you non-relevant hits and bothersome background noise.

Solution:
  • do not use these keywords with your search
  •  increase stringency by delimitation or combination
  •  limit search to single database fields (title, claims, e.g.)
  • use acronyms in combination with other keywords only

Filing dates

Several circumstances create problems with time period limitations used by your search. E.g. by the period of application, by the time gap between filing and database entry as well as by different characteristics of static and dynamic literature databases. As a result, you don’t get some publications you should.

Solution:
  • include “preview” databases with your search
  •  repeat search after 18 months to completely cover the time frame of one general application period
  •  monitoring

 Hidden applications and “submarines”

With some search strategies you might accidentally miss relevant publications. E.g. using IPCs in search profile increases stringency…. but might overlook applications that are located in exceptional classes. Another issue are unpublished US applications.

Solution:
  • try a search with excluding your IPCs of choice (“NOT”)

High numbers of hits

Solution:
  • check search profile for sources of “background noise”
  • check efficiency of family sort
  • go back to database index
  • with full-text databases, limit search to selected fields (title, claims, abstract, …)
  • increase stringency – further delimitation possible?
  • reduce truncations
  • reduce acronyms
  • use IPCs
  • create sub-searches

 

Step 7 – Have positive control references up your sleeve

Hold back at least one internal positive control (publication) that should be found by the search strategy. If the positive control(s) was not found, improve the search strategy.

 

Step 8 – Ensure availability of specialist expertise for special topics and tasks

Some types of FTO searches, like on bio-sequences, chemical structures or statistical analysis (competitive intelligence) – require specialized tools, special sources as well as particular knowledge and expertise of the analyst. It is vital to have all three in place!

 

Step 9 – Carefully interpret results

Here is a list of my recommendations with interpreting results …

  1. summarize results by family sort and/or removal of duplicates
  2. benefit from report functionalities of tools – e.g. text file export for printout or table export for subsequent sorting and easier post-processing
  3. keep references to full-text documents – e.g. links to free EPO, USPTO or JPO documents
  4. consider peculiarities of source database(s) of results – e.g. a full-text search does not necessarily give better results or ensure completeness

 

Step 10 – Stay up-to-date

To my opinion, it is not sufficient to just state FTO at a certain time point. It needs to be watched. So, monitoring comes into game. Most professional database providers offer alert functions for a given search profile, which automatically drop you a note to your mailbox once a new piece of information is available. It is a quick win to use this functionality. In addition, current awareness searches might be needed at larger intervals to complete the full picture. This approach also allows you fine tuning or search strategies, resp. the adjustment to a changed “football field”.

 

Special: 10 steps to keep down your costs

  1. Invest time in the preparation of your search strategy.
  2. Invest time in the preparation of your search strategy.
  3. Invest time in the preparation of your search strategy.
  4. In advance to database searches “play” with the index.
  5. If your search strategy does not work properly within the databases, stop immediately and go back to step 1.
  6. Do a multi-file search, put cheap databases first in the row.
  7. Avoid search steps for date or region.
  8. Be as stringent as useful.
  9. Use standardized preview formats for display of hits.
  10. Use family sort and duplicate remove.

 


 

This post is based on a presentation first given at the C5’s European FTO Congress, Munich, November 2006.

Don’t forget to gaggle!

post20130301zur deutschen VersionWisdom out of life for (working) life:

Once there was a countrywoman and her three chickens. While the three chickens were laying their eggs into the same shared nest, the countrywoman found only two new eggs in the nest every day.

So, she started to watch her hens. And after a while evidence seemed to be clear:

Every day always the same two chicken left the nest gaggling loudly. The third one, also always the same, quietly stole off.

So, the countrywoman quickly came to an inevitable  decision … and the modest chicken ended up in the stockpot.

But, from the next day on – to her very surprise – there was just one egg in the nest every day!

Now, what are the conclusions of this story:

  1. Some gaggle loudly even without having performed and achieved.
  2. Achieving without gaggling can kill!

 (translation from German, unknown author)

From Builders and Maintainers

zur deutschen VersionI so far met basically three types of human characters within – esp. larger – companies: Builders, Maintainers and Destroyers.

Builders

post20130120Building is their passion. They are restless. The status quo never is good enough. After the implementation is before the implementation.

Builders are thinking forward, innovatively and constructively. They see changes as tools for improvement and development. But they set a high value on a well-founded and provable rational for any changes needed as part of their overall plan.

Builders know that for being successful they have to convince others (like Maintainers) and bring them in. They are usually quite clever in positively influencing people, and they can be very inspiring and motivating for others. On the other side of the coin, Builders can be quickly frustrated by resistance to – in their view – obvious room for improvement. E.g., Builders have the tendency to underestimate the importance of politics, esp. when going beyond factual businesslike objectives. If they fail it is often due to a outflanking by games at work.

Beyond that, Builders will always be strong drivers of innovation and development.

Maintainers

Maintainers merge into ensuring stability and consistency … of processes, services, tools, etc. They can do the same set of tasks over and over again, day after day, year after year. Continuity is their mission. As a convenient side effect, Maintainers are extremely good in identifying deviations and threads.

So, Maintainers love the status quo. But they are not just resistant to changes, a common misunderstanding and complete misinterpretation. Factually, they just insist on a well-founded and convincing justification for a change. What is actually a fair approach!

Factually, Maintainers are the backbone of most companies, ensuring business continuity. They bring overeager Builders back to earth, and steadily mop up behind Destroyers.

Destroyers

The dilemma of Destroyers is that most of them are deeply convinced they would be Builders. So, a mismatch between self- and external perception is definitely an issue with Destroyers.

Well, basically they are right. Building often needs changes, and changes sometimes also need destruction. But they make 2 major – to my opinion – mistakes. First, they are biased and fixated on change. And second, they generally mistake change with destruction.

Many Destroyers follow the illusion that the event of a change itself would be good. They are disciples of change. In their thinking it boosts organizational creativity and evolution. The origin of this misconception is an outdated and wrong sociological interpretation of the biological evolution paradigm. On top, Destroyers often undervalue the importance of sound change management – not in proclamation but in implementation. Then, destruction is not an intrinsic consequence of the change but of bad (or no true) change management.

“Chopper managers” are typical Destroyers. So, you don’t know “chopper managers”? I am sure you do!  “Chopper managers” are hopping from one position to the other, like tourist doing a helicopter sightseeing tour. They simply fly in (whencesoever), make a lot of wind when landing, create a maximum of confusion, and fly out again soon enough before they need to face the outcomes or take responsibility for long-term consequences.

Unfortunately, Destroyers have the highest impact in many companies, giving Builders and Maintainers a hard time.

So, what are you?!

I found myself without doubt having a very strong Builder component. I love to develop, to implement and to provide new solutions. I can also be a Maintainer … for a while. But sooner or later this stops satisfying me, and I start looking for opportunities to do some “building” and improvement at least within my proximate range. I am also open to destruction, but I insist on well-founded and convincing rational as well as sound change management. And I absolutely hate destruction of a so-called “running system” without true need, or doing a change just for its own sake.

Altogether, it looks like that I seem to be a Builder, with a secondary Maintainer facet, and only constructive Destroyer qualities.

Builder, Maintainer or Destroyer … what are you?