scoping - in short

Scoping creates strategic directions that meet the ambition. 

Challenged with a project or problem? Scoping eases your decision-making with three informed directions founded in technical analysis and creative problem solving.

project or problem

Learn how Scoping can help you. Case by case.

Browse through the selected cases below to see how Scoping
has framed a new project or solved an unexpected problem:

Projects

Challenge: A large pharmaceutical wanted to enter a new market which required them to tweak their product so that it could deliver either a larger or smaller dose. By introducing a larger dose, there is a possibility of the dose being split into two separate doses. This could in turn result in them undermining their own market position due to the financial gain being larger on two small doses rather than one large.

Solution: In order to meet the client’s needs, we created a set of rules between us and them to reach an understanding and agreement on the confinements of the project. We conceptualized mechanical add-on solutions that would seek to prevent dose split without having the entire product go through a new approval process. Furthermore, we made a report on cost, complexity, user steps etc.

Result: By quantifying the cost of development, the company was able to decide, based on data, how to ensure that the right doses were selected for the appropriate group of users.

Challenge: A client had a vision of creating a product, a closed environment from which one could sample biopsy without being exposed to the chemicals involved in the process. As new legislation was passed the clients vision would soon become a requirement.

Solution: We were contacted by the client who had made a sketch of the solution on a napkin. We took the idea and turned it into a functioning product. We set up the production was a national manufacturer and arranged post market surveillance with another company.

 

Result: The client now has a product, which sells very well. The product is very easy to handle and does not require much attention from our client.

Challenge: A client wanted to invest in a startup, who developed a concept for a new drug-delivery-system. There was an account on the size of the investment needed to reach a certain milestone, and they were interested to learn if this statement was realistic.

 

Solution: So, we reviewed the plan thoroughly and assessed it in the light of our experience and knowledge in such matters. We also took an assessment on the organizational set-up which were supposed to carry out the plan, double-checked if everything seemed to be well framed in terms of time and budget compared to the ambition and objective. We found only a few points to pay attention to, but otherwise we couldn’t find any reason not to proceed.

Result: And it appears as we were right as the project had its investment and is well under way in development. 

Challenge: A client who provides drugs in various constellations, wanted to outline, and investigate the market and suppliers of platforms. Especially, an on-body-injector was within their focus. Our assignment was to qualify a vendor selection, who could be able to deliver on such.

Solution: We did so with a classic and very profound research method – conducting interviews with both current on-the-market vendors as well as all the ones in process of entering the market. The project included screening, analyzing, and comparing a lot of information and gained quite an insight.

Result: The result was a small selection of very qualified vendors for the client to proceed with, as they had to close the final discussions. 

Challenge: A large international company within biotechnology was interested in expanding their ownership of device development. Hence, they teamed up with a consultancy to make the initial concept development. Soon they had to realize that they were also in need of a partner to take on the role as main driver of an autoinjector platform.

Solution: And as such we has been operating on first one generation of an auto-injector and since then another one. In this case we were scoping the project as to breaking down the tasks in different value streams and thereafter in different tasks connected to those streams — everything in order to quantify and be able to plan timing and make everything work.

Result: The process of approval is well under way and the work proceeds as there are more drugs planned for this platform. 

Challenge: A biological medicament often comes in a higher volume, thicker and with a higher viscosity than a synthetic medicament. This makes a short injection time difficult and subsequently it calls for changes in related devices.

The client being a platform  provider was looking for help to materialize a concept into a prototype accommodating these challenges and for the purpose of demonstrating the capabilities to potential stakeholders.

Solution: An advanced prototype was developed including packaging, instructions for use on video and a small IFU. The prototype included the possibility of refilling drug, activation and withdrawal of the needle followed by a visual and tactile feedback on the usage. So, we made almost a fully functional product.

Result: The client was able to demonstrate this kind of product and test on market whether the readiness for such one was there or not before any further development.

Challenge: The client was looking for a new technology for drug delivery. Beyond all known and established methods and ways to deliver a drug. There is a common experience with drug delivery through nose, eyes, ears, skin etc but in this case the client was looking for something completely new. Something to be mechanically activated inside the body.

Solution: We made a lot of calculations and planning for how such a project could be framed and carried out. Many requisites had to be considered; Who should be the owner and overall responsible for clinic, development, and manufacturing? At which level was the documentation needed and how was the prototype designed so it would enabling approved animal testing.

Result: We provided the client with directions on what to outsource and what to drive internally. A framing was made for how to conduct such a project.

Challenge: A client with a platform, a product with a configuration, simple and with very few variants (enabling a low SKU) was interested in making their product more attractive in terms of being able to customize a lot more. So, the issue was to do a mapping of the sparse knowledge and data we had at our disposal for sorting the customization options of their clients. These were internal drug teams, who were seeking a product of their own.

   

Solution: So, we did this mapping and looked further into the ones feasible. Then they were quantified in terms of cost and time and added to the baseline onboarding on this platform. That gave us the possibility to prepare a very transparent indication on the necessary investment for each change in the customization. 

Result: An improved dialogue with different drug teams was the outcome of this, as a more direct and precise indication on cost related to customizations was enabled. Thus, a much faster and better process for all concerned.

Challenge: A company reached out to us with a desire to expand the market for one of their products. The issue was the complexity of the product, and the fact that it was a very expensive solution. It was a limiting factor regarding potential markets.

Solution: They reached out to us and wanted a simpler mechanical solution. We conceptualized on several while keeping the usability of the product in mind. We created different handles for the product to ensure that the user would have enough force available to handle the product.

Result: A development plan was made and the concept was materialized to aid the internal communication of the overall benefit and selling points of this project.

Problems

Challenge: A cooperation within the business of creating climate control systems for test animals sought to reduce the overall cost of their product, and to increase their amount of customers by making their product more customizable.

Solution: Our job was to identify which components had the highest impact on the cost, create a product architecture that mitigated these, and in the process optimize for assembly and manufacturing. By optimizing assembly and manufacturing you create a faster process which in turn will lower the overall cost. Furthermore, we created a new, and more appealing industrial design while enhancing the user experience of the product.

Result: The result for the client was a better and cheaper product that had potential to reach more customers.

Challenge: A client of ours was approaching a deadline, and it was essential for the project that the deadline was not postponed. During verification, it was concluded that the product, in uncommon incidents, did not pass the drop test. At this stage, it was too late to change anything about the product.

Solution: We instead looked at everything revolving the product such as manufacturing processes, test methods used, ISO-standards, assembly and handling during transport etc. Based on this research we created a bunch of hypotheses that we could use to determine the most likely scenarios for failure and how we could ensure that the deadline was met. We found that the chosen verification test, was close to impossible to achieve. By increasing the number of devices in the verification test, and rethinking the statistical scenario, we were able to pass the verification test in time for the deadline. 

Result: By solving the problem in this manner we ensured that the project deadline was met and thereby saving the client a larger amount of money.

Challenge: A larger cooperation was developing a drug delivery platform at the early stages of the project, it was decided not to look at IP’s during the development process. This proved to be an issue since the product violated other patents on 5 occasions. We were contacted by the company and given the task of developing 5 new concepts to mitigate the patenting issues.

Solution: We initiated a taskforce to deep dive into the mechanisms, not just which mechanism but which exact part of the mechanism, that could be causing the IP issue.

In our research we found that several of the claims made by the patenting officials did not hold up, and we could therefore minimize the number of thigs that we needed the treat thus reducing the cost of the project. The 2 remaining mechanisms required minimal changes in order to resolve the patenting conflict.

Result: By debunking several patenting claims and fixing the two remaining in a lean fashion, we were able to save the company several years in development cost.

Challenge: A client had an IVD-product on the market of which they had a desire to change the method of indication. Through a thorough analysis, we identified an assembly problem which led the fluid to inappropriate locations due to present capillary forces.

Solution: We created concepts for how we could keep the fluid at the right locations and by simulating these concepts we determined the direction. Furthermore, we identified appropriate choice of materials and ways to weld the product together.

Result: By doing this, we solved the client’s problem by increasing the measuring precision of the device, found a more appropriate method to weld the product together and qualified a new material. All this within just a few months before launch.

Challenge: A client was in the process of running a due diligence on a company that they were interested in buying. They were able to conduct the financial due diligence themselves but needed a companion with technical insights to establish technical knowledge and evidence regarding claims that the customer made about their products.

Solution: We were contacted with very short notice and quickly gathered a team to analyze the products of the potentially acquired company. We cross referenced them with similar products made by competitors to determine their position in the market. Furthermore, we reverse engineered them to determine whether their claims of product superiority were in fact legit.

Result: Our conclusion was that there was a bit too much discrepancy regarding the company’s claims and the products performance compared to competitors. The client decided not to buy the company.

Challenge: A large pharmaceutical needed to set the requirements for the pull force in separation of cap and device within a certain user group.

Solution: Our solution was to establish a usability study and test different users within different intervals. To avoid creating a lot of caps with different pull forces we constructed a cap in which we could insert magnets to adjust the pull force. By placing a thin plastic material in between the magnets, we were able to tweak the pull force very precisely

Result: The result was that we could determine the available pull force, for their specific user group, very precisely by creating a smart and adjustable cap.

Challenge: A large pharmaceutical working on a drug delivery platform had an issue during the development of a product, as it was not capable of standing the required height for a drop test of 1m given by ISO.

Solution: To avoid delay of the overall project, we made a parallel track of the development process. Starting with various strategies for where and how to intervene with most feasible outcome. Soon it was determined that the solution was not to influence the inner mechanics for activation, not to cause enormous rework. It was decided to make a shock-absorber. After a lot of test and verification, simulation, prototyping and dialogue with the form-builder, it was designed with channels and shells in the rear cover turning the drop-test-margin to an acceptable level.        

Result: So, for the client it means that they have a fully tested and documented solution mitigating the risk of not being able to pass V & V – and that even prior to the situation.

Challenge: A large international pharmaceutical provider for whom we were developing an autoinjector-device was in the process of onboarding internally — meaning that they were trying to find a way to introduce the platform in the organization.

Solution: The natural choice would be to just make some marketing material promoting all the features and benefits. But we took a reversed approach and asked the drug-teams what they would be needing in terms of information. That in combination with our profound understanding of the parameters of importance, lead to an extensive and useful structure for this material. Containing very diverse information, from volume of drug filling in the cartridges to PFS, tolerance gaps and something about cavities and glass-breakage. Everything nicely structured and designed in a user-friendly playbook.

Result: The company was given a useful playbook which is instrumental in the success of this product, and especially now when more than one drug has been signed up to it.

Challenge: Another case concerning a root cause analysis took place at a large international pharmaceutical client working on a drug delivery platform. It was discovered during tests that there was a failure in the activation mechanism. Hence there was an increased risk of not being able to pass V&V.

Solution: A root cause analysis containing the usual strings was initialized. Test method, and test set-up with subsequent assessment of the results, followed by thorough investigations into manufacturing, assembly and handling were conducted. In addition, it was a matter of making sure that certain checkpoints in the specifications were absolutely followed.

Result: For the client it meant that the risk of not passing the V & V was reduced and on top of that they received a package of directions on how to mitigate the issue going forward. 

Some of our Scoping tools

-Project planning

-Project budgeting

-Project charter

-Product economy mapping

-Technology scouting

-IP assessment 

-Competitor mapping and analysis

-Supplier mapping and analysis

-Organizational GAP analysis

-Concept development

-Concept Analysis

-Risk matrix

-Risk & GAP analysis 

-Risk mitigation

-Proof of concept

-Product specification

-Platform mapping

-Strategic option mapping

 

-Vendor CMO qualification

-Project governance map

-Stage gate planning

-Product cost 

-Project preconditioning mapping 

-Root cause analysis 

-SWOT analysis

related cases

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scoping - the long read

Scoping gives you a foundation for strategic decisions within a short timeframe

MedTech and Pharma development is well-known for a high level of complexity. When challenges arise unexpectedly during an otherwise well-planned development process, or during new product development efforts, solving these strategic R&D challenges can become an expensive and time-consuming endeavour for MedTech and Pharma companies. This is where Scoping becomes highly relevant.

Making tangible recommendations fast

With the Technolution Scoping approach, our team of specialists works closely with clients to create a foundation for strategic decisions within a short timeframe. With 24 years of industry experience and more than 65 specialists working within ten MedTech areas, we are ready to combine our R&D expertise to quantify possible directions and solve your strategic R&D challenge efficiently through a holistic approach. Our extensive experience with real-world MedTech projects ensures that our recommendations for clients are tangible and actionable.

A key aspect of our Scoping approach is that we always obtain a deep understanding of the client’s specific problem context. This is crucial in order to correctly diagnose the strategic R&D challenge, create strategic directions forward and ultimately help the client mitigate risk and keep time-to-market. We can assist throughout a project regardless of project maturity and offer clients a variety of collaboration models depending on the timeframe and level of engagement of the client. Whatever the problem context, we are here to help on the terms and conditions that suit our clients best.

what people say

What people say

We have reached the clinical trials faster because there have been far fewer errors than in similar research projects. The smooth cooperation is due to a special dynamic, where we have been able to mutually teach each other a few things. In addition, the collaboration has been supported by a common language and frame of reference, which has meant that we have been able to understand each other and our challenges”.
Michael Hasenkam
Professor at the Department of Clinical Medicine at University of Aarhus.
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